MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Antiretroviral combination therapy of HIV infection in adults and adolescents ADULTS & ADOLESCENT from 12 years of age with (> 12 years of age): the following criteria: Recommended dose is one Abacavir Sulphate 600 i) Patients unsuitable or J05AR02964T1001 tablet once daily. Not to be 1. mg and Lamivudine 300 A* failed other HAART XX used in adults or adolescents mg Tablet treatment weigh less than 40kg. ii) Patients who are at high CHILDREN : Not risk of renal impairment recommended iii) Patients with osteoporosis or at high risk of bone loss Only for treatment of: i) Non insulin dependent diabetes mellitus (NIDDM) when diet therapy is Initially 50 mg daily, increase insufficient. A10BF01000T1001 to 3 times daily up to 100 mg 2. Acarbose 50 mg Tablet A/KK ii) Non insulin dependent XX 3 times daily. Max 200 mg 3 diabetes mellitus (NIDDM) times daily in combination with existing conventional oral therapy where glycaemic control is inadequate Reduction of intraocular pressure in open-angle 250mg 1-4 times a day, the Acetazolamide 250 mg S01EC01000T1001 glaucoma, secondary dosage being titrated 3. B Tablet XX glaucoma and peri- according to patient operatively in angle-closure response glaucoma Reduction of intra-ocular pressure in open-angle Adult : 250-1000mg per Acetazolamide 500 mg S01EC01000P400 glaucoma, secondary 24hours, usually in divided 4. B Injection 1XX glaucoma and peri- doses for amounts over operatively in angle-closure 250mg daily glaucoma Diluted with dextrose 5% and infused IV. Initial, 150 mg/kg IV in 200 ml over 60 minutes, Acetylcysteine 200 mg/ml V03AB23520P3001 Antidote for paracetamol then 50 mg/kg IV in 500 ml 5. A* Injection XX poisoning over 4 hours, followed by 100 mg/kg IV in 1000 ml over 16 hours. Total dose: 300mg/kg in 20 hour Prevention of myocardial infarct, stroke, vascular Acetylsalicylic Acid 100 B01AC06259T1001 6. B occlusion and deep vein 1 tablet daily mg, Glycine 45 mg Tablet XX thrombosis. Transient ischaemic attacks Acetylsalicylic Acid 300 N02BA01000T4001 300 - 900 mg every 4 - 6 7. C Mild to moderate pain mg Soluble Tablet XX hours as required. Max 4 g

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber daily. Use in children not recommended ADULT: initially 25-30 mg i) Severe form of psoriasis daily for 2-4 weeks, then including erythrodermic adjusted according to psoriasis and local or response, usually within generalized pustular range 25-50 mg daily for psoriasis. further 6-8 weeks (max: 75 ii) Severe disorders of mg daily). In disorders of D05BB02000C100 8. Acitretin 10 mg Capsule A* keratinization, such as - keratinization, maintenance 1XX congenital ichthyosis - therapy of less than pityriasis rubra pilaris - 20mg/day and should not Darier's disease -other exceed 50mg/day CHILD: disorders of keratinization 0.5mg/kg daily occasionally which may be resistant to up to 1 mg/kg daily to a max. other therapies 35 mg daily for limited periods ADULT: initially 25-30 mg i) Severe form of psoriasis daily for 2-4 weeks, then including erythrodermic adjusted according to psoriasis and local or response, usually within generalized pustular range 25-50 mg daily for psoriasis. further 6-8 weeks (max: 75 ii) Severe disorders of mg daily). In disorders of D05BB02000C100 9. Acitretin 25 mg Capsule A* keratinization, such as - keratinization, maintenance 2XX congenital ichthyosis - therapy of less than pityriasis rubra pilaris - 20mg/day and should not Darier's disease -other exceed 50mg/day CHILD: disorders of keratinization 0.5mg/kg daily occasionally which may be resistant to up to 1 mg/kg daily to a max. other therapies 35 mg daily for limited periods Infected skin, lesions, cuts, D08AA03000L6001 Apply undiluted three times 10. Acriflavine 0.1% Lotion C+ abrasions, wounds and XX daily to the affected part . burns. i) ADULT: 500 mcg IV daily for max of 5 days. CHILD: 1.5 mg/m2 once every 3 weeks (if weight less than 10 Actinomycin D i) For solid tumours L01DA01110P4001 kg, 50 mcg/kg) 11. (Dactinomycin) 500 A ii) Gestational trophoblastic XX ii) 500 mcg IV on Days 2, 4, mcg/ml Injection disease 6, 8, 10, repeat every 7 - 10 days or 500 mcg IV bolus on Days 1 and 2, repeat every 15 days

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Mucocutaneous Herpes Simplex infection in immunocompromised and AIDS patients ii) Primary and recurrent i) ADULT: initially 400 mg 5 Varicella Zoster infection in times daily for 7 - 14 days. immunocompromised and CHILD less than 2 years: AIDS patients 200 mg 4 times daily, CHILD iii) Severe Kaposi Varicella more than 2 years: 400 mg 4 Eruption (Eczema times daily herpeticum) ii), iii) and iv) ADULT: 200 - iv) Severe primary HSV 400 mg 4 times daily. CHILD: infections (eg. Neonatal less than 2 years, half adult herpes, encephalitis, dose; more than 2 years, J05AB01000T1001 12. Acyclovir 200 mg Tablet A/KK eczema herpeticum, genital adult dose XX herpes, gingival stomatitis, v) ADULT: 800 mg 5 times vaginal delivery with daily for 7 days maternal vulva herpes) vi) ADULT: 20 mg/kg v) Severe and complicated (maximum: 800 mg) four varicella infection (eg. times daily for 5 days, CHILD Encephalitis, purpura 6 years: 800 mg four times fulminans) daily. CHILD less than 2 vi) Severe zoster infection years; 400mg 4 times daily, in paediatrics (eg. more than 2 years; 800mg 4 Encephalitis, purpura times daily fulminans, immunocompromised patients and facial, sacral and motor zoster) i) Mucocutaneous Herpes Simplex infection in i) ADULT: initially 400 mg 5 immunocompromised and times daily for 7 - 14 days. AIDS patients. CHILD less than 2 years: ii) Primary and recurrent 200 mg 4 times daily, CHILD Varicella Zoster infection in more than 2 years: 400 mg 4 immunocompromised and times daily. AIDS patients. ii), iii) and iv) ADULT: 200 - iii) Severe Kaposi Varicella 400 mg 4 times daily. CHILD: Eruption (Eczema less than 2 years, half adult herpeticum). dose; more than 2 years, Acyclovir 200 mg/5 ml J05AB01000L8001 13. A* iv) Severe primary HSV adult dose. Suspension XX infections (eg. Neonatal v) ADULT: 800 mg 5 times herpes, encephalitis, daily for 7 days eczema herpeticum, genital vi) ADULT: 20 mg/kg herpes, gingival stomatitis, (maximum: 800 mg) four vaginal delivery with times daily for 5 days, CHILD maternal vulva herpes). 6 years: 800 mg four times v) Severe and complicated daily. CHILD less than 2 varicella infection (eg. years; 400mg 4 times daily, Encephalitis, purpura more than 2 years; 800mg 4 fulminans). times daily. vi) Severe zoster infection

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber in paediatrics (eg. Encephalitis, purpura fulminans, immunocompromised patients and facial, sacral and motor zoster). ADULT: 5 mg/kg by IV infusion 8 hourly for 5 days, doubled to 10mg/kg every 8 hourly in varicella-zoster in the immunocompromised and in simplex encephalitis (usually given for at least 10 days in encephalitis; possibly for 14 - 21 days). NEONATE & INFANT up to 3 months with disseminated herpes Treatment and prophylaxis simplex: 20mg/kg every 8 of herpes simplex in J05AB01000P4001 hourly for 14 days (21 days 14. Acyclovir 250 mg Injection A* immunocompromised, XX in CNS involvement), severe initial genital herpes varicella-zoster 10-20mg/kg and Varicella -Zoster every 8 hourly usually for 7 days. CHILD, 3 months - 12 years: Herpes simplex or Varicella Zoster: 250 mg/m2 8 hourly for 5 days, doubled to 500 mg/m2 8 hourly for varicella-zoster in the immunocompromised and in simplex encephalitis (usually given for 10 days in encephalitis) Apply 1 cm 5 times daily. Acyclovir 3% Eye S01AD03000G510 Only for the treatment of 15. A* Continue for at least 3 days Ointment 1XX herpes simplex keratitis after healing Herpes simplex infections of the skin, including initial D06BB03000G100 Apply every 4 hours for 5 - 16. Acyclovir 5% Cream A* and recurrent labial and 1XX 10 days genital herpes simplex infections

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Mucocutaneous Herpes Simplex infection in immunocompromised and AIDS patients. ii) Primary and recurrent i) ADULT: initially 400 mg 5 Varicella Zoster infection in times daily for 7 - 14 days. immunocompromised and CHILD less than 2 years: AIDS patients. 200 mg 4 times daily, CHILD iii) Severe Kaposi Varicella more than 2 years: 400 mg 4 Eruption (Eczema times daily. herpeticum). ii), iii) and iv) ADULT: 200 - iv) Severe primary HSV 400 mg 4 times daily. CHILD: infections (eg. Neonatal less than 2 years, half adult herpes, encephalitis, dose; more than 2 years, J05AB01000T1002 17. Acyclovir 800 mg Tablet A/KK eczema herpeticum, genital adult dose. XX herpes, gingival stomatitis, v) ADULT: 800 mg 5 times vaginal delivery with daily for 7 days maternal vulva herpes). vi) ADULT: 20 mg/kg v) Severe and complicated (maximum: 800 mg) four varicella infection (eg. times daily for 5 days, CHILD Encephalitis, purpura 6 years: 800 mg four times fulminans). daily. CHILD less than 2 vi) Severe zoster infection years; 400mg 4 times daily, in paediatrics (eg. more than 2 years; 800mg 4 Encephalitis, purpura times daily. fulminans, immunocompromised patients and facial, sacral and motor zoster).

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Third line treatment of: - Severe rheumatoid arthritis - Psoriatic arthritis - Ankylosing spondylitis after failure of conventional DMARDs or other biologics ii)Treatment of adults with moderate to severe chronic plaque psoriasis who have not responded to, have contraindication or are i) Severe rheumatoid unable to tolerate arthritis, Psoriatic arthritis, phototherapy and/or Ankylosing spondylitis : systemic therapies Subcutaneous 40 mg every including acitretin, other week methotreaxate and ii) Chronic plaque psoriasis : cyclosporine Initial, 80 mg SC, followed by iii) Crohn's Disease 40 mg SC every other week a) For treatment of starting one week after the moderately to severely initial dose active Crohn's Disease in Adalimumab 40 mg L04AB04000P5001 iii) & iv) Crohn's disease & 18. A* adult patients who have Injection XX Ulcerative colitis: 160mg at inadequate response to week 0 (dose can be conventional therapy administered as four b) For treatment of injections in one day or as moderately to severely two injections per day for two active Crohn's Disease in consecutive days) and 80mg adult patients who have lost at week 2. After induction response to or are treatment, the recommended intolerant to infliximab maintenance dose is 40mg iv) Ulcerative Colitis - For every other week via treatment of moderately to subcutaneous injection. severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6- mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies Acne vulgaris where comedones, papules and Apply once daily to the D10AD03000G100 pustules predominate in 19. Adapalene 0.1% Cream A* affected areas after washing 1XX those sensitive to benzoyl at bedtime peroxide or topical tretinoin [third line treatment]

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Acne vulgaris where comedones, papules and Apply once daily to the D10AD03000G300 pustules predominate in 20. Adapalene 0.1% Gel A* affected areas after washing 1XX those sensitive to benzoyl at bedtime peroxide or topical tretinoin [third line treatment] i) Treatment of chronic HBeAg positive and HBeAg negative hepatitis B infection in adults with compensated liver function Adult (18-65 years): 10mg (lamivudine should be tried Once Daily Renal Dose first) Adjustment : 10mg every Adefovir Dipivoxil 10 mg J05AF08000T1001 ii) Lamivudine-resistant 21. A* 48hours (30-49ml/min); Tablet XX chronic hepatitis B virus 10mg every 72hours (10- infection with either 29ml/min); 10mg every 7 compensated or days (Hemodialysis) decompensated hepatitis function (only by hepatologist and gastroenterologist for approved indications) ADULT: Initially: 3 mg given as a rapid IV bolus (over 2 seconds). Second dose: If the first dose does not result in elimination of the supraventricular tachycardia Rapid conversion of with in 1 or 2 minutes, 6 mg Adenosine 3 mg/ml C01EB10000P300 paroxysmal 22. B should be given also as a Injection 1XX supraventricular rapid IV bolus. Third dose: If tachycardia to sinus rhythm the second dose does not result in elimination of the supraventicular tachycardia with in 1-2 minutes, 12 mg should be given also as a rapid IV bolus Adrenaline Acid 1 mg by intravenous injection C01CA24123P300 Cardiopulmonary 23. (Epinephrine) Tartrate 1 B repeated every 3-5 minutes 1XX resuscitation mg/ml Injection according to response The recommended dose is 2mg aflibercept, equivalent to 0.05mL (50 μL) given as intra-vitreal injection. Treatment of neovascular Aflibercept 40mg/ml S01LA05000P3001 Aflibercept treatment is 24. A* (wet) age-related macular solution vial for injection XX initiated with one injection degeneration (wet AMD). per month for three consecutive doses, followed by one injection every two months.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber The recommended dose is N06AX22000T1001 25mg once daily at bedtime, 25. Agomelatine 25 mg Tablet A* Major depression XX maybe increased to 50mg once daily at bedtime. i) Child 12-24months: 200mg as a single dose i) Single or mixed ii) Adult & Child above 2 Albendazole 200 mg P02CA03000T1001 infestations of intestinal years: 400mg as a single 26. C+ Tablet XX parasites dose for 3 consecutive days; ii) Strongyloides infection Child 12 - 24months: 200mg as a single dose for 3 consecutive days i) Child 12-24months: 200mg as a single dose i) Single or mixed ii) Adult & Child above 2 Albendazole 200 mg/5 ml P02CA03000L8001 infestations of intestinal years: 400mg as a single 27. C+ Suspension XX parasites dose for 3 consecutive days; ii) Strongyloides infection Child 12 - 24months: 200mg as a single dose for 3 consecutive days D08AX08000L9901 Use as antiseptic and Apply to the skin undiluted or 28. Alcohol 70% Solution C+ XX disinfectant when needed 1 tablet once weekly Osteoporosis in [70mg/5600 IU]. Patient postmenopausal women should receive supplemental with a history of vertebral calcium or vitamin D, if fracture and whom dietary vitamin D inadequate. oestrogen replacement The tablet should be taken at therapy is contraindicated. least half and hour before the Review treatment after 2 first food, beverage, or years and if there is positive medication of the day with Alendronate Sodium 70 response, treatment may be M05BB03972T100 plain water only. To facilitate 29. mg and Cholecalciferol A* continued up to 5 years and 2XX delivery to stomach and thus 5600 IU Tablet then re-evaluate. Treatment reduce the potential for should be stopped if there esophageal irritation, it is no positive response after should only be swallowed 5 years. Otherwise, patient upon arising for the day with needs to be given drug a full glass of water and holiday for 1 to 2 years and patient should not lie down then continue treatment for at least 30 minutes and shall the benefit outweigh until after their first food of the risk. the day.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Osteoporosis in postmenopausal women with a history of vertebral fracture and whom oestrogen replacement 70 mg once weekly. Swallow therapy is contraindicated. the tablet whole with a full Review treatment after 2 glass of plain water only on years and if there is positive an empty stomach at least response, treatment may be Alendronate Sodium 70 M05BA04520T100 30 minutes before breakfast 30. A* continued up to 5 years and mg Tablet 1XX (and any other oral then re-evaluate. Treatment medication); stand or sit should be stopped if there upright for at least 30 is no positive response after minutes and do not lie down 5 years. Otherwise, patient until after eating breakfast needs to be given drug holiday for 1 to 2 years and then continue treatment shall the benefit outweigh the risk. i) Renal osteodystrophy in patients on haemodialysis Initial dose ADULT and ii) Hypoparathyroidism and CHILD above 20kg body pseudohypoparathyroidism weight : 1 mcg daily; CHILD Alfacalcidol 0.25 mcg A11CC03000C100 31. A/KK iii) Adjunct to the under 20kg body weight : Capsule 1XX management of tertiary 0.05 mcg/kg/day. hyperparathyroidism iv) Maintenance dose : 0.25 Rickets and osteomalacia mcg to 2 mcg daily v) Osteoporosis i) Renal osteodystrophy in patients on haemodialysis Initial dose ADULT and ii) Hypoparathyroidism and CHILD above 20kg body pseudohypoparathyroidism weight : 1 mcg daily; CHILD Alfacalcidol 1 mcg A11CC03000C100 iii) Adjunct to the 32. A/KK under 20kg body weight : Capsule 2XX management of tertiary 0.05 mcg/kg/day. hyperparathyroidism Maintenance dose : 0.25 iv) Rickets and mcg to 2 mcg daily osteomalacia v) Osteoporosis i) Renal osteodystrophy in patients on haemodialysis ii) Hypoparathyroidism and pseudohypoparathyroidism Alfacalcidol 2 mcg/ml A11CC03000D500 iii) Adjunct to the NEONATES : 0.1 33. A* Drops 1XX management of tertiary mcg/kg/day hyperparathyroidism iv) Rickets and osteomalacia v) Osteoporosis

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Treatment of: i) Renal osteodystrophy in patients on haemodialysis Adult: Initially, 1 mcg daily. ii) Hypoparathyroidism and Maintenance: 0.25-1 mcg pseudohypoparathyroidism daily. Child: Premature Alfacalcidol 2 mcg/ml A11CC03000P300 34. A* iii) Adjunct to the infants and neonates: 0.05- Injection 1XX management of tertiary 0.1 mcg/kg daily; <20 kg: hyperparathyroidism 0.05 mcg/kg daily. Elderly: iv) Rickets and 0.5 mcg daily. osteomalacia v) Osteoporosis For use as short acting Initial dose: 20 - 40 mcg/kg. Alfentanil HCl 0.5 mg/ml N01AH02110P300 narcotic analgesic in short Supplemental dose: 15 35. A* Injection 1XX procedures and day-care mcg/kg or infusion 0.5 - 1.0 surgical procedures mcg/kg/min Treatment of functional Alfuzosin HCl 10 mg G04CA01110T100 symptoms related with 36. A* 10 mg once a day pre bed Tablet 1XX benign prostatic hypertrophy (BPH) 20 mg/kg of body weight administered once every 2 weeks as an intravenous infusion. Monitoring It is suggested that patients be monitored periodically for IgG antibody formation. Patients who experience Infusion-associated reactions Alglucosidase alfa 5 A16AB07000P4001 Infantile-onset Pompe suggestive of hypersensitivity 37. A* mg/ml Injection XX disease may be tested for IgE antibodies to alglucosidase alfa. Treated patients who experience a decrease in benefit despite continued treatment with Alglucosidase Alfa, in whom antibodies are suspected to play a role, may be tested for neutralization of enzyme uptake or activity. To be diluted with an equal R01A000999L5001 38. Alkaline Nasal Douche B To remove nasal plug volume of warm water before XX use

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Frequent and disabling attacks of gouty arthritis (3 or more attacks/year). ii) Clinical or radiographic signs of erosive gouty arthritis. Initial dose: 100-300 mg M04AA01000T100 iii) The presence of daily. Maintenance: 300-600 39. Allopurinol 100 mg Tablet A/KK 2XX tophaceous deposits. mg daily. Maximum: 900 mg iv) Urate nephropathy. daily v) Urate nephrolithiasis. vi) Impending cytotoxic chemotherapy or radiotherapy for lymphoma or leukaemia i) Frequent and disabling attacks of gouty arthritis (3 or more attacks/year). ii) Clinical or radiographic signs of erosive gouty arthritis. Initial dose: 100-300 mg M04AA01000T100 iii) The presence of daily. Maintenance: 300-600 40. Allopurinol 300 mg Tablet A/KK 1XX tophaceous deposits. mg daily. Maximum: 900 mg iv) Urate nephropathy. daily v) Urate nephrolithiasis. vi) Impending cytotoxic chemotherapy or radiotherapy for lymphoma or leukaemia Induction: 45 mg/m2 daily for 30 - 90 days. Maintenance: 45 mg/m2 daily for 2 weeks All-Trans Retinoic Acid 10 L01XX14000C1001 Acute promyelocytic 41. A* every 3 months. Renal/or mg Capsule XX leukaemia hepatic insufficiency: 25mg/m2 daily for 30-90 days. Refer to protocols 0.25 - 0.5 mg 3 times daily (elderly or delibitated 0.25 Alprazolam 0.25 mg N05BA12000T1001 mg 2-3 times daily), 42. A/KK Anxiety disorders Tablet XX increased if necessary to a total dose of 3 mg/day. Not recommended for children 0.25 - 0.5 mg 3 times daily (elderly or delibitated 0.25 N05BA12000T1002 mg 2-3 times daily), 43. Alprazolam 0.5 mg Tablet A Anxiety disorders XX increased if necessary to a total dose of 3 mg/day. Not recommended for children 0.25 - 0.5 mg 3 times daily N05BA12000T1003 (elderly or delibitated 0.25 44. Alprazolam 1 mg Tablet A Anxiety disorders XX mg 2-3 times daily), increased if necessary to a

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber total dose of 3 mg/day. Not recommended for children For treatment of congenital 0.05 - 0.1 mcg/kg/min by Alprostadil 500 mcg/ml C01EA01000P300 heart diseases which are continuous IV infusion, then 45. A* Injection 1XX ductus arteriosus decreased to lowest effective dependent dose 0.9 mg/kg (maximum of 90 mg) infused over 60 minutes with 10% of the total dose administered as an initial intravenous bolus. Treatment Alteplase 50 mg per vial B01AD02000P400 Thrombolytic treatment of must be started as early as 46. A* Injection 1XX acute ischaemic stroke. possible within 4.5 hours after onset of stroke symptoms and after exclusion of intracranial haemorrhage by appropriate imaging technique. 600 mg- 1.2 g 4 times daily Aluminium Hydroxide 600 A02AB01250T1001 Dyspepsia, 47. A and at bedtime or as mg Tablet XX hyperphosphataemia required Initial dose: 100 mg daily and is increased to 100 mg twice daily (not later than 4 p.m.) Amantadine HCl 100 mg N04BB01110C100 48. B Parkinson's disease after a week. Elderly over 65 Capsule 1XX years: less than 100 mg or 100 mg at intervals of more than 1 day ADULT: (IM or IV): 15 mg/kg/day 8 - 12 hourly for 7 - 10 days. Maximum: 1.5 g/day. CHILD: 15 mg/kg/day Amikacin 125 mg/ml J01GB06183P3003 Infections due to 8 - 12 hourly. Maximum: 1.5 49. A Injection XX susceptible organisms g/day. Neonates: Initial loading dose of 10 mg/kg followed by 7.5 mg/kg/day 12 hourly. Maximum 15mg/kg/day ADULT: (IM or IV): 15 mg/kg/day 8 - 12 hourly for 7 - 10 days. Maximum: 1.5 g/day. CHILD: 15 mg/kg/day Amikacin 250mg/ml J01GB06183P3002 Infections due to 8 - 12 hourly. Maximum: 1.5 50. A Injection XX susceptible organisms g/day. Neonates: Initial loading dose of 10 mg/kg followed by 7.5 mg/kg/day 12 hourly. Maximum 15mg/kg/day Amiloride HCl 5 mg & i) Initially 1 - 2 tab daily C03EA01900T1001 i) Diuretic as an adjunct to 51. Hydrochlorothiazide 50 B adjusted according to XX the management of mg Tablet response. Max : 4 tabs daily.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber oedematous states ii) 1 -2 tabs daily as a single ii) Hypertension or divided dose

Dose to be individualised. ADULT usually 500-2000 ml B05BA01910P3001 Source of amino acids in 52. Amino Acids Injection A by IV. ADULT usual XX patients needing IV nutrition requirement for amino acid: 1-2 g/kg/day Source of amino acids and Dose to be individualised. Amino Acids with B05BA10910P3002 53. A electrolytes in patients ADULT usual requirement for Electrolytes Injection XX needing IV nutrition amino acid 1-2 g/kg/day Source of amino acids, Dose to be individualised. Amino Acids with Glucose B05BA10910P3003 carbohydrate and ADULT usual requirement for 54. A with Electrolytes Injection XX electrolytes in patients amino acid 1-2 g/kg/day, needing IV nutrition carbohydrate 4-6 g/kg/day Dose to be individualised. ADULT: 500 - 2000 ml daily Source of amino acids, Amino Acids, Glucose given by IV. ADULT usual B05BA10910P3001 carbohydrate, lipid and 55. and Lipid with Electrolytes A requirement for amino acid XX electrolytes in patients Injection 1-2 g/kg/ day, carbohydrate needing IV nutrition 4-6 g/kg/day, lipid 2-3 g/kg/day Adult: Loading dose: 5 mg/kg (ideal body weight) or 250- 500 mg (25 mg/ml) by slow inj or infusion over 20-30 Reversible airways min. Maintenance infusion Aminophylline 25 mg/ml R03DA05000P300 56. B obstruction, acute severe dose: 0.5 mg/kg/hr. Max rate: Injection 1XX brochospasm 25 mg/min. Child: Loading dose: same as adult dose. Maintenance dose: 6 mth-9 yr: 1 mg/kg/hr and 10-16 yr: 0.8 mg/kg/hr. 200 mg 3 times daily for 1 week, then reduced to 200 mg twice daily for another Amiodarone 200 mg C01BD01110T100 57. A* Arrhythmias week. Maintenance dose, Tablet 1XX usually 200 mg daily or the minimum required to control the arrhythmia Initial infusion of 5mg/kg via large venous access over 20-120 minutes with ECG Arrhythmias when other Amiodarone 50 mg/ml C01BD01110P300 monitoring; subsequent 58. A* drugs are contraindicated or Injection 1XX infusion given if necessary ineffective according to response up to a maximum of 1.2 g in 24 hours

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Treatment of psychoses, Predominantly negative particularly acute or chronic episodes: 50-300 mg once schizophrenia disorders daily adjusted according to characterized by positive the patient?s response. symptoms(e.g. delusion, Mixed episodes with positive Amisulpride 100 mg N05AL05000T1001 hallucinations, thought and negative symptoms: 59. A* Tablet XX disorders) and/or negative 400-800 mg/day in 2 divided symptoms(e.g. blunted doses adjusted according to emotions, emotional and the patient?s response. social withdrawal) including Should be taken on an empty when the negative stomach (Preferably taken symptoms predominate before meals) Treatment of psychoses, Predominantly negative particularly acute or chronic episodes: 50-300 mg once schizophrenia disorders daily adjusted according to characterized by positive the patient?s response. symptoms(e.g. delusion, Mixed episodes with positive Amisulpride 400 mg N05AL05000T1002 hallucinations, thought and negative symptoms: 60. A* Tablet XX disorders) and/or negative 400-800 mg/day in 2 divided symptoms(e.g. blunted doses adjusted according to emotions, emotional and the patient?s response. social withdrawal) including Should be taken on an empty when the negative stomach (Preferably taken symptoms predominate before meals) Initially 25mg 3 times a day. Maintenance: 25-100mg daily in divided doses. Hospitalized patient: 100mg/day &gradually Amitriptyline HCl 25 mg N06AA09110T1001 increase to 200-300mg/day. 61. B Depression Tablet XX ADOLESCENT and ELDERLY: initially 20- 30mg/day in divided doses w/ gradual increments. CHILD under 16 years are not recommended Doses range from amlodipine besylate 5 mg/valsartan 160 mg to Essential hypertension in amlodipine besylate 10 Amlodipine 10 mg and C09DB01935T100 patients whose blood mg/valsartan 320 mg 62. A/KK Valsartan 160 mg Tablet 3XX pressure is not adequately ORALLY once daily, with controlled by monotherapy dose titration occurring every 1 to 2 weeks if necessary. MAX amlodipine besylate 10 mg/valsartan 320 mg C08CA01000T100 5 mg once daily. Max: 10 mg 63. Amlodipine 10 mg Tablet B Hypertension 2XX once daily

14 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Doses range from amlodipine besylate 5 mg/valsartan 160 mg to Essential hypertension in amlodipine besylate 10 Amlodipine 5 mg and C09DB01935T100 patients whose blood mg/valsartan 320 mg 64. A/KK Valsartan 160 mg Tablet 2XX pressure is not adequately ORALLY once daily, with controlled by monotherapy dose titration occurring every 1 to 2 weeks if necessary. MAX amlodipine besylate 10 mg/valsartan 320 mg C08CA01000T100 5 mg once daily. Max: 10 mg 65. Amlodipine 5 mg Tablet B Hypertension 1XX once daily One tablet daily i) A patient whose blood pressure is not adequately controlled on dual therapy with amlodipine besylate/valsartan/HCTZ. ii) For convenience, patients receiving valsartan, amlodipine and HCTZ from seperate tablets may be switched to amlodipine besylate/valsartan/HCTZ Treatment of essential Amlodipine besylate containing the same hypertension. This fixed 10mg, valsartan 160mg, C09DX01941T100 component dosses. Dosage 66. A/KK combination drug is not hydrochlorothiazide 1XX may be increased after 2 indicated for the initial 12.5mg tablet weeks. The maximum therapy of hypertension. antihypertensive effect of amlodipine besylate/valsartan/HCTZ is reached within 2 weeks of change in dose. The maximum recommended dose of amlodipine besylate/valsartan/HCTZ is 10/320/25 mg. It can be taken with or without food. It is recommended to take it with some water.

15 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber One tablet daily i) A patient whose blood pressure is not adequately controlled on dual therapy with amlodipine besylate/valsartan/HCTZ. ii) For convenience, patients receiving valsartan, amlodipine and HCTZ from seperate tablets may be switched to amlodipine besylate/valsartan/HCTZ Treatment of essential Amlodipine besylate containing the same hypertension. This fixed 10mg, valsartan 160mg, C09DX01941T100 component dosses. Dosage 67. A/KK combination drug is not hydrochlorothiazide 25mg 2XX may be increased after 2 indicated for the initial tablet weeks. The maximum therapy of hypertension. antihypertensive effect of amlodipine besylate/valsartan/HCTZ is reached within 2 weeks of change in dose. The maximum recommended dose of amlodipine besylate/valsartan/HCTZ is 10/320/25 mg. It can be taken with or without food. It is recommended to take it with some water. One tablet daily i) A patient whose blood pressure is not adequately controlled on dual therapy with amlodipine besylate/valsartan/HCTZ. ii) For convenience, patients receiving valsartan, amlodipine and HCTZ from seperate tablets may be Treatment of essential Amlodipine besylate switched to amlodipine hypertension. This fixed 5mg,valsartan C09DX01941T100 besylate/valsartan/HCTZ 68. A/KK combination drug is not 160mg,hydrochlorothiazid 4XX containing the same indicated for the initial e 12.5mg tablet component dosses. Dosage therapy of hypertension. may be increased after 2 weeks. The maximum antihypertensive effect of amlodipine besylate/valsartan/HCTZ is reached within 2 weeks of change in dose. The maximum recommended dose of amlodipine besylate/valsartan/HCTZ is

16 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber 10/320/25 mg. It can be taken with or without food. It is recommended to take it with some water. Amlodipine 5mg/losartan 50mg OR amlodipine 5mg/losartan 100mg orally once daily. MAXIMUM DOSE: amlodipine 5mg/losartan 100mg. No Treatment of essential dosage adjustment in mild hypertension in adults renal impairment. Not Amlodipine Camsylate 5 C09DB06935T100 patients whose blood recommended in moderate 69. mg and Losartan A/KK 2XX pressure is not adequately to severe renal impairment or Potassium 100 mg Tablet controlled on either in patients on dialysis. Not monotherapy recommended in patients who require lower dose of losartan (25mg). Not recommended in patients < 18 years as safety and efficacy is not established in this group Amlodipine 5mg/losartan 50mg OR amlodipine 5mg/losartan 100mg orally once daily. MAXIMUM DOSE: amlodipine 5mg/losartan 100mg. No Treatment of essential dosage adjustment in mild hypertension in adults renal impairment. Not Amlodipine Camsylate 5 C09DB06935T100 patients whose blood recommended in moderate 70. mg and Losartan A/KK 1XX pressure is not adequately to severe renal impairment or Potassium 50 mg Tablet controlled on either in patients on dialysis. Not monotherapy recommended in patients who require lower dose of losartan (25mg). Not recommended in patients < 18 years as safety and efficacy is not established in this group Adults, the elderly and children over 12 years: 10- Ammonium Bicarbonate, R05CA04900L2101 20ml, repeated after 4 hours 71. Tincture Ipecac, etc C Cough XX if required. Not more than 4 Mixture doses to be taken in any 24 hours. Apply to affected nail once or sometimes twice a week Amorolfine 5 % Nail D01AE16110L5001 72. A* Fungal nail infections after filling and cleansing, Lacquer XX allow to dry, treat finger nail for 6 months, toe nail for 9 -

17 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber 12 months (review at intervals of 3 months) Mild to Moderate infection: 25mg/kg/day (based on Amoxicillin dose) in 2 divided Amoxicillin & Clavulanate J01CR02961F2102 Infections caused by 73. A/KK dose. Severe infection: 228 mg/5 ml Syrup XX susceptible organisms 45mg/kg/day (based on Amoxicillin dose) in 2 divided dose Infections caused by CHILD less than 3 months: susceptible organisms. 30mg/kg 12 hourly. 3 months Amoxicillin 1 g & Respiratory tract, skin, soft J01CR02961P4002 - 12 years: 30mg/kg 6 - 8 74. Clavulanate 200 mg A tissue, GUT infection, XX hourly. ADULT: 1.2 g by IV Injection septicaemia, peritonitis, or intermittent infusion 6 - 8 post-operative infection & hourly osteomyelitis Infections caused by ADULT: 250 - 500 mg 3 Amoxicillin 250 mg J01CA04012C1001 susceptible strains of gram times daily. CHILD: 20 - 40 75. B Capsule XX positive and gram negative mg/kg/day in divided doses 8 organisms hourly Infections due to beta- lactamase producing strain where amoxicillin alone is ADULT & CHILD more than Amoxicillin 500 mg & J01CR02961T1002 not appropriate. Respiratory 12 years: Mild to moderate 76. Clavulanate 125 mg A/KK XX tract, skin, soft tissue, GUT infections: 625 mg twice Tablet infection, septicaemia, daily. peritonitis, post-operative infection & osteomyelitis Infections caused by CHILD less than 3 months: susceptible organisms. 30mg/kg 12 hourly. 3 months Amoxicillin 500 mg and Respiratory tract, skin, soft J01CR02961P4001 - 12 years: 30 mg/kg 6 - 8 77. Clavulanate 100 mg A tissue, GUT infection, XX hourly. ADULT: 1.2 g by IV Injection septicaemia, peritonitis, or intermittent infusion 6 - 8 post-operative infection and hourly osteomyelitis Infections caused by ADULT: 250 - 500 mg 3 Amoxicillin 500 mg J01CA04012C1002 susceptible strains of gram times daily. CHILD: 20 - 40 78. B Capsule XX positive and gram negative mg/kg/day in divided doses 8 organisms hourly CHILD less than 10 years: Infections caused by 125 - 250 mg 8 hourly. Amoxicillin Trihydrate 125 J01CA04012F1001 susceptible strains of gram 79. B CHILD less than 20 kg: 20 - mg/5 ml Syrup XX positive and gram negative 40 mg/kg/day in 3 - 4 divided organisms doses Amphotericin B 0.15% S01A000801D2002 Fungal infection of the 80. A 1 drop hourly or 2 hourly Eye Drops XX cornea Amphotericin B 0.25% S01A000801D2003 Fungal infection of the 81. A 1 drop hourly or 2 hourly Eye Drops XX cornea

18 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber ADULT: 0.25 mg/kg/day by IV infusion, gradually increase if tolerated to 1 Amphotericin B 50 mg J02AA01801P4001 mg/kg/day. Maximum in 82. A Systemic fungal infections Injection XX severe cases: 1.5 mg/kg daily or on alternate days. For neonates, lower doses are recommended ADULT: (1-) 2-6g daily CHILDREN: (25-) 50- Ampicillin Sodium & J01CR01961F2101 Treatment of susceptible 100mg/kg daily 83. Sulbactam Sodium 250 A XX bacterial infections PREMATURE AND mg/5 ml Suspension NEWBORNS: 25-50mg/kg daily ADULT: 375-750mg twice Ampicillin Sodium & daily CHILDREN AND J01CR01961T1001 Treatment of susceptible 84. Sulbactam Sodium 375 A/KK INFANTS: 25-50mg/kg/day XX bacterial infections mg Tablet in 2 divided doses, if ≥ 30kg use an adult dose ADULT: 1.5 - 12 g/day in divided doses 6 - 8 hourly. Maximum: 4 g Sulbactam. CHILD: 150-300 mg/kg/day 6 Ampicillin Sodium 1g & - 8 hourly. Prophylaxis of J01CR01961P4002 Treatment of susceptible 85. Sulbactam Sodium A surgical infections: 1.5 - 3 g XX bacterial infections 500mg Injection at induction of anaesthesia. May be repeated 6 - 8 hourly. NEONATES: First week of life, 75mg/kg/day in divided doses every 12 hour ADULT: 1.5 - 12 g/day in divided doses 6 - 8 hourly. Maximum: 4 g Sulbactam per Ampicillin Sodium 500 mg J01CR01961P4001 Treatment of susceptible day. CHILD: 150- 86. & Sulbactam Sodium 250 A XX bacterial infections 300mg/kg/day 6 - 8 hourly. mg Injection Prophylaxis: 1.5 -3 g at induction of anaesthesia. May be repeated 6 - 8 hourly 250 - 500 mg IM/IV every 4 - 6 hours. Maximum: 400 Treatment of susceptible mg/kg/day. Meningitis: 2 g 6 Ampicillin Sodium 500 mg J01CA01520P4001 bacterial infections (non hourly. CHILD: 150 87. B Injection XX beta-lactamase-producing mg/kg/daily IV in divided organisms); meningitis doses. Usual children dose less than 10 years, half adult dose CHILD: 50 - 100 mg/kg/day 4 Treatment of susceptible times daily. Under 1 year: Ampicillin Trihydrate 125 J01CA01012F2101 bacterial infections (non 88. B 62.5 - 125 mg 4 times daily, mg/5 ml Suspension XX beta-lactamase-producing 1 - 10 years: 125 - 250 mg 4 organisms) times daily

19 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Treatment of hormone responsive metastatic or L02BG03000T1001 89. Anastrozole 1 mg Tablet A* locally advanced breast 1 mg daily XX cancer after failure of tamoxifen Treatment of invasive Loading dose of 200 mg on candidiasis, including day 1, then 100 mg once Anidulafungin 100mg J02AX06000P3001 candidemia in adults when 90. A* daily thereafter for at least 14 Injection XX intolerance or resistance to days after the last positive Amphotericin B or culture. Fluconazole ADULT : Instill 1 drop, 3 - 4 Antazoline HCl, Hay fever, conjunctivitis, times daily, into the lower Tetrahydrozoline HCl and S01GA52110D200 allergic conjunctivitis, vernal 91. A/KK eyelid. CHILD 2 - 12 years : Benzalkonium Cloride 1XX keratoconjunctivitis and Instill 1 drop daily or twice Eye Drops eczematosa daily Prevention of Rh(D) sensitisation to Rh(D)- i) Antepartum prophylaxis: negative woman: i) The recommended dose is a Pregnancy/delivery of single dose of 300mcg Rh(D)-positive infant ii) administered by IV or IM Abortion/threatened injection ii) Postpartum Anti RhD Gamma abortion, ectopic pregnancy prophylaxis: 300mcg should Globulin 300 mcg/2 ml J06BB01000P3001 or hydatidiform mole iii) be administered as soon as 92. B Injection (150 mcg = 750 XX Transplacental possible after delivery and no IU) haemorrhage resulting from later than 72 hours antepartum haemorrhage, thereafter, by IV or IM route. amniocentesis, chorionic If the 72-hour limit is biopsy or obstetric exceeded, anti-Rh(D) manipulative procedures immunoglobulin must be e.g. external version or administered anyway. abdominal trauma i) To be used when conventional anti-rejection therapy is not successful ii) Treatment of aplastic anaemia not responding to oxymethalone after 3 months, in which there is 10 - 30 mg/kg body weight persistent pancytopenia daily. Slow IV infusion (over with repeated attacks of Antilymphocyte/Antithymo at least 4 hours) diluted in L04AA03000P3001 septicaemia and bleeding. 93. cyte Immunoglobulin A* 250 - 500 ml Normal Saline. XX iii) Severe aplastic anaemia (from Horse) Injection For Graft versus host with the following disease treatment:40 parameters: a) Granulocyte mg/kg/day less than 0.5x109/L b) Platelet less than 20x109/L c) Reticulocyte less than 20x109/L iv) As a conditioning regime prior to transplant. v) Graft-versus- host disease treatment

20 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Antirabies 20 iu/kg; half by IM and half J06BB05000P3001 Treatment of rabies, post- 94. Immunoglobulin (Human) B by infiltration around the XX exposure 300 iu/2ml wound i)1.0 - 1.5 mg/kg/day for 2 - 9 days after transplantation of i)Prophylaxis of acute graft a kidney, pancreas or liver, rejection ii)Treatment of for 2 - 5 days after heart acute graft rejection transplantation iii)Prophylaxis of acute and Antithymocyte ii)1.5 mg/kg/day for 3 - 14 L04AA04000P3001 chronic graft versus host 95. Immunoglobulin (from A* days XX disease iv)Treatment of rabbit) Injection iii)2.5 - 5.0 mg/kg/day for 4 steroid-resistant, acute graft days versus host disease iv)2.5 - 5.0 mg/kg/day for 5 v)Treatment of aplastic days anemia v)2.5 - 3.5 mg/kg/day for 5 days Initial dose of 100ml of reconstituted antivenene given by slow intravenous infusion (2ml/min). Treatment of patients who Subsequent dose can be exhibit manifestations of given every 12 hours Antivenene Cobra J06AA03000P3002 96. B systemic envenoming according to the clinical Injection XX following a bite by Cobra symptoms. As product may (Naja kaouthia). differ from batches and manufacturer, it is strongly recommended to refer to the product insert on dosing recommendation. Initial dose of 30ml of reconstituted antivenene given by slow intravenous infusion (2ml/min). Treatment of patients who Subsequent dose can be exhibit manifestations of given every 6 hours Antivenene Pit Viper J06AA03000P3001 systemic envenoming 97. B according to the clinical Injection XX following a bite by Malayan symptoms. As product may Pit Viper (Calloselasma differ from batches and rhodostoma). manufacturer, it is strongly recommended to refer to the product insert on dosing recommendation. Treatment of patients who 1000 units by IV infusion Antivenene Serum (Sea exhibit manifestations of J06AA03000P3003 over 1/2 to 1 hour. In severe 98. snake) 1000 units B systemic envenoming XX cases 3000 -10000 units Injection following a bite by sea may be required snake.

21 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Recommended initial dose is Treatment of patients who 20ml by intravenous infusion. exhibit manifestations of The injection should be given systemic envenoming very slowly as 5 minutes by following a bite by Indian Antivenene Serum Snake J06AA03000P3004 direct slow intravenous route 99. B Cobra (Naja naja),Common Polyvalent Injection XX or 1hour by infusion. If Krait (Bungarus caeruleus), symptoms continue, further Russell's Viper (Daboia doses are administered as russelli) and Saw-scaled required until symptoms Viper (Echis carinatus). completely disappear. Prevention of stroke and systemic embolism in adult patients with non-valvular 5 mg taken orally twice daily. atrial fibrillation (NVAF), with Dose reduction: 2.5mg taken one or more risk factors, orally twice daily in NVAF such as prior stroke or patients with at least two of Apixaban 2.5mg film B01AF02000T3201 100. A* transient ischaemic attack the following characteristics: coated tablet. XX (TIA); age ≥ 75 years; age ≥80 years old, body hypertension; diabetes weight≤60kg, or serum mellitus; symptomatic heart creatinine≥1.5mg/dL failure (NYHA Class ≥ II). (133micromole/L). Restriction: Only for renal patients. Prevention of stroke and systemic embolism in adult patients with non-valvular 5 mg taken orally twice daily. atrial fibrillation (NVAF), with Dose reduction: 2.5mg taken one or more risk factors, orally twice daily in NVAF such as prior stroke or patients with at least two of Apixaban 5mg film coated B01AF02000T3202 101. A* transient ischaemic attack the following characteristics: tablet. XX (TIA); age ≥ 75 years; age ≥80 years old, body hypertension; diabetes weight≤60kg, or serum mellitus; symptomatic heart creatinine≥1.5mg/dL failure (NYHA Class ≥ II). (133micromole/L). Restriction: Only for renal patients. In combination with other 125 mg 1 hour prior to antiemetic agents for chemotherapy on Day 1. To prevention of delayed Aprepitant 125 mg A04AD12000C100 be given as part of a 3-day 102. A* nausea and vomiting Capsule 2XX regimen that includes a associated with initial and corticosteroid and a 5-HT3 repeat course of highly antagonist emetogenic chemotherapy In combination with other 80 mg once daily in the antiemetic agents for morning on Days 2 and Day prevention of delayed A04AD12000C100 3. To be given as part of a 3- 103. Aprepitant 80 mg Capsule A* nausea and vomitting 1XX day regimen that includes a associated with initial and corticosteroid & a 5-HT3 repeat course of highly antagonist emetogenic chemotherapy

22 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber All patients should receive a 1 ml IV test dose at least 10 minutes prior to loading dose. Initially 2 million KIU Only for Open Heart Aprotinin 10,000 KIU/ml B02AB01000P3001 bolus followed by 2 million 104. A* Surgery (extracorporeal Injection XX KIU in heart-lung machine circulation) followed by a slow infusion of 500,000 KIU/hr until end of surgery. CHILD: 20,000 KIU/kg/day D02AX00000G100 As a soap or apply to the 105. Aqueous Cream C+ Dry skin 1XX skin as an emollient cream i) Treatment of acute Schizophrenia: 10 or 15 episodes of schizophrenia mg/day. Maintenance dose: and for maintenance of 15 mg/day. Bipolar mania: N05AX12000T1001 clinical improvement during 106. Aripiprazole 10mg Tablet A* Starting dose: 15 or 30 XX continuation therapy. mg/day. Dose adjustment ii) Treatment of acute manic should occur at intervals of episodes associated with not less than 24 hour bipolar I disorder i) Treatment of acute Schizophrenia: 10 or 15 episodes of schizophrenia mg/day. Maintenance dose: and for maintenance of 15 mg/day. Bipolar mania: N05AX12000T1002 clinical improvement during 107. Aripiprazole 15mg Tablet A* Starting dose: 15 or 30 XX continuation therapy. mg/day. Dose adjustment ii) Treatment of acute manic should occur at intervals of episodes associated with not less than 24 hour bipolar I disorder Induction : 0.15 mg/kg/day IV until bone marrow remission. Total induction dose ≤ 60 Relapsed acute doses. Consolidation : 0.15 promyelocytic leukaemia mg/kg/day IV for 25 doses in Arsenic Trioxide 1 mg/ml L01XX27550P3001 108. A* (APML). To be prescribed 5 weeks (5 days per week, Injection XX by consultant haematologist followed by 2 days only interruption; treatment should begin 3-6 weeks after completion of induction therapy). ADULT and CHILD over 12 years weighing over 35 kg : 4 tablets as a single dose at the time of initial diagnosis, again 4 tablets after 8 hours and then 4 tablets twice daily Artemether 20mg + P01BE52981T1001 Acute uncomplicated 109. B (morning and evening) on Lumefantrine 120mg XX falciparum malaria each of the following two days (total course comprises 24 tablets). INFANT and CHILD weighing 5 kg to less than 35 kg : A 6 dose regimen with 1 to 3 tablets

23 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber per dose, depending on bodyweight Weight 5-8kg, Age 6-11 months, Dose: One tablet 25/55mg OD x 3 days Treatment of acute Weight : 9-17kg, Age 1-6 uncomplicated Plasmodium years, Dose : Two tablet Artesunate 100 mg and P01BF02000T1002 falciparummalaria, resulting 25/55mg OD x 3 days 110. Mefloquine HCI 220 mg A XX either from P. falciparum Weight :18-29kg, Age 7-12 Tablet mono-infection or mixed years, Dose :One tablet infection with P. vivax. 100/220mg OD x 3 days Weight ≥30kg, Age ≥13 years, Dose:Two tablet 100/220mg OD x 3 days Weight 5-8kg, Age 6-11 months, Dose: One tablet 25/55mg OD x 3 days Treatment of acute Weight : 9-17kg, Age 1-6 uncomplicated Plasmodium years, Dose : Two tablet Artesunate 25 mg and P01BF02000T1001 falciparummalaria, resulting 25/55mg OD x 3 days 111. Mefloquine HCI 55 mg A XX either from P. falciparum Weight :18-29kg, Age 7-12 Tablet mono-infection or mixed years, Dose :One tablet infection with P. vivax. 100/220mg OD x 3 days Weight ≥30kg, Age ≥13 years, Dose:Two tablet 100/220mg OD x 3 days 2.4mg of artesunate/kg body weight, by intravenous (IV) or intramuscular (IM) injection, at 0, 12 and 24 hours, then once daily until oral treatment can be substituted. Treatment of severe For adults and children with Artesunate 60 mg P01BE03000P3001 malaria caused by severe malaria or who are 112. A Injection XX Plasmodium falciparum in unable to tolerate oral adults and children medicines, artesunate 2.4 mg/kg body weight IV or IM given on admission (time = 0), then at 12 hrs and 24 hrs, then once a day for 5-7 days is the recommended treatment. ADULT: 100-250 mg once or twice daily CHILD: 100 mg Ascorbic Acid 100 mg A11GA01000T100 113. C+ Vitamin C deficiency three times daily for one Tablet 2XX week followed by 100mg daily until symptoms abate. ADULT: 100-250 mg once or twice daily CHILD: 100 mg Ascorbic Acid 500 mg A11GA01000T100 114. C+ Vitamin C deficiency three times daily for one Tablet 3XX week followed by 100mg daily until symptoms abate.

24 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Therapeutic: Not less than Ascorbic Acid 500 mg/2 A11GA01000P300 For prevention and 115. B 250 mg daily in divided ml Injection 1XX treatment of scurvy doses For second or third line i) Schizophrenia: - Acute treatment in adult for: treatment in adults: i) Schizophrenia Recommended starting and ii) Bipolar Disorder - target dose of asenapine is Monotherapy: Acute 5mg given twice daily. - treatment of manic or mixed Maintenance dose: 5mg episodes associated with twice daily. Asenapine 10mg N05AH05253T700 116. A* Bipolar I disorder. - ii) Bipolar Disorder: - Sublingual Tablet 2XX Adjunctive therapy: As Monotherapy: 10mg twice adjunctive therapy with daily. Adjunctive therapy: either lithium or valproate 5mg twice daily with lithium for the acute treatment of or valproate. Dose can be manic or mixed episodes increased to 10mg twice associated with Bipolar I daily based on clinical Disorder. response. For second or third line i) Schizophrenia: - Acute treatment in adult for: treatment in adults: i) Schizophrenia Recommended starting and ii) Bipolar Disorder - target dose of asenapine is Monotherapy: Acute 5mg given twice daily. - treatment of manic or mixed Maintenance dose: 5mg episodes associated with twice daily. Asenapine 5mg N05AH05253T700 117. A* Bipolar I disorder. - ii) Bipolar Disorder: - Sublingual Tablet 1XX Adjunctive therapy: As Monotherapy: 10mg twice adjunctive therapy with daily. Adjunctive therapy: either lithium or valproate 5mg twice daily with lithium for the acute treatment of or valproate. Dose can be manic or mixed episodes increased to 10mg twice associated with Bipolar I daily based on clinical Disorder. response. Hypertension and Hypertension, angina arrythmias; 50 - 100 mg C07AB03000T1002 118. Atenolol 100 mg Tablet B pectoris, myocardial daily, Angina; 100 mg daily, XX infarction and arrhythmias Myocardial infarction; individualised Hypertension and Hypertension, angina arrythmias; 50 - 100 mg C07AB03000T1001 119. Atenolol 50 mg Tablet B pectoris, myocardial daily, Angina; 100 mg daily, XX infarction and arrhythmias Myocardial infarction; individualised CHILD and ADOLESCENTS Attention deficit up to 70 kg: Initially 0.5 hyperactivity disorder mg/kg/day for at least 7 (ADHD) in children 6 years days, then increased Atomoxetine HCl 10 mg N06BA09110C100 and older who do not 120. A* according to response. Capsule 1XX respond to methylphenidate Maintenance: 1.2 mg/kg/day. or who have intolerable ADULTS and effects or have tics. ADOLESCENTS more than Diagnosis should be made 70 kg: Initially 40 mg/day for

25 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber according to DSM IV criteria at least 7 days then or the guidelines in ICD-10 increased according to response. Maintenance: 80 mg/day. Max 100 mg/ day

CHILD and ADOLESCENTS up to 70 kg: Initially 0.5 Attention deficit mg/kg/day for at least 7 hyperactivity disorder days, then increased (ADHD) in children 6 years according to response. and older who do not Maintenance: 1.2 mg/kg/day. Atomoxetine HCl 18 mg N06BA09110C100 respond to methylphenidate 121. A* ADULTS and Capsule 2XX or who have intolerable ADOLESCENTS more than effects or have tics. 70 kg: Initially 40 mg/day for Diagnosis should be made at least 7 days then according to DSM IV criteria increased according to or the guidelines in ICD-10 response. Maintenance: 80 mg/day. Max 100 mg/ day CHILD and ADOLESCENTS up to 70 kg: Initially 0.5 Attention deficit mg/kg/day for at least 7 hyperactivity disorder days, then increased (ADHD) in children 6 years according to response. and older who do not Maintenance: 1.2 mg/kg/day. Atomoxetine HCl 25 mg N06BA09110C100 respond to methylphenidate 122. A* ADULTS and Capsule 3XX or who have intolerable ADOLESCENTS more than effects or have tics. 70 kg: Initially 40 mg/day for Diagnosis should be made at least 7 days then according to DSM IV criteria increased according to or the guidelines in ICD-10 response. Maintenance: 80 mg/day. Max 100 mg/ day CHILD and ADOLESCENTS up to 70 kg: Initially 0.5 Attention deficit mg/kg/day for at least 7 hyperactivity disorder days, then increased (ADHD) in children 6 years according to response. and older who do not Maintenance: 1.2 mg/kg/day. Atomoxetine HCl 40 mg N06BA09110C100 respond to methylphenidate 123. A* ADULTS and Capsule 4XX or who have intolerable ADOLESCENTS more than effects or have tics. 70 kg: Initially 40 mg/day for Diagnosis should be made at least 7 days then according to DSM IV criteria increased according to or the guidelines in ICD-10 response. Maintenance: 80 mg/day. Max 100 mg/ day

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber CHILD and ADOLESCENTS up to 70 kg: Initially 0.5 Attention deficit mg/kg/day for at least 7 hyperactivity disorder days, then increased (ADHD) in children 6 years according to response. and older who do not Maintenance: 1.2 mg/kg/day. Atomoxetine HCl 60mg N06BA09110C100 respond to methylphenidate 124. A* ADULTS and Capsule 5XX or who have intolerable ADOLESCENTS more than effects or have tics. 70 kg: Initially 40 mg/day for Diagnosis should be made at least 7 days then according to DSM IV criteria increased according to or the guidelines in ICD-10 response. Maintenance: 80 mg/day. Max 100 mg/ day Hypercholesterolaemia and C10AA05000T1002 coronary heart disease 10 mg once daily. Maximum: 125. Atorvastatin 20 mg Tablet A/KK XX intolerant or not responsive 80 mg daily to other forms of therapy Hypercholesterolaemia and C10AA05000T1001 coronary heart disease 10 mg once daily. Maximum: 126. Atorvastatin 40 mg Tablet A/KK XX intolerant or not responsive 80 mg daily to other forms of therapy Hypercholesterolaemia and C10AA05000T1004 coronary heart disease 10 mg once daily. Maximum: 127. Atorvastatin 80 mg Tablet A/KK XX intolerant or not responsive 80 mg daily to other forms of therapy Initial intravenous bolus dose of 6.75mg (using 7.5mg/ml To delay imminent preterm solution for injection). birth in pregnant women Immediately followed by a with i)Regular uterine continuous high dose contractions of at least 30 infusion (loading infusion 300 seconds duration at a rate mcg/min using 7.5mg/ml of ≥ 4 per 30 minutes ii) A concentrate for solution for Atosiban 7.5 mg/ml G02CX01122P300 128. A* cervical dilation of 1 to 3 cm infusion) during three hours, Injection 1XX (0 - 3 nulliparas) and followed by lower infusion of effacement of ≥ 50% iii) 100mcg/min up to 45 hours. Age ≥ 18 years iv) A Duration of treatment should gestational age from 28 not exceed 48 hours. Total until 33 completed weeks v) dose given during a full A normal foetal heart rate. course should not exceed 330mg of the active substance. Adult & childn >2 mth 0.3-0.6 mg/kg IV. Endotracheal intubation dose: 0.5-0.6 Muscle relaxant in general mg/kg. Supplementary dose: Atracurium Besylate 10 M03AC04197P300 anaesthesia, Endotracheal 129. A* 0.1-0.2 mg/kg as required. mg /ml in 2.5 ml Injection 1XX intubation, Aid controlled Continuous infusion rates of ventilation. 0.3-0.6 mg/kg/hr to maintain neuromuscular block during long surgical procedure.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Adult & childn >2 mth 0.3-0.6 mg/kg IV. Endotracheal intubation dose: 0.5-0.6 Muscle relaxant in general mg/kg. Supplementary dose: Atracurium Besylate 10 M03AC04197P300 anaesthesia, Endotracheal 130. A* 0.1-0.2 mg/kg as required. mg /ml in 5 ml Injection 2XX intubation, Aid controlled Continuous infusion rates of ventilation. 0.3-0.6 mg/kg/hr to maintain neuromuscular block during long surgical procedure. Atropine Sulphate 0.3%, Subconjunctival injection to Cocaine HCl 1.7%, S01F000183P3001 131. A dilate pupils resistant to 1 - 2 drops Adrenaline Acid Tartrate XX topical mydriatics 0.03% Mydriatic Injection PREOPERATIVE MYDRIASIS : one drop of a 1% solution supplemented Determination of refraction, with one drop of 2.5 or 10% strabismus, iritis and phenylephrine prior to Atropine Sulphate 1% Eye S01FA01183D2001 132. B iridocyclitis, after extra or surgery. ANTERIOR Drops XX intracapsular extraction of UVEITIS or lens POSTOPERATIVE MYDRIASIS : one drop of a 1% or 2% solution up to 3 times a day i) Adult: 300-600 mcg IM/SC 30-60 minutes before anaesthesia. Alternatively, 300-600 mcg IV immediately before induction of anaesthesia. Child: >20 kg: 300-600 mcg; 12-16 kg: 300 i) Reduce vagal mcg; 7-9 kg: 200 mcg; >3 kg: inhibition,salivary and 100 mcg. Doses to be given bronchiol secretion in via IM/SC admin 30-60 anaesthesia minutes before anaesthesia. ii) Reversal of excessive ii) Adult: 500 mcg every 3-5 bradycardia minutes. Total: 3 mg. Max Atropine Sulphate 1mg/ml A03BA01183P3001 iii) Reversal of effect of Dosage: 0.04 mg/kg body 133. B Injection XX competitive muscle weight. relaxants iii) Adult 0.6-1.2 mg before or iv) Overdosage with other with anticholinesterase compounds having iv) Adult: 0.6-1 mg IV/IM/SC, muscarinic action repeated every 2 hr. v) Organophosphate v) Adult: 2 mg IV/IM, every poisoning 10-30 minutes until muscarinic effects disappear or atropine toxicity appears. In severe cases, dose can be given as often as every 5 minutes. In moderate to severe poisoning, a state of atropinisation is maintained

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber for at least 2 days and continued for as long as symptoms are present. Child: 20 mcg/kg given every 5-10 minutes. Recommended starting dose for the first treatment cycle, First line therapy for for all patients regardless of intermediate-2 and high risk baseline haematology Azacitidine Powder for MDS, CMMOL with 10-29% laboratory values, is L01BC07000P4001 134. suspension for injection A* blasts with no transplant 75mg/m2 of body surface XX 100mg/vial option and elderly AML with area. Injected 20-30% blasts and subcutaneously. Daily for 7 multilineage dysplasia. days, followed by a rest period of 21 days (28 day treatment cycle) i) Adult: 1-5 mg/kg/day. Adjust dose according to clinical response and haematological tolerance. Dose may also be given via IV administration. ii) Adult: 1-3 mg/kg/day. Discontinue treatment if i) Prophylaxis of rejection in there is no improvement after L04AX01000T1001 organ and tissue transplant 135. Azathioprine 50 mg Tablet A 12 week. XX ii) Auto-immune diseases iii) Adult: Initially, 1 iii) Rheumatoid arthritis mg/kg/day given in 1-2 divided doses for 6-8 week, may increase by 0.5 mg/kg every 4 week until response or up to 2.5 mg/kg/day. Maintenance: Reduce dose gradually to achieve the lowest effective dose. Apply twice daily (sensitive D10AX03000G100 skin, once daily for 1st 136. Azelaic Acid 20% Cream A* Acne vulgaris 1XX week). Treatment should not exceed 6 months CHILD 36 - 45 kg: 400 mg, 26 - 35 kg: 300mg, 15 - 25 Treatment of complicated kg 200 mg, less than 15 kg: Azithromycin 200 mg/5 ml J01FA10011F1001 respiratory tract infections 10 mg/kg. To be taken daily 137. A* Granules XX not responding to standard for 3 days or to be taken as a macrolides single dose on day 1, then half the daily dose on days 2 - 5

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Treatment of complicated respiratory tract infection not responding to standard macrolides ii) Adult treatment of uncomplicated genital i) 500 mg daily for 3 days Azithromycin 250 mg J01FA10011T1001 138. A* infections due to Chlamydia ii) 1 g as a single dose Tablet XX trichomatis or susceptible iii) 1 g weekly Neisseria gonorrhoea iii) Prophylaxis against Mycobacterium avium complex in patients with advanced HIV 500 mg IV as a single daily dose for a minimum of two Azithromycin 500 mg J01FA10011P4001 Only for treatment of severe days followed by 500 mg oral 139. A* Injection XX atypical pneumonia dose as a single daily dose to complete a 7 - 10 days course ADULT: 400 mg twice daily. Infections caused by Severe infection: 800 mg Bacampicillin 400 mg J01CA06000T1001 ampicillin-sensitive gram 140. B twice daily. CHILD more than Tablet XX positive& gram negative 25 kg: 12.5 - 25 mg/kg 12 microorganisms hourly ADULT: 5 mg 3 times daily. Max: 80 mg daily. CHILD: M03BX01000T100 Spasticity of the skeletal 141. Baclofen 10 mg Tablet B 0.75 - 2 mg/kg daily (more 1XX muscle than 10 years, maximum: 2.5 mg/kg daily) B05CB10907L5001 For irrigation during ocular 142. Balanced Salt Solution A Irrigate as directed XX surgery For irrigation during Balanced Salt Solution intraocular surgery PLUS (fortified with B05CB10905L5001 especially in patients with 143. A Irrigate as directed sodium bicarbonate, XX poor cornea endothelium glucose & glutathione) and poorly controlled diabetes i) Up to 150 ml of a 50% - For x-ray examination of the 200% suspension orally alimentary tract: i) Barium Sulphate V08BA01183L8001 ii) Up to 300 ml of a 30% - 144. B Oesophagus Suspension XX 200% suspension orally ii) Stomach and duodenum iii) Up to 2 litre of a 30% - iii) Colon 200% suspension orally ADULT & CHILD 2 years and above & 35 kg or more:20 mg /dose. 2 years or more Prophylaxis of acute organ Basiliximab 20 mg L04AC02000P3001 but less than 35kg:10 145. A* rejection in de novo renal Injection XX mg/dose. First dose given transplantation. within 2 hours before start of transplantation and second dose 4th day after transplant

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber 81 mg intravesically once weekly for 6 weeks, followed L03AX03000P3001 146. BCG 81 mg/3 ml A* Superficial bladder cancer by treatments at 3, 6, 12, 18, XX and 24 months after initial treatment 0.1 ml by intradermal BCG Vaccine Freeze- J07AN01000P4001 For the prevention of 147. C+ injection. INFANT under 12 Dried Injection XX tuberculosis months: 0.05 ml Adults: The usual maintenance dose is one to two inhalations (200-400 mcg) twice daily.If needed,the dose can be Prophylaxis of asthma increased up to 1600 Beclomethasone R03BA01133A210 especially if not fully mcg/day divided in two to 148. Dipropionate 100 B 1XX controlled by four doses : Children 6-12 mcg/dose Inhaler bronchodilators years old: One inhalation (200 mcg) two times daily and dose may be increased up to 800 mcg/day in divided two to four doses if necessary. Regular treatment of asthma where use of a combination product (inhaled corticosteroid and Dose recommended for long-acting beta2 agonist) patients 18 years and above. Beclomethasone is appropriate in: One or two inhalations twice dipropionate 100mcg and i.Patients not adequately daily. The maximum daily formoterol fumarate R03AK07986A210 controlled with inhaled dose is 4 inhalations daily. 149. A/KK dihydrate 6mcg 1XX corticosteroids and 'as No need to adjust dose in pressurized inhalation needed' inhaled short- elderly patients. There are no solution acting beta2 agonist or data available for use in ii.Patients already patients with hepatic or renal adequately controlled on impairment. both inhaled corticosteroids and long-acting beta2- agonists ADULT : 1 - 2 puff twice Prophylaxis of asthma daily. May increase to 2 puff Beclomethasone R03BA01133A210 especially if not fully 2 - 4 times daily CHILD : 1 150. Dipropionate 200 A/KK 2XX controlled by puff twice daily. May mcg/dose Inhaler bronchodilators increase to 1 puff 2 - 4 times daily ADULT and CHILD over 6 years : Apply 100 mcg (2 Prophylaxis and treatment sprays) into each nostril Beclomethasone R01AD01133A410 of perennial and seasonal twice daily or 50 mcg (1 151. Dipropionate 50 mcg/dose A/KK 1XX allergic rhinitis and spray) into each nostril 3 - 4 Nasal Spray vasomotor rhinitis times/day. Maximum 400 mcg daily (8 sprays). When symptoms controlled, reduce

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber dose to 50 mcg (1 spray) into each nostril twice daily Bendamustine is indicated for monotherapy in patients Monotherapy for iNHL with indolent B-cell non- Bendamustine refractory to rituximab: Hodgkin's lymphomas Hydrochloride 100mg/vial L01AA09110P3102 120mg/m2 body surface area 152. A* (iNHL) that has progressed powder for concentrate for XX bendamustine hydrochloride during or within six months solution for infusion on days 1 and 2; every 3 of treatment with rituximab weeks. or a rituximab-containing regimen. Bendamustine is indicated for monotherapy in patients Monotherapy for iNHL with indolent B-cell non- Bendamustine refractory to rituximab: Hodgkin's lymphomas Hydrochloride 25mg/vial L01AA09110P3101 120mg/m2 body surface area 153. A* (iNHL) that has progressed powder for concentrate for XX bendamustine hydrochloride during or within six months solution for infusion on days 1 and 2; every 3 of treatment with rituximab weeks. or a rituximab-containing regimen. Wash and dry baby's bottom. Apply by spreading the Benzalkonium 0.01% D08AJ01000G1001 Prevention and treatment of cream evenly paying 154. B Cream XX nappy rash particular attention to the fold of the skin, after every nappy change Low level disinfectant Cleaning purposes: Dilute 1 Benzalkonium Chloride V07AV00100L9908 suitable for general 155. C in 10. Disinfection, use Disinfectant Solution XX cleaning and disinfection of undiluted hard surface i) Treatment of mild to moderately severe i) ADULT: 1.2 mega units IM Benzathine Penicillin 2.4 J01CE08702P4001 156. B infections due to Penicillin ii) For syphillis: 2.4 mega MIU (1.8 g) Injection XX G-sensitive organisms units weekly for 1 - 3 weeks ii) Treatment of syphillis ADULT: Initially 1 mg daily, i) Parkinson's disease increase gradually. N04AA01110T1001 ii) Drug induced 157. Benzhexol 2 mg Tablet B Maintenance: 5 - 15 mg daily XX parkinsonism in 3 - 4 divided doses. (Max iii) Dystonias 15mg/day) Benzoic Acid Compound D01AE12952G500 Apply sparingly to affected 158. Half Strength (Paed) C Tinea infections of the skin 1XX area once or twice daily Ointment Tinea infections of Benzoic Acid Compound D01AE12952G500 Apply sparingly to affected 159. C thickened skin of palms and Ointment 2XX area once or twice daily soles Apply undiluted to the skin 1 Infected skin, lesions, cuts, or 2 times daily. Duration of Benzoin Compound D08AX00000L5001 160. C abrasions, wounds and therapy, may be weeks to Tincture XX burns months depending on the infection being treated

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Apply 1-2 times daily Benzoyl Peroxide 10% D10AE01241G300 Mild to moderate acne 161. B preferably after washing with Gel 2XX vulgaris soap and water Apply 1-2 times daily D10AE01241G300 Mild to moderate acne 162. Benzoyl Peroxide 5% Gel B preferably after washing with 1XX vulgaris soap and water Used as a 30 seconds gargle or rinse, undiluted. ADULT Benzydamine HCl 0.15% A01AD02110M200 For relief of painful 15 ml. CHILD less 12 years 163. B Solution 1XX condition of the oral cavity 5-15 ml. Uninterrupted treatment should not be more than 7 days ADULTS and CHILDREN OVER 12 YEARS: 2-4 Temporary relief of painful sprays (1-2mg) directly onto conditions of the mouth and the sore/inflamed area and throat including tonsillitis, swallow gently. Repeat every sore throat, radiation 1 1/2 to 3 hours as mucositis, aphthous ulcers, necessary. CHILDREN 6-12 Benzydamine pharyngitis, swelling, YEARS: 2 sprays (1mg) A01AD02110A420 164. Hydrochloride 3.0 mg/ml A* redness, inflammatory directly onto sore/ inflamed 1XX throat spray conditions, post-orosurgical area and swallow gently. and periodontal procedures. Repeat every 11/2 to 3 hours (For pediatric and as necessary. CHILDREN otorhinolaringology use. UNDER 6 YEARS: Not Restrict to patients who are recommended. Uninterrupted not able to gargle) treatment should not exceed seven days, unless under medical supervision After bath, apply over the whole body, neck down and leave on for 24 hours then wash off. Reapply for Benzyl Benzoate 12.5 % P03AX01252L2001 Scabies, for child under 2 another 24 hours, the first 165. C Emulsion (Child) XX years repeat application should be within 5 days of the initial application, a third application may be required in some cases After bath, apply over the whole body, neck down and leave on for 24 hours then wash off. Reapply for Benzyl Benzoate 25 % P03AX01000L2002 another 24 hours, the first 166. C+ Scabies Emulsion (Adult) XX repeat application should be within 5 days of the initial application, a third application may be required in some cases

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Adult: 600mg - 3600mg (1 - 6 mega units) daily, divided into 4 to 6 doses. Higher doses (24 mega units) in divided doses may be given in serious infections such as meningitis. Child 1 month to i) Infections caused by 12 years old: 100mg/kg/day Benzylpenicillin 1 mega J01CE01702P4001 167. B susceptible organisms in 4 divided doses, not unit (600 mg) Injection XX ii) Infective endocarditis exceeding 4g/day; Infants 1 - 4 weeks: 75mg/kg/day in 3 divided doses; Newborn Infants: 50mg/kg/day in 2 divided doses ii)7.2 to 12g (12 - 20 mega units) maybe given daily in divided doses 1-2 drops every 15 minutes Benzylpenicillin 10,000 S01AA14702D200 168. B Eye infection or accordingly to needs of units/ml Eye Drops 2XX the patient Benzylpenicillin 2,500 1-2 drops every 15 minutes S01AA14702D200 169. units/ml (1.5 mg/ml) Eye B Eye infection or accordingly to needs of 1XX Drops the patient i) ADULT: 600 - 1200 mg IM 4 times daily, increased if necessary in more serious i) Infections caused by infections. CHILD: 50 - 100 Benzylpenicillin 5 mega J01CE01702P4002 170. B susceptible organisms mg/kg body weight daily IV in units (3 g) Injection XX ii) Infective endocarditis 2 - 4 divided doses ii) ADULT: 7.2 g daily by slow IV infusion in 6 divided doses Treatment of newborn baby 100 mg/kg (4 ml/kg) body with birth weight of 700 g or weight intratracheally up to 4 greater undergoing Beractant Intratracheal doses in 1st 48 hr. Doses R07AA02000L8001 mechanical ventilation for 171. Suspension (200 mg A* should not be given more XX respiratory distress phospholipids in 8 ml vial) frequently than 6 hrly. To be syndrome, whose heart rate administered as soon as and arterial oxygenation are possible. continuously monitored i) Meniere's Syndrome as defined by the following core symptoms: - Vertigo Given in doses of 8 to 16 mg Betahistine (with nausea/vomiting). - orally 3 times daily (total 24 N07CA01110T100 172. Dihydrochloride 16 mg A/KK Hearing loss (Hardness of to 48 mg/day) preferably with 2XX Tablet hearing). - Tinnitus (ringing food. CHILD not in the ears) recommended ii)Symptomatic treatment of vestibular vertigo

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Meniere's Syndrome as defined by the following core symptoms: - Vertigo Betahistine (with nausea/vomiting). - N07CA01110T100 24-48mg in divided doses 173. Dihydrochloride 24 mg A* Hearing loss (Hardness of 3XX daily Tablet hearing). - Tinnitus (ringing in the ears) ii)Symptomatic treatment of vestibular vertigo i) Meniere's Syndrome as defined by the following core symptoms: - Vertigo Given in doses of 8 to 16 mg Betahistine (with nausea/vomiting). - orally 3 times daily (total 24 N07CA01110T100 174. Dihydrochloride 8 mg A/KK Hearing loss (Hardness of to 48 mg/day) preferably with 1XX Tablet hearing). - Tinnitus (ringing food. CHILD not in the ears) recommended ii)Symptomatic treatment of vestibular vertigo Suppression of 0.5 - 9 mg daily in divided inflammatory and allergic Betamethasone 0.5 mg H02AB01000T1001 doses. CHILD: 0.5 - 7.5 175. A disorders, congenital Tablet XX mg/m2/day divided every 6 - adrenal hyperplasia, 12 hours cerebral oedema Apply sparingly to affected Betamethasone 17- Eczemas, prurigo nodularis, D07AC01256G100 area 2 - 3 times daily then 176. Valerate 0.01-0.05% B limited psoriasis in 1XX reduced to once daily when Cream appropriate in sites improvement occurs Apply sparingly to affected Betamethasone 17- Eczema, prurigo nodularis, D07AC01256G500 area 2 - 3 times daily then 177. Valerate 0.01-0.05% B limited psoriasis in 1XX reduced to once daily when Ointment appropriate in sites improvement occurs Eczemas, prurigo nodularis, Apply sparingly to affected Betamethasone 17- D07AC01256G100 psoriasis (excluding area 2 - 3 times daily then 178. A Valerate 0.1% Cream 2XX widespread plaque reduced to once daily when psoriasis) improvement occurs Eczema, prurigo nodularis, Apply sparingly to affected Betamethasone 17- D07AC01256G500 psoriasis (excluding area 2-3 times daily then 179. A Valerate 0.1% Ointment 2XX widespread plaque reduced to once daily when psoriasis) improvement occurs Apply 2 - 3 drops every 2 - 3 Betamethasone Disodium S03BA03162D100 Non-infected inflammatory 180. B hours, reduce frequency Phoshate 0.1% Ear Drops 1XX conditions when relief obtained Apply 2 - 3 drops every 2 - 3 Betamethasone Disodium S03BA03162D100 Non-infected inflammatory 181. B hours, reduce frequency Phoshate 0.5% Ear Drops 2XX conditions when relief obtained Betamethasone Disodium 1 - 2 drops every 1 - 2 hours S01BA06162D200 Non-infected inflammatory 182. Phosphate 0.1% Eye A until controlled then reduce 1XX conditions of the eyes Drops frequency Betamethasone Disodium S01BA06162G510 Non-infected inflammatory 2 - 4 times daily or at night 183. Phosphate 0.1% Eye A 1XX conditions of the eyes when used with eye drops Ointment

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Betamethasone Disodium Apply 2 - 3 drops 3 - 4 times S03CA06991D100 Allergic dermatosis in the 184. Phosphate and Neomycin B daily, reduce frequency when 1XX ear Sulphate 0.5% Ear Drops relief obtained Betamethasone Disodium S01CA05991D200 Infected inflammatory 185. Phosphate and Neomycin A 2 - 3 drops every 2 - 3 hours 1XX conditions of the eyes Sulphate Eye Drops Pre-operative and in Usual intravenous doses are serious trauma or illness, up to 9 mg/day of the sodium shock, as adjunctive phosphate salt only. CHILD: Betamethasone Sodium H02AB01162P300 therapy in rheumatoid IM: 0.5 - 7.7 mg base/m2/day 186. Phosphate 4 mg/ml B 1XX disorders, ocular, divided every 6 - 12 hours. Injection dermatologic and ADOLESCENT and ADULT, respiratory allergic and IM: 0.6 - 9 mg divided every inflammatory states 12 - 24 hours Chronic open-angle Betaxolol 0.25% Eye S01ED02110D200 One to two drops in the 187. A glaucoma, ocular Suspension 1XX affected eye(s) twice daily hypertension 50 mg once daily. (morning or evening), with or without food. Take on the same time Advanced prostate cancer each day. Adult: When used Bicalutamide 50 mg L02BB03000T1001 in combination with LHRH with gonadorelin analogue: 188. A* Tablet XX analogue therapy or Usual dose: 50 mg once surgical castration. daily. May be started with or at least 3 days before starting gonadorelin analogue therapy. Lowering of intraocular pressure in patients with open-angle glaucoma and ocular hypertension who are intolerant of other Bimatoprost 0.03% S01EE03000D200 1 drop in affected eye(s) 189. A* intraocular pressure Ophthalmic Solution 1XX once daily at evening lowering medications or insufficiently responsive to another intraocular pressure lowering medication i) ADULT and CHILD over 10 years: 10 mg, CHILD less i) Constipation than 10 years 5 mg insert Bisacodyl 10 mg A06AB02000S2002 ii) Bowel preparation for rectally 190. C Suppository XX radiological procedures and ii) ADULT 10-20 mg, CHILD surgery over 4 years 5 mg the following morning before procedures insert rectally i) ADULT and CHILD over 10 i) Constipation years: 10 mg, CHILD less Bisacodyl 5 mg A06AB02000S2001 ii) Bowel preparation for 191. C than 10 years 5 mg insert Suppository XX radiological procedures and rectally surgery ii) ADULT 10-20 mg, CHILD

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber over 4 years 5 mg the following morning before procedures insert rectally

i) ADULT and CHILD over 10 years 5-10 mg, CHILD 4-10 years 5 mg. To be taken at i) Constipation night for effect on the A06AB02000T1001 ii) Bowel preparation for 192. Bisacodyl 5 mg Tablet C following morning XX radiological procedures and ii) ADULT 10-20 mg the night surgery before procedures, CHILD over 4 years 5 mg the night before procedures As a mild antiseptic for wounds and abscesses. Bismuth Subnitrate, R01AX30984G600 Sterile gauze impregnated As directed for local 193. Iodoform and Liquid B 1XX with paste for packing application Paraffin Paste cavities after otorhinological surgery Treatment of stable moderate to severe Bisoprolol Fumarate 2.5 C07AB07000T1001 1.25 mg once daily to 5 - 10 194. B congestive cardiac failure in mg Tablet XX mg daily addition to ACEI's and diuretics Treatment of stable moderate to severe Bisoprolol Fumarate 5 mg C07AB07000T1002 1.25 mg once daily to 5 - 10 195. B congestive cardiac failure in Tablet XX mg daily addition to ACEI's and diuretics 15 - 30 mg weekly in divided doses or 10 - 20 mg/m2 once Squamous cell carcinoma, or twice weekly or 10 mg/m2 germ cell tumours, slow bolus in 15 minutes D1 Bleomycin HCl 15 mg L01DC01110P4001 lymphomas. Routes: SC, 196. A and D15. Total Injection XX IM, IV (either as bolus or as dosage:should not exceed infusion over 24 hours), 300 mg. CHILD: 10 - 15 intra-arterial, intra-pleural mg/m2 over 6 hours every 3 - 4 weeks Boric Acid with Spirit 2% S02AA03000D100 3 drops instilled into affected 197. C Perforated eardrum w/v Ear Drops 1XX ear 3 - 4 times daily i) Treatment of multiple myeloma in patient who 1.3 mg/ m2/dose given as IV have received at least one bolus injection twice weekly prior therapy. for two weeks (days 1, 4, 8, Bortezomib 3.5 mg L01XX32000P3001 ii) For use in combination and 11) followed by a 10- 198. A* Injection XX with conventional therapy day rest period (days 12-21). for the treatment of At least 3 days should elapse previously untreated between consecutive doses multiple myeloma patients of bortezomib who are not eligible for

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber haematopoietic stem cell transplantation. For the treatment of pulmonary arterial hypertension (PAH) in patients with WHO Class III Initially 62.5 mg bd for 4 or IV symptoms, to improve C02KX01000T1001 weeks, then increase to the 199. Bosentan 125 mg tablet A* exercise ability and XX maintenance dose of 125 mg decrease the rate of clinical bd worsening (To be used by those who are trained and specialized in treating and managing PAH) Lowering of intraocular Brimonidine Tartrate S01EA05123D200 pressure in patients with 1 drop in the affected eye(s) 200. A* 0.15% Ophthalmic 1XX open-angle glaucoma or 3 times daily ocular hypertension Adult: Initially, 6-18 mg daily in divided doses. Doses up N05BA08000T1002 201. Bromazepam 3 mg Tablet A Anxiety disorders to 60 mg daily have been XX used. Elderly: Max initial dose: 3 mg daily Secretolytic therapy in acute and chronic 4 to 8 mg SC, IM or IV 2 - 3 bronchopulmonary Bromhexine HCl 4 mg/2 R05CB02110P300 times daily (maximum 24mg/ 202. A diseases associated with ml Injection 1XX day). Elderly: Max initial abnormal mucous secretion dose: 3 mg daily. and impaired mucous transport Secretolytic therapy in 1) Adults :10 ml three times a acute and chronic day.Can increase up to 15 ml bronchopulmonary Bromhexine HCl 4 mg/5 R05CB02110L1001 four times a day. 2)Children 203. B diseases associated with ml Elixir XX 5 to 12 years : 5 ml four abnormal mucous secretion times a day 3)Children 2 to 5 and impaired mucous years: 5 ml two times a day transport Secretolytic therapy in acute and chronic ADULT and CHILD more bronchopulmonary than 12 years : 8 mg 3 times Bromhexine HCl 8 mg R05CB02110T100 204. B diseases associated with daily, 6 - 12 years : 4 mg 3 Tablet 1XX abnormal mucous secretion times daily, 2 - 6 years : 4 and impaired mucous mg 2 times daily transport i) Initially 1 - 1.25 mg at bedtime increased gradually, usual dose: 7.5 mg daily in i) Hypogonadism or Bromocriptine Mesilate 10 G02CB01196T100 divided doses. Max 30 mg 205. A/KK Galactorrhoea mg Tablet 3XX daily ii) Acromegaly ii) 1.25 - 2.5 mg at bedtime for 3 days and may be increased by 1.25 - 2.5 mg

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber every 3 - 7 days up to 30 mg a day in divided doses i) Initially 1 - 1.25 mg at bedtime increased gradually, usual dose: 7.5 mg daily in divided doses. Max 30 mg i) Hypogonadism or Bromocriptine Mesilate G02CB01196T100 daily 206. A/KK Galactorrhoea 2.5 mg Tablet 1XX ii) 1.25 - 2.5 mg at bedtime ii) Acromegaly for 3 days and may be increased by 1.25 - 2.5 mg every 3 - 7 days up to 30 mg a day in divided doses i) Initially 1 - 1.25 mg at bedtime increased gradually, usual dose: 7.5 mg daily in divided doses. Max 30 mg i) Hypogonadism or Bromocriptine Mesilate 5 G02CB01196T100 daily 207. A/KK Galactorrhoea mg Tablet 2XX ii) 1.25 - 2.5 mg at bedtime ii) Acromegaly for 3 days and may be increased by 1.25 - 2.5 mg every 3 - 7 days up to 30 mg a day in divided doses Maintenance treatment of ADULT : Initially 1 - 2 mg asthma as prophylactic twice daily. CHILD 3 months Budesonide 1 mg/2 ml R03BA02000A300 208. B therapy especially if not - 12 years of age : 500 mcg - Nebuliser Solution 2XX fully controlled by 1 mg. Maintenance dose : bronchodilators half of the above doses ADULT : 200 - 1600 mcg daily in 2 - 4 divided doses. Maintenance treatment of Maintenance with twice daily asthma as prophylactic Budesonide 100 R03BA02000A210 dosing. CHILD more than 7 209. B therapy especially if not mcg/dose Inhaler 1XX years 200 - 800 mcg, 2 - 7 fully controlled by years 200 - 400 mcg. To be bronchodilators taken orally in 2 - 4 divided doses

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Asthma Maintenance therapy Adult ≥18 yr 160 mcg to 320 mcg bd. Some patients may require up to a max of 640 mcg bd. Adolescent 12-17 yr 160 mcg to 320 mcg bd. Childn 6-11 yr 160 mcg bd, <6 yr Not recommended. i)Regular treatment of Maintenance & relief Adult asthma where use of a ≥18 yr 320 mcg/day either as combination (inhaled 160 mcg bd or 320 mcg corticosteroid and long- either morning or evening. acting beta2-agonist) is For some patients a appropriate:- - Patients not maintenance dose of 320 adequately controlled with mcg bd may be appropriate. inhaled corticosteroids and Patients should take 160 'as needed' inhaled short- mcg additional inhalation as acting beta2-agonists. or - needed in response to Budesonide 160 mcg and Patients already adequately R03AKO7989A210 symptoms. If symptoms 210. Formoterol 4.5 mcg A/KK controlled on both inhaled 1XX persist after a few minutes, Inhalation corticosteroids and long- an additional inhalation acting beta2-agonists. should be taken. Not more ii) Symptomatic treatment of than 960 mcg should be patients with severe COPD taken on any single (FEV1 <50% predicted occasion. A total daily dose normal) and a history of of more than 1280 mcg is not repeated exacerbations, normally needed, however a who have significant total daily dose of up to 1920 symptoms despite regular mcg could be used for a therapy with long-acting limited period. Patients using bronchodilators. more than 1280 mcg daily should seek medical advice, should be reassessed & their maintenance therapy reconsidered. Childn & adolescent <18 yr Not recommended. COPD Adult ≥18 yr 320 mcg bd. ADULT : 200 - 1600 mcg daily in 2 - 4 divided doses. Maintenance treatment of Maintenance with twice daily asthma as prophylactic Budesonide 200 R03BA02000A210 dosing. CHILD more than 7 211. B therapy especially if not mcg/dose Inhalation 2XX years 200 - 800 mcg, 2 - 7 fully controlled by years 200 - 400 mcg. To be bronchodilators taken orally in 2 - 4 divided doses

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Asthma; Maintenance therapy: Adult ≥18 yr 160 mcg to 320 mcg bd. Some patients may require up to a max of 640 mcg bd. Adolescent 12-17 yr 160 mcg to 320 mcg bd. Children 6-11 yr 160 mcg bd, <6 yr Not recommended. Maintenance i)Regular treatment of & relief: Adult ≥18 yr 320 asthma where use of a mcg/day either as 160 mcg combination (inhaled bd or 320 mcg either corticosteroid and long- morning or evening. For acting beta2-agonist) is some patients a appropriate:- - Patients not maintenance dose of 320 adequately controlled with mcg bd may be appropriate. inhaled corticosteroids and Patients should take 160 'as needed' inhaled short- mcg additional inhalation as acting beta2-agonists. or - needed in response to Budesonide 320 mcg and Patients already adequately R03AK07989A210 symptoms. If symptoms 212. Formoterol 9 mcg A/KK controlled on both inhaled 2XX persist after a few minutes, Inhalation corticosteroids and long- an additional inhalation acting beta2-agonists. should be taken. Not more ii) Symptomatic treatment of than 960 mcg should be patients with severe COPD taken on any single (FEV1 <50% predicted occasion. A total daily dose normal) and a history of of more than 1280 mcg is not repeated exacerbations, normally needed, however a who have significant total daily dose of up to 1920 symptoms despite regular mcg could be used for a therapy with long-acting limited period. Patients using bronchodilators. more than 1280 mcg daily should seek medical advice, should be reassessed & their maintenance therapy reconsidered. Children & adolescent less than 18 yr: Not recommended. COPD; Adult more than or equal to 18 yr: 320 mcg bd. Maintenance treatment of ADULT : Initially 1 - 2 mg asthma as prophylactic twice daily. CHILD 3 months Budesonide 500 mcg/2 ml R03BA02000A300 213. B therapy especially if not - 12 years of age : 500 mcg - Nebuliser Solution 1XX fully controlled by 1 mg. Maintenance dose : bronchodilators half of the above doses ADULT and CHILD 6 years and older. Rhinitis : 2 spray into each nostril once daily in Budesonide 64mcg Nasal R01AD05000A410 Seasonal allergic, perennial 214. A the morning or 1 spray into Spray 3XX rhinitis and nasal polyposis each nostril twice daily. Nasal polyps : 2 spray twice daily

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber IV injection: 1 - 2 mg Bumetanide 0.5 mg/ml C03CA02000P300 Oedema used in repeated after 20 mins. IV 215. A* Injection 1XX furosemide allergic patient infusion: 2 - 5 mg over 30 - 60 mins C03CA02000T100 Oedema used in 1 mg in the early evening. Up 216. Bumetanide 1 mg Tablet A* 1XX furosemide allergic patient to 5 mg daily in severe cases Infuse at 6 - 15 ml/hour. Not Bupivacaine 0.125% N01BB01110P300 Epidural analgesia for 217. A to exceed 2 mg/kg in a single Epidural Injection 4XX postoperative pain relief. dose. ADULT: 2 - 4 ml. Not to Bupivacaine 0.5 % Heavy N01BB01110P300 218. A Used for spinal anaesthesia exceed 2 mg/kg in a single Injection 3XX dose Regional nerve block or epidural block: 15 - 30 ml. For peripheral sympathetic Nerve block of finger or toe: nerve and epidural Bupivacaine 0.5 % N01BB01110P300 2 - 6 ml. Maximum: 2 mg/kg 219. B (excluding caudal) Injection 2XX body weight in any 4 hours anaesthesia and obstetrics period, equivalent to 25 - 30 anaesthesia ml in adults of average weight 10 - 40 ml (0.25 %) or Bupivacaine 0.5 % with maximum : 2 mg/kg body N01BB51975P300 Regional nerve block or 220. Adrenaline 1:200,000 B weight in any 4 hours period, 1XX epidural block. Injection equivalent to 25 - 30 ml of 0.5% solution Once weekly transdermal patch/for hospital use only. Patient aged 18 years and over. Initial dose: 5 mcg/hr Treatment of non-malignant For elderly: Renal pain of moderate intensity impairment. No special dose when an opioid is adjustments necessary in necessary for obtaining patients with renal Buprenorphine 10mcg/hr N02AE01110M700 adequate analgesia. Not impairment Hepatic 221. A* transdermal patch 1XX suitable for the treatment of impairment Patients with acute pain. Restrictions: For hepatic insufficiency should elderly patients or patients be carefully monitored during with comorbidities/difficult to the treatment with swallow buprenorphine patch. Alternate therapy should be considered. Patch should be used with cautions in severe hepatic impairment patient

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Once weekly transdermal patch/for hospital use only. Patient aged 18 years and over. Initial dose: 5 mcg/hr Treatment of non-malignant For elderly: Renal pain of moderate intensity impairment. No special dose when an opioid is adjustments necessary in necessary for obtaining patients with renal Buprenorphine 5mcg/hr N02AE01110M700 adequate analgesia. Not impairment Hepatic 222. A* transdermal patch 3XX suitable for the treatment of impairment Patients with acute pain. Restrictions: For hepatic insufficiency should elderly patients or patients be carefully monitored during with comorbidities/difficult to the treatment with swallow buprenorphine patch. Alternate therapy should be considered. Patch should be used with cautions in severe hepatic impairment patient i) ADULT: Initial: 2 - 4 mg daily. Maintenance: 0.5 - 2 mg daily. Stop when white blood cell less than 20 x i) Chronic myeloid 109/L. CHILD: 60 mcg/kg leukaemia (CML) and other body weight daily L01AB01000T1001 myeloproliferative diseases ii) CHILD: Induction 60 223. Busulfan 2 mg Tablet A XX ii) Haemopoietic stem cell mcg/kg body weight daily transplant (HSCT)- refer to (maximum 4 mg) if specific protocols leucocytes more than 20,000/mm3 and platelets more than 100,000/mm3. Maintenance 10 - 30mcg/kg (maximum 2 mg daily) For use in combination with cyclophosphamide as a 0.8 mg/kg of ideal body conditioning regimen prior weight or actual body weight, to allogeneic hematopoietic whichever is lower via central stem cell transplantation venous catheter as a 2-hour (HSCT) for chronic infusion on the basis of every Busulfan 6 mg/ml L01AB01000P3001 myelogenous leukemia in 224. A* 6 hours for 4 days, for a total Injection XX selected cases with high of 16 doses. For obese or risk of liver toxicity and severely obese patients, IV intolerance to oral busulfan. Busulfan should be To be prescribed by administered based on paediatric oncologist and adjusted ideal body weight consultant haematologist trained in transplant only. i)0.5mg per week given in 1 i) Treatment of or 2 (one-helf of one 0.5mg hyperprolactinaemic Cabergoline 0.5 mg G02CB03000T100 tablet) doses per week 225. A* disorders Tablet 1XX ii) HIV mothers only : Prevent ii) Prevention of puerperal lactation 2 tab first day after lactation and suppression of delivery. Interruption of

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber lactation in HIV infected laction : 0.25mg 12 hourly for mothers only 2 days Soothes and relieves nappy rashes, prickly heat, minor D04AX00000G100 Apply to the affected area as 226. Calamine Cream C+ skin irritations, insect bites 1XX required, 1-3 times daily and sunburn, Pruritic skin conditions. Soothes and relieves nappy rashes, prickly heat, minor Apply to the skin as required D04AX00000L8001 227. Calamine Lotion C+ skin irritations, insect bites and allow to dry, 1-3 times XX and sunburn, Pruritic skin daily conditions. Soothes and relieves nappy rashes, prickly heat, minor Apply to the skin as required Calamine with 0.25 - 0.5% D04AX00952L6001 228. C skin irritations, insect bites and allow to dry, 1 - 3 times Menthol Lotion XX and sunburn, Pruritic skin daily conditions. Calamine with 0.5% D04AX00952G100 Apply to the affected area as 229. C For use as a mild astringent Phenol Cream 1XX required Calamine with 2 - 6% Apply to the skin as required D04AX00952L6002 230. Precipitated Sulphur C Acne vulgaris and allow to dry, 1 - 3 times XX Lotion daily ADULT Apply to the affected skin lesions twice daily. Maintenance therapy may be achieved with less frequent application. The weekly dose Calcipotriol 50 mcg/g D05AX02000G100 Only for the treatment of 231. A* should not exceed 100 g. Cream 1XX Psoriasis Vulgaris CHILD over 6 years, apply twice daily. 6-12 years maximum 50gm weekly, over 12 years maximum 75gm weekly ADULT Apply to the affected skin lesions twice daily. Maintenance therapy may be achieved with less frequent application. The weekly dose Calcipotriol 50 mcg/g D05AX02000G500 Only for the treatment of 232. A* should not exceed 100 g. Ointment 1XX Psoriasis Vulgaris CHILD over 6 years, apply twice daily. 6-12 years maximum 50gm weekly, over 12 years maximum 75gm weekly Calcipotriol 50 mcg/ml D05AX02000L9901 Only for the treatment of Apply to scalp twice daily. 233. A* Scalp Solution XX Psoriasis Vulgaris Maximum 60 mL weekly. Apply once daily up to 4 Calcipotriol Hydrate 50 weeks with maximum weekly mcg/g & Betamethasone D05AX52952G500 234. A* Resistant plaque psoriasis dose of 100g and maximum Dipropionate 0.5 mg/g 1XX treatment area 30% of body Ointment surface

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Should be applied to affected areas once daily. The recommended treatment period is 4 weeks for scalp Calcipotriol monohydrate areas and 8 weeks for non- Topical treatment of scalp 50 mcg/g and D05AX52952G300 scalp areas. The body 235. A* and non-scalp plaque Betamethasone 1XX surface area treated with psoriasis vulgaris in adults dipropionate 0.5 mg/g Gel calcipotriol containing products should not exceed 30% and maximum dose should not exceed 15g or 100g/ week 5-10 IU per kg body weight in 500mL physiological saline daily by i.v. infusion over at Calcitonin (synthetic H05BA01000P300 least 6 hours or by slow i.v. 236. A* Acute hypercalcaemia Salmon) 100 IU Injection 2XX injection in 2-4 divided doses spread over the day. Renal impairment: Dosage adjustment needed. Calcitonin (Synthetic H05BA01000A410 237. Salmon) 200 IU Nasal A* Osteoporosis 200 units daily 1XX Spray 5-10 IU per kg body weight in 500mL physiological saline daily by i.v. infusion over at Calcitonin (Synthetic H05BA01000P300 least 6 hours or by slow i.v. 238. A* Acute hypercalcaemia Salmon) 50 IU Injection 1XX injection in 2-4 divided doses spread over the day. Renal impairment: Dosage adjustment needed. i) 0.25 mcg 2 times daily ii) Initial dose 0.25 mcg. In i)Established patients with normal or only postmenopausal slightly reduced serum osteoporosis calcium levels, doses of 0.25 ii) Renal osteodystrophy in mcg every other day is Calcitriol 0.25 mcg A11CC04000C100 patients on haemodialysis 239. A/KK sufficient Capsule 1XX iii)Hypoparathyroidism and iii) 0.25 mcg/day given in the rickets morning iv)Secondary iv) ADULT and CHILD 3 hyperparathyroidism in years and older : Initially 0.25 renal failure mcg/ml. CHILD less than 3 years : 10 to 15 ng/kg/day Management of Initially dose, depending on hypocalcaemia and/or severity, 1 mcg (0.02 mg/kg) Calcitriol 1 mcg/ml A11CC04000P300 secondary 240. A* to 2 mcg 3 times weekly, Injection 1XX hyperparathyroidism in approximately every other patients undergoing chronic day renal dialysis

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Management of Initially dose, depending on hypocalcaemia and/or severity, 1 mg (0.02 mg/kg) Calcitriol 2 mcg/ml A11CC04000P300 secondary 241. A* to 2 mg 3 times weekly, Injection 2XX hyperparathyroidism in approximately every other patients undergoing chronic day renal dialysis ADULT:Typical oral doses of calcium carbonate range from about 3gm to 7gm daily in divided dose. US National Foundation suggest the i) Elemental calcium calcium-based phosphate Calcium Carbonate 500 A12AA04121C100 supplementation ii) 242. B binder should not exceed mg Capsule 1XX Phosphate binder in chronic 1.5gm daily in those with renal failure patients kidney failure. CHILD (12-18 years old): 1.25gm 3 or 4 times daily with or before meals and adjusted as necessary. To be used only for elemental calcium Calcium Carbonate 500 A12AA04121T1001 supplementation and Initial 2.5 g daily and 243. B mg Tablet XX phosphate binding activity increased up to 17 g daily in patients with chronic renal failure The maximum infusion rate Calcium Chloride depends on the needs of the Dihydrate, Sodium Replacement of patient in fluid replacement Chloride, Magnesium extracellular fluid losses in and electrolytes, patient?s Chloride Hexahydrate, B05BB01905P6002 244. A the case of isotonic weight, clinical condition, and Sodium Acetate XX dehydration, where acidosis biological status. Adults, Trihydrate,Potassium is present or imminent. elderly, adolescents:500ml- Chloride, and Malic Acid 3L/24hr. Babies, children: Solution 20ml to 100ml/kg/24 hr. IM (Lead encephalopathy): 1000 mg/m(2)/day IM in divided equal doses 8 to 12 hours apart, for 5 days. Therapy is interrupted for 2 to 4 days, and followed by an additional 5-day course of Calcium Disodium V03AB03999P3001 therapy, if indicated. Do not 245. A Lead Poisoning Edetate 200 mg Injection XX exceed the recommended daily dosage. IV: 1000 mg/m(2)/day administered IV over 8 to 12 hours for 5 days. Therapy is interrupted for 2 to 4 days, and followed by an additional 5-day course of therapy, if indicated.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) 1-2 g (2.25-4.5 mmol). CHILD 50 mg/kg ii) ADULT 1g (2.2 mmol) by i)Acute hypocalcaemia Calcium Gluconate 10% A12AA03000P3001 slow IV injection followed by 246. B ii)Hypocalcaemic tetany Injection XX continuous infusion of 4 g iii)Cardiac resuscitation (8.8 mmol) daily iii) IV or intracardiac injection, 10 ml For prophylaxis of calcium Calcium Lactate 300 mg A12AA05125T1001 ADULT 1-5 g daily in divided 247. C deficiency and treatment of Tablet XX doses chronic hypocalcaemia 15 - 30g daily in 2-3 divided Hyperkalemia resulting from doses. Each dose should be Calcium Polystyrene V03AE01999F2101 248. A acute or chronic renal suspended in 30 - 50ml of Sulphonate Powder XX failure water and administered orally i) Metastatic breast cancer in elderly and poor i) & ii) 1250 mg/m2 twice performance status patients daily (morning and evening) and refractory to taxanes. for 2 weeks, every 21 days. ii) Metastatic colon cancer, iii) Recommended for a total first line in elderly and poor of 24 weeks (8 cycles of 2 performance status weeks of drug administration Capecitabine 150 mg L01BC06000T1002 patients. and 1 week rest period. 249. A* Tablet XX iii) Colon cancer, adjuvant iv) In combination with a therapy for stage III (Duke's platinum on day 1, give Stage C) following surgery. capecitabine 1250 mg/m2 iv) First line treatment of twice daily for 14 days. patients with advanced Repeated every 3 weeks for gastric cancer in 8 cycles or optimum number combination with a of cycles platinum-based regimen i) Metastatic breast cancer i) & ii) 1250 mg/m2 twice in elderly and poor daily (morning and evening) performance status patients for 2 weeks, every 21 days and refractory to taxanes iii) Recommended for a total ii) Metastatic colon cancer, of 24 weeks (8 cycles of 2 first line in elderly and poor weeks of drug administration performance status patients Capecitabine 500 mg L01BC06000T1001 and 1 week rest period 250. A* iii) Colon cancer, adjuvant Tablet XX iv) In combination with a therapy for stage III (Duke's platinum on day 1, give Stage C) following surgery capecitabine 1250 mg/m2 iv) First line treatment of twice daily for 14 days. patients with advanced Repeated every 3 weeks for gastric cancer in 8 cycles or optimum number combination with a of cycles platinum-based regimen

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Initially 12.5 mg twice daily. Maintenance: 25-50 mg 2 - 3 times daily, may be increased to maximum 450 mg/day in divided doses ii) Initially 6.25 - 12.5 mg 3 times daily, increase after i) Hypertension several days to 25 - 50 mg 3 ii) Congestive heart failure times daily C09AA01000T1002 251. Captopril 25 mg Tablet B iii) Post-myocardial iii) Start 3 days after MI XX infarction Initially 6.25 mg daily, iv) Diabetic nephropathy gradually increased to 37.5 mg daily in divided doses. May increase after several week to 150 mg/day in divided doses if needed and tolerated iv)75 - 100 mg daily in divided dose. Instill no more than 0.5 ml Carbachol 0.01% S01EB02100D200 For intraocular use for 252. A gently into the anterior Intraocular Solution 1XX miosis during surgery chamber ADULT: Initially, 100-200 mg once or twice daily gradually increased by increments of 100-200 mg every 2 week. Maintenance: 0.8-1.2 g daily in divided doses. CHILD: 10- Carbamazepine 100 mg/5 N03AF01000L9001 15 years: 0.6-1 g daily; 5-10 253. A Epilepsy ml (2% w/v) Syrup XX years: 400-600 mg daily; 1-5 years: 200-400 mg daily; less than or equal to 1 year: 100- 200 mg daily. Alternatively, 10-20 mg/kg body weight daily in divided doses. Max: Adult: 1.6 g daily ADULT: Initial, 200 mg twice daily for the first week, may increase dosage by 200 mg/day at weekly intervals until optimal response is Carbamazepine 200 mg N03AF01000T5001 obtained. Maximum 1.6 254. A Epilepsy CR Tablet XX g/day. CHILD: usual maximum dosage 1000 mg/day in children 12-15 years of age, 1200 mg/day in patients above 15 years of age

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) ADULT: 100 - 200 mg 1 - 3 times daily increased gradually to usual dose of 0.8 - 1.2 g daily in divided doses. CHILD: Up to 1 year: 100 - 200 mg daily; 1 - 5 yrs: 200 - 400 mg daily; 5 - 10 years: 400 - 600 mg daily; 10 - 15 years: 0.6 - 1 g daily ii) The initial dosage of 200 Carbamazepine 200 mg N03AF01000T1001 i) Epilepsy 255. B to 400mg should be slowly Tablet XX ii) Trigeminal neuralgia raised daily until freedom from pain is achieved (normally at 200mg 3 to 4 times daily). The dosage should then be gradually reduced to the lowest possible maintenance level. In elderly patients, an initial dose of 100mg twice daily is recommended. ADULT: Initial, 200 mg twice daily for the first week, may increase dosage by 200 mg/day at weekly intervals until optimal response is Carbamazepine 400 mg N03AF01000T5002 obtained. Maximum 1.6 256. A Epilepsy CR Tablet XX g/day. CHILD: usual maximum dosage 1000 mg/day in children 12-15 years of age, 1200 mg/day in patients above 15 years of age Contact irritant dermatitis, Apply sparingly and rub into infantile eczemas, acute Carbamide (Urea) 10 % D02AE01000G100 affected area 2 - 3 times 257. B and chronic allergic Cream 1XX daily and when required after eczemas, icthyosis, cleansing skin hyperkeratotic A single IV dose of 100mcg (1ml) is adminitered by bolus Prevention of uterine atony injection, slowly over and postpartum 1minute, only when delivery Carbetocin 100 mcg/ ml H01BB03000P200 hemorrhage following 258. A* of the infant has been Injection 1XX elective cesarean section completed by caesarean under epidural or spinal section under epidural or anaesthesia spinal anaesthesia, before or after delivery of the placenta. ADULT: Initially, 10-60mg daily in divided doses given 8 H03BB01000T1001 259. Carbimazole 5 mg Tablet B Hyperthyroidism hourly. Maintenance: 5 to XX 20mg daily. CHILDREN > 6 years: Initially 15mg daily in

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber divided doses. CHILDREN 1- 6 years: Initially 7.5mg daily in divided doses

360 - 400 mg/m2 BSA, by IV infusion over 15 mins to 1 hour on Day 1 every 4 weeks. Alternatively, prescription may be based Adult solid tumours, on Area Under Curve (AUC) Carboplatin 150 mg L01XA02000P4001 260. A* paediatric tumours. Salvage calculations. CHILD: 500-600 Injection XX therapy for lymphoma mg/m2 over 1 hour once every 3 weeks. Salvage regimes in lymphomas - refer to specific protocols. Starting dose in renal impairment, please refer to product insert. 360 - 400 mg/m2 BSA, by IV infusion over 15 mins to 1 hour on Day 1 every 4 weeks. Alternatively, prescription may be based Adult solid tumours, on Area Under Curve (AUC) Carboplatin 450 mg L01XA02000P4002 261. A* paediatric tumours. Salvage calculations. CHILD: 500-600 Injection XX therapy for lymphoma mg/m2 over 1 hour once every 3 weeks. Salvage regimes in lymphomas - refer to specific protocols. Starting dose in renal impairment, please refer to product insert. Initially 250 mcg deep IM inj. The dose may be repeated Carboprost Tromethamine G02AD04999P300 Postpartum haemorrhage 262. A* at intervals of 15-90 min if 250 mcg Injection 1XX refractory to oxytocin necessary. Max total dose: 2 mg. Dilute 20 ml to 1 L of Ringer solution (cooled to 2-8 °C prior to use). Initial rapid Cardioplegia solution For myocardial instillation into aortic root at containing Potassium B05XA16934P3001 preservation(prevent 300 ml/m² body surface 263. Chloride, Magnesium A* XX myocardial damage) during area/min for 3 minutes. chloride & Procaine HCl cardiac surgery Should myocardial activity Injection persist or recur instill at 300ml/m² body surface area/min for 2 minutes 3.125 mg twice daily for 2 Treatment of stable weeks, then 6.25 mg twice moderate to severe C07AG02000T100 daily for 2 weeks, then 12.5 264. Carvedilol 25 mg Tablet A/KK congestive cardiac failure in 2XX mg twice daily for 2 weeks addition to ACEI's and then 25 mg twice daily diuretics (titrated up to the highest

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber tolerated level). Max: <85 kg: 25 mg bid; >85 kg: 50 mg bid.

3.125 mg twice daily for 2 weeks, then 6.25 mg twice Treatment of stable daily for 2 weeks, then 12.5 moderate to severe mg twice daily for 2 weeks C07AG02000T100 265. Carvedilol 6.25 mg Tablet A/KK congestive cardiac failure in then 25 mg twice daily 1XX addition to ACEI's and (titrated up to the highest diuretics tolerated level). Max: <85 kg: 25 mg bid; >85 kg: 50 mg bid. i) Confirmed systemic fungal infection in patients who are refractory or intolerant to other fungal therapies. ii) For pediatric patient (12 month and older) for the i) Invasive aspergillosis & following indications : invasive candidiasis: ADULT: a) Empirical therapy for Initially, 70 mg infused over 1 presumed fungal infections hour followed by subsequent in febrile, neutropenic doses of 50 mg/day. patients Oesophageal candidiasis: Caspofungin Acetate 50 J02AX04122P4001 b) Treatment of invasive 266. A* ADULT: 50 mg by slow IV mg Injection XX candidiasis, including infusion over approximately 1 candidemia and the hour following Candida infections ii) For all indications, a ; intra-abdominal loading dose of 70mg/m2 on abscesses, peritonitis and D1 followed by maintenance pleural space infections dose of 50mg/m2 od. c) Treatment of esophageal candidiasis d) Treatment of invasive Aspergillosis in patients who are refractory to or intolerant of others therapy (eg : Amphotericin B)

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber For adult and pediatric patient (12 month and i) Invasive aspergillosis & older) for the following invasive candidiasis: ADULT: indications: Initially, 70 mg infused over 1 a) Treatment of invasive hour followed by subsequent candidiasis, including doses of 50 mg/day. candidemia and the Oesophageal candidiasis: following Candida infections ADULT: 50 mg by slow IV ; intra-abdominal infusion over approximately 1 Caspofungin Acetate 70 J02AX04122P4002 267. A* abscesses, peritonitis and hour daily mg Injection XX pleural space infections ii) Child (12months to 17 b) Treatment of invasive years) : For all indication) A Aspergillosis in patients single 70mg/m2 loading dose who are refractory to or (not to exceed an actual intolerant of others therapy dose of 70mg) by slow IV (eg : Amphotericin B) infusion over 1hour; followed c) Treatment of esophageal by 50mg/m2 (not to exceed candidiasis (need to follow an actual dose of 70mg) the current indications) Infections caused by susceptible organisms CHILD:>1 mth: 20 mg/kg including Staphylococcus daily in 3 divided doses, aureus and H. influenzae, increased to 40 mg/kg daily if Cefaclor 125 mg/5 ml J01DC04000F2101 268. A treatment of sinusitis and necessary, <1 yr: 62.5 mg Suspension XX infections involving the tid, 1-5 yr: 125 mg tid, >5 yr: respiratory tract, skin and 250 mg tid. Maximum: 1 g skin structure, bone and daily joint, and urinary tract i) Adult pharyngitis, i) 375 mg twice daily tonsillitis, skin& soft tissue ii) 375 mg or 500 mg twice Cefaclor 375 mg MR J01DC04010T5001 infections daily 269. A Tablet XX ii) Bronchitis iii) 750mg twice daily iii) Pneumonia iv) 375mg twice daily or 500 iv) Lower UTI mg once daily ADULT: 250 mg 3 times daily Infections caused by for 10 days. For severe susceptible organisms infections, double the including Staphylococcus dosage. Maximum: 4 g daily. aureus and H. influenzae, CHILD:>1 mth: 20 mg/kg J01DC04000C1002 270. Cefaclor 500 mg Capsule A treatment of sinusitis and daily in 3 divided doses, XX infections involving the increased to 40 mg/kg daily if respiratory tract, skin and necessary, <1 yr: 62.5 mg skin structure, bone and tid, 1-5 yr: 125 mg tid, >5 yr: joint, and urinary tract 250 mg tid . Maximum: 1 g daily

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber ADULT: Uncomplicated Infection caused by infections: 500 - 1000 mg 2 - cefazolin-sensitive 3 times daily. Moderately microorganism, infection of severe and severe infections: the respiratory tract, 500 - 1000 mg 3 - 4 times Cefazolin Sodium 1 g J01DB04520P3001 urogenital tract, skin and 271. A daily. Severe life-threatening Injection XX soft tissue, bile duct, bones infections: 1 - 1.5 g 4 times and joint, endocarditis, daily. Rarely, dose up to 12 g systemic septic infection, daily. CHILDREN >1 month: peri-operative/ surgical 25-50mg/kg/day in 3-4 prophylaxis divided dose Febrile neutropenia, ADULT: 1 - 2 g twice daily for septicaemia, lower most infections. For severe respiratory tract infection, infections including febrile J01DE01110P4002 urinary tract infection, skin 272. Cefepime 1 g Injection A* neutropenia: 2 g 3 times XX and skin structure daily. CHILD:2 mth - 16 yr: infections, gynaecologic ≤40 kg: 50 mg/kg every 8-12 and intra-abdominal hr for 7-10 days infections Febrile neutropenia, ADULT: 1 - 2 g twice daily for septicaemia, lower most infections. For severe respiratory tract infection, infections including febrile Cefepime 500 mg J01DE01110P4001 urinary tract infection, skin 273. A* neutropenia: 2 g 3 times Injection XX and skin structure daily. CHILD: 2 mth - 16 yr: infections, gynaecologic ≤40 kg: 50 mg/kg every 8-12 and intra-abdominal hr for 7-10 days infections ADULT: 1 - 2 g twice daily IM or IV. By IV, adult dose may be doubled. Maximum: 16 g daily in divided doses. Cefoperazone Sodium 1 g J01DD12520P4002 Infections due to gram- 274. A CHILD & INFANT: 50 - 200 Injection XX negative bacteria mg/kg/day in 2 - 4 divided doses. NEONATE less than 8 days: 50 - 200 mg/kg/day 12 hourly ADULT: 1 - 2 g twice daily IM or IV. By IV, adult dose may be doubled. Maximum: 16 g daily in divided doses. Cefoperazone Sodium 2 g J01DD12520P4003 Infections due to gram- 275. A CHILD & INFANT: 50 - 200 Injection XX negative bacteria mg/kg/day in 2 - 4 divided doses. NEONATE less than 8 days: 50 - 200 mg/kg/day 12 hourly

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber ADULT: 1 - 2 g twice daily. In severe or refractory infections the daily dosage of i) Treatment of infections sulbactam/cefoperazone due to multi-drug resistance may be increased up to 8g Cefoperazone Sodium pathogens producing B- J01DD62000P4001 (4g cefopreazone activity) 276. 500 mg & Sulbactam A lactamase XX CHILD: 40 - 80 mg/kg/day in Sodium 500 mg Injection ii) Treatment of infections 2 to 4 equally divided doses; caused by Acinetobacter in serious or refractory species infections, may increase to 160mg/kg/d in 2 - 4 equally divided doses. ADULT: 1 - 2 g twice daily IM or IV. By IV, adult dose may be doubled. Maximum: 16 g daily in divided doses. Cefoperazone Sodium J01DD12520P4001 Infections due to gram- 277. A CHILD & INFANT: 50 - 200 500 mg Injection XX negative bacteria mg/kg/day in 2 - 4 divided doses. NEONATE less than 8 days: 50 - 200 mg/kg/day 12 hourly ADULT: 1 g 12 hourly (up to J01DD01520P4002 Infections due to gram- 12 g/day in severe cases). 278. Cefotaxime 1 g Injection A XX negative bacteria CHILD: 50 - 180 mg/kg/day in 4 - 6 divided doses ADULT: 1 g 12 hourly (up to Cefotaxime 500 mg J01DD01520P4001 Infections due to gram- 12 g/day in severe cases). 279. A Injection XX negative bacteria CHILD: 50 - 180 mg/kg/day in 4 - 6 divided doses 600mg administered every 12 hours by intravenous infusion over 60 minutes for 5-14 days. Dose adjustment in renal impairment: - CrCl > 30 to ≤50 ml/min : Treatment of complicated 400mg (IV) every 12 hours skin and soft tissue (over 60 minutes) Ceftaroline Fosamil infections (cSSTI) in adults - CrCl ≥ 15 ≤ 30 ml/min: 600mg Powder for J01D102000P4001 Restriction: Restricted for 280. A* 300mg (IV) every 2 hoours concentrate for solution XX only complicated SSTI in (over 60 minutes) for infusion patients who are unable to - CrCl < 30ml/min including tolerate or not responding hemodialysis to vancomycin. *: 200mg (IV) every 12 hours (over 60 minutes) * Ceftaroline is hemodialyzable, thus should be administered after hemodialysis. ADULT: 1 g 8 hourly or 2 g J01DD02520P4003 Severe gram negative 281. Ceftazidime 1 g Injection A 12 hourly. In severe XX bacterial infections infections: 2 g 8 hourly.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber CHILD: 25 - 150 mg/kg/day in 2 - 3 divided doses

ADULT: 1 g 8 hourly or 2 g 12 hourly. In severe J01DD02520P4004 Severe gram negative 282. Ceftazidime 2 g Injection A infections: 2 g 8 hourly. XX bacterial infections CHILD: 25 - 150 mg/kg/day in 2 - 3 divided doses ADULT: 1 g 8 hourly or 2 g 12 hourly. In severe Ceftazidime 250 mg J01DD02520P4001 Severe gram negative 283. A infections: 2 g 8 hourly. Injection XX bacterial infections CHILD: 25 - 150 mg/kg/day in 2 - 3 divided doses ADULT: 1 g 8 hourly or 2 g 12 hourly. In severe Ceftazidime 500 mg J01DD02520P4002 Severe gram negative 284. A infections: 2 g 8 hourly. Injection XX bacterial infections CHILD: 25 - 150 mg/kg/day in 2 - 3 divided doses i) 250 mg by deep IM injection Ceftriaxone 0.25 g J01DD04520P4001 i) Gonorrhoea 285. A/KK ii) single IM injection 250 mg Injection XX ii) Chancroid only. For severe infection up to 100 mg/kg/day ADULT: 1 - 2 g once daily. Severe infection: 4 g daily at 12 hour intervals. INFANT & CHILD, 3 weeks - 12 years: 20 - 80 mg/kg body weight J01DD04520P4002 Infections caused by 286. Ceftriaxone 0.5 g Injection A daily. CHILD with body XX susceptible organisms weight 50 kg or more: adult dose. NEONATE up to 2 weeks: 20 - 50 mg/kg body weight daily, not to exceed 50 mg/kg ADULT: 1 - 2 g once daily. Severe infection: 4 g daily at 12 hour intervals. INFANT & CHILD, 3 weeks - 12 years: 20 - 80 mg/kg body weight J01DD04520P4003 Infections caused by 287. Ceftriaxone 1g Injection A daily. CHILD with body XX susceptible organisms weight 50 kg or more: adult dose. NEONATE up to 2 weeks: 20 - 50 mg/kg body weight daily, not to exceed 50 mg/kg ADULT: 250 mg twice daily Upper and lower respiratory ;UTI: 125 mg twice daily. Cefuroxime Axetil 125 mg J01DC02233T1001 tract, genito-urinary tract, 288. A/KK CHILD:30 mg/kg/day in 2 Tablet XX skin & soft tissue and divided doses, up to 500 mg urinary tract infections (UTI) daily

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Cefuroxime Axetil 125 J01DC02233F2101 Infections caused by 30 mg/kg/day in 2 divided 289. A mg/5 ml Suspension XX susceptible organisms doses, up to 500 mg daily. ADULT: 250 mg twice daily Upper and lower respiratory ;UTI: 125 mg twice daily. Cefuroxime Axetil 250 mg J01DC02233T1002 tract, genito-urinary tract, 290. A/KK CHILD:30 mg/kg/day in 2 Tablet XX skin & soft tissue and divided doses, up to 500 mg urinary tract infections (UTI) daily ADULT: 750 mg every 6 - 8 hours as IM or IV. Severe infections: 1.5 g every 6 - 8 Infections caused by Cefuroxime Sodium 1.5 g J01DC02520P4003 hours as IV. CHILD: 30 - 100 291. A susceptible organisms, Injection XX mg/kg/day in 3 - 4 divided surgical prophylaxis doses or 2-3 divided doses in neonates. Surgical prophylaxis: 1.5 g IV ADULT: 750 mg every 6 - 8 hours as IM or IV. Severe infections: 1.5 g every 6 - 8 Infections caused by Cefuroxime Sodium 250 J01DC02520P4001 hours as IV. CHILD: 30 - 100 292. A susceptible organisms, mg Injection XX mg/kg/day in 3 - 4 divided surgical prophylaxis doses or 2-3 divided doses in neonates. Surgical prophylaxis: 1.5 g IV ADULT: 750 mg every 6 - 8 hours as IM or IV. Severe infections: 1.5 g every 6 - 8 Infections caused by Cefuroxime Sodium 750 J01DC02520P4002 hours as IV. CHILD: 30 - 100 293. A susceptible organisms, mg Injection XX mg/kg/day in 3 - 4 divided surgical prophylaxis doses or 2-3 divided doses in neonates. Surgical prophylaxis: 1.5 g IV i) ADULTS: 200 mg once daily. May increase to 200 mg bid, if necessary. CHILD not recommended ii) 100mg twice daily, increased if necessary to 200 mg 2 times daily; CHILD not recommended iii) 400mg as i) Osteoarthritis ii) a single dose on first day Celecoxib 200 mg M01AH01000C100 Rheumatoid Arthritis iii) 294. A followed by 200mg once Capsule 1XX Acute pain iv) Ankylosing daily on subsequent days iv) Spondylitis Initial, 200 mg once daily or 100 mg twice daily; if no effect after 6 weeks, may increase to max. 400 mg daily in 1-2 divided doses. If no response following 2 weeks of treatment with 400 mg/day, consider

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber discontinuation and alternative treatment i) ADULTS: 200 mg once daily. CHILD not recommended ii) 100 mg twice daily, increased if necessary to 200 mg 2 times daily; CHILD not recommended iii) 400 mg as a single dose on first day followed by 200 i) Osteoarthritis mg once daily on subsequent Celecoxib 400 mg M01AH01000C100 ii) Rheumatoid Arthritis 295. A* days Capsule 2XX iii) Acute pain iv) Ankylosing iv) Initial, 200 mg once daily Spondylitis or 100 mg twice daily; if no effect after 6 weeks, may increase to max. 400 mg daily in 1-2 divided doses. If no response following 2 weeks of treatment with 400 mg/day, consider discontinuation and alternative treatment Respiratory tract infections, ear, nose and throat CHILD: 25 - 100 mg/kg/day Cephalexin Monohydrate J01DB01010F2101 296. B infections, urinary tract every 6 hourly. Maximum: 4 125 mg/5 ml Syrup XX infections, obstetric and g daily gynaecologic infections i) Respiratory tract infection, i) 250 mg 6 hourly ii) 250 - urinary tract infection 500 mg 6 hourly iii) 1 - 1.5 g Cephalexin Monohydrate J01DB01010C1001 ii) Complicated, recurrent or 3 times daily or 4 times daily. 297. B 250 mg Capsule XX chronic infections, Maximum: 6 g/day Child: 25- bronchitis 100 mg/kg daily in divided iii) Pneumonia doses. Max: 4 g daily. i) 250 mg 6 hourly i) Respiratory tract infection, ii) 250 - 500 mg 6 hourly urinary tract infection iii) 1 - 1.5 g 3 times daily or 4 Cephalexin Monohydrate J01DB01010T1001 ii) Complicated, recurrent or 298. B times daily. Maximum: 6 250 mg Tablet XX chronic infections, g/day Child: 25-100 mg/kg bronchitis daily in divided doses. Max: iii) Pneumonia 4 g daily. i) 250 mg 6 hourly i) Respiratory tract infection, ii) 250 - 500 mg 6 hourly urinary tract infection iii) 1 - 1.5 g 3 times daily or 4 Cephalexin Monohydrate J01DB01010C1002 ii) Complicated, recurrent or 299. B times daily. Maximum: 6 500 mg Capsule XX chronic infections, g/day Child: 25-100 mg/kg bronchitis daily in divided doses. Max: iii) Pneumonia 4 g daily.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) 250 mg 6 hourly i) Respiratory tract infection, ii) 250 - 500 mg 6 hourly urinary tract infection iii) 1 - 1.5 g 3 times daily or 4 Cephalexin Monohydrate J01DB01010T1002 ii) Complicated, recurrent or 300. B times daily. Maximum: 6 500 mg Tablet XX chronic infections, g/day Child: 25-100 mg/kg bronchitis daily in divided doses. Max: iii) Pneumonia 4 g daily. ADULT and CHILD over 6 Urticaria, allergic years:10 mg daily or 5 mg Cetirizine HCl 10 mg R06AE07110T1001 dermatoses (insect bites, 301. A/KK twice daily. Child 2-6 years: 5 Tablet XX atopic eczema), perennial mg once daily or 2.5 mg rhinitis, allergic rhinitis twice daily D08AJ04000L6001 As shampoo and cleansing 302. Cetrimide 1-2% Lotion. C+ Apply to affected area XX agent Prevention of premature Given by SC 0.25 mg/day, ovulation in patients given either in the morning undergoing a controlled beginning on the day 5 or 6 Cetrorelix 0.25 mg H01CC02122P400 303. A* ovarian stimulation, of ovarian stimulation or in Injection 1XX followed by oocyte pick-up the evening beginning on and assisted reproductive day 5, and continued until techniques ovulation induction For neo-adjuvant treatment of KRAS wild type metastatic colorectal cancer with the aim of liver resection with the following Administered once a week. conditions: The very first dose is 400mg i) The primary colorectal cetuximab per m2 body tumour has been resected surface area with a or is potentially resected. recommended infusion ii) The metastatic disease is period of 120 minutes. All Cetuximab 5 mg/ml L01XC06000P5002 confined to the liver and is 304. A* subsequent weekly doses Solution for Infusion XX unresectable are 250mg per m2 body iii) The patient is fit enough surface area each with a to undergo surgery to recommended infusion resect the primary period of 60 minutes. The colorectal tumour and to maximum infusion rate must undergo liver surgery if the not exceed 10mg/min. metastases become resectable after treatment with cetuximab. iv)The treatment is limited to 16 weeks

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) ADULT 0.5-1 g given 3-4 times daily. CHILD half adult dose. ii) Need to be dissolved in liquid (slurry consistency). ADULT and CHILD over 12 years: initial 30-100 g or 1-2 g/kg; repeat i) Diarrhoea and food initial dose as soon as poisoning possible or 20-50 g every 2-6 Charcoal, Activated 250 A07BA01000T1001 ii) Reduce absorption of hours. CHILD over 1-12 305. C mg Tablet XX drugs, plant, inorganic years, 25-50 g or 1-2 g/kg; poison and chemicals in may repeat half the initial poisoning cases dose every 2-6 hour as needed. CHILD to 1 year of age, 1 g/kg; may repeat half the initial dose every 2-6 hours as needed. For maximum efficacy administer within 1 hour after ingestion of toxic compound ADULT:Acute poisoning: 50 - 100g in suspension. Severe Emergency treatment of Charcoal, Activated 50 g A07BA01000F1001 poisoning: 50 - 100g as an 306. A acute oral poisoning and Granules XX initial dose followed by 20g drug overdose every 4 - 6 hours. CHILDREN: 1g/kg/dose ADULT : 0.5 - 1 g (max 2 g) with plenty of water at bedtime. CHILD : Neonate: 30-50 mg/kg; up to 100 mg/kg may be used with respiratory monitoring. 1 Chloral Hydrate 200 mg/5 N05CC01010L210 mth-12 yr: 30-50 mg/kg 307. B Preoperative sedation ml Mixture 1XX (max: 1 g); up to 100 mg/kg (max: 2 g) may be used; 12- 18 yr: 1-2 g. Doses to be taken 45-60 minutes before procedure. May be given rectally if oral route is not available. General : Initial :0.1 -0.2 mg/kg body weight daily for 4 - 8 weeks maintanance : given either by reduced daily dosage or intermittent course Low grade lymphoma, L01AA02000T1001 of treatment. Chronic 308. Chlorambucil 2 mg Tablet A chronic lymphocytic XX Lymphocytic Leukaemia: leukaemia. Ovarian cancer initial : 0.15mg/kg/day untill total leukocyte count has fallen to 10,000peruL, then resumed treatment untill 4 weeks after the end of the

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber first course then continued at a dosage 0.1mg/kg/day. Instill 1 drop of a 0.5% solution every 2 hr. Increase Chloramphenicol 0.5% S01AA01000D200 Broad spectrum antibiotic in dosage interval upon 309. C Eye Drops 1XX superficial eye infections improvement. To continue treatment for at least 48 hr after complete healing Treatment of ocular ADULT and CHILD : Apply to infections involving the the conjunctiva, a thin strip Chloramphenicol 1% Eye S01AA01000G510 310. C conjunctiva and/or cornea (approximately 1 cm) of Ointment 1XX caused by chloramphenicol ointment every 3 hours or susceptible organisms more frequently CHILD: 25 - 50 mg/kg/day in 4 divided doses. Severe infections, premature& full- Typhoid fever, salmonella term infants less than 2 Chloramphenicol 125 J01BA01126L8001 infections, meningitis, 311. B weeks: 25mg/kg/day in mg/5 ml Suspension XX cholera, anaerobic and divided doses. Full-term rickettsial infections infants more than 2 weeks: up to 50mg/kg/day in divided doses ADULT: 500 mg 4 times daily Treatment of typhoid, or 50 mg/kg/day in 4 divided Chloramphenicol 250 mg J01BA01126C1001 paratyphoid fevers, 312. B doses. Maximum dose: 4 Capsule XX bronchopneumonia and g/day. CHILD: 25 - 100 enteric infection mg/kg/day in 4 divided doses Apply 2 - 3 drops into the ear Chloramphenicol 5% w/v S02AA01000D100 Acute otitis media, otitis 313. C 2 - 3 times daily. Not to be Ear Drops 1XX externa with perforation used for long term Adult:50 to 100 mg/kg/day in 4 divided doses. Premature and full-term neonates: 25 Treatment of typhoid, mg/kg/day in 4 divided Chloramphenicol Sodium J01BA01520P4001 paratyphoid fevers, 314. B doses. Full-term infants >2 Succinate 1 g Injection XX bronchopneumonia and wk: 50 mg/kg/day in 4 enteric infection divided doses. Children: 50- 100 mg/kg/day in 4 divided doses Pre-op surgical hand disinfection: Spread 5ml throughly over both hands and forearms, rubbing vigorously. When dry apply a Chlorhexidine 1:200 in further 5ml and repeat D08AC52137L9901 To be used undiluted for 315. Alcohol with Emollient C+ procedure. Antiseptic hand XX hand and skin disinfections (Hand Disinfectant). disinfection on the ward: Spread 3ml throughly over the hands and wrist rubbing vigorously until dry. Disinfection of patient's skin: Prior to surgery, apply to a

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber sterile swab and rub thoroughly over the operation site for a minimum of 2 mins Chlorhexidine Gluconate R02AA05137M200 Rinse mouth with 10 ml for 316. C As a gargle 0.2 % Mouthwash 1XX about 1 minute twice daily Skin Preparation:Use Chlorhexidine Gluconate 2% in Isopropyl Alcohol 70% and Chlorhexidine Gluconate Use as disinfectant in D08AC52137L9902 allow to dry. Catheter 317. 2% in Alcohol 70% C central venous catheter XX acces:Apply to catheter ports Solution care bundle or hubs prior to accessing the line for administering fluids or injections Surgical hand disinfection: Apply 5ml to clean hands and forearms for 1 min. Rinse and repeat with Surgical hand Chlorhexidine Gluconate D08AC02137M990 another 5ml for a further 2 318. C+ scrub/disinfection, pre-op 4% Scrub 1XX mins and then rinse and dry. skin preparation General skin disinfection: Apply appropriate quantity to wet area and scrub for 1 min. Rinse thoroughly & dry i) Preoperative skin disinfection Chlorhexidine Gluconate D08AC02137L9901 i) & iii) 1 : 10 in 70 % Alcohol 319. C+ ii) Wounds or burns 5% Solution XX ii) 1 : 100 iii) Emergency disinfection of instruments V07AV00000F9901 320. Chlorinated Lime Powder C Antiseptic and disinfectants Not applicable XX Chlorinated Lime Solution Apply to affected areas D08A000999G990 321. & Buffered Acetate C Wound or ulcer undiluted as a cleansing 1XX Solution agent ADULT 600 mg base stat, 300 mg 6 - 8 hours later and a further 300 mg on each of 2 following days. CHILD 3 - 4 Chloroquine Phosphate P01BA01162T1001 Treatment of malaria - years : 150 mg base stat, 75 322. 250 mg Tablet (150 mg C XX acute attack mg 6 hours later, then 75 mg Chloroquine base) daily for 2 days. CHILD 5 - 8 years : 300 mg stat, 150 mg 6 hours later, then 150 mg daily for 2 days 10 - 20 mg IM or SC, Chlorpheniramine repeated if required. Not to R06AB04253P300 323. Maleate 10 mg/ml B Allergic conditions exceed 40 mg in 24 hours. 1XX Injection 10 - 20 mg over 1 minute by slow IV

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber CHILD 2 - 5 years : 1 mg Symptomatic treatment of every 4 - 6 hours (maximum Chlorpheniramine R06AB04253L9001 324. C allergic conditions 6 mg daily) 6 - 12 years : 2 Maleate 2 mg/5 ml Syrup XX responsive to antihistamine mg every 4 - 6 hours (maximum 12 mg daily) ADULT : 4 mg every 4 - 6 hours. Maximum 24 mg Symptomatic treatment of daily. CHILD 2 - 5 years : 1 Chlorpheniramine R06AB04253T1001 allergic conditions mg every 4 - 6 hours 325. C Maleate 4 mg Tablet XX responsive to (maximum 6 mg daily) 6 - 12 antihistamines years : 2 mg every 4 - 6 hours (maximum 12 mg daily) ADULT : Initial dose - 25 mg 3 times daily according to response up to 1 g daily. PAEDIATRIC: Up to 5 years: Chlorpromazine HCl 100 N05AA01110T1002 Psychosis mania and 326. B 0.5 mg/kg body weight every mg Tablet XX agitation 4 - 6 hours (Maximum 40 mg daily). CHILD 6 - 12 years: A third to half adult dose (Maximum 75 mg daily) ADULT : Initial dose - 25 mg 3 times daily according to response up to 1 g daily. PAEDIATRIC: Up to 5 years: Chlorpromazine HCl 25 N05AA01110T1001 Psychosis mania and 327. B 0.5 mg/kg body weight every mg Tablet XX agitation 4 - 6 hours (Maximum 40 mg daily). CHILD 6 - 12 years: A third to half adult dose (Maximum 75 mg daily) Apply thin strip Chlortetracycline 1% Eye S01AA02000G510 Eye infections requiring a (approximately 1 cm) to the 328. B Ointment 1XX broad spectrum antibiotic conjuctiva 2 to 4 hourly or more frequently. Apply directly to affected Chlortetracycline 1-3 % D06AA02000G100 329. B Bacterial skin infections area twice daily as required Cream 1XX for 1 - 2 weeks Prophylactic ADULT: First dose of 0.5 ml SC/IM followed after 1 - 4 weeks by a second dose of 1 ml. CHILD: 1 - 5 years: 0.1 ml (1st dose), 0.3 ml (2nd J07AE01000P3001 330. Cholera Vaccine B Immunisation of cholera dose). CHILD; 5 - 10 years: XX 0.3 ml (1st dose), 0.5ml (2nd dose). Booster: For optimum long-term protection, a booster dose is recommended for adults after 2 years. Children 2-6

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber years should receive a booster dose after 6 months. i) Hypercholesterolemia ii) Familial hypercholesterolemia - Hypercholesterolemia: heterozygous Adjunct: initial, 4 g orally 1-2 iii) Generalized C10AC01000M400 times daily, maintenance, 8 331. Cholestyramine Resin 4 G A atherosclerosis 1XX to 16 g in divided doses, max iv) Diarrhoea due to bile 24 g daily CHILD: 50 - 150 acid malabsorption mg/ kg 6 - 8 hourly oral v) Pruritus of skin associated with partial biliary obstruction For relief of the pain and Choline Salicylate 8.7%, N02BA03900G300 discomfort in mouth ulcers 332. Cetylkonium Chloride B Apply to area 4 times daily 1XX and sores, infant teething 0.01% Dental Gel and denture irritation i) Women undergoing superovulation prior to 250 mcg 24-48 hour after the Choriogonadotropin Alfa assisted reproductive last administration of an FSH G03GA01000P500 333. 250 mcg/0.5 ml Injection A* techniques such as in-vitro or hMG preparation, when 1XX in Prefilled Syringe fertilization (IVF) optimal stimulation of ii) Anovulatory or oligo- follicular growth is achieved. ovulatory women i) & ii) Induction of ovulation: 5000 - 10,000 units one day i)Treatment of infertile following last dose of Chorionic Gonadotrophin women to induce ovulation G03GA01000P400 menotropin. Up to 3 repeat 334. Human (HCG) 5000 IU A* ii) As a luteal support in 1XX injections of 5000 units each Injection controlled ovarian may be given within the hyperstimulation cycles following 9 days to prevent insufficiency corpus luteum For adults and adolescents Prophylactic treatment of over 12 years of age with asthma in adults, mild to moderate asthma is Ciclesonide 160mcg R03BA08000A210 adolescents and children 335. A* 160 to 640mcg per day: Inhaler 1XX over 6 years (follow current severe asthma dose may be indication) Not meant for 6 increased to 1280mcg per yo) day.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i & ii) Initially 12.5 - 15 mg/kg/day, beginning on the day before transplant. Maintenance approx 12.5 mg/kg/day for 3 - 6 months Only for: i) Patients in before being tapered off to whom donor specific zero by 1 year of transplantation cannot be transplantation carried out and in young iii) 3 mg/kg/day in 2 divided children to minimise side- doses for first 6 weeks. May effects of steroids increased gradually to ii) Follow-up cases of bone maximum 5 mg/kg. marrow transplant Treatment withdrawn if no iii) Patients with severe response after 3 months rheumatoid arthritis not iv) ADULT: 5 mg/kg/day in 2 responding to other second divided doses. CHILD: 6 line drugs mg/kg/day in 2 divided Ciclosporin 100 mg L04AD01000C1002 336. A* iv) Patients with idiopathic doses. Patients with Capsule XX nephrotic syndrome who permitted levels of kidney are steroid toxic or poor failure, the starting dose response to must not more than 2.5 cyclophosphamide mg/kg/day v) Severe aplastic anemia, v) 12 mg/kg/day. pure red cell aplasia vi) 2.5 mg/kg/day in 2 divided vi) Cases of recalcitrant doses increasing if there is psoriasis and atopic no improvement after 4 eczema weeks by 0.5 -1 vii) Treatment of chronic mg/kg/month up to maximum ocular inflammatory 5 mg/kg/day vii) 5 mg/kg/day disorders/uveitis in 2 divided doses, may increase to 7 mg/kg/day in resistant cases. Maintenance: Less than 5 mg/kg/day especially during remission Only for : i) Patients in i & ii) Initially 12.5 - 15 whom donor specific mg/kg/day, beginning on the transplantation cannot be day before transplant. carried out and in young Maintenance approx 12.5 children to minimise side- mg/kg/day for 3 - 6 months effects of steroids before being tapered off to ii) Follow-up cases of bone zero by 1 year of marrow transplant transplantation iii) 3 Ciclosporin 100 mg/ml L04AD01000L5002 337. A* iii) Patients with severe mg/kg/day in 2 divided doses Drink Solution XX Rheumatoid arthritis not for first 6 weeks. May responding to other second increased gradually to line drugs maximum 5 mg/kg. iv) Patients with idiopathic Treatment withdrawn if no nephrotic syndrome who response after 3 months are steroid toxic or poor iv) ADULT: 5 mg/kg/day in 2 response to divided doses. CHILD: 6 cyclophosphamide mg/kg/day in 2 divided

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber v) Severe aplastic anaemia, doses. Patients with pure red cell aplasia permitted levels of kidney vi) Cases of recalcitrant failure, the starting dose psoriasis and atopic must not more than 2.5 eczema mg/kg/day v) 12 mg/kg/day vi) 2.5 mg/kg/day in 2 divided doses increasing if there is no improvement after 4 weeks by 0.5 -1 mg/kg/month up to maximum 5 mg/kg/day i & ii) Initially 12.5 - 15 mg/kg/day, beginning on the day before transplant. Maintenance approx 12.5 mg/kg/day for 3 - 6 months Only for: i) Patients in before being tapered off to whom donor specific zero by 1 year of transplantation cannot be transplantation carried out and in young iii) 3 mg/kg/day in 2 divided children to minimise side- doses for first 6 weeks. May effects of steroids increased gradually to ii) Follow-up cases of bone maximum 5 mg/kg. marrow transplant Treatment withdrawn if no iii) Patients with severe response after 3 months rheumatoid arthritis not iv) ADULT: 5 mg/kg/day in 2 responding to other second divided doses. CHILD: 6 line drugs mg/kg/day in 2 divided Ciclosporin 25 mg L04AD01000C1001 338. A* iv) Patients with idiopathic doses. Patients with Capsule XX nephrotic syndrome who permitted levels of kidney are steroid toxic or poor failure, the starting dose response to must not more than 2.5 cyclophosphamide mg/kg/day v) Severe aplastic anemia, v) 12 mg/kg/day pure red cell aplasia vi) 2.5 mg/kg/day in 2 divided vi) Cases of recalcitrant doses increasing if there is psoriasis and atopic no improvement after 4 eczema weeks by 0.5 -1 vii) Treatment of chronic mg/kg/month up to maximum ocular inflammatory 5 mg/kg/day vii) 5 mg/kg/day disorders/uveitis in 2 divided doses, may increase to 7 mg/kg/day in resistant cases. Maintenance: Less than 5 mg/kg/day especially during remission i) 3 - 5 mg/kg/day until i) Post bone marrow tolerate orally Ciclosporin 50 mg/ml L04AD01000P3001 339. A* transplant ii) 2 - 3 mg/kg/day for Injection XX ii) Solid organ transplant recipients who are unable to take orally 65 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Improvement of the maximal and pain-free walking distances in B01AC00000T1002 patients with intermittent 340. Cilostazol 100 mg Tablet A* 100 mg twice daily XX claudication, who do not have rest pain and who do not have evidence of peripheral tissue necrosis. Traditionally used for the Cimicifuga Racemosa HG03WA5001T100 relief of hot flushes, 341. Rhizome Extract 20 mg A 20 mg twice daily 1XX sweating, restlessness Tablet associated with menopause Secondary hyperparathyroidism in patients undergoing maintenance dialysis with hypercalcaemia. Restriction(s): For treatment of refractory secondary The starting dose for adults is hyperparathyroidism in 25mg once daily to be patients with end-stage administered orally. Depends renal disease (including on the serum parathyroid those with calciphylaxis) hormone (PTH) and calcium only in those: levels, the dose may be i) who have "very adjusted within a range of 25- uncontrolled" plasma levels 75mg once daily. If no of intact parathyroid improvement in PTH, the hormone (defined as greater dose may be increased up to than 85pmol/L [800 pg/mL] 100 mg once daily. Dose can that are refractory to be increased by 25mg at a standard therapy, and an time at intervals of at least 3 Cinacalcet Hydrochloride H05BX01110T1001 adjusted serum calcium 342. A* weeks. The safety of 25mg tablet XX level at upper limit of normal cinacalcet in low birth weight or high, despite appropriate infants, newborns, sucklings, adjustment of phosphate infants and children has not binders including non- been established. Caution calcium based phosphate when cinacalcet is binders. administered to patients aged ii) in whom surgical 65 years or older. It is parathyroidectomy is recommended not to use contraindicated in that the cinacalcet in pregnant risks of surgery are women or in women who may considered to outweigh the possibly be pregnant. benefits, or if there is likely to Cinacalcet should be avoided be a significant delay for in nursing mothers. surgery. Response to treatment should be monitored regularly and treatment should be continued with dose escalation as appropriate. If a reduction in the plasma

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber levels of intact parathyroid hormone of 30% or more is not seen within 4 months of treatment, then consideration should be given to stopping treatment. N07CA02000T100 343. Cinnarizine 25 mg Tablet B Vestibular disorders One tablet 3 times daily 1XX ADULT: the dosage range is 100-400mg twice daily Gonorrhoea: 100mg single dose Upper and Lower Urinary Tract Infection: Treatment of infections due 100mg bd Upper and Lower Ciprofloxacin 100 mg/50 J01MA02125P3001 344. A to susceptible bacterial Respiratory Tract Infection: ml Injection XX strains 200mg bd-400mg twice daily Cystic Fibrosis with psuedomonal Lower RTI: 400mg bd Others: 200- 400mg bd inhalation Anthrax: 400mg bd Suggest to rephrase ADULT: the dosage range is 100- 400mg twice daily Gonorrhoea: 100mg single dose Upper and Lower Urinary Tract Infection: Treatment of infections due Ciprofloxacin 200 mg/100 J01MA02125P3002 100mg bd Upper and Lower 345. A to susceptible bacterial ml Injection XX Respiratory Tract Infection: strains 200mg bd-400mg twice daily Cystic Fibrosis with psuedomonal Lower RTI: 400mg bd Others: 200- 400mg bd inhalation Anthrax: 400mg bd Treatment of infections due ADULT: 125-750 mg twice Ciprofloxacin 250 mg J01MA02110T1001 346. A to susceptible bacterial daily. Acute gonorrhoea: a Tablet XX strains single dose of 250 mg Treatment of infections due ADULT: 125-750 mg twice Ciprofloxacin 500 mg J01MA02110T1002 347. A to susceptible bacterial daily. Acute gonorrhoea: a Tablet XX strains single dose of 250 mg i) 2 drops every 15 minutes for the first 6 hours, then 2 drops every 30 minutes for Treatment of bacterial the rest of the first day. infections caused by Ciprofloxacin HCl 0.3% S01AX13110D200 Second day : 2 drops every 348. A* susceptible strains in Ophthalmic Solution 1XX hour. Subsequent days (3rd - i) corneal ulcers 14th day) : 2 drops every 4 ii) bacterial conjunctivitis hours. Treatment may be continued after 14 days if corneal re-epithelialization

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber has not occured ii) 1 - 2 drops every 2 hours into the conjunctival sac while awake for 2 days and 1-2 drops every 4 hours while awake for the next 5 days Administered as bolus intravenous injection. May be As an adjunct to general administered as infusion in anaesthesia to facilitate ICU patients at a rate of endotracheal intubation, to 3mcg/kg/min. Adult dose: a) provide skeletal muscle Cisatracurium Besylate 2 M03AC11197P300 Induction: 0.15mg/kg over 5- 349. A* relaxation during surgery mg/ml Injection 1XX 10 secs, b) Maintenance: and to facilitate mechanical 0.03 mg/kg. ventilation. Restricted to Children 2-12 years: patients with lung problem a) Induction: 0.1 mg/kg over such as asthma. 5-10 secs, b) Maintenance: 0.02 mg/kg Germ cell tumours: 20 mg/m2 daily for 5 days every 3 weeks for 3 - 4 courses. Ovarian tumours: 75 mg/m2 once every 3 weeks as part of combination therapy with paclitaxel or 50-60mg/m2 IV once every 3 weeks as a Germ cell tumours, ovarian single agent. Baseline L01XA01000P3001 350. Cisplatin 10 mg Injection A tumours, adult solid creatinine clearance, XX tumours, lymphomas pretreatment hydration and forced diuresis are mandatory. CHILD: 100mg/m2 over 6 hours once every 3 weeks. Lymphomas: Refer to protocols CHILD: 100mg/m2 over 6 hours once every 3 weeks. Lymphomas: Refer to protocols Germ cell tumours: 20 mg/m2 daily for 5 days every 3 weeks for 3 - 4 courses. Ovarian tumours: 75 mg/m2 once every 3 weeks as part of combination therapy or Germ cell tumours, ovarian L01XA01000P3002 100 mg/m2 IV once every 3 351. Cisplatin 50 mg Injection A tumours, adult solid XX weeks as a single agent. tumours, lymphomas Baseline creatinine clearance, pretreatment hydration and forced diuresis are mandatory. CHILD: 100mg/m2 over 6 hours once every 3 weeks. Lymphomas:

68 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Refer to protocols CHILD: 100mg/m2 over 6 hours once every 3 weeks. Lymphomas: Refer to protocols CHILD: 8 - 12 years: 30 - 40 kg 10 mL, 4 - 8 years: 20 - Treatment of complicated 29 kg 7.5 mL, 2 - 4 years: 12 Clarithromycin 125 mg/5 J01FA09000F1001 respiratory tract infections 352. A* - 19 kg 5 mL, 1 - 2 years: 8 - ml Granules XX not responding to standard 11 kg 2.5 mL, less than 8 kg: macrolides 7.5 mg/kg. To be given twice daily. Maximum dose: 1g/day Only for i) treatment of complicated i) 250 - 500 mg twice daily. respiratory tract infection Up to 6 - 14 days Clarithromycin 250 mg J01FA09000T1001 353. A* not responding to standard ii) 500 mg twice daily with Tablet XX macrolides omeprazole & amoxicillin. Up ii) eradication of to 2 weeks Helicobacter pylori infection Susceptible infections Adult: 500 mg bid for 2-5 days. Dose to be infused over 60 minutes in a 0.2% solution; Only for treatment of revert to oral therapy complicated respiratory whenever possible. Child: 1 Clarithromycin 500 mg J01FA09000P3001 354. A* tract infection not mth-12 yr: 7.5 mg/kg every Injection XX responding to standard 12 hr. Dose to be given via macrolides infusion into proximal vein. Dosage Recommendation CrCl (ml/min)<30 : Half the dosage or double dosing interval i) ADULT: 150 - 300 mg every 6 hours; up to 450 mg i) Skin and soft tissue every 6 hours in severe infections, bone& joint infections; Max: 1.8g/day infections ii) Cerebral CHILD: 3 - 6 mg/kg every 6 toxoplasmosis iii) Children hours. Children weighing <10 Clindamycin HCl 300 mg J01FF01110C1001 less than 8 years 355. A* kg should receive at least Capsule XX old:Treatment and 37.5 mg every 8 hr. ii) 600 prophylaxis of malaria in mg 6 hourly for 6 weeks iii) combination with quinine, 10mg/kg twice a day, in as an alternative to combination with quinine. doxycline The combination to be given for 7 days i) ADULT: 0.6 - 2.7 g daily (in 2 - 4 divided doses); up to i) Skin and soft tissue 4.8 g daily; CHILD over 1 Clindamycin Phosphate J01FF01162P3001 infections, bone & joint month, 20 - 40 mg/kg/day or 356. A* 150 mg/ml Injection XX infections 350 mg/m2/day in 3 - 4 ii) Cerebral toxoplasmosis divided doses ii) 1200 mg every 6 hours for 3 weeks followed by 300 mg

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber orally every 6 hours for another 3 weeks The initial dose in adults and adolescents >15 yr should be low (5 to15mg daily), if necessary, increased gradually to a maximum daily As adjunctive therapy in dose of about 80mg. Doses N05BA09000T1001 patients with epilepsy not of up to 30mg may be taken 357. Clobazam 10 mg tablet A* XX adequately stabilised with as a single dose in the their basic medication. evening. The initial dose in children from 3 to15 yr is normally 5mg. A maintenance dose of 0.3 to 1.0mg/kg body weight daily is usually sufficient. Apply sparingly once or twice Short term treatment only of daily, changing to lower more resistant dermatoses potency therapy as soon as eg. psoriasis, recalcitrant condition is controlled. For eczemas, lichen planus, Clobetasol Propionate D07AD01133G100 mild to moderate use 358. A discoid lupus 0.05% Cream 1XX maximum for 2 weeks. For erythematosus and other moderate to severe conditions which do not maximum duration 4 respond satisfactorily to consecutive weeks. Max: 50 less potent steroids g/week Apply sparingly once or twice Short term treatment only of daily, changing to lower more resistant dermatoses potency therapy as soon as eg. psoriasis, recalcitrant condition is controlled. For eczemas, lichen planus, Clobetasol Propionate D07AD01133G500 mild to moderate use 359. A discoid lupus 0.05% Ointment 1XX maximum for 2 weeks. For erythematosus and other moderate to severe conditions which do not maximum duration 4 respond satisfactorily to consecutive weeks. Max:50 less potent steroids g/week Apply up to four times daily Clobetasone Butyrate D07AB01255G100 Eczema and dermatitis of 360. A/KK until condition improves, then 0.05% Cream 1XX all types reduce frequency Apply up to four times daily Clobetasone Butyrate D07AB01255G500 Eczema and dermatitis of 361. A until condition improves, then 0.05% Ointment 1XX all types reduce frequency Treatment of M05BA02011T101 2 tablets in single or two 362. Clodronate 800 mg Tablet A* hypercalcaemia due to 1XX divided doses malignancy

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) ADULT: 100 mg each other day or 50 mg daily with 100mg Dapsone & 300mg once a month with 600mg rifampicin under supervision. Maximum: 200 mg/day. CHILD: 10-14 yr: 50mg i) Previously untreated clofazimine on alternate days leprosy patients with 50mg dapsone & 150 Clofazimine 100 mg J04BA01000C1002 ii) Leprosy patients resistant 363. B mg clofazimine with 450 mg Capsule XX to sulphones rifampicin once a iii) Suppression of lepra month.Maximum: 100 reactions mg/day. ii) 100 mg daily iii) 200-300mg usually effective. Treatment with minimum suppression dose continued for at least 6 months i) ADULT: 100 mg each other day or 50 mg daily with 100mg Dapsone & 300mg once a month with 600mg rifampicin under supervision. Maximum: 200 mg/day. CHILD: 10-14 yr: 50mg i) Previously untreated clofazimine on alternate days leprosy patients with 50mg dapsone & 150 Clofazimine 50 mg J04BA01000C1001 ii) Leprosy patients resistant 364. B mg clofazimine with 450 mg Capsule XX to sulphones rifampicin once a iii) Suppression of lepra month.Maximum: 100 reactions mg/day. ii) 100 mg daily iii) 200-300mg usually effective. Treatment with minimum suppression dose continued for at least 6 months 50 mg daily from 2nd - 6th or 5th - 9th day of menstrual cycle. Increase dose gradually by increments of 50 mg if there is no response until a dosage of 200 mg Clomiphene Citrate 50mg G03GB02136T100 365. A Anovulatory infertility daily is achieved (starting as Tablet 1XX early as 30 days afer the previous course). Further treatment may not be recommended if pregnancy has not occurred after a total of 6 treatment cycles.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Initially 10 mg daily, increased gradually as necessary to 30 - 150 mg daily in divided doses or as a single dose at bedtime; max 250 mg daily. ELDERLY initially 10 mg daily increased carefully over approximately Clomipramine HCI 25 mg N06AA04110T1001 Depression, obsessive- 366. A 10 days to 30 - 75 mg Tablet XX compulsive disorder. daily;Child: ≥10 yr: Initially, 25 mg daily, increased gradually over 2 wk. Max: 3 mg/kg/day or 100 mg daily, whichever is smaller. Give in divided doses. Once titrated, dose may be given as a single dose at bedtime. i) & ii) ADULT: Initial dose should not exceed 1.5mg/day divided into 3 doses, may be increased in increments of 0.5mg every 3 days until seizures are controlled. Maintenance dose: 3-6mg/day. Maximum: 20mg/day. CHILD up to 10 years: initial dose 0.01-0.03 Clonazepam 0.5 mg N03AE01000T1001 i) Epilepsy mg/kg/day in 2-3 divided 367. B Tablet XX ii) Non-epileptic myoclonus doses, increased by no more than 0.25-0.5mg every third day, maximum 0.2mg/kg/day. CHILD 10-16 years: initial dose 1- 1.5mg/day in 2-3 divided dose, may be increased by 0.25-0.5mg every third day until individual maintenance dose of 3-6mg/day is reached. i) & ii) ADULT: Initial dose should not exceed 1.5mg/day divided into 3 doses, may be increased in increments of 0.5mg every 3 days until seizures are N03AE01000T1002 i) Epilepsy 368. Clonazepam 2 mg Tablet B controlled. Maintenance XX ii) Non-epileptic myoclonus dose: 3-6mg/day. Maximum: 20mg/day. CHILD up to 10 years: initial dose 0.01-0.03 mg/kg/day in 2-3 divided doses, increased by no more than 0.25-0.5mg every third

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber day, maximum 0.2mg/kg/day. CHILD 10-16 years: initial dose 1- 1.5mg/day in 2-3 divided dose, may be increased by 0.25-0.5mg every third day until individual maintenance dose of 3-6mg/day is reached. Rapid detoxification in 4-5 days (use with naltrexone): 6 mcg/kg ORALLY divided in 3 doses 6 to 8 hours apart the first day, increasing to 11 Rapid opiod detoxification Clonidine HCl 0.025 mg N02CX02110T100 mcg/kg divided in 3 doses 369. A combination use with Tablet 1XX given day two, tapering to naltrexone 0.6 mcg/kg the third day. Rapid opioid detoxification for 7 days ( use with naltrexone) : 0.1 to 0.2 mg every 4 hours as needed Prevention of myocardial infarct, stroke or established peripheral arterial disease. As B01AC04192T1001 370. Clopidogrel 75 mg Tablet A* second/third line treatment 75 mg once daily XX in patients who are sensitive to acetylsalicylic acid & intolerant to ticlopidine i) Focal dystonias Clostridium Botulinum M03AX01000P400 ii) Hemifacial spasm 371. A* 20 - 200 units 3 months once Toxin Type A 100 units 1XX iii) Spasticity including cerebral palsy Initially 20 U/kg divided between both calf muscles. Clostridium Botulinum May be titrated 10-30 U/kg i) Focal dystonias Type A toxin up to max of not >1000 M03AX01000P400 ii) Hemifacial spasm 372. haemagglutinin complex A* U/patient. Should only be 3XX iii) Spasticity including 300 units/vial powder for used in children > 2 years of cerebral palsy injection age. Repeat injections given not less than 3 months from previous injection. Initially 20 U/kg divided between both calf muscles. Clostridium botulinum May be titrated 10-30 U/kg i) Focal dystonias Type A toxin up to max of not >1000 M03AX01000P400 ii) Hemifacial spasm 373. haemagglutinin complex A* U/patient. Should only be 2XX iii) Spasticity including 500U/vial powder for used in children > 2 years of cerebral palsy injection age. Repeat injections given not less than 3 months from previous injection.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Rub in gently onto affected Cutaneous candidiasis, and surrounding skin 2 or 3 D01AC01000G100 Tinea corporis, Tinea cruris, times daily continuing for 374. Clotrimazole 1% Cream B 1XX Tinea pedis and Tinea about 2 weeks beyond the versicolor dissapearance of all symptoms Otomycosis; concomitant S02AA00000D100 4 to 5 drops 3 to 4 times 375. Clotrimazole 1% Ear Drop B therapy with antibiotics and 2XX daily corticosteroid ear drops Cutaneous candidiasis, Apply gently onto affected D01AC01000L6001 tinea orporis, tinea cruris, and surrounding skin area 2 376. Clotrimazole 1% Solution A XX tinea pedis and tinea or 3 times daily continuing for versicolor 2-4 weeks 200 mg once daily, Clotrimazole 200 mg G01AF02000S100 377. B Vaginal candidiasis preferably at bedtime for Vaginal Tablet 2XX three consecutive days Clotrimazole 500 mg G01AF02000S100 500 mg as a single one-time 378. B Vaginal candidiasis Vaginal Tablet 3XX dose Treatment of susceptible Cloxacillin Sodium 125 J01CF02520L8001 bacterial infections, notably Child: 50-100 mg/kg in 379. B mg/5 ml Suspension XX penicillinase-producing divided doses every 6 hr staphylococci Treatment of susceptible ADULT: 250 - 500 mg every Cloxacillin Sodium 250 J01CF02520C1001 bacterial infections, notably 380. B 6 hours. Child: 50-100 mg/kg mg Capsule XX penicillinase-producing in divided doses every 6 hr. staphylococci ADULT: 250 to 500 mg every Treatment of susceptible 6 hours depending on type Cloxacillin Sodium 250 J01CF02520P4001 bacterial infections, notably and severity of infection. 381. B mg Injection XX penicillinase-producing CHILD less than 20 kg: 25 to staphylococci infections 50 mg/kg/day in equally divided doses every 6 hours Treatment of susceptible ADULT: 250 - 500 mg every Cloxacillin Sodium 500 J01CF02520C1002 bacterial infections, notably 382. B 6 hours. Child: 50-100 mg/kg mg Capsule XX penicillinase-producing in divided doses every 6 hr. staphylococci ADULT: 250 to 500 mg every Treatment of susceptible 6 hours depending on type Cloxacillin Sodium 500 J01CF02520P4002 bacterial infections, notably and severity of infection. 383. B mg Injection XX penicillinase-producing CHILD less than 20 kg: 25 to staphylococci infections 50 mg/kg/day in equally divided doses every 6 hours Initial dose : 12.5 mg ( once or twice ) daily, increase N05AH02000T100 Treatment of resistant slowly in steps of 25 - 50 mg 384. Clozapine 100 mg Tablet A 2XX schizophrenia up to 300 mg daily within 2 - 3 weeks. Maximum 900 mg/day Initial dose : 12.5 mg ( once N05AH02000T100 Treatment of resistant 385. Clozapine 25 mg Tablet A or twice ) daily, increase 1XX schizophrenia slowly in steps of 25 - 50 mg

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber up to 300 mg daily within 2 - 3 weeks. Maximum 900 mg/day

Coal Tar 1- 6 % in Dandruff, seborrhoeic D05AA00946G500 Apply to the affected areas 386. Betamethasone 17 - B dermatitis, atopic dermatitis, 3XX sparingly 1-2 times daily Valerate 0.01 % Ointment eczema and psoriasis Dandruff, seborrhoeic dermatitis, atopic dermatitis, eczema and psoriasis. Apply sparingly to the D05AA00000G500 Used as a mild astringent affected area 1-3 times daily 387. Coal Tar 1-9% Ointment B 1XX for the skin, as a soothing starting with low strength and protective application in preparations eczema and as a protective to slight excoriation Dandruff, seborrhoeic D05AA00000L5201 388. Coal Tar 20% Solution B dermatitis, atopic dermatitis, Use 100 ml in a bath XX eczema and psoriasis Coal Tar and Salicylic Dandruff, seborrhoeic D05AA00946G500 389. Acid (various B dermatitis, atopic dermatitis, Apply to the affected areas 2XX concentrations) Ointment eczema and psoriasis Coal Tar with Salicylic Dandruff, seborrhoeic D05AA00000L5202 Apply to the affected areas 390. Acid (various B dermatitis, atopic dermatitis, XX or as in product leaflet concentrations) Solution eczema and psoriasis To produce local Maximum total dose anaesthesia or recommended for application N01BC01110L5001 vasoconstriction during to the nasal mucosa in 391. Cocaine 10% Solution B XX endoscopic nasal surgery, healthy adult is 1.5 to 2 turbinectomy septoplasty, mg/kg of a 10% cocaine polypectomy etc solution D05AA00946G500 Scalp psoriasis and severe Rub a small amount into the 392. Cocois Co. Ointment B 1XX seborrhoeic dermatitis scalp gently i) Initial dose, 0.5-1.2 mg, then 0.5-0.6 mg every hour i) Acute gout and until relief of pain is obtained prophylaxis of recurrent or vomiting or diarrhoea gout. occurs (Maximum : 8 mg). ii) Leucocytoclastic The course should not be Vasculitis either cutaneous repeated within 3 days. M04AC01000T100 or systemic involvement, Prevention of attacks during 393. Colchicine 0.5 mg Tablet B 1XX Behcet's syndrome, initial treatment with Urticarial vasculitis, allopurinol or uricosuric Systemic sclerosis, Sweet's drugs: 0.5 mg 1-3 times syndrome and severe daily. recalcitrant aphthous ii) 0.5 mg 1-3 times daily stomatitis depends on disease and severity, up to a maximum of 3 mg/day

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber A minimum of 5 days treatment is generally recommended. For the treatment of respiratory exacerbations in cystic fibrosis patients, treatment should be continued up to 12 days. Children and adults (including elderly): Up to 60kg: 50,000 units/kg/day to a maximum of 75,000 units/kg/day. The total daily dose should be divided into Intravenous administration three doses given at for the treatment of serious approximately 8-hour infections caused by Gram intervals. Over 60kg: 1-2 negative bacteria, when million units three times a Colistimethate Sodium 1 J01XB01520P4001 more commonly used day. The maximum dose is 6 394. million IU per vial A* XX systemic antibacterial million units in 24 hours. (Polymyxin E) agents may be Renal impairment: In contraindicated or may be moderate to severe renal ineffective because of impairment, excretion of bacterial resistance. colistimethate sodium is delayed. Therefore, the dose and dose interval should be adjusted in order to prevent accumulation. Suggested Dosage Adjustment in Renal Impairment (for over 60 kg body weight): - Mild (CrCl 20- 50 ml/min): 1-2 million units every 8 hr. - Moderate (CrCl 10-20 ml/min): 1 million units every 12-18 hr. - Severe (CrCl <10 ml/min): 1 million units every 18-24 hr. Eradication therapy for Colloidal Bismuth A02BX05136T1001 Helicobacter Pylori in 240 mg twice daily for 1-2 395. A Subcitrate 120 mg Tablet XX combination with antibiotics weeks and antisecretory drugs Replacement of Compound Sodium 100-1000 ml by IV or B05XA30125P6001 extracellular losses of fluid 396. Lactate (Hartmanns C according to the needs of the XX and electrolytes, as an Solution) patient alkaliniser agent i) Osteoporosis associated with oestrogen deficiency ii) Female hypoestrogenism i) 0.3 - 0.625 mg daily Conjugated estrogens 0.3 G03CA57000T100 iii) Vasomotor symptoms ii) 0.3- 1.25mg daily for 397. A mg Tablet 3XX associated with oestrogen 3weeks, then off for 1 week deficiency iii) & iv) 0.3mg-1.25mg daily iv)atrophic vaginitis and urethritis

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Management of moderate to severe vasomotor symptoms associated with menopause, prevention and Conjugated Estrogens management of 0.625 mg & G03FA12295T1002 398. A postmenopausal 1 tablet daily Medroxyprogesterone XX osteoporosis, atropic Acetate 2.5 mg Tablet vaginitis and atropic urethritis in post menopausal woman with intact uterus i) Osteoporosis associated with oestrogen deficiency ii) Female hypoestrogenism i) 0.3 - 0.625 mg daily Conjugated Oestrogens G03CA57000T100 iii) Vasomotor symptoms ii) 0.3- 1.25mg daily for 399. A 0.625 mg Tablet 1XX associated with oestrogen 3weeks, then off for 1 week deficiency iii) & iv) 0.3mg-1.25mg daily iv)atrophic vaginitis and urethritis Intravaginally or topically 0.5- 2g daily depending on severity of condition. Administration should be cyclic, with 3 weeks on conjugated estrogens and one week off. Estrogens Atrophic vaginitis and post should be used for the Conjugated Oestrogens G03CA57000G100 400. A menopausal atrophic shortest duration possible 0.625 mg/g Cream 1XX urethritis when treating atrophic vaginitis. Every 3 to 6 months attempts should be made to taper or discontinue therapy and conjugated estrogens should be titrated to give the lowest possible dosage to control symptoms Continuous Ambulatory For chronic renal diseases Peritoneal Dialysis requiring dialysis and acute (CAPD) Solution B05DB00908H250 Dose depending on clinical 401. B therapy-resistance renal containing 2.3% glucose 4XX cases failure eg. prior to transfer (Calcium 1.75mmol/L) & to a dialysis centre (Calcium 1.25mmol/L) For chronic renal diseases Continuous Ambulatory requiring dialysis and acute Peritoneal Dialysis B05DB00908H250 Dose depending on clinical 402. B therapy-resistance renal Solution containing 1.5% 1XX cases failure eg. prior to transfer Dextrose to a dialysis centre For chronic renal diseases Continuous Ambulatory requiring dialysis and acute Peritoneal Dialysis B05DB00908H250 Dose depending on clinical 403. B therapy-resistance renal Solution containing 2.5% 2XX cases failure eg. prior to transfer Dextrose to a dialysis centre

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber For chronic renal diseases Continuous Ambulatory requiring dialysis and acute Peritoneal Dialysis B05DB00908H250 Dose depending on clinical 404. B therapy-resistance renal Solution containing 4.25% 3XX cases failure eg. prior to transfer Dextrose to a dialysis centre One unit intrauterine device to be inserted into the uterine cavity on the last day of the Copper 250 mm2 G02BA02000M900 menstrual flow or in the first 405. B Intrauterine contraception Intrauterine Device 1XX days afterwards. It is advised that the Multiload Cu 250 devices are replaced every 3 years One unit intrauterine device to be inserted into the uterine cavity on the last day of the Copper 375 mm2 G02BA02000M900 menstrual flow or in the first 406. B Contraception Intrauterine Device 2XX days afterwards. It is advised that the Multiload Cu 375 devices are replaced every 5 years The tip of the crystal should D08A000183F9901 be moistened by dipping in 407. Copper Sulphate Crystal C Wounds XX water and applied carefully to the lesion Controlled Ovarian Stimulation (COS) in combination with a GnRH Women with Body Weight antagonist for the ≤60 kg: A single dose of 100 development of multiple mcg should be administered. Corifollitropin Alfa G03GA09000P500 follicles in woman Women with Body Weight 408. 100mcg/0.5ml solution for A* 1XX participating in an Assisted >60 kg: A single dose of 150 injection Reproductive Technology mcg should be administered. (ART) program Restriction: Details : Refer to Product As second line treatment Information alternative to other recombinant FSH Controlled Ovarian Stimulation (COS) in combination with a GnRH Women with Body Weight antagonist for the ≤60 kg: A single dose of 100 development of multiple mcg should be administered. Corifollitropin Alfa G03GA09000P500 follicles in woman Women with Body Weight 409. 150mcg/0.5ml solution for A* 2XX participating in an Assisted >60 kg: A single dose of 150 injection Reproductive Technology mcg should be administered. (ART) program Restriction: Details : Refer to Product As second line treatment Information alternative to other recombinant FSH 20-30 mg/m2 daily. Doses Cortisone Acetate 5 mg H02AB10122T1002 For salt losing congenital 410. B may be divided with two- Tablet XX adrenal hyperplasia in thirds in the morning and

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber newborn and paediatric one-third late in the patients afternoon i) and iii) Massage into affected area until the medication is completely absorbed. Repeat as i) Pruritus needed. Apply 2 or 3 times P03A000000G1001 411. Crotamiton 10 % Cream B ii) Scabies daily XX iii) Insect bite reactions ii) Apply to the whole body from below the chin. 2nd application is applied 24 hr later. May need to use once daily for up to 5 days. i) Prophylaxis of anaemia: 250-1000 mcg IM every month ii) Uncomplicated pernicious anaemia or Vitamin B12 malabsorption: Initial 100 mcg daily for 5-10 days i) Prophylaxis of anaemia followed by 100-200 mcg Cyanocobalamin 0.1 mg B03BA01000P3001 ii) Uncomplicated 412. B monthly until complete Injection XX pernicious anaemia or remission is achieved. Vitamin B12 malabsorption Maintenance: up to 1000 mcg monthly. CHILD 30-50 mcg daily for 2 or more weeks (to a total dose of 1- 5mg). Maintenance: 100 mcg monthly to sustain remission OR AS PRESCRIBED. i) Prophylaxis of anaemia: 250-1000 mcg IM every month ii) Uncomplicated pernicious anaemia or Vitamin B12 i) Prophylaxis of anaemia malabsorption: Initial 100 associated with Vitamin mcg daily for 5-10 days Cyanocobalamin 1 mg B03BA01000P3002 B12 deficiency 413. B followed by 100-200 mcg Injection XX ii) Uncomplicated monthly until complete pernicious anaemia or remission is achieved. Vitamin B12 malabsorption Maintenance: up to 1000 mcg monthly. CHILD 30-50 mcg daily for 2 or more weeks (to a total dose of 1- 5mg). OR AS PRESCRIBED. ADULT 50-150 mcg daily. Cyanocobalamin 50 mcg B03BA01000T1002 Vitamin B12 deficiency of 414. B CHILD 50-105 mcg daily in Tablet XX dietary origin 1-3 divided doses

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber 1 drop every 5 - 10 minutes; Cyclopentolate 0.2% with not exceeding three times to S01GA55990D200 Dilating agent for premature 415. Phenylephrine 1% Eye A produce rapid mydriasis. 1XX babies Drops Observe infants closely for at least 30 minutes 1 drop of solution in eye(s); may repeat after 5 to 10 minutes if needed. INFANT : Single instillation of 1 drop of 0.5% solution in the eye; Cyclopentolate 0.5% Eye S01FA04000D2001 apply pressure to 416. A Mydriasis and cycloplegia Drops XX nasolacrimal sac for 2 to 3 minutes; observe infant closely for at least 30 minutes for signs or symptoms of systemic absorption ADULT : 1 drop of solution in eye(s); may repeat after 5-10 minutes if needed. CHILD : 1 drop of solution in eye(s); may repeat after 5-10 Cyclopentolate 1% Eye S01FA04000D2002 417. A Mydriasis and cycloplegia minutes if needed. Pre- Drops XX treatment on the day prior to examination is usually not necessary. If desirable, 1 or 2 drops may be instilled the evening prior to examination. i) ADULT: 600 - 750 mg/m2 IV once every 3 weeks as part of combination regime. CHILD: Dose variable depending on disease and protocol. Range 600 mg/m2 i) Solid tumours (adult and to 2 g/m2 infusion over 1 paediatric), leukaemia, non- hour to 6 hours (lower doses Hodgkin's lymphoma, can be given as bolus). Care multiple myeloma with pre and post-hydration. ii) Severe lupus nephritis Mesna to be given with (Class III and IV) Cyclophosphamide 1 g L01AA01000P4002 doses more than 1 g/m2. 418. A iii) Other systemic vasculitis Injection XX Higher doses are used in iv) Systemic lupus haematopoetic stem cell erythematosus, rheumatoid transplant-refer to specific arthritis, polyarteritis protocols nodosa, wegener ii) 750 mg/m2 BSA monthly granulomatosis for 18 months v) Pemphigus vulgaris iii) 750 mg/m2 BSA monthly for 6 months. Dose can be adjusted up to 1,000 mg/m2 BSA to achieve adequate leucocyte suppression iv) 500 - 1000 mg

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber intravenously (Regime varies according to indication). Starting dose may be given fortnightly then at monthly intervals followed by 3 monthly intervals v) 500 mg infusion on the 2nd day of the dexamethasone- cyclophosphamide pulsed regime, the cycle is repeated every 4 weeks up to 6 cycles or till remission followed by oral cyclophosphamide i) ADULT: 600 - 750 mg/m2 IV once every 3 weeks as part of combination regime. CHILD: Dose variable depending on disease and protocol. Range 600 mg/m2 to 2 g/m2 infusion over 1 hour to 6 hours (lower doses can be given as bolus). Care with pre and post-hydration. Mesna to be given with doses more than 1 g/m2. Higher doses are used in i) Solid tumours (adult and haematopoetic stem cell paediatric), leukaemia, non- transplant-refer to specific Hodgkin's lymphoma, protocols multiple myeloma ii) 750 mg/m2 BSA monthly ii) Severe lupus nephritis for 18 months iii) 750 mg/m2 (Class III and IV) Cyclophosphamide 200 L01AA01000P4001 BSA monthly for 6 months. 419. A iii) Other systemic vasculitis mg Injection XX Dose can be adjusted up to iv) Systemic lupus 1,000 mg/m2 BSA to achieve erythematosus, rheumatoid adequate leucocyte arthritis, polyarteritis suppression nodosa, wegener iv) 500 - 1000 mg granulomatosis intravenously (Regime varies v) Pemphigus vulgaris according to indication). Starting dose may be given fortnightly then at monthly intervals followed by 3 monthly intervals v) 500 mg infusion on the 2nd day of the dexamethasone- cyclophosphamide pulsed regime, the cycle is repeated every 4 weeks up to 6 cycles or till remission followed by oral cyclophosphamide

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Solid tumours, leukaemia, lymphoma, autoimmune disorders, autoimmune i) ADULT: 50 - 100 mg/day. bullous diseases, Monitor full blood count connective tissue disease, (FBC), liver function, urine pyoderma gangrenosum microscopy and renal ii) For severe lupus function. CHILD, up to 1 Cyclophosphamide 50 mg L01AA01000T1001 nephritis (Class III & IV), year: 10 - 20 mg daily, 1 - 5 420. A Tablet XX systemic vasculitis and years: 30 - 50 mg daily, 6 - steroid resistant/dependent 12 years: 50 - 100 mg daily nephrotic syndrome ii) 2 mg/kg/day for 3 - 4 iii) Systemic lupus months erythematosus (SLE), iii) 1 - 1.5 mg/kg/day orally in rheumatoid arthritis, divided doses polyarteritis nodosa, wegener granulomatosis ADULT: Initial: 250 mg every 12 hours for 14 days, then administer 0.5 - 1 g daily in 2 Multi-Drug Resistance divided doses for 18 - 24 Cycloserine 250 mg J04AB01000C1001 Tuberculosis treatment 421. A* months (maximum daily Capsule XX failure. (For respiratory dose: 1 g). CHILD: 2-12 yr: 5 physicians) mg/kg bid; 12-18 yr: 250 mg bid for 2 wk then adjusted to a max dose of 1 g daily To increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation 1 drop twice a day in each Cyclosporine Ophthalmic S01XA18000D200 associated with 422. A* eye approximately 12 hours Emulsion 0.05% 1XX keratoconjunctivitis sicca. apart. Increased tear production was not seen in patients currently taking anti inflammatory drugs or using punctal plugs. 1 tablet daily for 21 days on the first day of the cycle, followed by 7 tab free days. Cyproterone Acetate 2 mg G03HB01954T100 Androgen dependent Starting on day 2 to 5 is 423. & Ethinyloestradiol 0.035 A* 1XX diseases in women allowed, but during the first mg Tablet cycle a barrier method is recommended for the first 7days of tablet taking. i) After orchidectomy, 100 mg once daily or twice daily ii) If used together with Cyproterone Acetate 50 G03HA01122T100 424. A* Carcinoma of prostate LHRH agonists, the initial mg Tablet 1XX dose is 100 mg twice daily for 5 to 7 days before the start of LHRH agonist, then

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber 100 mg twice daily for 3 to 4 weeks together with the LHRH agonist Standard doses 100 - 200 i) Central nervous system mg/m2 daily over 5 - 10 lymphoma days. Higher doses for ii) Meningeal leukemia intensification/consolidation: iii) Non Hodgkin's 1000 - 3000 mg/m2 daily Lymphoma over 3 - 5 days depending on iv) High dose cytarabine as specific protocols. CHILD: conditioning to cytoreduce Dose variable depending on the disease before stem cell disease and protocol. Range L01BC01000P4004 transplant for relapsed or from 100 mg/m2 to 3 g/m2 425. Cytarabine 1 g Injection A XX refractory leukemia twice daily. May be given as v) As salvage for acute SC, IV bolus or infusion. lymphocytic leukemia Intrathecal dose: Less than 1 vi) As salvage for acute year: 15 mg, 1 - 2 years: 20 myeloid leukemia mg, 2 - 3 years: 25 mg, more vii) As palliative than 3 years: 30 mg. chemotherapy in elderly (ENSURE THAT acute myeloid leukemia/ PREPARATION IS myelodysplastic syndrome SUITABLE FOR INTRATHECAL USE) Standard doses 100 - 200 i) Central nervous system mg/m2 daily over 5 - 10 lymphoma days. Higher doses for ii) Meningeal leukemia intensification/consolidation: iii) Non Hodgkin's 1000 - 3000 mg/m2 daily Lymphoma over 3 - 5 days depending on iv) High dose cytarabine as specific protocols. CHILD: conditioning to cytoreduce Dose variable depending on the disease before stem cell disease and protocol. Range Cytarabine 100 mg L01BC01000P4002 transplant for relapsed or from 100 mg/m2 to 3 g/m2 426. A Injection XX refractory leukemia twice daily. May be given as v) As salvage for acute SC, IV bolus or infusion. lymphocytic leukemia Intrathecal dose: Less than 1 vi) As salvage for acute year: 15 mg, 1 - 2 years: 20 myeloid leukemia mg, 2 - 3 years: 25 mg, more vii) As palliative than 3 years: 30 mg. chemotherapy in elderly (ENSURE THAT acute myeloid leukemia/ PREPARATION IS myelodysplastic syndrome SUITABLE FOR INTRATHECAL USE)

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Standard doses 100 - 200 i) Central nervous system mg/m2 daily over 5 - 10 lymphoma days. Higher doses for ii) Meningeal leukemia intensification/consolidation: iii) Non Hodgkin's 1000 - 3000 mg/m2 daily Lymphoma over 3 - 5 days depending on iv) High dose cytarabine as specific protocols. CHILD: conditioning to cytoreduce Dose variable depending on the disease before stem cell disease and protocol. Range Cytarabine 500 mg L01BC01000P4003 transplant for relapsed or from 100 mg/m2 to 3 g/m2 427. A Injection XX refractory leukemia twice daily. May be given as v) As salvage for acute SC, IV bolus or infusion. lymphocytic leukemia Intrathecal dose: Less than 1 vi) As salvage for acute year: 15 mg, 1 - 2 years: 20 myeloid leukemia mg, 2 - 3 years: 25 mg, more vii) As palliative than 3 years: 30 mg. chemotherapy in elderly (ENSURE THAT acute myeloid leukemia/ PREPARATION IS myelodysplastic syndrome SUITABLE FOR INTRATHECAL USE) i) Following total knee replacement: Initially ADULT 110mg (ELDERLY, 75 mg) within 1- 4 hours after surgery, then 220 mg (ELDERLY, 150 mg) once daily thereafter for 6-10 days Following total hip i) Prevention of venous replacement: Initially ADULT thromboembolic events in 110 mg (ELDERLY, 75 mg) patients who have within 1- 4 hours after undergone total knee surgery, then 220 mg replacement or total hip (ELDERLY, 150 mg) once replacement surgery. daily thereafter for 28-35 ii) Reduction of the risk of days Dabigatran Etexilate 110 B01AE07999C100 stroke and systemic ii) Recommended daily dose 428. A* mg Capsule 2XX embolism in patients with is 300mg taken orally as non-valvular atrial fibrillation 150mg hard capsule twice (AF). daily. Therapy should be iii) Treatment of deep vein continued lifelong. thrombosis (DVT) and iii) Recommended daily dose pulmonary embolism (PE) is 300mg taken as one and prevention of recurrent 150mg capsule BD following DVT and PE in adults. treatment with a parenteral anticoagulant for at least 5 days. The duration of therapy should be individualized after careful assessment of the treatment benefit against the risk for bleeding. ii) & iii) For the following groups, the recommended daily dose is

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber 220 mg taken as one 110mg capsule twice daily: - Patients aged 80 years or above -Patients who receive concomitant verapamil Special patient population for renal impairment : Renal function should be assessed by calculating the creatinine clearance (CrCl) prior to initiation of treatment with Dabigatran to exclude patients for treatment with severe renal impairment (i.e. CrCl < 30 ml/min). Following total knee replacement: Initially ADULT 110 mg (ELDERLY, 75 mg) within 1- 4 hours after surgery, then 220 mg Prevention of venous (ELDERLY, 150 mg) once thromboembolic events in daily thereafter for 6-10 days Dabigatran Etexilate 75 B01AE07999C100 patients who have 429. A* Following total hip mg Capsule 1XX undergone total knee replacement: Initially ADULT replacement or total hip 110 mg (ELDERLY, 75 mg) replacement surgery within 1- 4 hours after surgery, then 220 mg (ELDERLY, 150 mg) once daily thereafter for 28-35 days i) Recommended daily dose is 300mg taken orally as 150mg hard capsule twice daily. Therapy should be continued lifelong. ii) Recommended daily dose i) Reduction of the risk of is 300mg taken as one stroke and systemic 150mg capsule BD following embolism in patients with treatment with a parenteral non-valvular atrial fibrillation anticoagulant for at least 5 Dabigatran Etexilate150 B01AE07999C100 (AF). 430. A* days. The duration of therapy mg Capsule 3XX ii) Treatment of deep vein should be individualized after thrombosis (DVT) and careful assessment of the pulmonary embolism (PE) treatment benefit against the and prevention of recurrent risk for bleeding. For the DVT and PE in adults. following groups, the recommended daily dose is 220 mg taken as one 110mg capsule twice daily: - Patients aged 80 years or above -Patients who receive

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber concomitant verapamil Special patient population for renal impairment : Renal function should be assessed by calculating the creatinine clearance (CrCl) prior to initiation of treatment with Dabigatran to exclude patients for treatment with severe renal impairment (i.e. CrCl < 30 ml/min). i) Malignant melanoma, i) 250 mg/m2 for 5 days, may sarcomas, neuroblastomas Dacarbazine 100 mg L01AX04000P4001 be repeated every 3 weeks 431. A* and other childhood solid Injection XX ii) 375 mg/m2 IV every 2 tumours weeks ii) Hodgkin's Disease i)200 - 800 mg daily for max i)Endometriosis and of 9 months gynaecomastia G03XA01000C100 ii)200 mg daily for 12 weeks 432. Danazol 100 mg Capsule A/KK ii)Menorrhagia 1XX ii)400 mg daily. Reduce to iii)Prophylaxis of hereditary 200 mg daily after 2 months angioedema attack free period i) 200 - 800 mg daily for max i) Endometriosis and of 9 months gynaecomastia G03XA01000C100 ii) 200 mg daily for 12 weeks 433. Danazol 200 mg Capsule A/KK ii) Menorrhagia 2XX ii) 400 mg daily. Reduce to iii) Prophylaxis of hereditary 200 mg daily after 2 months angioedema attack free period i) ADULT: 6 - 10 mg/kg weekly/ 1.4mg/kg daily J04BA02000T1001 i)Leprosy (around 50 - 100 mg daily). 434. Dapsone 100 mg Tablet B XX ii) Dermatitis herpetiformis CHILD: 1 - 2 mg/kg/day. Maximum: 100 mg/day ii) ADULT: 50 - 300 mg daily i) 45 - 60 mg/m2 IV daily for 3 - 5 days ii) 25 - 45 mg/m2 once a week for first 4 weeks during induction phase. Caution: Total cumulative dose of daunorubicin and i) Acute myeloblastic doxorubicin must not exceed Daunorubicin HCl 20 mg L01DB02110P4001 leukaemia (AML) 500 mg/m2 due to risk of 435. A* Injection XX ii) Acute lymphoblastic cardiotoxicity. CHILD: 30-45 leukemia (ALL) mg/m2/dose infusion over 6 hours. Schedule depends on protocol. Need to check cardiac function closely by echocardiography every cumulative dose of 100mg/m2 to max. 360 mg/m2

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Myelodysplastic syndromes (MDS) including: Previously treated and untreated de novo and secondary MDS 15 mg/m2 by continuous IV of all French-American- infusion over 3 hours British subtypes (refractory repeated every 8 hours for 3 anemia, refractory anemia days. Repeat this treatment with ringed sideroblasts, cycle every 6 weeks for a Decitabine 50 mg L01BC08000P3001 refractory anemia with 436. A* minimum of 4 cycles. Injection XX excess blasts, refractory However, complete or partial anemia with excess blasts response may take longer in transformation, and than 4 cycles. Treatment chronic myelomonocytic may be continued as long as leukemia) and Intermediate- there is continued 1, Intermediate-2, and High- Risk International Prognostic Scoring System (IPSS) groups Treatment of chronic iron Initial 20 mg/kg/day. Starting overload due to blood dose can also be based on Deferasirox 125 mg V03AC03000T4001 transfusions (transfusional 437. A* transfusion rate and existing Dispersible Tablet XX haemosiderosis) in adult iron burden. Max is 30 and pediatric patients aged mg/kg/day 2 years and above Treatment of chronic iron Initial 20 mg/kg/day. Starting overload due to blood dose can also be based on Deferasirox 500 mg V03AC03000T4002 transfusions (transfusional 438. A* transfusion rate and existing Dispersible Tablet XX haemosiderosis) in adult iron burden. Max is 30 and pediatric patients aged mg/kg/day 2 years and above Treatment of iron overload in patients with thalassemia major for whom 25 mg/kg 3 times a day for desferrioxamine therapy is Deferiprone 500 mg V03AC02000T1001 total daily dose of 75 mg/kg. 439. A* contraindicated or Tablet XX Doses greater 100 mg/kg are inadequate. Add on therapy not recommended to desferrioxamine for thalassemia patients with cardiac complication A single subcutaneous Post-Menopausal injection of 60 mg Denosumab in 1.0 mL Osteoporosis. (To be used administered once every 6 solution (60 mg/mL) Pre‐ M05BX04000P400 440. A* by Orthopaedic Specialist, months. Patients should filled syringe 1XX Rheumatologist and receive calcium and vitamin (subcutaneous injection) Endocrinologist) D supplements whilst undergoing treatment.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) 2 g by IM immediately and 5 g by mouth after gastric i) Acute iron poisoning in lavage children ii) 0.5 - 1.5 g by IM injection ii) Investigation and daily treatment of iii) Diagnosis: 5 mg per kg by Desferrioxamine B haemochromatosis V03AC01196P300 slow intravenous infusion 441. Methanesulphonate 0.5 g A iii) Diagnosis and treatment 1XX during the last hour of Injection of aluminium toxicity in haemodialysis. Treatment: 5 patients with renal failure mg per kg once a week by and dialysis slow intravenous infusion iv) Chronic iron toxicity or during the last hour of overload dialysis iv) 30 - 50 mg/kg ADULT: Induction , initially 3% in oxygen or nitrous oxide/oxygen and increased by 0.5%-1% every 2-3 i) Induction and breaths or as tolerated (up to maintenance of 11%), until loss of N01AB07000L5001 anaesthesia in adult consciousness. 442. Desflurane Liquid A XX ii) Maintenance of Maintenance: 2.5%-8.5% anaesthesia in infants & with or without concomitant children nitrous oxide CHILD: maintenance, inhaled in concentrations of 5.2%-10% with or without concomitant nitrous oxide Adults and Adolescents (12 Desloratadine 5 mg R06AX27000T1001 Allergic rhinitis and chronic years of age and older): 5mg 443. A* Tablet XX idiopathic urticaria once a day regardless of mealtime. i)ADULT and CHILD : 0.1- 0.2mg 3 times daily, up to i) Central diabetes insipidus 0.1-1.2mg daily ii) Primary nocturnal ii) ADULT & Child≥5 yr 0.2- Desmopressin 0.1 mg H01BA02122T1001 enuresis 444. A 0.4mg at night Tablet XX iii) Treatment of nocturia iii)Initially 0.1 mg at night. associated with nocturnal May be increased to 0.2 mg polyuria in adult and then to 0.4 mg by means of weekly increase i) ADULT and CHILD : 0.1- 0.2mg 3 times daily, up to i) Central diabetes insipidus 0.1-1.2mg daily ii) Primary nocturnal ii) ADULT & Child≥5 yr 0.2- Desmopressin 0.2 mg H01BA02122T1002 enuresis 445. A 0.4mg at night Tablet XX ii) Treatment of nocturia iii) Initially 0.1 mg at night. associated with nocturnal May be increased to 0.2 mg polyuria in adult and then to 0.4 mg by means of weekly increase

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) ADULT : 10 - 20 mcg 1-2 i) Diabetes Insipidus Desmopressin 100 H01BA02122A410 times daily. CHILD: 5 - 446. A ii) Primary nocturnal mcg/ml Nasal Spray 1XX 10mcg 1-2 times daily enuresis ii) 10-40 mcg nocte Desmopressin Acetate 4 H01BA02122P300 ADULT : 1 - 4 mcg IV daily. 447. A Diabetes insipidus mcg/ml Injection 1XX CHILD :0.4 mcg daily Tablets must be taken in the order directed on the Contraception. Only for package every day at about women who should not take the same time with some Desogestrel 0.075 mg G03AC09000T100 combined oral liquid as needed. One tablet 448. A* Tablet 1XX contraceptives (COCs) eg is to be taken daily for 28 Obese, smoker, migraine, consecutive days. Each breast feeding subsequent pack is started immediately after finishing the previous pack. One tablet daily for 21 days Desogestrel 150 mcg & G03AA09954T100 starting on 1st day of 449. Ethinylestradiol 20 mcg A/KK Oral contraception 2XX menses followed by 7 tablet- Tablet free days. 1 tablet daily for 21 days, Desogestrel 150 mcg & subsequent courses G03AB05954T100 450. Ethinylestradiol 30 mcg C+ Contraception repeated after 7 day interval 1XX Tablet (during which withdrawal bleeding occurs) Desvenlafaxine Succinate Recommended dose is 50mg N06AX23999T5002 451. 50 mg Extended Release A* Major depression once daily, with or without XX Tablet food. i) Prophylaxis and management of nausea and vomiting in cancer chemotherapy, post- 0.5mg to 10mg daily is given operation and palliative for oral administration, Dexamethasone 0.5 mg H02AB02000T1001 care, 452. A depending upon the disease Tablet XX ii) Treatment of being treated. Up to 15 mg adrenocortical function daily in severe disease. abnormalities, iii) Any other treatment requiring corticosteroid therapy. i) Prophylaxis and management of nausea and vomiting in cancer chemotherapy, post- 0.5mg to 10mg daily is given Dexamethasone 4mg H02AB02000T1003 operation and palliative for oral administration, 453. A Tablet XX care, depending upon the disease ii) Treatment of being treated. adrenocortical function abnormalities, iii) Any other treatment

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber requiring corticosteroid therapy. Treatment of ocular Dexamethasone and Apply 1 - 1.5 cm 3 - 4 times inflammation when Neomycin Sulphate and S01CA01990G510 daily, may be used 454. A concurrent use of an Polymyxin B Eye 1XX adjunctively with drops at antimicrobial is judged Ointment bedtime necessary Treatment of ocular Dexamethasone and inflammation when 1 - 2 drops hourly for severe Neomycin Sulphate and S01CA01990D200 455. A concurrent use of an cases and 4 - 6 hourly for Polymyxin B Sulphate 1XX antimicrobial is judged mild infection Ophthalmic Suspension necessary Dexamethasone Sodium Acute steroid responsive S01BA01162D200 456. Phosphate 0.1% Eye A inflammatory and allergic 1 - 2 drops 4 - 6 times a day 1XX Drops conditions i) Prophylaxis and management of nausea and vomiting in cancer chemotherapy, post- operation and palliative Initially 0.5 - 9 mg IM, IV or Dexamethasone Sodium H02AB02162P300 care, infusion daily, depending 457. Phosphate 4 mg/ml B 1XX ii) Treatment of upon the disease being Injection adrenocortical function treated abnormalities, iii) Any other treatment requiring corticosteroid therapy. Symptomatic treatment of ADULT : 2 mg 3 times daily. Dexchlorpheniramine R06AB02253T1001 458. B allergic rhinitis and allergic CHILD : 2 - 12 years : 2 mg 3 Maleate 2 mg Tablet XX dermatoses times daily CHILD 2 - 5 years : 0.5 mg Dexchlorpheniramine R06AB02253L9001 Symptomatic treatment of every 4 - 6 hours; 6 - 11 459. B Maleate 2 mg/5 ml Syrup XX allergic rhinitis years : 1 mg every 4 - 6 hours i) Not to be infused for more i) Sedation of intubated and than 24 hours, 1 mcg/kg over mechanically ventilated ICU 10 minutes as loading dose. patients. For use only by Maintenance dose: 0.2 - 0.7 Dexmedetomidine HCl N05CM18110P400 specialist anaesthetist mcg/kg/hr 460. A* 100 mcg/ml Injection 1XX ii) For sedation of non- ii) Not to be infused for more intubated patients prior to than 24 hours, 1 mcg/kg over and/or during surgical and 10 minutes as loading dose. other procedures Maintenance dose: 0.2 - 0.7 mcg/kg/hr Condition associated with Initially 500-1000 ml by peripheral local slowing of B05AA05000P6001 infusion, further doses are 461. Dextran 40 Injection A* the blood flow, prophylaxis XX given according to the of post surgical patient's condition thromboembolic disease

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber For parenteral replenishment of fluid and B05BA03000P6002 minimal carbohydrate According to the needs of the 462. Dextrose 10% Injection B XX calories as required by the patient clinical condition of the patient For parenteral replenishment of fluid and B05BA03000P6003 minimal carbohydrate According to the needs of the 463. Dextrose 20% Injection B XX calories as required by the patient clinical condition of the patient For parenteral replenishment of fluid and B05BA03000P3004 minimal carbohydrate According to the needs of the 464. Dextrose 30% Injection B XX calories as required by the patient clinical condition of the patient For parenteral replenishment of fluid and B05BA03000P6001 minimal carbohydrate According to the needs of the 465. Dextrose 5% Injection B XX calories as required by the patient clinical condition of the patient For parenteral replenishment of fluid and B05BA03000P3005 minimal carbohydrate According to the needs of the 466. Dextrose 50% Injection B XX calories as required by the patient clinical condition of the patient V04CA02000F2101 Use as a diagnostic agent 467. Dextrose Powder B 75 g stat XX for diabetes i) ADULT and CHILD more than 10 year, ORALLY: 60 - 100 ml RECTALLY, contrast medium should be diluted with 3-4 times its volume of i) Contrast medium for the water. ORALLY: CHILD less radiological examination of than 10 years,: 15- 30 ml the gastrointestinal tract NEWBORN, INFANT (primarily in cases in which Diatrizoate Meglumine contrast medium should be V08AA01254L9901 barium sulphate is 468. and Sodium A diluted with 3 times its XX contraindicated) ii) Amidotrizoate Solution volume of water. Computerised tomography RECTALLY: CHILD more in abdominal region iii) than 5 years, contrast Treatment of Mecolinium medium should be diluted ileus with 4-5 times its volume of water. Younger patients a dilution with 5 times its volume is recommended ii) Adult, orally, 25-77 mL in

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber 1000 mL tap water 15-30 minutes prior to imaging i) ADULT: 2-10 mg 3-4 times daily. CHILD 6 months and older: 0.12 - 0.8 mg/kg daily in divided doses, every 6-8 hours i) Muscle spasm of varied N05BA01000T1001 ii) ADULT : 2 mg 3 times 469. Diazepam 2 mg Tablet B aetiology, including tetanus XX daily, increased in severe ii) Anxiety disorders anxiety to 15 - 30 mg daily in divided doses. ELDERLY (or delibitated) half adult dose. CHILD (night terrors), 1 - 5 mg at bedtime Status epilepticus - ADULT: 0.5 mg/kg repeated after 12 hours if necessary. CHILD (febrile convulsions, Diazepam 5 mg Rectal N05BA01000G200 Status epilepticus, skeletal 470. C prolonged or recurrent): 0.5 Solution 1XX muscle spasm mg/kg (maximum 10 mg), repeated if necessary. Not recommended for children below 2 years i) ADULT: 2-10 mg 3-4 times daily. CHILD 6 months and older: 0.12 - 0.8 mg/kg daily in divided doses, every 6-8 hours i) Muscle spasm of varied N05BA01000T1002 ii) ADULT : 2 mg 3 times 471. Diazepam 5 mg Tablet B aetiology, including tetanus XX daily, increased in severe ii) Anxiety disorders anxiety to 15 - 30 mg daily in divided doses. ELDERLY (or delibitated) half adult dose. CHILD (night terrors), 1 - 5 mg at bedtime

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Status epilepticus, by slow IV: 5-10 every 10-15 minute (rate not more than 5 mg/min), to a total dose of 30 mg, may repeat in 2 hour if needed. Infants 30 days to 5 years, 0.05-0.3 mg/kg/dose given over 2-3 minutes, every 15-30 minutes to a total dose of 5 mg, repeat in 2-4 hours if necessary. CHILD more than 5 years, 1 mg by slow IV, every 2-5 i) Status epilepticus minutes, maximum 10 mg, Diazepam 5 mg/ml N05BA01000P300 472. B ii) Skeletal muscle spasm repeat in 2-4 hours if Injection 1XX iii) Anxiety disorders necessary ii) Skeletal muscle spasm, by slow IV or IM, 5-10 mg repeated if necessary in 3-4 hours. CHILD (tetanus): 30 days - 5 years, 1-2 mg IM or IV slowly every 3-4 hours as needed. 5 years and above, 5-10 mg IM or IV slowly every 3-4 hours if needed iii) Anxiety disorders, 2-10 mg by slow IV (not more than 5 mg/min). Repeat if necessary every 3-4 hours Post-traumatic inflammation of the tendons,ligaments & M02AA15520G300 Apply 3 - 4 times daily and 473. Diclofenac 1% Gel A joints. Localised forms of 1XX gently rubbed in soft tissue rheumatism and degenerative rheumatism Diclofenac Suppositories are Pain and inflammation in normally inserted one, two or Diclofenac 100mg M01AB05520S200 474. A rheumatic disease and three times a day up to a Suppository 4XX juvenile arthritis maximum total daily dose of 150 mg. Pain and inflammation in ADULT: 75 - 150 mg daily in Diclofenac 12.5 mg M01AB05520S200 475. A rheumatic disease and divided doses. CHILD 1-12 Suppository 1XX juvenile arthritis years, 12.5- 25 mg daily Pain and inflammation in ADULT: 75 - 150 mg daily in Diclofenac 25 mg M01AB05520S200 476. A rheumatic disease and divided doses. CHILD 1-12 Suppository 2XX juvenile arthritis years, 12.5- 25 mg daily ADULTS: Initial dose of 150 mg daily. Mild or long term: 75 - 150 mg daily in 2 to 3 M01AB05520T100 Pain and inflammation in 477. Diclofenac 50 mg Tablet B divided doses after food. 1XX rheumatic disease Maximum 200mg/day. PAEDS more than 6 months : 1 - 3 mg/kg body weight

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber daily in divided doses. Maximum 3mg/kg/day (Max 150mg/day).

ADULTS: 75 - 150 mg daily in divided doses. Maximum Pain and inflammation in 150mg/day. PAEDS more Diclofenac Sodium 50 mg M01AB05520S200 478. A rheumatic disease and than 6 months : 1 - 3 mg/kg Suppository 3XX juvenile arthritis body weight daily in divided doses. Maximum 3mg/kg/day (Max 150mg/day). IM 75 mg once daily (2 times daily in severe cases) for not Diclofenac Sodium 75 M01AB05520P300 Pain and inflammation in 479. A/KK more than 2 days. Max mg/3 ml Injection 1XX rheumatic disease 150mg/day. Not suitable for children. ADULT less than 60 kg: 125 mg twice daily or 250 mg once daily; more than 60 kg: HIV infection, in 400 mg once daily or 200 mg Didanosine 100 mg Tablet J05AF02000T1002 480. A* combination with other twice daily. CHILD: 2 weeks (ddI) XX antiretrovirals to less than 3 months: 50mg/m2 twice daily; 3-8 months: 100mg/m2 twice daily ADULT less than 60 kg: 125 mg twice daily or 250 mg once daily; more than 60 kg: HIV infection, in 400 mg once daily or 200 mg Didanosine 2 g Oral J05AF02000F2101 481. A* combination with other twice daily. CHILD: 2 weeks Solution (ddI) XX antiretrovirals to less than 3 months: 50mg/m2 twice daily; 3-8 months: 100mg/m2 twice daily ADULT less than 60 kg: 125 mg twice daily or 250 mg once daily; more than 60 kg: HIV infection, in 400 mg once daily or 200 mg Didanosine 25 mg Tablet J05AF02000T1001 482. A* combination with other twice daily. CHILD: 2 weeks (ddI) XX antiretrovirals to less than 3 months: 50mg/m2 twice daily; 3-8 months: 100mg/m2 twice daily ADULT less than 60 kg: 250 HIV infection, in mg once daily; 60 kg or Didanosine 250 mg J05AF02000C1001 483. A* combination with other greater: 400 mg once daily. Enteric Coated Capsule XX antiretrovirals Dose may varies if taken in combination with tenofovir

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber ADULT less than 60 kg: 250 HIV infection, in mg once daily; 60 kg or Didanosine 400 mg J05AF02000C1002 484. A* combination with other greater: 400 mg once daily. Enteric Coated Capsule XX antiretrovirals Dose may varies if taken in combination with tenofovir One tablet daily. Treatment can be started on any day of G03DB08000T100 menstrual cycle. Tablets 485. Dienogest 2mg tablet A/KK Treatment of endometriosis 1XX must be taken continously without regard to vaginal bleeding. i) 1 mg/kg on the first day and increased gradually over 3 days to 6 mg/kg daily in i) Bancrofti filariasis, divided doses. This dosage onchocerciasis, loasis, Diethylcarbamazine P02CB02136T1001 is maintained for 21 days. 486. B creeping eruption Citrate 50 mg Tablet XX ii) 13 mg/kg once daily for 7 ii) Ascariasis days. CHILD : 6 - 10 mg/kg 3 iii) Tropical eosinophilia times daily for 7 days iii) 6 mg/kg/day in 3 divided doses for 21 days Rapid digitalisation: 0.75 -1.5 mg in divided doses over 24 hours; less urgent digitalisation, 250 mcg-500 mcg daily (higher dose may Heart failure , with atrial be divided). Maintenance : C01AA05000T1001 fibrillation, supraventricular 62.5mg -500 mcg daily 487. Digoxin 0.25 mg Tablet B XX arrhythmias (particularly, (higher dose may be divided) atrial fibrillation) according to renal function and , in atrial fibrillation, on heart rate response; usual range, 125-250 mcg daily (lower dose may be appropriate in elderly) Rapid digitilisation: ADULT & Heart failure with atrial CHILD over 10 years, initially Digoxin 250 mcg/ml C01AA05000P300 fibrillation, supraventricular 488. A 0.75 - 1.5 mg, followed by Injection 1XX arrhythmias (particularly 250 mcg 6 hourly until atrial fibrillation) digitilisation is complete Rapid digitalization, give in divided doses; PREMATURE: 20-30 mcg/kg; FULLTERM: 25-35 Heart failure, mcg/kg; CHILD 1-2 years : C01AA05000L1001 supraventricular 35 to 60 mcg/kg; CHILD 2-5 489. Digoxin 50 mcg/ml Elixir B XX arrhythmias (particularly years: 30-40 mcg/kg; CHILD atrial fibrillation) 5-10 years: 20- 35 mcg/kg; CHILD over 10 years: 10-15 mcg/kg. For daily maintenance doses or for gradual digitalization, give

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber 20% to 30% of oral digitalizing dose for premature infants or 25% to 35% of oral digitalizing dose for all other pediatric patients Rapid digitalisation: 1-1.5 mg in divided doses over 24 hours; less urgent digitalisation, 250 mcg-500 mcg daily (higher dose may Heart failure, with atrial be divided). Maintenance: C01AA05000T1002 fibrillation, supraventricular 62.5 - 500 mcg dailly (higher 490. Digoxin 62.5 mcg Tablet B XX arrhythmias (particularly, dose may be divided) atrial fibrillation) according to renal fuction, and in atrial fibrillation, on heart-response; usual range :125 - 250 mcg daily (lower doses may be appropriate in the elderly) ADULT: 30 - 60 mg every 4 - Dihydrocodeine Tartrate N02AA08123T1001 For the control of moderate 6 hours. PAED, over 4 yrs: 491. B 30 mg Tablet XX to severe chronic pain 0.5 - 1 mg/kg body weight every 4-6 hours Adjunct in elderly with mild Dihydroergocristine or Co- C04AE01196T1001 to moderate dementia, 492. dergocrine Mesilate 1 mg A/KK 3-6 mg daily in divided doses XX prevention of migraine and Tablet vascular headache Treatment of angina pectoris in the following cases: Initially 30mg tds, may i) inadequate response or Diltiazem HCl 30 mg C08DB01110T100 increase to 60mg tds (elderly 493. B intolerance to beta-blockers Tablet 1XX initially twice daily; increased and Isosorbide Dinitrate if necessary to 360 mg daily. ii) contraindication to beta- blockers iii) coronary artery spasm Usual Adult & Adolescent Dose: Antiemetic; or Antivertigo agent ? Intramuscular, 50 mg Prevention and relief of repeated every four hours as motion sickness, treatment needed. Intravenous, 50 mg of vertigo, nausea or in 10 mL of 0.9% sodium Dimenhydrinate Injection N07CA00000P200 vomiting associated with chloride injection, 494. B 10ml/vial (50mg/ml) 1XX electroshock therapy, administered slowly over a anaesthesia and surgery; period of at least two labyrinthine disturbances minutes, repeated every four and radiation sickness. hours as needed. Usual Pediatric Dose: Antiemetic; or Antivertigo agent ? Intramuscular, 1.25 mg per kg of body weight or 37.5 mg

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber per square meter of body surface, every six hours as needed, not to exceed 300 mg per day. Intravenous, 1.25 mg per kg of body weight or 37.5 mg per square meter of body surface, in 10 ml of 0.9% sodium chloride injection, administered slowly over a period of at least two minutes, every six hours as needed, not to exceed 300 mg per day. For prevention and ADULT: 50-100 mg every 4 treatment of motion hours as needed. For motion sickness. Also used as anti- sickness, take medicine at emetic agent in irradiation least 30 minutes, and sickness, postoperative preferably 1-2 hours before Dimenhydrinate Syrup N07CA00000L9003 vomiting, drug induced 495. B travelling. Usual adult 15mg/5ml XX nausea and vomiting, and prescribing limit: Up to 400 for symptomatic treatment mg daily. CHILD: Children 6- of nausea and vertigo due 12 years: 25-50 mg every 6- to Meniere`s disease and 8 hours as needed other labyrinthine (maximum of 150 mg daily). disturbances. ADULT: 50-100 mg every 4 Prevention and treatment of hours as needed. For motion the nausea, vomiting and sickness, take medicine at dizziness associated with least 30 minutes, and motion sickness. preferably 1-2 hours before Dimenhydrinate Tablet N07CA00000T100 496. B Symptomatic treatment of travelling. Usual adult 50mg 1XX nausea and vertigo caused prescribing limit: Up to 400 by Meniere's disease and mg daily. CHILD: 6-12 years: other vestibular 25-50 mg every 6-8 hours as disturbances. needed (maximum of 150 mg daily). By IM: 2.5 - 3 mg/kg every 4 hours for 2 days, 2 - 4 times Poisoning by antimony, on the third day, then 1 - 2 arsenic, bismuth, gold, times daily for 10 days or Dimercaprol 50 mg/ml V03AB09000P3001 mercury, possibly thallium; 497. B until recovery. For Injection XX adjunct (with calcium ophthalmic use : instillation disodium edetate) in lead of 50 mg/ml oily solution in poisoning conjunctival sac, within 5 minutes of contamination 3 mg vaginal tablet to be inserted high into the Dinoprostone G02AD02000S100 posterior formix. A second 3 498. (Prostagladin E2) 3 mg A Induction of labour 1XX mg tablet may be inserted Vaginal Tablet after 6-8 hours if labour is not established. Max 6 mg

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Acute attack: 6 tablets daily for the first 4 days, then 4 i) Haemorrhoids tablets daily in 2 divided Diosmin 450 mg and C05CA53931T100 499. A/KK ii) Chronic venous doses for 3 days and 2 Hesperidin 50 mg Tablet 1XX insufficiency tablets thereafter. Chronic: 2 tablets daily ii) 2 tab daily with meals Allergic rhinitis 1) Adults & Children over 12 years of age : 25 to 50 mg 3 to 4 times a day 2) Children 6 to 12 years of age: 10 mg 3 to 4 times a day 3) Children 1 to 6 years of age: 5 mg 3 to 4 times a day. Maximum daily Diphenhydramine dosage <300 mg (adults and R06AA02110L1001 500. Hydrochloride 10 mg/5 ml C Cough and allergic rhinitis children) Cough and cold XX Oral solution 1) Adults: 25 mg every 4 hrs. Not to exceed 150 mg in 24 hours 2) Children (6 to 12years): 12.5 mg every 4 hours. Not to exceed 75 mg in 24 hours 3) Children (2 to 6 years): 6.25 mg every 4 hours. Not to exceed 25 mg in 24 hours ADULT : 5 - 10 ml 2 - 3 times Diphenhydramine daily. CHILD : 2.5 - 5 ml 2 - 3 R06AA52110L2101 501. Hydrochloride 14 mg/5 ml C Cough times daily (not to be used in XX Expectorant children less than 2 years of age) ADULT : 5 - 10 ml 2 - 3 times Diphenhydramine daily. CHILD : 2.5 - 5 ml 2 - 3 R06AA52110L9003 502. Hydrochloride 7 mg/5 ml C Cough times daily (not to be used in XX Expectorant children less than 2 years of age) ADULT initially 4 tablet Diphenoxylate HCl 2.5mg A07DA01922T1001 followed by 2 tablet 4 times 503. with Atropine Sulphate B Acute diarrhoea XX daily until diarrhoea is 0.025mg Tablet controlled Prophylactic: 2 or 3 doses by deep SC or IM injection, 0.5 Diphtheria and Tetanus J07AM51963P3001 Immunisation against or 1 ml. Each second dose at 504. C+ Vaccine Injection XX diphtheria and tetanus 4 - 6 weeks then 4 - 6 months. Booster at 4 - 6 years Therapeutic: 10,000 - 30,000 units by IM or IV. Increase to Diphtheria Antitoxin J07AF01000P3001 40,000 - 100,000 units in 505. B Diphtheria Injection XX severe cases. Doses up to 30,000 units may be given IM

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Diphtheria, Pertussis, Immunisation of children Tetanus and Conjugated J07AG52000P3001 against Haemophilus Type 506. C 0.5 ml given by IM Haemophilus Type B 10 XX B infections, diphtheria, mcg Vaccine tetanus and pertussis Primary vaccination: 3 doses Active immunisation against of 0.5 ml each within the first Diphtheria, Pertussis, diphtheria, tetanus, 6 months of life. Administer J07CA05963P3001 507. Tetanus and Hepatitis B C+ pertussis and hepatitis B in each dose at intervals of at XX Vaccine infants from 6 weeks least 4 weeks. A booster onwards dose can be administered in the second year of life By deep SC or IM injection: 3 doses each of 0.5 or 1 ml Prophylactic immunisation with intervals of 6 - 8 weeks Diphtheria, Pertussis, J07AJ52963P3001 508. C against diphtheria, pertussis and 4 - 6 months Tetanus Vaccine Injection XX and tetanus respectively between the doses. Booster 1 and 5 years after primary immunisation Diphtheria, Tetanus, Immunisation of children Acellular Pertussis, against Diphtheria, Inactivated Polio Virus, Primary : 0.5 ml by IM at 1 - J07CA06963P3001 Tetanus, Acellular 509. Haemophilus Influenza C+ 2 months intervals Booster : XX Pertussis, Polio and Type B (DTaP-IPV-HiB) Second year of life Haemophilus Influenza Vaccine Injection (Single Type B infection Dose) As an adjunct to oral Dipyridamole 75 mg B01AC07000T1001 anticoagulation/ antiplatelet 75-150 mg 3 times daily to 510. B Tablet XX therapy in the prophylaxis be taken 1 hour before meals of cerebrovascular events i) ADULT : 5 mg daily 30 minutes before breakfast. Increase at intervals of 3 - 4 days if necessary to i) Myasthenia gravis maximum of 20 mg daily. ii) Prevention and treatment CHILD : Up to 10 mg daily Distigmine Bromide 5 mg N07AA03320T1001 511. A of post-operative intestinal according to age Tablet XX atony, urinary retention and ii) Urinary retention : 5 mg neurogenic bladder daily 30 minutes before breakfast. Neurogenic bladder : 5 mg daily or on alternate days 30 minutes before breakfast For application to skin or Short contact treatment for Dithranol 0.1 - 5% in D05AC01000G500 scalp. 0.1-0.5% suitable for 512. A plaque psoriasis and Vaseline/ Ointment 1XX overnight treatment. 1-2% for alopecia areata max 1 hour. Treatment of quiescent or Apply liberally and carefully Dithranol 1 % in Lassars D05AC01000G600 chronic psoriasis of the to the lesions with a suitable 513. A Paste 1XX skin, scalp and alopecia applicator. A dressing may areata be applied

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Initial 0.5-1 mcg/kg/min by IV, maintenance 2.5- 10mcg/kg/min. Frequently,doses up to Dobutamine 12.5 mg/ml C01CA07110P300 Hypotension and heart 514. A 20mcg/kg/min are required Injection 1XX failure for adequate hemodynamic improvement. On rare occasions,infusion rates up to 40mcg/kg/min i) 75 mg/m2 IV over 1 hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 i) Adjuvant treatment of mg/m2 every 3 weeks for 6 patients with high risk node- cycles positive breast cancer in ii) 75 mg/m2 IV over 1 hour combination with every 3 week in combination doxorubicin and with doxorubicin 50 mg/m2 cyclophosphamide iii) Administer IV over 1 hour ii) Breast cancer, locally every 3 weeks. advanced or metastatic, not Chemotherapy-naive previously on cytotoxic patients 75 mg/m2 therapy, in combination with immediately followed by 75 doxorubicin mg/m2 cisplatin over 30-60 iii) First line therapy in non Docetaxel 40mg/ml L01CD02000P3002 mins or carboplatin (AUC 6 515. A* small cell lung cancer in Injection XX mg/mL/min) over 30-60 stage 3- 4 and performance minutes. Monotherapy of non status 0-1, in combination small cell lung cancer with cisplatin (NSCLC) after failure of prior iv) Inoperable locally platinum-based advanced squamous cell chemotherapy 75 mg/m2 carcinoma of head and iv) 75 mg/m2 as a 1 hour neck, in combination with infusion followed by cisplatin cisplatin and 5-FU for 75 mg/m2 over 1 hour, on induction treatment day one, followed by 5- v) Prostate cancer, in fluorouracil as a continuous combination with infusion at 750 mg/m2 per prednisolone day for five days. This regimen is administered every 3 weeks for 4 cycles. Chronic dyspepsia : CHILD 2.5 mL/10 kg body weight 3 times daily and once more in the evening if necessary. Dosage may be doubled in Nausea, vomiting, Domperidone 1 mg/ml A03FA03000L8001 adults & childs over 1 year. 516. B dyspepsia, gastro- Suspension XX Acute and subacute esophageal reflux conditions (particularly nausea and vomiting). CHILD: 5 mL/10 kg bodyweight. All to be taken 3-4 times daily

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Chronic dyspepsia ADULT 10 mg 3 times daily. Acute Nausea, vomiting, Domperidone 10 mg A03FA03253T1001 and subacute conditions 517. B dyspepsia, gastro- Tablet XX (particularly nausea and esophageal reflux vomiting):ADULT 20 mg 3-4 times daily Treatment of mild to moderate dementia in Alzheimer's disease, as well 5 - 10 mg once daily at Donepezil HCl 10 mg N06DA02110T100 518. A as in patients with severe bedtime. Maximum 10 mg Tablet 2XX Alzheimer's disease. daily [psychiatrists and neurologists only] Treatment of mild to moderate dementia in 5 - 10 mg once daily at Donepezil HCl 5 mg N06DA02110T100 519. A Alzheimer's disease, as well bedtime. Maximum 10 mg Tablet 1XX as in patients with severe daily Alzheimer's disease. Initiated at 5mg/day (one a day dosing), should be Treatment of mild to maintained for at least 1 moderate dementia in month in order to allow the Donepezil Hydrochloride Alzheimer's disease, as well N06DA02110T400 earliest clinical responses 520. 10mg Orodispersible A* as in patients with severe 2XX and to allow steady state Tablet Alzheimer's disease. concentration to be [psychiatrists and achieved. The maximum neurologists only] recommended daily dose is 10 mg. Initiated at 5mg/day (one a day dosing), should be Treatment of mild to maintained for at least 1 moderate dementia in month in order to allow the Donepezil Hydrochloride Alzheimer's disease, as well N06DA02110T400 earliest clinical responses 521. 5mg Orodispersible A* as in patients with severe 1XX and to allow steady state Tablet Alzheimer's disease. concentration to be [psychiatrists and achieved. The maximum neurologists only] recommended daily dose is 10 mg. Initial dose 2-5 mcg/kg/min with incremental changes of 5-10 mcg/kg/min at 10-15 minutes intervals until Dopamine HCl 40 mg/ml C01CA04110P300 Non-hypovolemic adequate response is noted. 522. B Injection 1XX hypotension Most patients are maintained at less than 20 mcg/kg/min. If dosage exceeds 50 mcg/kg/min, assess renal function frequently

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Ventilator-associated 500mg every 8 hours as a pneumonia (VAP) patients one hour infusion for 5 to 14 Doripenem Monohydrate J01DH04000P4001 at risk or involving multidrug 523. A* days according to severity, 500 mg Injection XX resistant pathogens site of infection and the especially Pseudomonas patient's clinical response. aeruginosa infections Monotherapy : 1 drop 3 times daily. Adjunctive therapy with an ophthalmic beta-blocker : 1 drop 2 times daily. When substituting for another All glaucoma patients ophthalmic antiglaucoma where beta-blockers are agent with this product, Dorzolamide HCl 2% S01EC03110D200 contraindicated and when 524. A* discontinue the other agent Ophthalmic Solution 1XX intraocular pressure is not after proper dosing on one well controlled by other day and start Trusopt on the drugs next day. If more than 1 topical ophthalmic drug is used, the drugs should be administered at least 10 mins apart Initially 75 mg (ELDERLY 50- 75 mg) daily in divided doses or single dose at bedtime, increased gradually as Dothiepin HCl 25 mg N06AA16110C100 525. A Depression of any aetiology necessary to 150 mg daily Capsule 1XX (ELDERLY 75 mg may be sufficient), up to 225 mg daily in some circumstances. CHILD is not recommended Initially 75 mg (ELDERLY 50- 75 mg) daily in divided doses or single dose at bedtime, increased gradually as Dothiepin HCl 75 mg N06AA16110T1001 526. A Depression of any aetiology necessary to 150 mg daily Tablet XX (ELDERLY 75 mg may be sufficient), up to 225 mg daily in some circumstances. CHILD is not recommended Doxazosin Mesilate 4 mg C02CA04196T500 Benign Prostatic 4 mg once daily to maximum 527. A* CR Tablet 1XX Hyperplasia 8mg/day

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) 30 - 75 mg/m2 IV as a single dose at 21 day intervals ii) 25 - 45 mg/m2 once a week for the first 4 weeks during induction or re- induction phase (refer to specific protocol. Caution: Total cumulative dose of i) Solid tumours, leukaemia, doxorubicin must not exceed non-Hodgkin's lymphoma Doxorubicin HCl 10 mg L01DB01110P4001 550 mg/m2 due to risk of 528. A ii) Leukaemia (ALL Injection XX cardiotoxicity. CHILD: 30 induction) mg/m2/dose over 6 - 24 iii) Multiple myeloma hours for 1 - 2 days. Need to check cardiac function closely by echocardiography every cumulative dose of 100 mg/m2 to maximum 360 mg/m2 iii) 9 mg/m2 over 24 hours infusion for 4 days at monthly intervals i) 30 - 75 mg/m2 IV as a single dose at 21 day intervals ii) 25 - 45 mg/m2 once a week for the first 4 weeks during induction or re- induction phase (refer to specific protocol. Caution: Total cumulative dose of i) Solid tumours, leukaemia, doxorubicin must not exceed non-Hodgkin's lymphoma Doxorubicin HCl 50 mg L01DB01110P4002 550 mg/m2 due to risk of 529. A ii) Leukaemia (ALL Injection XX cardiotoxicity. CHILD: 30 induction) mg/m2/dose over 6 - 24 iii) Multiple myeloma hours for 1 - 2 days. Need to check cardiac function closely by echocardiography every cumulative dose of 100 mg/m2 to maximum 360 mg/m2 iii) 9 mg/m2 over 24 hours infusion for 4 days at monthly intervals ADULT: 200 mg on the first Doxycycline 100 mg J01AA02000C1001 Infections due to day followed by 100 mg 530. B Capsule XX susceptible organisms daily. Severe infections: 200 mg daily ADULT: 200 mg on the first Doxycycline 100 mg J01AA02000T1001 Infections due to day followed by 100 mg 531. B Tablet XX susceptible organisms daily. Severe infections: 200 mg daily

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Treatment of severe lead i) Heavy metal poisoning: poisoning, it is used as 900mg-1800mg daily. adjunctive treatment Duration of treatment is following initial treatment dictated by the urinary heavy with another chelating metal excretion. agent. May also be used as Simultaneous oral vitamin B6 D-Penicillamine 0.25 g M01CC01000C100 532. A sole therapy in the replacement with at least Capsule 1XX treatment of asymptomatic 40mg daily is essential patients with moderately ii) Wilson's disease: 0.25g - elevated blood 1.5g daily on an incremental concentrations basis. Maximal daily dose: ii) Wilson's Disease: to aid 2g. Maintenance dose: 0.75g in elimination of copper ions - 1g daily ADULT: 60 mg once daily up to a maximum dose of Major depressive disorder, Duloxetine 30 mg N06AX21110C100 120mg/day (in divided 533. A* diabetic peripheral Capsule 1XX doses) CHILD and neuropathic pain ADOLESCENT under 18 years not recommended ADULT: 60 mg once daily up to a maximum dose of Duloxetine 60 mg N06AX21110C100 Major depression, diabetic 120mg/day (in divided 534. A* Capsule 2XX peripheral neuropathic pain doses) CHILD and ADOLESCENT under 18 years not recommended Benign prostatic Dutasteride 0.5 mg G04CB02000C100 535. A* hyperplasia in men with an 0.5 mg daily Capsule 1XX enlarged prostate gland Combination therapy for the treatment of moderate to severe symptoms of BPH Dutasteride 0.5mg and G04CA52953C100 with: i) Large prostate 536. Tamsulosin 0.4mg A* One capsule daily 1XX (>30g) ii) Poor risk or not fit Capsule for surgery iii)Those who are awaiting their turn for surgery i) 10 mg bd from day 5 - 25 of cycle i) Dysmenorrhoea ii) 10 mg bd - tds from day 5 ii) Endometriosis - 25 of the cycle or iii) Dysfunctional uterine continuously bleeding (to arrest and to iii) To arrest bleeding :10 mg prevent bleeding) bd with an oestrogen once Dydrogesterone 10 mg G03DB01110T100 iv) Threatened abortion 537. A/KK daily for 5 - 7 days, To Tablet 1XX v) Habitual abortion prevent bleeding : 10 mg bd vi) Post menopausal with an oestrogen once daily complaints (hormone from day 11 - 25 of the cycle replacement therapy in iv) 40 mg at once, then 10mg combination with 8hrly until symptoms remit oestrogen) v) 10 mg bd until 20th week of pregnancy

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber vi) 10-20 mg daily during last 12-14 days of each cycle i) Intravenous injection on over several minutes, 500 - 700 mcg/kg (after or with i) For reversal of atropine sulphate 600 mcg) Edrophonium Chloride 10 N07AA00100P300 neuromuscular block ii) Intravenous injection 2 mg 538. B mg/ml Injection 1XX ii) Diagnosis of myasthenia followed by 8 mg if no gravis response occurs within 30 seconds. CHILD: 20 mcg followed by 80 mcg/kg after 30 seconds ADULT: 600 mg once daily. ADOLESCENT & CHILD less than 17 years, more than 40 kg: 600 mg once daily, 32.5 - less than 40 kg: Combination therapy for 400 mg once daily, 25 - less HIV infections with a than 32.5 kg: 350 mg once Efavirenz 100 mg J05AG03000C1002 protease inhibitor and or daily, 20 - less than 25 kg: 539. A* Capsule XX Nucleoside Reverse 300 mg once daily, 15 - less Transcriptase Inhibitors than 20 kg: 250 mg once (NRTIs) daily, 13 - less than 15 kg: 200 mg once daily. No studies in children less than 3 years or less than 13 kg. Formulation unsuitable for children less than 40 kg ADULT: 600 mg once daily. ADOLESCENT & CHILD less than 17 years, more than 40 kg: 600 mg once daily, 32.5 - less than 40 kg: Combination therapy for 400 mg once daily, 25 - less HIV infections with a than 32.5 kg: 350 mg once Efavirenz 200 mg J05AG03000C1003 protease inhibitor and or daily, 20 - less than 25 kg: 540. A* Capsule XX Nucleoside Reverse 300 mg once daily, 15 - less Transcriptase Inhibitors than 20 kg: 250 mg once (NRTIs) daily, 13 - less than 15 kg: 200 mg once daily. No studies in children less than 3 years or less than 13 kg. Formulation unsuitable for children less than 40 kg

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber ADULT: 600 mg once daily. ADOLESCENT & CHILD less than 17 years, more than 40 kg: 600 mg once daily, 32.5 - less than 40 kg: Combination therapy for 400 mg once daily, 25 - less HIV infections with a than 32.5 kg: 350 mg once J05AG03000C1001 protease inhibitor and or daily, 20 - less than 25 kg: 541. Efavirenz 50 mg Capsule A* XX Nucleoside Reverse 300 mg once daily, 15 - less Transcriptase Inhibitors than 20 kg: 250 mg once (NRTIs) daily, 13 - less than 15 kg: 200 mg once daily. No studies in children less than 3 years or less than 13 kg. Formulation unsuitable for children less than 40 kg ADULT: 600 mg once daily. ADOLESCENT & CHILD less than 17 years, more than 40 kg: 600 mg once daily, 32.5 - less than 40 kg: Combination therapy for 400 mg once daily, 25 - less HIV infections with a than 32.5 kg: 350 mg once J05AG03000T1001 protease inhibitor and or daily, 20 - less than 25 kg: 542. Efavirenz 600 mg Tablet A/KK XX Nucleoside Reverse 300 mg once daily, 15 - less Transcriptase Inhibitors than 20 kg: 250 mg once (NRTIs) daily, 13 - less than 15 kg: 200 mg once daily. No studies in children less than 3 years or less than 13 kg. Formulation unsuitable for children less than 40 kg Individualised dosage based on the patient's platelet Short term use in idiopathic count. Adult Initially 50 mg thrombocytopenic purpura once daily. East Asian Eltrombopag Olamine 25 B02BX05999T1001 patients as bridging therapy 543. A* patient 25 mg once daily. mg Film-coated Tablet XX for splenectomy or surgery Then, adjust dose to and in cases of severe maintain platelet count bleeding. ≥50,000/microliter. Max: 75 mg daily. D02AC00952G500 544. Emulsificants Ointment C Xerosis and ichthyosis Use as a soap and emollient 1XX i) Initially 5 mg daily, (ELDERLY 2.5 mg once daily), usual maintenance C09AA02253T1002 i) Hypertension dose 10 - 20 mg daily. 545. Enalapril 10 mg Tablet B XX ii) Congestive heart failure Maximum: 40 mg/day in 1 - 2 divided doses ii) Initially 2.5 mg daily, usual maintenance dose 20 mg

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber daily in 1 - 2 divided doses; maximum: 40 mg/day i) Initially 5 mg daily, (ELDERLY 2.5 mg once daily), usual maintenance dose 10 - 20 mg daily. C09AA02253T1003 i) Hypertension Maximum: 40 mg/day in 1 - 2 546. Enalapril 20 mg Tablet B XX ii) Congestive heart failure divided doses ii) Initially 2.5 mg daily, usual maintenance dose 20 mg daily in 1 - 2 divided doses; maximum: 40 mg/day i) Initially 5 mg daily, (ELDERLY 2.5 mg once daily), usual maintenance dose 10 - 20 mg daily. C09AA02253T1001 i) Hypertension Maximum: 40 mg/day in 1 - 2 547. Enalapril 5 mg Tablet B XX ii) Congestive heart failure divided doses ii) Initially 2.5 mg daily, usual maintenance dose 20 mg daily in 1 - 2 divided doses; maximum: 40 mg/day i) Prophylaxis fo DVT especially in surgical patients: moderate risk, 20 mg SC approximately 2 hours before surgery then 20 mg every 24 hours for minimum 7 - 10 days, high risk (eg orthopaedic surgery, i) Prevention of Deep Vein medical patients, 40mg every Thrombosis(DVT) 24 hours for at least 6 days especially in perioperative until patient ambulant, max Enoxaparin Sodium 20 B01AB05520P5001 and high risk surgical cases 548. A* 14 days. mg Injection XX ii) Treatment of DVT ii) Treatment of DVT or iii) Unstable angina and non pulmonary embolism, 1.5 Q wave Myocardial mg/kg every 24 hours, Infarction usually for 5 days and until adequate oral anticoagulation established. iii) Unstable angina and non- ST-segment-elevation myocardial infarction 1 mg/kg every 12 hours, usually for 2 - 8 days

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Prophylaxis for DVT especially in surgical patients: moderate risk, 20 mg SC approximately 2 hours before surgery then 20 mg every 24 hours for minimum 7 - 10 days, high risk (eg orthopaedic surgery, i) Prevention of Deep Vein medical patients, 40mg every Thrombosis(DVT) 24 hours for at least 6 days especially in perioperative until patient ambulant, max Enoxaparin Sodium 40 B01AB05520P5002 and high risk surgical cases 549. A* 14 days. mg Injection XX ii) Treatment of DVT ii) Treatment of DVT or iii) Unstable angina and non pulmonary embolism, 1.5 Q wave Myocardial mg/kg every 24 hours, Infarction usually for 5 days and until adequate oral anticoagulation established. iii) Unstable angina and non- ST-segment-elevation myocardial infarction 1 mg/kg every 12 hours, usually for 2 - 8 days i) Prophylaxis fo DVT especially in surgical patients: moderate risk, 20 mg SC approximately 2 hours before surgery then 20 mg every 24 hours for minimum 7 - 10 days, high risk (eg orthopaedic surgery, i) Prevention of Deep Vein medical patients, 40mg every Thrombosis(DVT) 24 hours for at least 6 days especially in perioperative until patient ambulant, max Enoxaparin Sodium 60 B01AB05520P5003 and high risk surgical cases 550. A* 14 days. mg Injection XX ii) Treatment of DVT ii) Treatment of DVT or iii) Unstable angina and non pulmonary embolism, 1.5 Q wave Myocardial mg/kg every 24 hours, Infarction usually for 5 days and until adequate oral anticoagulation established. iii) Unstable angina and non- ST-segment-elevation myocardial infarction 1 mg/kg every 12 hours, usually for 2 - 8 days Parkinson's Disease. An 200 mg to be taken with adjunct to standard each daily dose of Entacapone 200 mg N04BX02000T1001 levodopa/benserazide or levodopa/dopa- 551. A Tablet XX levodopa/carbidopa for use decarboxylase inhibitor. Max in patients with parkinson's 2g daily. May be taken with disease and end of dose or without food

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber motor fluctuations, who cannot be stabilised on those combinations First line treatment of 0.5-1mg once daily. Renal Chronic Hepatitis B in Dose Adjustment: 0.5-1mg patients who satisfy the every 48hours (30- J05AF10000T1001 552. Entecavir 0.5 mg Tablet A* criteria for treatment and 49ml/min); 0.5-1mg every XX require long-term therapy or 72hours (10-29ml/min); have a very high baseline 0.5mg-1mg every 5-7 days viral load (<10ml/min; HD or CAPD). Myotonic symptoms associated with cervical Eperisone HCl 50 mg M03BX09110T100 553. A syndrome, periarthritis of 50 mg 3 times daily Tablet 1XX shoulder and lumbago spastic paralysis Ephedrine 0.5% w/v R01AA03110D600 Decongestion of the upper 2 drops 3 times daily. 554. A/KK Nasal Drops 1XX respiratory tract Maximum use for 1 week By IM, SC or IV. Severe, acute bronchospasm : 12.5- 25 mg. Further dosage should be determine by patient response. When used as a pressor agent : ADULT Treatment of bronchial 25 - 50 mg SC/IM. If spasm in asthma, adjunct to necessary, a second IM dose Ephedrine HCl 30 mg/ml R03CA02110P300 correct haemodynamic 555. B of 50 mg or an IV dose of 25 Injection 1XX imbalances and treat mg may be given. Direct IV hypotension in epidural and injection, 10 - 25 mg may be spinal anaesthesia given slowly. Maximum parenteral ADULT dose : 150 mg in 24 hours. CHILD : 3 mg/kg or 100 mg/m2 SC or IV daily, in 4 - 6 divided doses i) 75 - 90mg/m2 body area injected IV in 3 - 5 min, repeated at 21 day Breast cancer, Non- intervals.Higher doses up to Hodgkin's lymphoma, 135mg/m2 as single agent L01DB03110P4001 556. Epirubicin 10 mg Injection A* Leukaemia (ALL induction), and 120mg/m2 as XX gastric cancer, ovarian combination (effective in cancer treatment of breast cancer) CHILD: 50 mg/m2 over 6 hours. Schedule depends on protocol. i) 75 - 90mg/m2 body area Breast cancer, Non- injected IV in 3 - 5 min, Hodgkin's lymphoma, repeated at 21 day L01DB03110P4002 557. Epirubicin 50 mg Injection A* Leukaemia (ALL induction), intervals.Higher doses up to XX gastric cancer, ovarian 135mg/m2 as single agent cancer and 120mg/m2 as combination (effective in

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber treatment of breast cancer) CHILD: 50 mg/m2 over 6 hours. Schedule depends on protocol. i) As monotherapy for maintenance treatment in patients with locally advanced or metastatic 150 mg taken at least one non-small cell lung cancer hour before or two hours (NSCLC) with stable after the ingestion of food disease after 4 cycles of once daily. Reduce in steps standard platinum-based of 50 mg when necessary. first-line chemotherapy. Continue treatment until L01XE03110T1003 ii) For the treatment of disease progression or 558. Erlotinib 100 mg Tablet A* XX patients with locally unacceptable toxicity occurs. advanced or metastatic May require dose NSCLC after failure of at modifications when least one prior coadministered with strong chemotherapy regimen. CYP3A4 inhibitors or Restricted to non-smoker, inducers; or in cigarette female, epidermal growth smoking patients. factor receptor (EGFR) positive and Asian patients only i) As monotherapy for maintenance treatment in patients with locally advanced or metastatic 150 mg taken at least one non-small cell lung cancer hour before or two hours (NSCLC) with stable after the ingestion of food disease after 4 cycles of once daily. Reduce in steps standard platinum-based of 50 mg when necessary. first-line chemotherapy. Continue treatment until L01XE03110T1002 ii) For the treatment of disease progression or 559. Erlotinib 150 mg Tablet A* XX patients with locally unacceptable toxicity occurs. advanced or metastatic May require dose NSCLC after failure of at modifications when least one prior coadministered with strong chemotherapy regimen. CYP3A4 inhibitors or Restricted to non-smoker, inducers; or in cigarette female, epidermal growth smoking patients. factor receptor (EGFR) positive and Asian patients only. i) Patient with confirm ESBL producing gram-negative ADULT: 1 g once daily. infection. J01DH03520P4001 CHILD 3 month to 12 years: 560. Ertapenem 1 g Injection A* ii) Empiric treatment for XX 15 mg/kg twice daily. Not to severe community acquired exceed 1 g/ day pneumonia or other infections when

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Pseudomonas aeruginosa is not suspected. Child: 30-50 mg/kg daily, increased to twice the usual Erythromycin J01FA01238F2101 Treatment of susceptible dose in severe cases. 2-8 yr: 561. Ethylsuccinate 200 mg/5 B XX bacterial infections 1 g daily in divided doses; <2 ml Suspension yr: 500 mg daily in divided doses. Adult 400 mg 6 hrly or 800 mg 12 hrly. Max: 4 g/day. Childn 30-50 mg/kg in Erythromycin J01FA01238T1001 Treatment of susceptible divided doses. Childn 2-8 yr 562. Ethylsuccinate 400 mg B XX bacterial infections 1 g/day in divided doses in Tablet severe cases. Infant & childn ≤2 yr 500 mg/day in divided doses. Child: 30-50 mg/kg daily, increased to twice the usual Erythromycin J01FA01238F2102 Treatment of susceptible dose in severe cases. 2-8 yr: 563. Ethylsuccinate 400 mg/5 B XX bacterial infections 1 g daily in divided doses; <2 ml Suspension yr: 500 mg daily in divided doses. Only for treatment of i) certain forms of meningitis ii) septicaemia not responding to usual antibiotics Erythromycin Adult & Child: 25 - 50mg/kg J01FA01129P3001 iii) mycoplasma pneumonia 564. Lactobionate 500 mg A* /day infusion every 6 hours. XX iv) infection with gram- Injection Maximum: 4 g/day. positive organisms (e.g. tetanus, streptococcal infection) associated with Penicillin allergy, only when oral erythromycin cannot be given Child: 30-50 mg/kg daily, increased to twice the usual Erythromycin Stearate J01FA01258T1001 Infections due to dose in severe cases. 2-8 yr: 565. B 250 mg Tablet XX susceptible organism 1 g daily in divided doses; <2 yr: 500 mg daily in divided doses.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) ADULT by IV injection over 1-5 minutes, initially 50 units/kg 3 times weekly adjusted according to response in step of 25 units/kg 3 times weekly at interval of at least 4 weeks. i) Treatment of anaemia CHILD initially as for adult. associated with chronic Maintenance, bodyweight renal failure. Dialysis under 10 kg usually 75-150 patients who are units/kg 3 times weekly, haemoglobin less than 8 g bodyweight 10-30 kg usually Erythropoietin Human B03XA01000P5005 or exhibiting symptoms of 60-150 units/kg 3 times 566. Recombinant 10,000 A* XX anaemia although weekly, bodyweight over 30 IU/ml Injection haemoglobin more than 8 g kg usually 30-100 units/kg 3 and pre-transplant cases times weekly ii) Anaemia in cancer (non- ii) ADULT by SC injection myeloid malignancies) with (max. 1 ml per injection site), concomitant chemotherapy initially 150 units/kg 3 times weekly, increased if appropriate rise in haemoglobin not achieved after 4 weeks to 300 units/kg 3 times weekly. Discontinue if inadequate response after 4 weeks at higher dose i) ADULT by IV injection over 1-5 minutes, initially 50 units/kg 3 times weekly adjusted according to response in step of 25 units/kg 3 times weekly at interval of at least 4 weeks. i) Treatment of anaemia CHILD initially as for adult. associated with chronic Maintenance, bodyweight renal failure. Dialysis under 10 kg usually 75-150 patients who are units/kg 3 times weekly, haemoglobin less than 8 g bodyweight 10-30 kg usually Erythropoietin Human B03XA01000P5001 or exhibiting symptoms of 60-150 units/kg 3 times 567. Recombinant 1000 A* XX anaemia although weekly, bodyweight over 30 IU/0.5ml Injection haemoglobin more than 8 g kg usually 30-100 units/kg 3 and pre-transplant cases times weekly ii) Anaemia in cancer (non- ii) ADULT by SC injection myeloid malignancies) with (max. 1 ml per injection site), concomitant chemotherapy initially 150 units/kg 3 times weekly, increased if appropriate rise in haemoglobin not achieved after 4 weeks to 300 units/kg 3 times weekly. Discontinue if inadequate response after 4 weeks at higher dose

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) ADULT by IV injection over 1-5 minutes, initially 50 units/kg 3 times weekly adjusted according to response in step of 25 units/kg 3 times weekly at interval of at least 4 weeks. i) Treatment of anaemia CHILD initially as for adult. associated with chronic Maintenance, bodyweight renal failure. Dialysis under 10 kg usually 75-150 patients who are units/kg 3 times weekly, haemoglobin less than 8 g bodyweight 10-30 kg usually Erythropoietin Human B03XA01000P5002 or exhibiting symptoms of 60-150 units/kg 3 times 568. Recombinant 2000 A XX anaemia although weekly, bodyweight over 30 IU/0.5ml Injection haemoglobin more than 8 g kg usually 30-100 units/kg 3 and pre-transplant cases times weekly ii) Anaemia in cancer (non- ii) ADULT by SC injection myeloid malignancies) with (max. 1 ml per injection site), concomitant chemotherapy initially 150 units/kg 3 times weekly, increased if appropriate rise in haemoglobin not achieved after 4 weeks to 300 units/kg 3 times weekly. Discontinue if inadequate response after 4 weeks at higher dose i) ADULT by IV injection over 1-5 minutes, initially 50 units/kg 3 times weekly adjusted according to response in step of 25 units/kg 3 times weekly at interval of at least 4 weeks. i) Treatment of anaemia CHILD initially as for adult. associated with chronic Maintenance, bodyweight renal failure. Dialysis under 10 kg usually 75-150 patients who are units/kg 3 times weekly, haemoglobin less than 8 g bodyweight 10-30 kg usually Erythropoietin Human B03XA01000P5003 or exhibiting symptoms of 60-150 units/kg 3 times 569. Recombinant 3000 A* XX anaemia although weekly, bodyweight over 30 IU/0.3ml Injection haemoglobin more than 8 g kg usually 30-100 units/kg 3 and pre-transplant cases times weekly ii) Anaemia in cancer (non- ii) ADULT by SC injection myeloid malignancies) with (max. 1 ml per injection site), concomitant chemotherapy initially 150 units/kg 3 times weekly, increased if appropriate rise in haemoglobin not achieved after 4 weeks to 300 units/kg 3 times weekly. Discontinue if inadequate response after 4 weeks at higher dose

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) ADULT by IV injection over 1-5 minutes, initially 50 units/kg 3 times weekly adjusted according to response in step of 25 units/kg 3 times weekly at interval of at least 4 weeks. i) Treatment of anaemia CHILD initially as for adult. associated with chronic Maintenance, bodyweight renal failure. Dialysis under 10 kg usually 75-150 patients who are units/kg 3 times weekly, haemoglobin less than 8 g bodyweight 10-30 kg usually Erythropoietin Human B03XA01000P5004 or exhibiting symptoms of 60-150 units/kg 3 times 570. Recombinant 4000 A XX anaemia although weekly, bodyweight over 30 IU/0.4ml Injection haemoglobin more than 8 g kg usually 30-100 units/kg 3 and pre-transplant cases times weekly ii) Anaemia in cancer (non- ii) ADULT by SC injection myeloid malignancies) with (max. 1 ml per injection site), concomitant chemotherapy initially 150 units/kg 3 times weekly, increased if appropriate rise in haemoglobin not achieved after 4 weeks to 300 units/kg 3 times weekly. Discontinue if inadequate response after 4 weeks at higher dose i) 10 mg once daily; may be increased to max 20 mg daily. ii) Panic disorder with or without agoraphobia :Initially i) Major depression 5 mg for the first week, Escitalopram 10 mg N06AB10124T1001 ii) Treatment of panic thereafter increased to 10 571. A* Tablet XX disorder with or without mg daily. Max 20 mg daily, agoraphobia ELDERLY initially half the adult dose, lower maintenance dose may be sufficient. CHILD and ADOLESCENT under 18 years not recommended Tachycardia and Esmolol HCl 10 mg/ml C07AB09110P300 By IV infusion usually within 572. A* hypertension in Injection 1XX range of 50 - 200 mcg/kg/min perioperative period i) 20mg daily for 4-8 weeks ii) 40mg daily for 10 days in i) Gastro-oesophageal Esomeprazole 20 mg A02BC05000T1002 combination with amoxicillin 573. A* reflux disease Tablet XX 1g twice daily or ii) H. pylori eradication clarithromycin 500mg twice daily Esomeprazole 40 mg A02BC05000P300 i) Acute erosive/ ulcerative i) 20- 40 mg once daily for 2- 574. A* Injection 1XX oesophagitis 5 days ii) 80 mg by IV bolus

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber ii) Non -variceal upper followed by 8mg/hour gastrointestinal bleed infusion for 72 hours i) 20mg daily for 4-8 weeks ii) 40mg daily for 10 days in i) Gastro-oesophageal Esomeprazole 40 mg A02BC05000T1001 combination with amoxicillin 575. A* reflux disease Tablet XX 1g twice daily or ii) H. pylori eradication clarithromycin 500mg twice daily Essential Phospholipids, nicotinamide, cyanocobalamine, A05BA00924C100 Nutritional supplement in Please refer to product 576. A/KK tocopheryl, pyridoxine, 1XX liver disorders leaflet thiamine, riboflavine capsule One tablet daily without pill- Hormone Replacement free interval, starting with 1 Therapy for women with Estradiol 1 mg & Estradiol mg of Estradiol for first 14 G03FB08954T1001 disorders due to natural or 577. 1 mg with Dydrogesterone A* days, followed by 1mg XX surgically induced 10 mg Estradiol with 10 mg menopause with intact Dydrogestrone daily for the uterus. next 14 days Hormone replacement therapy for oestrogen Estradiol 1 mg & deficiency symptoms in G03FA01122T1001 1 tablet per day without 578. Norethisterone Acetate A* women more than 1 year XX interruption 0.5 mg Tablet after menopause and prevention of osteoporosis in post menopausal women i) Hormone replacement therapy for the relief of One tablet daily, taken symptoms due to oestrogen continuously without Estradiol 1 mg with G03FB08954T1002 deficiency interruption. Should be used 579. Dydrogesterone 5 mg A* XX ii) Prevention of only in postmenopausal Tablet postmenopausal women more than 12 month osteoporosis in women with after menopause a uterus Oestrogen replacement 1 mg daily continuously or 21 Estradiol Valerate 1 mg G03CA03256T100 580. A* therapy - only those who day regimen with 1 week of Tablet 2XX cannot tolerate Premarin tablet free interval Pre and post menopausal Start on the 5th day of syndrome, primary and menstrual cycle - 1 tab daily Estradiol Valerate 2 mg secondary amenorrhea, for 21 days then stop for 7 and Norgestrel 500 mcg G03FB01953T1001 menstrual irregularities. 581. B days. If patient forgets dose with Estradiol Valerate 2 XX Deficiency symptoms after at usual time, it should be mg Tablet oophorectomy or taken within following 12 radiological castration for hours noncarcinomatous disease

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Moderately to severe Adult & geriatric dose: rheumatoid arthritis as Rheumatoid arthritis, monotherapy or in psoriatic arthritis, ankylosing combination with spondylitis; 50 mg SC once- methotrexate in patients weekly for once-weekly with inadequate response dosing or 25 mg SC twice to methotrexate alone. ii) weekly (individual doses Active polyarticular-course should be separated by 72 to juvenile idiopathic arthritis 96 hours) for twice-weekly in children 2-17 years with dosing. Plaque psoriasis; inadequate response to, or Initial: 50 mg SC twice who have proved intolerant weekly, 72 to 96 hours apart; of methotrexate. maintain initial dose for 3 iii) Psoriatic arthritis as Etanercept 25 mg L04AA11000P4001 months (starting doses of 25 582. A* monotherapy or in Injection XX or 50 mg once weekly have combination with also been used methotrexate in patients successfully). Maintenance inadequate response to dose: 50 mg SC once methotrexate alone. weekly. Paediatric dose (2 to iv) Active ankylosing 17 years): Juvenile idiopathic spondylitis in adults arthritis; 0.8 mg/kg (max. 25 v) Moderate to severe mg/dose) SC once weekly plaque psoriasis who failed for once-weekly dosing or to respond to, or who have 0.4 mg/kg (max. 25 mg/dose) a contraindication to, or are SC twice weekly (individual intolerant to other systemic doses should be separated therapy including by 72 to 96 hours) for twice- cyclosporine, methotrexate weekly dosing. or PUVA i) Moderately to severe Adult & geriatric dose: rheumatoid arthritis as Rheumatoid arthritis, monotherapy or in psoriatic arthritis, ankylosing combination with spondylitis; 50 mg SC once- methotrexate in patients weekly for once-weekly with inadequate response dosing or 25 mg SC twice to methotrexate alone. weekly (individual doses ii) Active polyarticular- should be separated by 72 to course juvenile idiopathic 96 hours) for twice-weekly arthritis in children 2-17 dosing. Plaque psoriasis; years with inadequate Initial: 50 mg SC twice Etanercept 50 mg L04AB01000P4002 583. A* response to, or who have weekly, 72 to 96 hours apart; Injection XX proved intolerant of maintain initial dose for 3 methotrexate. months (starting doses of 25 iii) Psoriatic arthritis as or 50 mg once weekly have monotherapy or in also been used combination with successfully). Maintenance methotrexate in patients dose: 50 mg SC once inadequate response to weekly. Paediatric dose (2 to methotrexate alone. 17 years): Juvenile idiopathic iv) Active ankylosing arthritis; 0.8 mg/kg (max. 25 spondylitis in adults mg/dose) SC once weekly v) Moderate to severe for once-weekly dosing or

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber plaque psoriasis who failed 0.4 mg/kg (max. 25 mg/dose) to respond to, or who have SC twice weekly (individual a contraindication to, or are doses should be separated intolerant to other systemic by 72 to 96 hours) for twice- therapy including weekly dosing. cyclosporine, methotrexate or PUVA Adult: 15-25mg/kg daily (max 1200mg) or 50mg/kg Ethambutol HCl 200 mg J04AK02110T1001 584. B Tuberculosis biweekly (max2000mg). Tablet XX Children: 15-25mg/kg daily or 50 mg/kg twice weekly. Adult: 15-25mg/kg daily (max 1200mg) or 50mg/kg Ethambutol HCl 400 mg J04AK02110T1002 585. B Tuberculosis biweekly (max2000mg). Tablet XX Children: 15-25mg/kg daily or 50 mg/kg twice weekly. N01AA01000L9901 To remove adhesive plaster Dose depending on the route 586. Ether Solvent C XX from the skin and procedure i) Oral contraception ii) Treatment of acne vulgaris in women seeking oral contraception. 1 tab daily for 28 consecutive Ethinylestradiol 20 mcg & G03AA12954T100 iii) Treatment of symptoms 587. A* days starting on 1st day of Drospirenone 3 mg Tablet 2XX of premenstrual dysphoric menstrual bleeding. disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. 1 tablet to be taken daily for 21 executive days starting on Ethinylestradiol 20 mcg & G03AA10954T100 the first day of menses. Each 588. A/KK Oral contraception Gestodene 75 mcg Tablet 1XX subsequent pack is started after a 7 days tablet free interval. i) Prevention of pregnancy ii) Treatment of moderate acne vulgaris not controlled by conventional therapy Beginning on day 1 of cycle, Ethinylestradiol 20 mcg & G03AA07954T100 (e.g topical preparations 1 tablet daily for 21 days 589. Levonorgestrel 100 mcg A/KK 2XX and oral antibiotics) in post- followed by 7 tablet-free Tablet menarchal, premenopausal days. women more than or 14 years who accept contraception. As second-line therapy in ADULT: 15-20mg/kg daily, in the treatment of Multi Drug divided doses if necessary; Resistant Tuberculosis only maximum dose 1g/day. Ethionamide 250 mg J04AD03000T1001 590. A* in combination with other CHILD: 10-20mg/kg in 2-3 Tablet XX efficacious agents and only divided doses or when therapy with 15mg/kg/24hrs as a single isoniazid, rifampicin, or daily dose.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber other first-line agents has failed. ADULT: Initially, 500 mg daily. Increased by 250 mg at intervals of 4-7 days to usual dose of 1-1.5 g daily. Maximum: Up to 2 g, under strict supervision. CHILD: Greater than or equal to 6 Ethosuximide 250 mg/5 N03AD01000L9001 years: Same as adult dose; 591. B Absence seizures ml Syrup XX less than 6 years: Initially, 250 mg daily. Increased gradually to usual dose of 20 mg/kg daily. Maximum: Children greater than or equal to 6 years: Same as adult dose; less than 6 years: Up to 1 g For minor surgical procedures including lancing boils, incision and Spray to affected area at a Ethyl Chloride 100ml N01BX01000A400 drainage of small 592. C distance of about 30cm until Spray 1XX abscesses, pain due to a fine white film is produced athletic injuries and pain due to injection administration Adult: 300 mcg/kg given slowly over 30-60 seconds Induction of general into a large vein in the arm. Etomidate 20 mg/10 ml N01AX07000P300 anaesthesia for Child: Up to 30% more than 593. A* Injection 1XX haemodynamically unstable the standard adult dose. patients Elderly: 150-200 mcg/kg, subsequently adjusted according to effects. A single implant inserted subdermally and can be left in place for three years. The Etonogestrel 68 mg G03AC08000P100 594. A/KK Contraception implant can be removed at Implant 1XX any time but not later than three years after the date of insertion. i) CHILD: 60-120 mg/m2/day i) For treatment of children by IV for 3 - 5 days every 3 - with solid tumours, juvenile 6 weeks depending on myelomonocytic leukemia protocols (JMML) and Langerhan cell ii) Maintenance or palliative Etoposide 100 mg/5 ml L01CB01000P3001 histiocytosis 595. A* chemotherapy for elderly Injection XX ii) Leukaemia, lymphoma acute myeloid leukemia, iii) Testicular cancer, lung consolidation therapy for cancer, gestational acute lymphoblastic trophoblastic disease, leukemia, stem cell gastric cancer, sarcoma mobilization (Refer to

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber protocol) iii) 100 mg/m2 by IV every other day for 3 doses repeated every 3-4 weeks Normal adult dose is 175mg- 200mg daily for 5 consecutive days orally, followed by recession Treatment of small cell lung (withdrawal) interval of 3 L01CB01000C1003 596. Etoposide 50mg capsule A* cancer and malignant weeks. Repeat XX lymphomas administration as necessary. Increase or reduce dose as appropriate, according to the particular disease or symptoms. i) OA: 60 mg once daily. RA: 90 mg once daily i) Acute and chronic ii & iii) Acute gouty arthritis treatment of signs and and acute pain: 120 mg once symptoms of osteoarthritis M01AH05000T100 daily (Given the exposure to 597. Etoricoxib 120 mg Tablet A* (OA) and rheumatoid 2XX COX-2 inhibitors, doctors are arthritis (RA) advised to use the lowest ii) Acute gouty arthritis effective dose for the iii) Acute pain shortest possible duration of treatment) i) OA: 60 mg once daily. RA: 90 mg once daily i) Acute and chronic ii & iii) Acute gouty arthritis treatment of signs and and acute pain: 120 mg once symptoms of osteoarthritis M01AH05000T100 daily (Given the exposure to 598. Etoricoxib 60 mg Tablet A* (OA) and rheumatoid 3XX COX-2 inhibitors, doctors are arthritis (RA) advised to use the lowest ii) Acute gouty arthritis effective dose for the iii) Acute pain shortest possible duration of treatment) i) OA: 60 mg once daily. RA: 90 mg once daily i) Acute and chronic ii & iii) Acute gouty arthritis treatment of signs and and acute pain: 120 mg once symptoms of osteoarthritis M01AH05000T100 daily (Given the exposure to 599. Etoricoxib 90 mg Tablet A* (OA) and rheumatoid 1XX COX-2 inhibitors, doctors are arthritis (RA) advised to use the lowest ii) Acute gouty arthritis effective dose for the iii) Acute pain shortest possible duration of treatment)

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Indicated for the prophylaxis of organ An initial dose regimen of rejection in adult patients at 0.75 mg b.i.d., which is low to moderate recommended for the immunological risk L04AA18000T1001 general kidney and heart 600. Everolimus 0.25mg tablet A* receiving an allogeneic XX transplant population. The renal or cardiac transplant daily dose of everolimus in combination with should always be given orally ciclosporin for in two divided doses (b.i.d.). microemulsion and corticosteroids. Indicated for the prophylaxis of organ An initial dose regimen of rejection in adult patients at 0.75 mg b.i.d., which is low to moderate recommended for the immunological risk L04AA18000T1003 general kidney and heart 601. Everolimus 0.75mg tablet A* receiving an allogeneic XX transplant population. The renal or cardiac transplant daily dose of everolimus in combination with should always be given orally ciclosporin for in two divided doses (b.i.d.). microemulsion and corticosteroids. Treatment of post- menopausal women with advanced breast cancer L02BG06000T1001 602. Exemestane 25 mg Tablet A* whose disease has 25 mg once daily XX progressed following tamoxifen and non-steroidal aromatase inhibitors Ezetimibe 10 mg & C10BA02000T1001 Primary Usual starting dose: 10/20 603. A* Simvastatin 20 mg Tablet XX hypercholesterolemia mg/day i) Co-administration with statins for patients who have chronic heart disease or are chronic heart disease equivalent or familial 10 mg once daily. Not C10AX09000T1001 hypercholesterolaemia with 604. Ezetimibe 10 mg Tablet A* recommended for children XX target LDL-C not achieved less than 10 years old by maximum dose of statins ii) Monotherapy in patients with documented biochemical intolerance to statins Ezetimibe 10mg/ C10BA02000T1003 Primary Usual starting dose: 10/20 605. A* Simvastatin 40mg Tablet XX hypercholesterolemia mg/day

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Dose varies according to the patient and the circumstances of the bleeding. i) Mild haemorrhage: initial dose of Prevention and control of 30 units/kg body weight. ii) B02BD04000P990 bleeding in patients with 606. Factor IX Injection A Moderate haemorrhage: 1XX factor IX deficiency due to initial dose of 50 units/kg iii) haemophilia B Major haemorrhage/surgery: Initial dose of 75 - 100 units/kg. Half of these doses may be repeated after 18-24 hrs if necessary. Amount and frequency of administration should be calculated on an individual patient basis. Individual i) Treatment and dosage requirements can perioperative prophylaxis of only be identified on the bleeding in acquired basis of regular deficiency of the determinations of the prothrombin complex individual plasma levels of coagulation factors, such as the coagulation factors of deficiency caused by interest or on the global tests treatment with vitamin K of the prothrombin complex antagonists, or in case of levels (INR, Quick's test) and Factor IX, Factor II, Factor overdose of vitamin K a continuous monitoring of B02BD01000P400 607. VII and Factor X In A* antagonists, when rapid the clinical condition of the 1XX Combination Injection correction of the deficiency patient. An approximate is required. ii) Treatment calculation is as follows: and perioperative Required dose (IU) = body prophylaxis of bleeding in weight (kg) x desired factor congenital deficiency of any rise (IU/dl or % of normal) x of the vitamin K dependent reciprocal of the estimated coagulation factors only if recovery, i.e. Factor II = 53 purified specific coagulation Factor VII = 59 Factor IX = factor product is not 77 Factor X = 56 As product available. may differ from one to another, it is strongly advised to refer to the manufacturer (product insert) in regards to dosing calculation. Initially 4.5 KIU (90 mcg)/kg Treatment of bleeding body weight IV bolus over 2- episodes and prevention of 5 minutes, followed by 3-6 Factor VIIa excessive bleeding in KIU (60-120 mcg)/kg body (Recombinant) eptacog B02BD08000P400 connection with surgery in weight depending on type & 608. A* alfa (activated) 100 KIU (2 5XX patients with inherited or severity of haemorrhage or mg) Injection acquired haemophilia with surgery performed. Dosing inhibitors to coagulation interval: initially 2-3 hour to factors VIII or IX obtain haemostasis and until clinically improved. If

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber continued therapy is needed, dose interval can be increased successively to every 4, 6, 8 or 12 hours Initially 4.5 KIU (90 mcg)/kg body weight IV bolus over 2- 5 minutes, followed by 3-6 Treatment of bleeding KIU (60-120 mcg)/kg body episodes and prevention of weight depending on type & Factor VIIa excessive bleeding in severity of haemorrhage or (Recombinant) eptacog B02BD08000P400 connection with surgery in surgery performed. Dosing 609. A* alfa (activated) 50 KIU (1 4XX patients with inherited or interval: initially 2-3 hour to mg) Injection acquired haemophilia with obtain haemostasis and until inhibitors to coagulation clinically improved. If factors VIII or IX continued therapy is needed, dose interval can be increased successively to every 4, 6, 8 or 12 hours i. Von Willebrand Disease: Spontaneous Bleeding Episodes: Initially, factor VIII 12.5-25 IU/kg and ristocetin cofactor 25-50 IU/kg followed by factor VIII 12.5 IU/kg and ristocetin cofactor 25 IU/kg subsequently every 12-24 hrs. Minor Surgery: Factor VIII 30 IU/kg and ristocetin i)The treatment and cofactor 60 IU/kg daily. Major prophylaxis of haemorrhage Surgery: Initially, factor VIII or surgical bleeding in Von 30-40 IU/kg and ristocetin Willebrand Disease (VWD) cofactor 60-80 IU/kg followed when 1-deamino-8-D- by factor VIII 15-30 IU/kg and arginine vasopressin Factor VIII (Human blood ristocetin cofactor 30-60 B02BD06000P400 (desmopressin, DDAVP) 610. coagulation factor) & Von A* IU/kg subsequently every 12- 2XX treatment alone is Willebrand factor Injection 24 hrs. Prophylaxis: Factor ineffective or VIII 12.5-20 IU/kg and contraindicated. ii)The ristocetin cofactor 25-40 treatment and prophylaxis IU/kg 3 times weekly. of bleeding associated with ii. Hemophilia A therapy: factor VIII deficiency due to Minor haemorrage: 10-15 haemophilia A. IU/kg every 12-24 hours. Moderate to severe haemorrhage: 15-40 IU/kg every 8 to 24 hours. Minor surgery: Loading dose 20-30 IU/kg, maintenance dose 15- 30 IU/kg. Major surgery: Loading dose 40-50 IU/kg, maintenance dose 10-40 IU/kg. Prophylaxis: 25-40

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber IU/kg three times weekly As product may differ from one to another, it is strongly advised to refer to the manufacturer (product insert) in regards to dosing calculation. The dosage and duration of treatment should be i) Control and prevention of individualised and taking into bleeding episodes in adults account the severity of factor and children (0-16 years) VIII deficiency, location and with hemophilia A. extent of bleeding and ii) Surgical prophylaxis in patient's clinical condition. adults and children with Dose can be calculated by hemophilia A. Factor VIII (Recombinant) using: B02BD02000P400 iii) Routine prophylactic 611. Octocog Alfa 250 IU A* i. Required dose (IU) = body 1XX treatment to reduce the Injection weight (kg) x desired factor frequency of bleeding VIII rise (IU/dl or % of episodes and the risk of normal) x 0.5 (IU/kg) or joint damage in children ii. Expected factor VIII rise with no pre-existing joint (% of normal) = 2 x (dose damage. Not indicated fot administered)/ bodyweight the treatment of von (kg) Dose administered willebrand's disease. should be titrated to patient's clinical response The dosage and duration of treatment should be i) Control and prevention of individualised and taking into bleeding episodes in adults account the severity of factor and children (0-16 years) VIII deficiency, location and with hemophilia A. extent of bleeding and ii) Surgical prophylaxis in patient's clinical condition. adults and children with Dose can be calculated by hemophilia A. Factor VIII (Recombinant) using: B02BD02000P400 iii) Routine prophylactic 612. Octocog Alfa 500 IU A* i. Required dose (IU) = body 2XX treatment to reduce the Injection weight (kg) x desired factor frequency of bleeding VIII rise (IU/dl or % of episodes and the risk of normal) x 0.5 (IU/kg) or joint damage in children ii. Expected factor VIII rise with no pre-existing joint (% of normal) = 2 x (dose damage. Not indicated for administered)/ bodyweight the treatment of von (kg) Dose administered willebrand's disease. should be titrated to patient's clinical response.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Treatment and prophylaxis of hemorrhages in hemophilia A and B patients with inhibitors. ii) Treatment and prophylaxis of hemorrhages in non-hemophilic patients who have developed inhibitors to Factors VIII, IX As a general guideline, a and XI. dose of 50 to 100IU/kg body Factor VIII Inhibitor iii) Treatment of patients weight is recommended, not B02BD03000P400 613. Bypassing Activity A with acquired inhibitors to exceeding an individual dose 1XX Injection Factors X and XIII. of 100IU/kg bw and a iv) In the combination with maximum daily dose of Factor VIII concentrate for a 200IU/kg bw. long-term therapy to achieve a complete and permanent elimination of the Factor VIII inhibitor so as to allow for regular treatment with Factor VIII concentrate as in patients without inhibitor. Dose varies according to the patient and the circumstances of the bleeding. i) Mild to moderate: Usually a single dose of 10- 15units/kg. ii) More serious Prevention and control of haemorrhage/minor B02BD02999P990 bleeding in patients with 614. Factor VIII Injection A surgery:Initially 15-25 1XX factor VIII deficiency due to units/kg followed by 10-15 classical haemophilia A units/kg every 8 - 12 hours if required iii) Severe haemorrhage/major surgery: Initial : 40 - 50 units/kg followed by 20 - 25 units/kg every 8-12 hrs. Dose to be individualised. Fat Emulsion 10% for IV B05BA02000P6001 Source of lipid in patients ADULT usual lipid 615. A Infusion Injection XX needing IV nutrition requirement 2-3 g/kg/day. INFANT 0.5 - 1 g/kg/day Dose to be individualised. Fat Emulsion 20% for IV B05BA02000P6002 Source of lipid in patients ADULT usual lipid 616. A Infusion Injection XX needing IV nutrition requirement 2-3 g/kg/day. INFANT 0.5-1 g/kg/day Initiate at 5 mg once daily. C08CA02000T100 617. Felodipine 10 mg Tablet A/KK Hypertension Usual dose, 5 - 10 mg once 2XX daily in the morning

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Initiate at 5 mg once daily. C08CA02000T100 618. Felodipine 5 mg Tablet A/KK Hypertension Usual dose, 5 - 10 mg once 1XX daily in the morning As second line therapy after failed gemfibrozil in patients: i) Hypercholesterolemia and hypertriglyceridemia alone or combined [type IIa,IIb,III and V dysplipidemias] in patients unresponsive to dietary and other non- pharmacological measures C10AB05000T1002 145mg once daily, with or 619. Fenofibrate 145 mg tablet A/KK especially when there is XX without food evidence of associated risk factors ii) Treatment of secondary hyperlipoproteinemias if hyperlipoprotenemia persists despite effective treatment of underlying disease iii) Dyslipidemia in Type 2 Diabetes Mellitus As a second line drug in the ADULT and CHILD over 2 management of chronic years previously treated with severe cancer pain not a strong opioid analgesic, responding to non-narcotic initial dose based on Fentanyl 12mcg/h N02AB03136M700 analgesic. Not to be used in previous 24-hour opioid 620. A* Transdermal Patch 5XX opiod naive patients.The requirement (consult product use is to be restricted to literature). If necessary dose pain specialists, palliative should be adjusted at 72- medicine specialists and hour intervals in steps of 12- oncologists 25 mcg/hr Patients who have not previously received a strong opioid analgesic, initial dose , one 25 mcg/hour patch to be As a second line drug in the replaced after 72 hours. management of chronic Patients who have received cancer pain. The use is to Fentanyl 25 mcg/h N02AB03136M700 a strong opioid analgesic, 621. A* be restricted to pain Transdermal Patch 1XX initial dose based on specialists, palliative previous 24 hours opioid medicine specialists and requirement (oral morphine oncologists. sulphate 90 mg over 24 hours = one 25 mcg/hour patch). Not recommended in children.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Patients who have not previously received a strong opioid analgesic, initial dose , one 25 mcg/hour patch to be As a second line drug in the replaced after 72 hours. management of chronic Patients who have received cancer pain. The use is to Fentanyl 50 mcg/h N02AB03136M700 a strong opioid analgesic, 622. A* be restricted to pain Transdermal Patch 2XX initial dose based on specialists, palliative previous 24 hours opioid medicine specialists and requirement (oral morphine oncologists sulphate 90 mg over 24 hours = one 25 mcg/hour patch). Not recommended in children. Dose should be individualized according to age, body weight, physical status, underlying pathological conditions and type of surgery and anaesthesia. ADULT: Premedication: IM 50 - 100 mcg, 30 - 60 mins prior to surgery. Adjunct to general anaesthesia: Induction IV 50 Short duration analgesia - 100mcg, repeat 2 - 3 mins during pre-medication intervals until desired effect Fentanyl Citrate 50 N01AH01136P300 induction and maintenance is achieved. IV/IM 25 - 623. A mcg/ml Injection 1XX of anaesthesia, and in the 50mcg in elderly and poor immediate post-operative risk patients. Maintenance: period. IV/IM 25 - 50mcg. Adjunct to regional anaesthesia: IM/slow IV 50 - 100mcg when additinal analgesia is required. Post-operatively (recovery room): IM 50 - 100mcg for pain control, tachypnoea and emergency delirium. May be repeated in 1- 2 hours as needed. CHILD (2 - 12 years): Induction & maintenance: 2 - 3 mcg/kg. Ferric Ammonium Citrate CHILD up to 1 year 5 ml, 1 - B03AB06136L2101 Prevention and treatment of 624. 800 mg/10 ml Paediatric C 5 years 10 ml, taken well XX iron-deficiency anaemias Mixture diluted with water Ferrous controlled release Anemia due to iron 500 mg, Vitamin B1, deficiency, megaloblastic Vitamin B2, Vitamin B6, anemia where there is an B03AE10903T1001 625. Vitamin B12, Vitamin C, A/KK associated deficiency of One tablet daily XX Niacinamide, Calcium Vitamin C and Vitamin B- Pantothenate, Folic Acid complex particularly in 800 mcg Tablet pregnancy. In primary

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber health clinic, the indication is restricted to anemia due to iron deficiency in pregnant women ONLY. Adult: Usual dose range: Up to 600 mg daily. May increase up to 1.2 g daily if Ferrous Fumarate 200 mg B03AA02138T1001 Prevention and treatment of necessary. Child: As syrup 626. C+ Tablet XX iron-deficiency anaemias containing 140 mg(45 mg iron)/5ml. Preterm neonate: 0.6-2.4 ml/kg daily; up to 6 years old: 2.5-5ml twice daily i) Reduction in the duration i) Adult: SC or IV 5 of neutropenia and mcg/kg/day. Initiation: 24 - incidence of febrile 72 hours after neutropenia in cytotoxic chemotherapy. Duration: chemotherapy for Until a clinically adequate Filgrastim (G-CSF) 30 L03AA02000P3001 malignancy except chronic 627. A* neutrophil recovery is MU/ml Injection XX myeloid leukemia and achieved (absolute myelodysplastic syndrome neutrophil count of at least 1 ii) Haemopoeitic stem cell x 109/L on 2 consecutive transplantation days) (HSCT)/stem cell ii) Refer to protocol harvesting i) Reduction in the duration of neutropenia and i) ADULT: 5 mcg/kg/day by incidence of febrile SC or IV. Initiation: 24 - 72 neutropenia in cytotoxic hours after chemotherapy. chemotherapy for Duration: Until a clinically Filgrastim 30 MU in 0.5 ml L03AA02000P5001 malignancy except chronic adequate neutrophil recovery 628. A* Injection XX myeloid leukemia and is achieved (absolute myelodysplastic syndrome neutrophil count of at least 1 ii) Haemopoeitic stem cell x 109/L on 2 consecutive transplantation days) (HSCT)/stem cell ii) Refer to protocol harvesting 5 mg a day as a single dose. Clinical responses occur within 12 weeks - 6 months G04CB01000T100 Treatment and control of 629. Finasteride 5 mg Tablet A* of initiation of therapy. Long- 1XX benign prostatic hyperplasia term administration is recommended for maximal response Treatment of patients with relapsing forms of multiple sclerosis to reduce the Fingolimod 0.5mg L04AA27110C1001 630. A* frequency of clinical 0.5mg orally once daily Capsule XX exacerbations and to delay the accumulation of physical disability

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Urinary frequency and ADULT: 200 mg 3 times Flavoxate HCl 100 mg G04BD02110T100 incontinence, dysuria, 631. A daily. CHILD under 12 years Tablet 1XX urgency, bladder spasm not recommended due to catheterisation i) Sustained monomorphic ventricular tachycardias ii) Preexcited atrial Ventricular arrhythmias: 100 fibrillation associated with mg twice daily, maximum Wolff-Parkinson White 400 mg/day (usually Syndrome reserved for rapid control or iii) Reciprocating Atrio- in heavily built patients), Flecainide Acetate 100 C01BC04122T100 632. A* Ventricular tachycardias reduced after 3 - 5 days if mg Tablet 1XX (AVT) associated with possible. Supraventricular Wolff-Parkinson White arrhythmias: 50 mg twice Syndrome daily, increased if required to iv) Supraventricular maximum of 150 mg twice tachycardias due to Intra- daily Atrio Ventricular Nodul Reentry i) Oropharyngeal candidiasis: 50 - 100 mg daily for 7 - 14 days (Maximum 14 days) except in severely i) Oropharyngeal immunocompromised candidiasis, atrophic oral patients, treatment can be candidiasis associated with continued for longer periods. dentures, other candidal Atrophic oral candidiasis infections of mucosa associated with dentures: 50 ii) Tinea pedis, corporis, mg daily for 14 days. Other cruris, versicolor and candidal infections of dermal candidiasis mucosa: 50 - 100 mg daily iii) Invasive candidal & for 14 - 30 days. CHILD: 3 - cryptococcal infections 6 mg/kg on first day then 3 (including meningitis) mg/kg daily (every 72 hours iv) Prevention of relapse of in NEONATE up to 2 weeks Fluconazole 100 mg J02AC01000C1002 633. A cryptococcal meningitis in old, every 48 hours in Capsule XX AIDS patients after NEONATE 2 - 4 weeks old) completion of primary ii) 50 mg daily for 2 - 4 therapy weeks, maximum 6 weeks v) Prevention of fungal iii) 400 mg initially then 200 - infections in 400 mg daily for 6 - 8 weeks. immunocompromised CHILD: 6 - 12 mg/kg daily patients considered at risk (every 72 hours in as a consequence of HIV NEONATE up to 2 weeks infections or neutropenia old, every 48 hours in following cytotoxic NEONATE 2 -4 weeks old) chemotherapy, radiotherapy iv) 100 - 200 mg daily or bone marrow transplant v) 50 - 400 mg daily. CHILD: 3 - 12 mg/kg daily (every 72 hours in NEONATE up to 2 weeks old, every 48 hours in NEONATE 2 - 4 weeks old)

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) 50 - 100 mg daily for 7 - 14 days (Maximum 14 days) except in severely immunocompromised i) Oropharyngeal patients, treatment can be candidiasis, atrophic oral continued for longer periods. candidiasis associated with Atrophic oral candidiasis dentures, other candidal associated with dentures: 50 infections of mucosa mg daily for 14 days. Other ii) Tinea pedis, corporis, candidal infections of cruris, versicolor and mucosa: 50 - 100 mg daily dermal candidiasis for 14 - 30 days. CHILD: 3 - iii) Invasive candidal& 6 mg/kg on first day then 3 cryptococcal infections mg/kg daily (every 72 hours (including meningitis) in NEONATE up to 2 weeks iv) Prevention of relapse of Fluconazole 2 mg/ml J02AC01000P9901 old, every 48 hours in 634. A cryptococcal meningitis in Injection XX NEONATE 2 - 4 weeks old) AIDS patients after ii) 50 mg daily for 2 - 4 completion of primary weeks, maximum 6 weeks therapy iii) 400 mg initially then 200 - v) Prevention of fungal 400 mg daily for 6 - 8 weeks. infections in CHILD: 6-12 mg/kg daily immunocompromised (every 72 hours in patients considered at risk NEONATE up to 2 weeks as a consequence of HIV old, every 48 hours in infections or neutropenia NEONATE 2 - 4 weeks old) following cytotoxic iv) 100 - 200 mg daily chemotherapy, radiotherapy v) 50 - 400 mg daily. CHILD: or bone marrow transplant 3 - 12 mg/kg daily (every 72 hours in NEONATE up to 2 weeks old, every 48 hours in NEONATE 2 - 4 weeks old)

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Oropharyngeal candidiasis: 50 - 100 mg daily for 7 - 14 days (Maximum 14 days) except in severely i) Oropharyngeal immunocompromised candidiasis, atrophic oral patients, treatment can be candidiasis associated with continued for longer periods. dentures, other candidal Atrophic oral candidiasis infections of mucosa associated with dentures: 50 ii) Tinea pedis, corporis, mg daily for 14 days. Other cruris, versicolor and candidal infections of dermal candidiasis mucosa: 50 - 100 mg daily iii) Invasive candidal & for 14 - 30 days. CHILD: 3 - cryptococcal infections 6 mg/kg on first day then 3 (including meningitis) mg/kg daily (every 72 hours iv) Prevention of relapse of in NEONATE up to 2 weeks Fluconazole 50 mg J02AC01000C1001 635. A cryptococcal meningitis in old, every 48 hours in Capsule XX AIDS patients after NEONATE 2 - 4 weeks old) completion of primary ii) 50 mg daily for 2 - 4 therapy weeks, maximum 6 weeks v) Prevention of fungal iii) 400 mg initially then 200 - infections in 400 mg daily for 6 - 8 weeks. immunocompromised CHILD: 6 - 12 mg/kg daily patients considered at risk (every 72 hours in as a consequence of HIV NEONATE up to 2 weeks infections or neutropenia old, every 48 hours in following cytotoxic NEONATE 2 -4 weeks old) chemotherapy, radiotherapy iv) 100 - 200 mg daily or bone marrow transplant v) 50 - 400 mg daily. CHILD: 3 - 12 mg/kg daily (every 72 hours in NEONATE up to 2 weeks old, every 48 hours in NEONATE 2 - 4 weeks old) ADULT: 100 - 200 mg/kg Flucytosine 2.5 g/250 ml J02AX01000P9901 Treatment of systemic daily in 4 divided doses by IV 636. A* Injection XX fungal infection infusion over 20 - 40 minutes not more than 7 days Flucytosine 500 mg J02AX01000T1001 Only for the treatment of ADULT: 50 - 150 mg/kg/day 637. A* Tablet XX fungal meningitis in 4 divided doses 40 mg /m2 given daily for 5 B-cell chronic lymphocytic consecutive days every 28 leukemia who have not days. Courses may be responded to or whose repeated every 28 days, Fludarabine Phosphate L01BB05162T1001 disease had progressed 638. A* usually for up to 6 cycles. 10 mg Tablet XX during or after treatment Duration of treatment with at least one standard depends on treatment alkylating-agent containing success and tolerability of regimen the drug

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber 25 mg/m2 daily for 5 consecutive days every 28 B-cell chronic lymphocytic days. May be administered leukaemia who have not up to the achievement of a responded to or whose maximal response (usually 6 Fludarabine Phosphate L01BB05162P4001 disease had progressed 639. A* cycles) and then the drug 50 mg Injection XX during or after treatment should be discontinued. with at least one standard Reduce dose by up to 50% alkylating-agent containing in patients with mild to regimen moderate renal impairment (30-70ml/min) As an adjunct to Adrenocorticoid insufficiency glucocorticoids in the (chronic): ADULT 1 tablet management of primary daily. Salt-losing Fludrocortisone Acetate H02AA02122T1001 640. A adrenocortical insufficiency adrenogenital syndrome: 0.1 mg Tablet XX in Addison's disease and ADULT 1 - 2 tablets daily. treatment of salt-losing CHILD and INFANT 0.5 - 1 adrenogenital syndrome tablet daily i) Initial, 0.2 mg IV over 30 seconds; if desired level of consciousness not obtained after an additional 30 seconds, give dose of 0.3 mg IV over 30 seconds; further doses of 0.5 mg IV over 30 seconds may be given at 1- minutes intervals if needed to maximum total dose of 3 mg; patients with only partial response to 3 mg may require additional slow i) Diagnosis and/or titration to a total dose of 5 management of mg; if no response 5 minutes benzodiazepine overdose after receiving total dose of 5 Flumazenil 0.1 mg/ml V03AB25000P3001 due to self-poisoning or mg, overdose is unlikely to 641. B Injection XX accidental overdose be benzodiazepine and ii) Reversal of sedation further treatment with following anaesthesia with flumazenil will not help benzodiazepine ii) 0.2 mg IV over 15 seconds; if desired level of consciousness is not obtained after waiting 45 seconds, a second dose of 0.2 mg IV may be given and repeated at 60-seconds intervals as needed (up to a maximum of 4 additional times) to a maximum total dose of 1 mg; most patients respond to doses of 0.6 to 1 mg; in the event of resedation, repeated doses

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber may be given at 20-minutes intervals if needed; for repeat treatment, no more than 1 mg (given as 0.5 mg/minute) should be given at any one time and no more than 3 mg should be given in any one hour i) ADULT: 5 - 10 mg daily preferably at night. i) Migraine prophylaxis ELDERLY more than 65 ii) Maintenance treatment of years: 5 mg at night. Flunarizine HCl 5 mg N07CA03110C100 642. B vestibular disturbances and Maintenance 5-day treatment Capsule 1XX of cerebral and peripheral at the same daily dose disorders ii) 5 - 10 mg at night. If no improvement after 1 month, discontinue treatment Moisten tip with tear fluid Diagnostic fluorescein from lower fornix, sterile Fluorescein 1 mg S01JA01520M9901 angiography or angioscopy 643. B water or ophthalmic solution Ophthalmic Strip XX of the fundus and of the iris and gently stroke across the vasculature conjunctiva Diagnostic fluorescein Fluorescein Sodium 10% S01JA01520P3001 angiography or angioscopy 644. A 500 mg IV in 5 ml Injection XX of the fundus and of the iris vasculature Treatment of steroid 1-2 drops qds. During the Fluorometholone 0.1% S01BA07000D200 645. A* responsive ocular initial 24-48 hr, dose may be Ophthalmic Suspension 1XX inflammation increased to 2 drops 2 hrly. 500 - 600 mg/m2 IV in combination with other cytotoxic agents, repeated every 3 weeks or 300 - 450 Cancers of gastro-intestinal mg/m2 IV slow bolus daily for tract, breast and pancreas, 5 days in combination with Fluorouracil 1 g/20 ml L01BC02000P4002 646. A* head and neck. biological response Injection XX Ophtalmological indication: modifiers, repeated every 4 trabeculectomy weeks or 3000 - 3750 mg/m2 as a continuous infusion over 5 days in combination with a platinum compound every 3 to 4 weeks 15 mg/kg (max: 1 g/day), Fluorouracil 100 mg L01BC02000T1001 may be given once weekly 647. A Colorectal cancer Tablet XX for maintenance. Max: 1 g/week.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Intravenous Infusion: 15 mg/kg bodyweight (to a maximum of 1 g daily) diluted in 300-500mL of 5% glucose given over a period of 4 hours. 12 mg/kg bodyweight daily for 3 consecutive days. Cancers of gastro-intestinal Providing there are no signs tract, breast and pancreas, of toxic effects, the patient Fluorouracil 50 mg / ml in L01BC02000P4001 648. A* head and neck. may then be given 6mg/kg 5 ml Injection XX Ophtalmological indication: I.V. on the 5th, 7th and 9th trabeculectomy days. If after the 9th day there is still no sign of toxicity, the patient may be placed on maintenance therapy. Maintenance Therapy: 5 - 10mg/kg bodyweight by I.V. injection once a week. i) 20 mg once daily increased after 3 weeks if necessary, usual dose 20 - 60 mg (ELDERLY 20 - 40 mg) once daily max 80 mg once daily (ELDERLY max 60 mg once daily). ii) Initially 20 mg once daily i) Depression Fluoxetine HCl 20 mg N06AB03110C100 increased after 2 weeks if 649. A ii) Obsessive-compulsive Capsule 1XX necessary, usual dose 20 - disorder 60 mg (ELDERLY 20 - 40 mg) once daily, max 80 mg (ELDERLY max 60 mg) once daily, discontinue if no improvement within 10 weeks. CHILD and ADOLESCENT under 18 years are not recommended By deep IM, initial test dose of 5-20 mg, then after at least 7 days. 20 - 40 mg repeated at intervals of 2 - 4 weeks. Maximum 400 mg weekly. Usual maintenance Flupenthixol Decanoate N05AF01135P2001 650. B Chronic psychoses dose 50 mg every 4 weeks to 20mg/ml lnjection XX 300 mg every 2 weeks. ELDERLY, initially quarter to half adult dose. CHILD not recommended. Deep IM recommended. Not for IV use

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber By deep IM : Test dose 12.5 mg (6.25 mg in ELDERLY), then after 4-7 days 12.5 mg- Fluphenazine Decanoate N05AB02135P300 Long term management of 651. B 100 mg repeated at intervals 25 mg/ml Injection 1XX psychotic disorders of 14-35 days, adjusted according to response. CHILD not recommended L02BB01000T1001 Metastatic prostatic 652. Flutamide 250 mg Tablet A* 250 mg 3 times daily XX carcinoma Treatment of nasal symptoms (rhinorrhea, Adults/Adolescents (≥12 nasal congestion, nasal years) : 1-2 sprays (27.5 itching and sneezing) and mcg/spray) in each nostril Fluticasone Furoate 27.5 R01AD08139A410 ocular symptoms 653. A* once daily. Children (2-11 mcg/dose Nasal Spray 1XX (itching/burning, years) : 1-2 sprays (27.5 tearing/watering, and mcg/spray) in each nostril redness of the eye) of once daily seasonal and perennial allergic rhinitis. ADULT and CHILD more than 16 years i) Mild asthma : 100 mcg - 250 mcg twice daily ii) Moderate asthma : 250 - 500 mcg twice daily iii) Severe asthma : 500 mcg - 1000 mcg twice daily. Alternatively, the starting Fluticasone Propionate R03BA05133A210 Prophylactic treatment for dose of fluticasone 654. B 125 mcg/dose Inhaler 1XX asthma dipropionate may be gauged at half the total daily dose of beclomethasone dipropionate or equivalent administered by inhalation. CHILD 4 - 11 years, 50 mcg twice daily (maximum 100 mcg twice daily), CHILD 1-4 years, 50-100mcg microgram twice daily For depression, initially 50 - 100 mg daily in the evening, increased if necessary to 300 mg daily (over 150 mg in Fluvoxamine 100 mg N06AB08253T1002 655. B Depression divided doses); usual Tablet XX maintenance dose 100 mg daily. CHILD and ADOLESCENT under 18 years not recommended

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber For depression, initially 50 - 100 mg daily in the evening, increased if necessary to 300 mg daily (over 150 mg in Fluvoxamine 50 mg N06AB08253T1001 656. B Depressive disorder divided doses); usual Tablet XX maintenance dose 100 mg daily. CHILD and ADOLESCENT under 18 years not recommended i) ADULT initially 10-20mg mg daily for 14 days or until haematopoietic response i) For the prevention and obtained. Daily maintenance: treatment of folate 2.5 mg-10mg .CHILD up to 1 B03BB01000T1001 deficiency states 657. Folic Acid 5 mg Tablet C+ year:250 mcg/kg daily; 1 to 5 XX ii) For the prevention of years:2.5mg/day;6-12 years: neural tube defect in the 5mg/day foetus ii) 5 mg daily starting before pregnancy and continued through the first trimester i) Infertility treatment in anovulatory women who i) 75 - 150 IU daily, should have been unresponsive to commence within the first 7 treatment with clomiphene days of the menstrual cycle citrate and increased by 37.5 IU or Follitropin Alpha ii) Stimulation of follicular 75 IU at 7 or 14 days (Recombinant Human G03GA05000P300 658. A* development for intra- interval. Max daily dose 225 FSH) 300 IU/0.5 ml 2XX uterine cycles IU Injection iii) Stimulation of follicular ii) 150 - 225 IU daily development in assisted commencing on days 2 or 3 reproductive technology in of the cycle. Max daily dose the management of 450 IU infertility i) Infertility treatment in anovulatory women who i) 75 - 150 IU daily, should have been unresponsive to commence within the first 7 treatment with clomiphene days of the menstrual cycle citrate and increased by 37.5 IU or Follitropin Alpha ii) Stimulation of follicular 75 IU at 7 or 14 days G03GA05000P300 659. (Recombinant Human A* development for intra- interval. Max daily dose 225 1XX FSH) 75 IU Injection uterine cycles IU iii) Stimulation of follicular ii) 150 - 225 IU daily development in assisted commencing on days 2 or 3 reproductive technology in of the cycle. Max daily dose the management of 450 IU infertility

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Infertility treatment in anovulatory women who have been unresponsive to To be individualized. Give in treatment with clomiphene multiples of 50 IU. Starting Follitropin Beta citrate. Stimulation of dose can be 50 IU - 200 IU G03GA06000P300 660. (Recombinant Human A* follicular development for daily. It can be a step-up 2XX FSH) 300 IU Injection intra-uterine insemination regime or a step-down, cycles and assisted depending on the protocol reproductive technology in and the ovarian response the management of infertility. Infertility treatment in anovulatory women who have been unresponsive to To be individualized. Give in treatment with clomiphene multiples of 50 IU. Starting Follitropin Beta citrate. Stimulation of dose can be 50 IU - 200 IU G03GA06000P300 661. (Recombinant Human A* follicular development for daily. It can be a step-up 1XX FSH) 50 IU Injection intra-uterine insemination regime or a step-down, cycles and assisted depending on the protocol reproductive technology in and the ovarian response the management of infertility. The recommended dose to be administered by SC injection once daily is: 5mg for body weight less than 50kg, 7.5mg for body weight 50 to 100kg, 10mg for body weight greater than 100kg. i) Treatment of acute Deep Treatment should be Fondaparinux Sodium B01AX05520P5002 Vein Thrombosis (DVT). continued for at least 5 days 662. 12.5 mg/ml Injection in A* XX ii) Treatment of Pulmonary and until adequate oral Prefilled Syringe Embolism (PE) anticoagulation is established (INR 2 to 3). Concomitant treatment with vitamin K antagonists should be initiated as soon as possible, usually within 72 hours. The usual duration of treatment is 5 to 9 days

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) 2.5 mg once daily given by SC, administered 6 hr following surgical closure provided homeostasis has been established. Usual duration of therapy is 5 to 9 days; for hip fracture patients, an extended course of up to 24 days is recommended. ii) ADULT more than 18 years: 2.5 mg once daily given by SC, initiated as i) Prevention of venous soon as possible after thromboembolic events diagnosis and continued for (VTE) in orthopedic surgery up to 8 days or until hospital (e.g. hip fracture, major discharge. If patient needs to knee or hip replacement undergo PCI, unfractionated surgery), abdominal surgery heparin to be admin as per in patients at risk of local practice protocol, taking thromboembolic into account the patient's complication. bleeding risk and time of last ii) Treatment of unstable dose of fondaparinux. angina or non-ST segment Fondaparinux may be Fondaparinux Sodium 2.5 B01AX05520P5001 elevation myocardial restarted no earlier than 2 hr 663. A* mg/0.5 ml Injection XX infarction [UA/NSTEMI] in after sheath removal. patients for whom urgent iii) ADULT more than 18 invasive management (PCI) years: 2.5 mg once daily; first is not indicated. dose to be given IV (directly iii) Treatment of ST through an existing IV line or segment elevation as infusion in 25 or 50 ml of myocardial infarction 0.9% saline over 1-2 min), (STEMI) in patients subsequent doses to be managed with thrombolytics given SC. Treatment to be or are not receiving other initiated as soon as forms of reperfusion diagnosis is made and therapy continued up to a max of 8 days or until hospital discharge, whichever comes earlier. If patient needs to undergo non-primary PCI, unfractionated heparin to be admin as per local practice protocol, taking into account the patient's bleeding risk and time of last dose of fondaparinux. Fondaparinux may be restarted no earlier than 3 hr after sheath removal

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Framycetin Sulphate 0.5%, Dexamethasone S01CA01991D100 Apply 2 - 3 drops 3 to 4 times 664. A/KK Otitis externa 0.05% and Gramicidin 1XX daily 0.005% Ear Drops Initially 20 -40 mg IM or slow Frusemide 10 mg/ml C03CA01000P300 IV (rate not exceeding 4 665. B Pulmonary oedema Injection 1XX mg/min). CHILD: 0.5 - 1.5 mg/kg. Max: 20 mg daily ADULT: Initial 40 - 80 mg on morning if required, can be increased to a max of 1 C03CA01000T100 666. Frusemide 40 mg Tablet B Pulmonary oedema g/day in certain cases 1XX especially in chronic renal failure. CHILD : 1 - 3 mg/kg daily Adult: 100-150g every 2-4 hours. Child: 1-2g/kg. (100g V03AB00000F2101 Adsorbent in pesticide of Fuller's Earth is mixed with 667. Fuller's Earth Powder C XX poisoning 200ml water. Repeat until Fuller's Earth is seen in stool (normally between 4-6 hours) ADULT : 1 oral or 1 nasal Local antibiotic, anti- inhalation 4 hourly, withdraw inflammatory treatment of if no improvement after 7 Fusafungine 1% Nasal R02AB03000A410 668. A infectious and inflammatory days. CHILD : 1 oral or 1 Spray 1XX syndromes of the nasal inhalation 6 hourly, respiratory mucosa withdraw if no improvement after 7 days Treatment of infections caused by susceptible ADULT: 500 mg 3 times organisms especially Fusidate, Sodium 250 mg J01XC01520T1001 daily, skin and soft tissue 669. A* Staphylococcal infections Tablet XX infection: 250 - 500 mg twice including Methicillin daily Resistant Staphylococcus aureus (MRSA) 1 drop in conjunctival sac 12 hourly. To be continued for 2 days after the eye appears normal. On the first day of Fusidic Acid 1% Eye S01AA13000D200 For staphylococcal 670. A treatment, may be applied Drops 1XX infections more frequently : 1 drop 4 hourly. Surgical prophylaxis : 1 drop every 12 hours, 24 - 48 hours before operation Skin infections caused by staphylococci, streptococci, D06AX01000G100 corynebacterium Apply to affected area 2 - 3 671. Fusidic Acid 2% Cream A 1XX minutissumun and other times daily sodium fusidate-sensitive organisms

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Inflammatory dermatosis where bacterial infection is likely to occur eg atopic Uncovered lesion- Apply 2 to Fusidic Acid 2% in eczema, discoid eczema, 3 times daily. Covered D07CC01948G100 672. Betamethasone Valerate A/KK stasis eczema, seborrhoic lesions- Less frequent 1XX 0.1% Cream dermatitis, contact applications may be dermatitis, lichen simplex adequate chronicus, psoriasis, discoid lupus erythematosus ADULT : 15 ml 3 times daily. Treatment of infections CHILD 1 - 5 years: 5 ml 3 caused by staphylococcal Fusidic Acid 50 mg/ml J01XC01000L8001 times daily; 5 - 12 years: 10 673. A* especially Methicillin Suspension XX ml 3 times daily. INFANT : 1 Resistant Staphylococcus ml/kg body weight daily in 3 - aureus (MRSA) 4 divided doses ADULT : 500 mg 3 times Treatment of severe daily diluted to 250 - 500 ml staphylococcal infections infused slowly over 2 hours. Fusidic Acid 500 mg J01XC01520P4001 especially Methicillin Maximum : 2 g daily. CHILD 674. A* Injection XX Resistant Staphylococcus and INFANT : 20 mg/kg/day aureus (MRSA). To be used divided into 3 equal doses in combination therapy only infused slowly over 2 - 4 hours ADULT & CHILD > 12 yrs: 900-3600mg/day. Therapy may be initiated by administering 300mg TDS on day 1, or by titrating the dose i) Add-on therapy for as: 300mg once on day 1, intractable partial epilepsy, 300mg BD on day 2, 300mg refractory to standard anti- TDS on day 3. Thereafter, epileptic drugs ii) Treatment then dose may be increased of various types of in 3 equally divided doses up Gabapentin 100 mg N03AX12000T1002 675. A* neuropathic pain, both to max 3600mg/day.CHILD Tablet XX peripheral (which includes 3-12 yr: Initially 10-15 diabetic neuropathy, post- mg/kg/day in 3 divided dose. herpetic neuralgia, Effective dose: CHILD 3 to trigeminal neuralgia) in less than 5 yrs: 40mg/kg/day adult more than 18 years in 3 divided doses, CHILD 5- 12 yrs: 25-35mg/kg/day in 3 divided doses ii) ADULT: 900mg/day in 3 equally divided doses. Max 3600mg/day

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber ADULT & CHILD > 12 yrs: 900-3600mg/day. Therapy may be initiated by administered 300mg TDS on day 1, or by titrating the dose i) Add-on therapy for as: 300mg once on day 1, intractable partial epilepsy, 300mg BD on day 2, 300mg refractory to standard anti- TDS on day 3. Thereafter, epileptic drugs may be increased in 3 ii) Treatment of various equally divided doses up to Gabapentin 300 mg N03AX12000C100 types of neuropathic pain, 676. A* max 3600mg/day.CHILD 3- Capsule 1XX both peripheral (which 12 yr: Initially 10-15 includes diabetic mg/kg/day in 3 divided dose. neuropathy, post-herpetic Effective dose: CHILD 3 to neuralgia, trigeminal less than 5 yrs: 40mg/kg/day neuralgia) in adult more in 3 divided doses, CHILD 5- than 18 years 12 yrs: 25-35mg/kg/day in 3 divided doses ii) ADULT: 900mg/day in 3 equally divided doses. Max 3600mg/day ADULT & CHILD > 12 yrs: 900-3600mg/day. Therapy may be initiated by administered 300mg TDS on day 1, or by titrating the dose i) Add-on therapy for as: 300mg once on day 1, intractable partial epilepsy, 300mg BD on day 2, 300mg refractory to standard anti- TDS on day 3. Thereafter, epileptic drugs may be increased in 3 ii) Treatment of various equally divided doses up to Gabapentin 600 mg N03AX12000T1001 types of neuropathic pain, 677. A* max 3600mg/day.CHILD 3- Tablet XX both peripheral (which 12 yr: Initially 10-15 includes diabetic mg/kg/day in 3 divided dose. neuropathy, post-herpetic Effective dose: CHILD 3 to neuralgia, trigeminal less than 5 yrs: 40mg/kg/day neuralgia) in adult over 18 in 3 divided doses, CHILD 5- years 12 yrs: 25-35mg/kg/day in 3 divided doses ii) ADULT: 900mg/day in 3 equally divided doses. Max 3600mg/day

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) MRI of the liver for the detection of focal liver lesions in patients with known or suspected primary liver cancer (e.g. Hepatocellular carcinoma) or metastatic disease; i) MRI of liver: 0.05ml/kg ii) MRI of the brain and body weight. This spine where it improves the corresponds to 0.1ml/kg of detection of lesion and the 0.5M solution provides diagnostic ii) MRI of brain & spine: Gadobenate Dimeglumine V08CA08996P300 information additional to 678. A* 0.1mmol/kg body weight. Injection Solution 1XX that obtained with This corresponds to 0.2ml/kg unenhanced MRI; of the 0.5M solution iii) Contrast-enhanced MR- iii) MRA: 0.1mmol/kg body angiography where it weight. This corresponds to improves the diagnostic 0.2ml/kg of the 0.5M solution accuracy for detecting clinically significant steno- occlusive vascular disease in patients with suspected or known vascular disease of the abdominal or peripheral arteries. In adults, adolescents and children aged 2 years and older with diagnostic difficulty especially in patients with renal impairment for: i) Contrast enhancement in cranial and spinal magnetic A single intravenous injection resonance imaging (MRI). of 0.1 mmol/kg (equivalent to Gadobutrol 1 mmol/ml V08CA09000P300 679. A* ii) Contrast enhanced MRI 0.1 ml/kg body weight). Max: injection 1XX of liver or kidneys in 0.3 mmol/kg (equivalent to patients with high suspicion 0.3 ml/kg body weight) or evidence of having focal lesion to classify these lesions as benign or malignant. iii) Contrast enhancement in Magnetic Resonance Angiography (CE-MRA).

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber The usual dose in adults, children, and neonates is 0.2 mL/kg (0.1 mmol/kg) intravenously. For cranial and spinal imaging, a further dose of 0.2 mL/kg (0.1 mmol/kg) may be given within 30 minutes if i) Cranial and spinal necessary; in adults this magnetic resonance second dose may be 0.4 Gadopentetate V08CA01000P300 680. A imaging mL/kg (0.2 mmol/kg). For Dimeglumine 469 mg/ml 1XX ii) Whole body magnetic whole body imaging in adults resonance imaging and children over 2 years, a dose of 0.4 mL/kg (0.2 mmol/kg) may be needed in some cases to produce adequate contrast and in special circumstances a dose of 0.6 mL/kg (0.3 mmol/kg) may be used in adults The recommended dose is 0.1 mmol/kg (equivalent to High risk patients 0.2 mL/kg in adults, children undergoing Magnetic and infants. In angiography, Gadoterate Meglumine Resonance Imaging for V08CA02254P300 depending on the results of 681. (Gadoteric Acid) 0.5 A cerebral and spinal disease, 1XX the examination being mmol/ ml Injection diseases of the vertebral performed, a second column and other whole injection may be body pathology administered during the same session if necessary 0.1ml/kg body weight Gadoxetic acid disodium For use in adults for the (equivalent to 25 µmol per 0.25 mmol/ml solution for V08CA10520P300 enhancement of magnetic 682. A* kg body weight). Not injection (10ml pre-filled 1XX resonance imaging (MRI) of recommended for patients syringe) focal liver lesions younger than 18 years Apply lotion to entire body Gamma Benzene P03AB02100L6001 683. B Treatment of head lice from neck down for 8 to 12 Hexachloride 0.1 % Lotion XX hours, then rinse Scabies Adult: Apply a thin layer of 1% topical preparation onto all skin Gamma Benzene P03AB02100G100 684. A/KK Only for scabies in adult areas from the neck to toes. Hexachloride 1% Cream 2XX Completely wash off from the body with warm water after 8-12 hr. Treatment of Initial: 5 mg/kg infused over 1 cytomegalovirus (CMV) hour 12 hourly for 14 - 21 Ganciclovir Sodium 50 J05AB06520P3001 disease in days (CMV retinitis 685. A* mg/ ml Injection XX immunocompromised treatment) or 7 - 14 days patients, prevention of CMV (CMV disease prevention). disease during Long term maintenance: 6

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber immunosuppressive mg/kg daily for 5 days/week therapy following organ or 5 mg/kg daily for 7 transplantation days/week

Prevention of premature luteinizing hormone surges Given by SC 0.25 mg once in women undergoing daily, starting on day 6 of Ganirelix 0.25 mg/0.5 ml H01CC01000P200 686. A* controlled ovarian ovarian stimulation and Injection 1XX hyperstimulation for continued until ovulation assisted reproduction induction technique For the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously failed L01XE02000T1001 250mg tablet once a day, 687. Gefitinib 250 mg tablet A* chemotherapy, and who XX taken with or without food have activating mutation of epidermal growth factor receptor (EGFR). Restricted to non-smoker, female, EGFR positive and Asian patients only. i) Locally advanced or i) Alone or with cisplatin: metastatic non-small cell 1000 mg/m2 day 1 & 8 every lung cancer 3 weeks or 1000 mg/m2 day ii) Locally advanced or 1, day 8, day 15 every 4 metastatic pancreatic weeks cancer ii) Initially 1000 mg/m2 iii) In combination with weekly for 7 weeks followed carboplatin in the treatment by 1 week rest. Subsequent of patients with recurrent cycles 1000 mg/ m2 weekly epithelial ovarian for 3 weeks followed by 1 carcinoma, who have week rest Gemcitabine HCl 1 g L01BC05110P4002 relapsed more than six 688. A* iii) Gemcitabine 1000 mg/m2 Injection XX months, following platinum- as 30 minutes IV infusion based therapy day 1 & 8 of each 21-day iv) In combination with cycle followed by carboplatin paclitaxel for treatment of on day 1 to attain a target patients with metastatic AUC of 4 mg/ml/minute breast cancer who have iv) 1250 mg/m2 on days 1 relapsed following adjuvant/ and 8 of each 21-day cycle neoadjuvant chemotherapy. with paclitaxel 175 mg/m2 Prior chemotherapy should given as a 3-hour infusion have included an before gemcitabine on day 1 anthracycline unless of each 21-day cycle clinically contraindicated

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Locally advanced or i) Alone or with cisplatin: metastatic non-small cell 1000 mg/m2 day 1 & 8 every lung cancer 3 weeks or 1000 mg/m2 day ii) Locally advanced or 1, day 8, day 15 every 4 metastatic pancreatic weeks cancer ii) Initially 1000 mg/m2 iii) In combination with weekly for 7 weeks followed carboplatin in the treatment by 1 week rest. Subsequent of patients with recurrent cycles 1000 mg/ m2 weekly epithelial ovarian for 3 weeks followed by 1 carcinoma, who have week rest Gemcitabine HCl 200 mg L01BC05110P4001 relapsed more than six 689. A* iii) Gemcitabine 1000 mg/m2 Injection XX months, following platinum- as 30 minutes IV infusion based therapy day 1 & 8 of each 21-day iv) In combination with cycle followed by carboplatin Paclitaxel, for treatment of on day 1 to attain a target patients with metastatic AUC of 4 mg/ml/minute breast cancer who have iv) 1250 mg/m2 on days 1 relapsed following adjuvant/ and 8 of each 21-day cycle, neoadjuvant chemotherapy. with paclitaxel 175 mg/m2 Prior chemotherapy should given as a 3-hour infusion have included an before gemcitabine on day 1 anthracycline unless of each 21-day cycle clinically contraindicated Cervical dilatation: 1 pessary Gemeprost (Prostagladin G02AD03000S100 Inducing abortion in the first 3 hourly before surgery to a 690. E1 Synthetic Analogue) 1 A 1XX trimester max of 5 pessaries over 24 mg Pessary hours ADULT: 1200 mg/day in 2 Treatment of divided doses, 30 minutes Gemfibrozil 300 mg C10AB04000C100 691. A/KK hyperlipoprotinaemias before breakfast and dinner. Capsule 1XX (TYPES IIA, IIB, III, IV, V) Dose range from 0.9-1.5 g daily D06AX07183G100 692. Gentamicin 0.1% Cream A* For localised infections Apply 2 - 3 times daily 1XX Broad spectrum antibiotic in 1 - 2 drops every 4 hours, in Gentamicin 0.3% Eye S01AA11183D200 superficial eye infections severe infection dosage may 693. A/KK Drops 1XX and also for Pseudomonas be increased up to 2 drops aeruginosa every hour Conjunctivitis, blepharitis, blepharo-conjunctivitis, keratitis, Gentamicin 0.3% Eye S01AA11183G510 Apply into the conjunctival 694. A/KK keratoconjunctivitis, Ointment 1XX sac 3 - 4 times daily episcleritis, dacrocystitis, corneal ulcers, styes and infected eye socket Broad spectrum antibiotic in Gentamicin 3% Fortified S01AA11183D200 superficial eye infections Dose according to the needs 695. A Eye Drops 2XX and also for Pseudomonas of the patient aeruginosa

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Treatment of chronic J01GB03183P1001 osteomyelitis of post- 7.5 - 22.5 mg chains to fill 696. Gentamicin 7.5 mg Beads A XX traumatic, post-operative or affected cavity hematogenous origin ADULT: 3 - 5 mg/kg/day 8 hourly IM or IV. CHILD up to Gentamicin Sulphate 10 J01GB03183P3002 Infections due to 697. B 2 weeks: 3mg/kg every 12 mg/ml Injection XX susceptible organisms hours; 2 weeks - 12 years: 2 mg/kg 8 hourly ADULT: 3 - 5 mg/kg/day 8 hourly IM or IV. CHILD up to Gentamicin Sulphate 40 J01GB03183P3003 Infections due to 698. B 2 weeks: 3mg/kg every 12 mg/ml Injection XX susceptible organisms hours; 2 weeks - 12 years: 2 mg/kg 8 hourly Inflammatory and allergic conditions involving superficial eye structures and when bacterial infection Gentamicin Sulphate and S01CA05990D200 is present : conjunctivitis, 699. Betamethasone Disodium A/KK 2 drops 3 - 4 times daily 1XX blepharitis, keratitis, Phosphate Eye Drops episcleritis, dacryocystitis, hordeolum, meibomianitis, injuries involving anterior segment of the eye Inflammatory and allergic conditions involving superficial eye structures and when bacterial infection Gentamicin Sulphate and S01CA05990G510 is present : conjunctivitis, Thin coating of ointment 3 - 4 700. Betamethasone Disodium A 1XX blepharitis, keratitis, times daily Phosphate Eye Ointment episcleritis, dacryocystitis, hordeolum, meibomianitis, injuries involving anterior segment of the eye Range: 2.5 - 15 mg daily (with or immediately after Diabetes mellitus type 2. Glibenclamide 5 mg A10BB01000T1001 breakfast). Initially 2.5 mg 701. B Restriction : Use only in Tablet XX daily increasing by 2.5 mg patient under 65 years old required for metabolic control. Max: 20mg daily. Initially, 30mg daily at breakfast time, may increase Gliclazide 30 mg Modified A10BB09000T5002 in successive steps to 60, 90 702. B Diabetes mellitus type 2 Release Tablet XX or 120mg daily at 1 month intervals. Max daily dose: 120mg

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Initially, 30mg daily at breakfast time, may increase in successive steps to 60, 90 or 120mg daily at 1 month Gliclazide 60 mg Modified A10BB09000T5001 703. B Diabetes mellitus type 2 intervals (except in patients Release Tablet XX whose blood glucose level was not reduced after 2 weeks of treatment). Max daily dose: 120mg Initially 40-80mg daily. A single dose should not exceed 160mg and when higher doses are required, a A10BB09000T1001 twice daily split dosage is 704. Gliclazide 80 mg Tablet B Diabetes mellitus type 2 XX advised and should be divided. Maximum daily dose: 320mg. For elderly, starting dose should be 40mg twice daily. Adult, children > 20kg: 1mg by SC, IM or IV. Children < 20kg : 0.5mg. If patient does Glucagon (Lyophilised) 1 H04AA01000P400 Management of 705. B not respond within 10 mg/ml Injection 1XX hypoglycaemia minutes, administer IV glucose. Repeat in 20 minutes if necessary. 20 minutes or more immersion is recommended 2% formulation - High level for endoscopes before the Glutaraldehyde Solution V07AV00000L9905 disinfection for heat session and between 706. A 2% XX sensitive equipments such patients after thorough as endoscopes cleaning based on manufacturer recommendation A06AX01000L5001 As a lubricant and osmotic 707. Glycerin C+ Apply to area when required XX dehydrating agent Glycerin 25% and Sodium A06AG20921G200 708. C+ Constipation 1 enema as required Chloride 15% Enema 1XX 0.5-1 mg sublingually may be repeated every 5 minutes Prophylaxis and treatment Glyceryl Trinitrate 0.5 mg C01DA02221T100 until relief is obtained. Seek 709. C of angina and left Sublingual Tablet 1XX physician if the pain persists ventricular failure after a total of 3 tablets in a 15 minutes period. Initial 5 mcg/min delivered via infusion pump. Prophylaxis and treatment Subsequent titration must be Glyceryl Trinitrate 5 mg/ml C01DA02221P300 of angina, left ventricular 710. A adjusted to clinical situation Injection 1XX failure. Not for direct IV with dose increment injection. becoming more cautious as partial response is seen.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber At the onset of an attack, one or two metered sprays should be administered on or under the tongue. A spray maybe repeated approximately every 5 minutes as needed. No more than 3 metered sprays are Glyceryl Trinitrate Aerosol Prophylaxis and treatment C01DA02221A100 recommended within 15 711. Spray 400mcg (metered B of angina and left 1XX minute period. If chest pain dose) ventricular failure persists after a total of 3 sprays, prompt medical attention is recommended. Aerosol may be used prophylactically 5 to 10 minutes before engaging in activities that might precipitate an acute attack The dosage depends on the Glycine 1.5% Irrigating B05CX03000H300 Bladder irrigation during 712. A extent of the procedure and Solution 1XX genitourinary surgery its duration i) Pre-op: 4 mcg/kg via IM administration 30-60 mins i) To reduce secretions before procedure. (respiratory tract) for certain Intraoperative: 0.1 mg via IV types of surgery Glycopyrrolate 200 A03AB02320P3001 administration, repeat at 2-3 713. A* ii) Reversal of mcg/ml Injection XX min intervals when needed. neuromuscular block in Max: 400 mcg/dose. patients where atropine is ii) 0.2 mg by IV for each 1 contraindicated mg of neostigmine or 5 mg pyridostigmine One capsule daily. The recommended dose is the For maintenance inhalation of the content of bronchodilator treatment to one capsule once daily using relieve symptoms in adult Glycopyrronium 50mcg, inhaler. It is recommended to R03BB06320A200 patients with chronic 714. Inhalation Powder Hard A/KK be administered, at the same 1XX obstructive pulmonary Capsules time of the day each day. No disease (COPD). COPD relevant use of diagnosis is confirmed by glycopyrronium in pediatric spirometry. population (<18 years) for COPD.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Rheumatoid arthritis (RA): In combination with methotrexate (MTX), is indicated for: - The treatment of moderate to severe active rheumatoid arthritis in adult patients when the response to DMARD therapy including MTX has been inadequate. - The treatment of active, i) Rheumatoid arthritis 50mg severe and progressive given as a subcutaneous rheumatoid arthritis in adult injection once a month, on patients not previously the same date each month. treated with MTX. ii)Psoriatic arthritis 50mg Golimumab 50mg (0.5ml) ii) Psoriatic arthritis (PsA): given as a subcutaneous L04AB06000P5001 715. solution for injection in a A* Golimumab alone or in injection once a month, on XX pre-filled syringe combination with MTX, is the same date each month. indicated for: The treatment iii) Ankylosing spondylitis of active psoriatic arthritis in 50mg given as a adult patients when the subcutaneous injection once response to previous a month, on the same date DMARD therapy has been each month. inadequate. iii) Ankylosing spondylitis (AS): Golimumab(used alone) is indicated for: The treatment of active ankylosing spondylitis in adult patients when the response to conventional therapy has been inadequate. Prostate cancer,endometriosis,leiom yoma uteri and assissted One 10.8mg depot injected Goserelin 10.8 mg Depot L02AE03000P2002 reproduction,breast cancer subcutaneously into the 716. A Injection XX in premenopausal and anterior abdominal wall, perimenopausal women every 12 weeks. suitable for hormonal manipulation Prostate cancer,endometriosis,leiom yoma uteri and assissted Goserelin 3.6 mg Depot L02AE03000P2001 reproduction,breast cancer 3.6 mg depot injection every 717. A Injection XX in premenopausal and 28 days perimenopausal women suitable for hormonal manipulation

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber ADULT 1 mg twice daily or 2 mg once daily with the first Prevention and treatment of dose to be administered nausea and vomiting Granisetron HCl 1 mg A04AA02110T1001 within 1 hour prior to 718. A associated with Tablet XX cytostatic therapy and can be chemotherapy and given for up to 1 week radiotherapy following radiotherapy. Maximum 9 mg/day i) ADULT 1-3 mg as an IV bolus not not less than 30 i) Prevention and treatment seconds; maximum 9 of nausea and vomiting mg/day. CHILD over 2 years; associated with single dose of 10-40 mcg/kg Granisetron HCl 1 mg/ml A04AA02110P3001 719. A chemotherapy and as an IV infusion; maximum Injection XX radiotherapy 3 mg/day ii) Post-operative nausea ii) ADULT 1 mg by slow IV and vomiting injection over 30 seconds prior to induction of anaesthesia ADULT: 500 mg daily up to 1 g daily in divided doses, 2-8 Dermatophyte infections of wk in hair and skin infections, Griseofulvin D01BA01000T1001 the skin, scalp, hair and 6 mth in fingernail infections 720. (Ultramicrosize 125 mg = B XX nails, where topical therapy and 12 mth or more for 250 mg Microsize) Tablet has failed or inappropriate toenail infections. CHILD: 10 mg/kg daily in divided doses or as a single dose For acute renal failure, chronic renal failure, Haemodialysis B05ZA00908H1001 Dose depending on clinical 721. A overhydration, intoxication, Concentrate with Acetate XX cases adjustment of acid-base and electrolyte balance For acute renal failure, Haemodialysis chronic renal failure, B05ZA00908H1002 Dose depending on clinical 722. Concentrate with A overhydration, intoxication, XX cases Bicarbonate adjustment of acid-base and electrolyte balance Haemophilus Influenza Immunisation of infants Type B Conjugate J07AG01000P4001 723. C against Haemophilus 0.5 ml IM Vaccine Injection (Single XX Influenzae Type B Dose) Adult: 0.5-5 mg bid/tid, may increase up to 100 mg daily in severe or resistant cases. Usual maintenance: 3-10 mg N05AD01000T100 Schizophrenia and other 724. Haloperidol 1.5 mg Tablet B daily. Child: >3 yr: Initially, 1XX psychoses 25-50 mcg/kg daily in 2 divided doses, increased gradually if necessary. Max: 10 mg/day.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Adult: 0.5-5 mg bid/tid, may increase up to 100 mg daily in severe or resistant cases. Usual maintenance: 3-10 mg N05AD01000T100 Schizophrenia and other 725. Haloperidol 5 mg Tablet B daily. Child: >3 yr: Initially, 2XX psychoses 25-50 mcg/kg daily in 2 divided doses, increased gradually if necessary. Max: 10 mg/day. ADULT: IM or IV , 2 mg - 10 mg then every 4 - 8 hours Haloperidol 5 mg/ml N05AD01000P300 Acute psychoses and according to response to 726. B Injection 1XX mania total maximum 18 mg daily. Use in child is not recommended i) By IV injection, loading dose of 5000 units (10,000 units in severe pulmonary embolism) followed by continuous infusion of 15-25 units/kg/hr. By SC injection (for DVT) of 15,000 units every 12 hours (laboratory monitoring on daily basis essential to adjust dose). Small adult or child, lower i) Prophylaxis and treatment loading dose then, 15-25 of venous thrombosis and units/kg/hr by IV infusion, or pulmonary embolism. 250 units/kg every 12 hours ii) Treatment of myocardial by SC injection. Heparin 1000 units/ml B01AB01520P3001 infarction and arterial 727. B ii) As i), for unstable angina Injection XX embolism. and acute peripheral arterial iii) Prevention of clotting in occlusion. arterial and heart surgery iii) Prophylaxis in general and for prevention of surgery, by SC injection, cerebral thrombosis 5000 units 2 hour before surgery, then every 8-12 hours for 7 days or until patient is ambulant, during pregnancy (with monitoring), 5000-10000 units every 12 hours. An adjusted dose regimen may be used for major orthopaedic surgery or low molecular weight heparin may be selected

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) By IV injection, loading dose of 5000 units (10,000 units in severe pulmonary embolism) followed by continuous infusion of 15-25 units/kg/hr. By SC injection (for DVT) of 15,000 units every 12 hours (laboratory monitoring on daily basis essential to adjust dose). Small adult or child, lower i) Prophylaxis and treatment loading dose then, 15-25 of venous thrombosis and units/kg/hr by IV infusion, or pulmonary embolism. 250 units/kg every 12 hours ii) Treatment of myocardial by SC injection. Heparin 5000 units/ml B01AB01520P3002 infarction and arterial 728. B ii) As i), for unstable angina Injection XX embolism. and acute peripheral arterial iii) Prevention of clotting in occlusion. arterial and heart surgery iii) Prophylaxis in general and for prevention of surgery, by SC injection, cerebral thrombosis 5000 units 2 hour before surgery, then every 8-12 hours for 7 days or until patient is ambulant, during pregnancy (with monitoring), 5000-10000 units every 12 hours. An adjusted dose regimen may be used for major orthopaedic surgery or low molecular weight heparin may be selected Heparin Sodium 50 units B01AB01930P3001 To maintain patency of Flush with 5 ml (50 units) 729. in Sodium Chloride B XX peripheral venous catheters every 4 hours or as required Injection Vaccination against hepatitis A especially in 0.5 ml per injection. ADULT those at risk of exposure to and CHILD more than 15 hepatitis A virus such as: years: A single primary dose Hepatitis A, Inactivated J07BC02000P5001 i) Visitors followed by a booster dose 6 730. Vaccine 160 antigen units A XX ii) Chronic hepatitis B and C - 12 months later. CHILD 2 - Injection patient 15 years: A single primary iii) Those requiring dose followed by a booster vaccination against dose 6 - 12 months later hepatitis A

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Adults: Recommended Dose: 1000-2000 IU IM and if necessary, the dose should be increased or repeated. Children: Inject 32-48 IU/kg of body weight, should be administered within 7 days after exposure to HBsAg (preferably within 48 hrs). i) For post-exposure Neonates: Recommended prophylaxis of hepatitis B Hepatitis B Initial Dose: 100-200 IU. The J06BB04000P3001 ii) Prophylaxis against 731. Immunoglobulin (Human) A 1st dose should be XX recurrence of hepatitis B Injection administered within 5 days infection in chronic hepatitis after birth (preferably within B post liver transplantation 48 hrs) and booster dose should be 32-48 IU/kg body weight. The booster dose should be administered between 2 and 3 months after the 1st administration. ii) Different regimens depending on hepatitis B virus (HBV) DNA positivity ADULTS over 20 years: 10 mcg/dose. ADOLESCENT 11 - 19 years: 5 mcg/dose. NEWBORN and CHILD up to Immunisation against Hepatitis B Vaccine J07BC01000P4001 10 years: 2.5 mcg/dose. 732. C+ infections caused by Injection XX INFANTS born to HBsAg Hepatitis B virus positive mothers: 3 doses of 0.5 ml each. Second dose to be given after 1 month and booster dose after 6 months i) Adult: Instill 1 or 2 drops of 2% solution immediately before the procedure, repeat at 5-10-minute intervals if necessary. Child: Instill 1 drop of 2% soln immediately i) Mydriasis and cycloplegia before the procedure, repeat Homatropine 2% Eye S01FA05330D2003 for refraction at 10-min intervals if 733. B Drops XX ii) Treatment of anterior necessary. segment inflammation ii) Adult: Instill 1-2 drops of 2% bd-tds up to every 3-4 hr as needed. Child: 3 mth- 2 yr: instill 1 drop of 0.5% soln once daily or on alternate days. >2 yr: instill 1 drop of 1% or 2% soln bd.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) ADULT 25 g. CHILD 0.6 g/kg body weight i) Acute hypovolemic shock ii) Maximum daily dose is 2g B05AA01000P3001 ii) Hypoproteinaemia 734. Human Albumin Injection B iii) 1 g/kg before exchange XX iii) Neonatal transfusion. Dose is given at hyperbilirubinaemia rate of 1 ml of 25% solution per minute i) i) 50 mg/kg body weight daily Hypogammaglobulinaemia for 5 days, then 25 - 50 and other deficiency states mg/kg weekly for ii) Severe refractory maintenance according to idiopathic thrombocytopenia the severity of the condition purpura (platelet less than ii) 400 mg/kg daily for 5 days 20,000) with internal with a further dose of 400 Human Normal Globulin J06BA02000P3001 bleeding, particularly central 735. A mg/kg as required Injection XX nervous system iii) Septicaemia in iii) Septicaemia in immunocompromised immunocompromised patients or patients not patients or patients not responding to antibiotics responding to antibiotics iv) 250 mg/kg per month iv) Chronic lymphocytic Dose varies depending on leukaemia not responding brand used to conventional therapy For the prevention of Given by IM into deltoid Human Papillomavirus cervical cancer due to J07BM02000P3001 region. ADULT and CHILD 736. (Types 16, 18) Vaccine C+ papilloma virus. To be used XX 10 - 25 years, 3 doses of 0.5 Injection as part of the public health mL, at 0, 1 and 6 months program only For the prevention of Given by IM into deltoid Human Papillomavirus cervical cancer due to region or higher anterolateral J07BM01000P3001 737. (Types 6, 11, 16, 18) C+ papilloma virus. To be used thigh. ADULT and CHILD 9 - XX Vaccine Injection as part of the public health 26 years, 3 doses of 0.5 mL, program only at 0, 2 and 6 months i) Slow IV injection, ADULT: 5-10 mg diluted with 10ml sodium chloride 0.9%. May Hydralazine HCl 20 mg C02DB02110P300 Hypertensive crisis in be repeated after 20-30 738. B Injection 1XX pregnancy minutes if necessary. ii) IV infusion 200-300 mcg/minutes. Maintenance dose 50-150 mcg/minutes ADULT: Diuretics; 25-200 mg daily. Hypertension 12.5- 25 mg daily CHILD: Oedema and hypertension; Adjunct; 1 to 2 mg/kg ORALLY daily in Hydrochlorothiazide 25 C03AA03000T1001 739. B Diuretic, hypertension single or two divided doses; mg Tablet XX Children 2-12 years old MAX dose, not to exceed 100 mg ORALLY daily; Infants less than 6 months old, may require doses up to 3 mg/kg

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber ORALLY daily in two divided doses, Infants up to 2 yrs old: MAX dose, not to exceed 37.5 mg ORALLY daily ADULT: Diuretics; 25-200 mg daily. Hypertension 12.5- 25 mg daily CHILD: Oedema and hypertension; Adjunct; 1 to 2 mg/kg ORALLY daily in single or two divided doses; Children 2-12 years old MAX Hydrochlorothiazide 50 C03AA03000T1002 dose, not to exceed 100 mg 740. B Diuretic, hypertension mg Tablet XX ORALLY daily; Infants less than 6 months old, may require doses up to 3 mg/kg ORALLY daily in two divided doses, Infants up to 2 yrs old: MAX dose, not to exceed 37.5 mg ORALLY daily Inflammatory and pruritic Apply to affected part 2-3 Hydrocortisone 1% & D07CA01952G100 manifestations of times daily (occasionally may 741. B Neomycin 0.5% Cream 1XX corticosteroid responsive cause sensitisation to dermatoses Neomycin) Inflammatory and pruritic Apply sparingly to affected Hydrocortisone 1% D07AA02000G100 manifestations of area 2 - 3 times daily until 742. B Cream 1XX corticosteroid responsive condition improve, then dermatoses reduce frequency Inflammatory and pruritic Apply sparingly to affected Hydrocortisone 1% D07AA02000G500 manifestations of area 2 - 3 times daily until 743. B Ointment 1XX corticosteroid responsive condition improve, then dermatoses reduce frequency Glucocorticoid replacement therapy in primary or secondary adrenal ADULT: 20 - 30 mg daily in Hydrocortisone 10 mg H02AB09000T1001 744. B insufficiencies and long divided doses. CHILD: 10 - Tablet XX term management of 30 mg daily in divided doses congenital adrenal hyperplasia in children ADULT 100 mg 1-2 Adjunctive treatment for times/day for 2-3 weeks. If Hydrocortisone Enema A07EA02000G200 745. B ulcerative colitis and used for longer than 3 0.1% 1XX proctitis weeks, taper treatment over 2-3 weeks Conditions responsive to Initially 100 - 500 mg IV over Hydrocortisone Sodium systemic or local 30 seconds to more than 10 H02AB09520P400 746. Succinate 100 mg C glucocorticoid injection minutes. Dose may be 1XX Injection therapy especially in repeated at intervals of 2, 4 emergencies or 6 hours

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Instill 1 - 2 drops into the ear Hydrogen Peroxide 1.5% S02AA06241D100 747. C To soften impacted ear wax as required (leave for a few Ear Drops 1XX minutess) Hydrogen Peroxide 6% (=approx. 20 vol) shall be dispensed. For cleansing wounds: 1.5% to 6% solution apply 2-3 times daily or when nescessary. As a mouthwash: rinse the mouth Skin disinfection, for 2-3 minutes with 15ml of Hydrogen Peroxide 20 D08AX01241L9901 particularly cleansing and hydrogen peroxide 6% 748. C volume Solution XX deodorising wounds and diluted in half a tumblerful of ulcers warm water 2-3 times daily. Disinfecting cleaned equipment: immersion for 30 minutes in 6% solution. As ear drop for removal of wax: hydrogen peroxide 6% diluted with 3 parts of water preferably just before use i) Initially 400 mg daily in divided dose. Maintenance : i) SLE and mixed 200 - 400 mg daily connective tissue disease Hydroxychloroquine P01BA02183T1001 ii) ADULT : 400 - 600 mg 749. A for skin, joint and serosa Sulphate 200 mg Tablet XX daily. Maintenance: 200 - ii) Second line therapy for 400 mg daily. CHILD : up to acute rheumatoid arthritis 6.5 mg/kg daily (maximum 400mg daily) Hydroxyethyl Cellulose V07AY00250G400 Apply sufficiently for 750. B For lubricating purpose Jelly 1XX lubricating purpose ADULT daily dose up to 20 ml/kg/day. Normally 500- Therapy and prophylaxis of 1500 ml. The rate of infusion hypovolaemia and shock in may approach 20 ml/kg/hour Hydroxyethyl Starch 6% B05AA07000P9901 751. B connection with surgery in acute haemorrhagic Injection XX trauma, infections and shock, slower rates in burns burns and septic shock. CHILD under 10 years do not exceed 15 ml /kg/hour. Hydroxyprogesterone G03DA03128P200 Habitual and threatened 250 - 500 mg once weekly by 752. Caproate 250 mg/ml A 1XX abortion IM injection Injection

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i)Intermittent therapy : 80 mg/kg orally as a single dose every 3rd day. Continuous therapy : 20 - 30 mg/kg orally as a single dose dly. Concomitant therapy with irradiation : 80 mg/kg orally i)Solid tumours as a single dose every 3rd ii) Chronic myelocytic day.(administration of leukaemia and hydroxyurea should be myeloproliferative disease Hydroxyurea 500 mg L01XX05000C1001 started at least 7 days before 753. A iii)Severe psoriasis eg. Capsule XX initiation of irradiation and Extensive plaque psoriasis, continued during erythrodermic psoriasis, radiotherapy as well). pustular psoriasis -as third ii)Continuous therapy (20 - line therapy. 30 mg/kg orally as a single dose daily, therapy should be interrupted if the white blood cell count drops below 2500/mm3, or the platelet count below 100,000/mm3. iii) 500 mg tds. Initially 25 mg at night, increased if necessary up to 25 mg 3-4 times daily. Hydroxyzine HCl 25 mg N05BB01110T1001 ADULT and CHILD more 754. A Allergic pruritus Tablet XX than 10 years : 50 - 75 mg; 6 - 10 years: 25 - 50 mg; 2 - 5 years: 12.5 - 25 mg; to be taken daily in divided doses 200-600 mcg given as SC or Hyoscine Hydrobromide A04AD01330P300 To reduce oral secretions IM 60 minutes before 755. B 400 mcg/ml Injection 1XX before surgery induction of anaesthesia. CHILD: 15 mcg/kg Gastrointestinal tract and ADULT 40mg 4 times a day. Hyoscine N-Butylbromide A03BB01320L5001 genito-urinary tract spasm, 756. B CHILD 6-12 years old: 10mg 1 mg/ml Liquid XX dyskinesia of the biliary 3 times a day. system Gastrointestinal tract and ADULT 40mg 4 times a day. Hyoscine N-Butylbromide A03BB01320T1001 genito-urinary tract spasm, 757. B CHILD 6-12 years old: 10mg 10 mg Tablet XX dyskinesia of the biliary 3 times a day. system Gastrointestinal tract and 20 mg IM/IV repeated after Hyoscine N-Butylbromide A03BB01320P3001 genito-urinary tract spasm, 758. B 30 min if needed. Max: 100 20 mg/ml Injection XX dyskinesia of the biliary mg daily. system Tear deficiency, ophthalmic Hypromellose 0.3% Eye S01XA20000D200 1 - 2 drops several times a 759. B lubricant; for relief of dry Drops 2XX day eyes and eye irritation

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Symptomatic relief of Hypromellose 0.3%, severe dry eye conditions S01KA02000G320 Instill 1-2 drops in affected 760. Carbomer 980 B and as lens lubricant during 1XX eye(s) as needed Ophthalmic Gel ophthalmic diagnostic procedures Treatment of postmenopausal osteoporosis to reduce the risk of fracture. Review treatment after 2 years and if there is positive response, treatment may be continued up to 5 years and then re- Ibandronic Acid 150 mg M05BA06000T100 761. A* evaluate. Treatment should 150 mg once monthly Tablet 3XX be stopped if there is no positive response after 5 years. Otherwise, patient needs to be given drug holiday for 1 to 2 years and then continue treatment shall the benefit outweigh the risk. Dosage: ADULT : 200 - 400 mg 3 times daily after food, maximum 3.2 g daily. CHILD M01AE01000T100 Pain and inflammation in : 30-50 mg/kg body weight 762. Ibuprofen 200 mg Tablet B 1XX rheumatic disease daily in divided doses, maximum 2.4g daily. Lowest effective dose for the shortest possible duration. 2 - 3 drops 3 - 4 times daily Ichthammol Glycerin 10% S02AA30000D100 Ear wick for otitis externa 763. C and in ear wick for otitis Ear Drops 1XX with oedema externa i) Induction phase: 12 mg/m2 IV slow bolus on Days 3, 5 i) Acute promyelocytic and 7. Consolidation phase, leukaemia month 1: 12 mg/m2 IV on ii) Relapse Acute myeloid Days 1 and 2. Repeat L01DB06110P4002 leukemia (with sibling 764. Idarubicin 10 mg Injection A* monthly for 3 courses XX match) ii) 12 mg/m2 D1-3 iii) Acute myeloid leukemia, iii) 12 mg/m2 D1-3 as part of acute lymphoblastic FLAG-IDA regimen. leukemia (salvage therapy) Children: 10mg/m2 IV daily for 3 days i) Acute promyelocytic i) Induction phase: 12 mg/m2 leukaemia IV slow bolus on Days 3, 5 ii) Relapse Acute myeloid and 7. Consolidation phase, L01DB06110P4001 leukemia (with sibling month 1: 12 mg/m2 IV on 765. Idarubicin 5 mg Injection A* XX match) Days 1 and 2. Repeat iii) Acute myeloid leukemia, monthly for 3 courses acute lymphoblastic ii) 12 mg/m2 D1-3 leukemia (salvage therapy) iii) 12 mg/m2 D1-3 as part of

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber FLAG-IDA regimen. Children: 10mg/m2 IV daily for 3 days Hunter syndrome 0.5 mg/kg of body weight Idursulfase 2 mg/ml A16AB09000P3001 766. A* (Mucopolysaccharidosis II, administered every week as Injection XX MPS ii). an intravenous infusion. i) 1.2 - 2.4 g/m2/day for 3 - 7 days as a 30 - 120 minutes infusion. Alternatively, can also be given as a single i) Solid tumours high dose, eg. 5 g/m2 in a 24 L01AA06000P4001 767. Ifosfamide 1 g Injection A* ii) Leukaemia hour infusion. Cycles may be XX iii) Lymphoma repeated every 3 - 4 weeks ii) CHILD: 400 - 3000 mg/m2/day for 3 - 5 days according to protocol iii) Refer to protocols i) ADULT and CHILD: i) ADULT: Chronic phase Philadelphia positive (Ph+) chronic myeloid leukemia: chronic myeloid leukaemia 400 mg once daily. in chronic phase and in Accelerated phase or blast early acceleration after crisis chronic myeloid Imatinib Mesylate 100 mg L01XE01196T1001 failure of interferon therapy leukemia: 600 mg once daily. 768. A* Tablet XX ii) Treatment of patients CHILD more than 2 years, with unresectable and/or chronic and advanced phase metastatic malignant chronic myeloid leukemia: gastrointestinal stromal 340 mg/m2 daily. Max: 800 tumours (GIST) who are mg/day positive for CD117/c-kit ii) ADULT : 400mg/day i) ADULT and CHILD: i) ADULT: Chronic phase Philadelphia positive (Ph+) chronic myeloid leukemia: chronic myeloid leukaemia 400 mg once daily. in chronic phase and in Accelerated phase or blast early acceleration after crisis chronic myeloid Imatinib Mesylate 400 mg L01XE01196T1002 failure of interferon therapy leukemia: 600 mg once daily. 769. A* Tablet XX ii) Treatment of patients CHILD more than 2 years, with unresectable and/or chronic and advanced phase metastatic malignant chronic myeloid leukemia: gastrointestinal stromal 340 mg/m2 daily. Max: 800 tumours (GIST) who are mg/day positive for CD117/c-kit ii) ADULT : 400mg/day

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease and who exhibit clinically significant non-neurological manifestations of the Dosage should be disease. The non- individualized to each neurological manifestations patient. Initial dosages range of Gaucher disease include Imiglucerase 400 IU A16AB02000P4002 from 2.5 units/kg of body 770. A* one or more of the following Injection XX weight 3 times a week to 60 conditions: - anemia, after units/kg once every 2 weeks. exclusion of other causes, Administered by intravenous such as iron deficiency - infusion over 1-2 hours. thrombocytopenia - bone disease, after exclusion of other causes, such as Vitamin D deficiency - hepatomegaly or splenomegaly Based on type or severity of infection, susceptibility of pathogen(s) and patient condition including body weight and renal function. ADULT: 1 - 2 g/day in 3 - 4 divided doses. Maximum: 4 Severe infections caused g/day or 50 mg/kg/day. by susceptible pathogens Infusion rate: less than 500 Imipenem 500 mg and J01DH51961P4002 especially useful in mg dose: over 20 - 30 771. Cilastatin 500 mg A* XX infections involving ESBL minutes, more than 500 mg: Injection organisms. Not to be used dose over 40 - 60 minutes. for prophylaxis CHILDREN: ≥ 40kg body weight should receive adult doses. CHILDREN AND INFANTS: <40kg body weight should receive 15mg/kg at six hour intervals. The total daily dose should not exceed 2g. Initially up to 75 mg daily in divided doses increased gradually to 150 - 200 mg (up to 300 mg in hospital Imipramine HCI 25 mg N06AA02110T1001 patients); up to 150 mg may 772. B Depression Tablet XX be given as a single dose at bedtime. ELDERLY initially 10 mg daily; increased gradually to 30 - 50 mg daily; CHILD is not recommended Imiquimod 5 % w/w D06BB10000G100 Treatment of external Apply to affected area at 773. A* Cream 1XX genital and perianal warts bedtime for 3 times a week

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber or condyloma acuminata in for up to 16 weeks; leave on adults skin for 6-10 hours Immunoglobulin Tetanus Prophylaxis of tetanus: IM J06BB02000P3001 Passive immunization 774. Human 250 Units/Vial B 250 units. Treatment of XX against tetanus Injection tetanus: IM 30 - 300 units/kg Maintenance bronchodilator Once-daily inhalation of the treatment of airflow content of one 150/300 Indacaterol Maleate 150 R03AC18253C990 obstruction in adult patients 775. A* microgram capsule. mcg Inhalation Capsule 1XX with chronic obstructive Maximum dose is 300 pulmonary disease microgram once-daily. (COPD). Maintenance bronchodilator Once-daily inhalation of the treatment of airflow content of one 150/300 Indacaterol Maleate 300 R03AC18253C990 obstruction in adult patients 776. A* microgram capsule. mcg Inhalation Capsule 2XX with chronic obstructive Maximum dose is 300 pulmonary disease microgram once-daily. (COPD). As a once-daily Indacaterol maleate and maintenance bronchodilator glycopyrronium bromide R03AL04989C1101 treatment to relieve 777. (fixed dose combination) A* One capsule inhalation daily. XX symptoms in adult patients 110/50mcg, inhalation with chronic obstructive powder hard capsules pulmonary disease (COPD). i) Post-exposure ADULT: 800 mg every 8 prophylaxis (PEP) among hours. CHILD healthcare workers in high- (investigational): 500 mg/m2 risk HIV occupational every 8 hours (patients with exposure Indinavir Sulfate 400 mg J05AE02183C1001 smaller body surface area 778. A* ii) For therapy as part of Capsule XX (BSA) may require lower combination antiretroviral doses of 300 - 400 mg/m2 treatment on adult HIV every 8 hours). Dosage may patients ie Highly Active varies depending on types of Anti-Retroviral Therapy combination therapy used. (HAART) Adult: As supp: 100 mg to be Indomethacin 100 mg M02AA23000S200 Pain and inflammation in inserted at night and 779. B Suppository 1XX rheumatic arthritis repeated in the morning if necessary. 50 - 200 mg daily in divided Indomethacin 25 mg M01AB01000C100 Pain and inflammation in 780. B doses, with food. Child not Capsule 1XX rheumatic disease recommended.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Rheumatoid arthritis: ADULT over 18 years old: 3 i) Rheumatoid arthritis mg/kg at 0, 2, 6 weeks, then (moderate to severe), in every 8 weeks; May increase combination with to 10 mg/kg or increase methotrexate dosing frequency to 4 weekly ii) Ankylosing spondylitis in for patients with incomplete patients with active disease response. Discontinue if no despite treatment with response by 12 weeks of methotrexate initial infusion or after dose iii) Crohn's Disease in adjustment patients who have an ii) Ankylosing spondylitis: Infliximab 100 mg L04AB02000P4001 781. A* inadequate response to ADULT over 18 years: 5 Injection XX conventional therapies. mg/kg IV over 2 hour given iv) Fistulizing Crohn's at week 0, 2, and 6 then Disease in patients who every 6-8 weeks. have an inadequate Discontinue if no response response to conventional by 6 weeks of initial infusion. therapies iii), iv) & v)5 mg/kg given as v) Ulcerative Colitis in an intravenous infusion over patients who have an a 2-hour period followed by inadequate response to additional 5 mg/kg infusion conventional therapies doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter Influenza Vaccine (Inactivated, trivalent) CHILD 6-35 months: Single Prophylaxis of influenza for Injection (containing 3 dose of 0.5 ml IM or deep frontliners (KKM staff and strains, two type A J07BB02963P3001 SC; 3-8 years: 1-2 doses of 782. B essential services subtypes, of which one XX 0.5 ml IM ADULT & CHILD personnel) and in high risk must include pandemic A more than 9 years: Single groups (H1N1) and one Type B dose of 0.5 ml IM subtype) Prevention of influenza and influenza related Influenzae Vaccine complications in high risk 19 to 59 years: Single dose (Inactivated,Trivalent) adult patients, in particular of 0.1ml 9mcg/strain Type A (H1N1) 15 mcg, J07BB02963P5002 individuals who have 783. B intradermally. ≥ 60 years: Type A (H3N2) 15 mcg & XX chronic cardiovascular, Single dose of 0.1ml Type B 15 mcg pulmonary, metabolic or 15mcg/strain intradermally Haemagglutinin Injection renal disease, or who are immunocompromized and elderly patients Prevention of influenza and Influenzae Vaccine influenza related 18 to 59 years: Single dose (Inactivated,Trivalent) complications in high risk of 0.1ml 9mcg/strain Type A (H1N1) 9 mcg, J07BB02963P5001 adult patients, in particular 784. B intradermally. ≥ 60 years: Type A (H3N2) 9 mcg & XX individuals who have Single dose of 0.1ml Type B 9 mcg chronic cardiovascular, 15mcg/strain intradermally Haemagglutinin Injection pulmonary, metabolic or renal disease, or who are

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber immunocompromized and elderly patients 25% Insulin Lispro & 75% Patients with Type 2 Dose to be individualized. Insulin Lispro Protamine A10AD04000P500 diabetes whom experience The average daily insulin 785. 100 U/ml Suspension for A* 1XX hypoglycemia with the use requirement is between 0.5 Injection in Prefilled of human premixed insulin. to 1.0 units/kg body weight Syringe/Cartridge 50% Insulin Lispro & 50% Patients with Type 2 Dose to be individualized. Insulin Lispro Protamine A10AD04000P500 diabetes whom experience The average daily insulin 786. 100U/ml Suspension for A* 2XX hypoglycemia with the use requirement is between 0.5 Injection in Prefilled of human premixed insulin. to 1.0 units/kg body weight. Syringe/Cartridge Diabetic Type 1 and 2 in Dose to be individualised. Insulin Aspart 100 IU/ml A10AB05000P3001 patients that still The average daily insulin 787. A* Injection XX experienced hypoglycaemia requirement is between 0.5 with use of human insulin to 1.0 units/kg body weight Insulin Aspart 30% and Diabetic type 1 and 2 in Dose to be individualised. Protaminated Insulin A10AD05000P300 patients that still The average daily insulin 788. A/KK Aspart 70% 100 U/ml 1XX experienced hypoglycaemia requirement is between 0.5 Injection with use of human insulin to 1.0 units/kg body weight i)Type 1 Diabetes patients on basal bolus regimen, whom experience Individualized dose given via hypoglycemia with SC once or twice daily. conventional insulin, to be Initiate at a dose of 10IU or used in combination with Insulin Detemir 100 IU/ml 0.1-0.2IU/kg. For twice daily A10AE05000P5001 rapid or short-acting insulin. 789. Injection in Prefilled A/KK dosing, the evening dose can XX ii)Type 2 Diabetes patients syringe/cartridge be administered either with on oral anti-diabetics and the evening meal, at basal insulin regimen or bedtime, or 12 hours after basal bolus insulin regimen the morning dose. whom experience hypoglycemia with conventional basal insulin. ADULT and CHILD over 6 i) Diabetes mellitus type I in years: individualised dose Insulin Glargine adults and child over 6 given by SC, once daily at A10AE04000P5001 790. 300IU/3ml Prefilled Pen A/KK years the same time every day. XX for Injection ii) Diabetes mellitus type II Adult patients who are insulin in adult naïve may be initiated with 10IU daily. Glulisine should be given shortly (0-15 min) before or Treatment of adults, soon after meals. Apidra Insulin Glulisine 100u/ml adolescents and children 6 should be used in regimens A10AB06000P5001 791. solution for injection in A* years or older with diabetes that include an intermediate XX pre-filled pen 3ml mellitus, where treatment or long acting insulin or basal with insulin is required. insulin analogue and can be used with oral hypoglycaemic agents. The

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber dosage of Apidra should be individually adjusted. i) As initial therapy in children with Type 1 diabetes ii)Type 1 diabetes patients on basal bolus regimen, not controlled or experience hypoglycaemia with conventional insulin, to be used in combination with long-acting insulin Dose to be individualized. iii)Type 2 diabetes patients The average daily insulin Insulin Lispro 100 IU/ml A10AB04000P5001 on basal bolus or premixed requirement is between 0.5 792. Injection in Prefilled A* XX regimen, not controlled or to 1.0 units/kg body weight, syringe/cartridge experience hypoglycaemia given within 15 minutes with conventional insulin, to before meal. be used in combination with intermediate-acting insulin or long-acting insulin iv)Patients with diabetes in pregnancy with poor postprandial control or experience hypoglycaemia with conventional short- acting insulin Dose to be individualised. The average daily insulin requirement is between 0.3- Insulin Recombinant 1.0 units/kg body weight/day. Neutral Human Short A10AB01000P3001 Daily insulin requirement 793. B Diabetes mellitus Acting 100 IU/ml Injection XX may be higher in patients in 10ml vial with insulin resistance, and lower in patients with residual, endogenous insulin production. Dose to be individualised. The average daily insulin requirement is between 0.3- Insulin Recombinant 1.0 units/kg body weight/day. Neutral Human Short- A10AB01000P5001 Daily insulin requirement 794. B Diabetes mellitus acting 100IU/ml Penfill XX may be higher in patients and Refill with insulin resistance, and lower in patients with residual, endogenous insulin production. Insulin Recombinant Dose to be individualised. Synthetic Human A10AC01000P300 The daily insulin requirement 795. Intermediate-Acting B Diabetes mellitus 1XX is usually between 0.3 and 100IU/ml in Vial for 1.0IU/kg /day Injection

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Dose to be individualised. The average daily insulin requirement is between 0.3- Insulin Recombinant 1.0 units/kg body weight/day. Synthetic Human A10AD01000P300 Daily insulin requirement 796. B Diabetes mellitus Premixed 100IU/ml in Vial 1XX may be higher in patients for Injection with insulin resistance, and lower in patients with residual, endogenous insulin production. Insulin dependent diabetes mellitus, non insulin dependent diabetes unresponsive to treatment Insulin Recombinant to diet or oral Dose to be individualised. Synthetic Human, A10AC01000P500 hypoglycaemics, The daily insulin requirement 797. B Intermediate-Acting 100 1XX hyperkalaemia to assure is usually between 0.3 and IU/ml Penfill and Refill proper utilisation of glucose 1.0IU/kg /day and reduce glucosuria in non diabetic patients receiving parenteral nutrition Insulin dependent diabetes mellitus, non insulin dependent diabetes unresponsive to treatment Insulin Recombinant to diet or oral Dose to be individualised. Synthetic Human, A10AD01000P500 hypoglycaemics, The average daily insulin 798. B Premixed 100 IU/ml 1XX hyperkalaemia to assure requirement is between 0.5- Penfill and Refill proper utilisation of glucose 1.0 units/kg body weight and reduce glucosuria in non diabetic patients receiving parenteral nutrition

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Initial : 3 MIU SC daily. If intolerant, 1.5 MIU daily or 3 MIU 3 times a week or 1.5 MIU 3 times a week. Maintenance : 1.5-3 MIU SC 3 times a week ii) Patient > 18 years : 3 MIU daily (days 1-3), 6 MIU daily (days 4-6), 9 MIU daily (days 7-84) iii) Patient > 18 years : For the treatment of Initially escalating dose to i) Hairy cell leukaemia 18-36 MIU SC/IM for 10-12 ii) Chronic myelogenous weeks. Maintenance: up to leukaemia 36 MIU 3 times a week Interferon Alfa - 2a 3 MIU L03AB04000P3001 iii) AIDS related Kaposi's 799. A* iv)2.5-5 MIU/m2 SC 3 times Injection XX Sarcoma a week for 4-6 months. iv) Chronic hepatitis B CHILD: up to 10 MIU/m2 v) Chronic hepatitis C vi) BSA v) Monotherapy : Initial : Advanced renal cell 3 - 6 MIU SC 3 times a week carcinoma for 6 months. Maintenance : 3 MIU 3 times a week for an additional 6 months. vi) As an adjunct to cytotoxic chemotherapy: An escalating dose of 3 MIU 3 times a week for 1 week, then 9 MIU 3 times a week for 1 week, then 18 MIU 3 times a week thereafter for 3-12 months SC i) 2 MIU SC or IM 3 times a week ii) Patient more than 18 years: 3 - 9 MIU 3 - 5 times a week or daily depending on response iii) Patient more than 18 For the treatment of years. Initially escalating i) Hairy cell leukaemia dose to 18-36 MIU SC/IM for ii) Chronic myelogenous 10-12 weeks. Maintenance: leukaemia up to 36 MIU 3 times weekly Interferon Alfa-2b 18 MIU L03AB05000P5001 iii) AIDS related Kaposi's 800. A iv) 2.5-5 MIU/m2 SC 3 times Multidose Injection Pen XX sarcoma weekly for 4-6 month. iv) Chronic hepatitis B CHILD: up to 10 MIU/m2 v) Chronic hepatitis C BSA vi) Advanced renal cell v) 3 MIU for 12 months carcinoma vi) As an adjunct to cytotoxic chemotherapy: An escalating dose of 3 million IU 3 times/week for 1 week, then 9 million IU 3 times/week for 1 week, then 18 million IU 3

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber times/week thereafter for 3- 12 month SC or IM i) 2 MIU SC or IM 3 times a week ii) Patient more than 18 years: 3 - 9 MIU 3 - 5 times a week or daily depending on response iii) Patient more than 18 For the treatment of years. Initially escalating i) Hairy cell leukaemia dose to 18-36 MIU SC/IM for ii) Chronic myelogenous 10-12 weeks. Maintenance: leukaemia up to 36 MIU 3 times weekly Interferon Alfa-2b 30 MIU L03AB05000P5002 iii) AIDS related Kaposi's iv) 2.5-5 MIU/m2 SC 3 times 801. A Multidose Injection Pen XX sarcoma weekly for 4-6 month. iv) Chronic hepatitis B CHILD: up to 10 MIU/m2 v) Chronic hepatitis C BSA vi) Advanced renal cell v) 3 MIU for 12 months carcinoma vi) As an adjunct to cytotoxic chemotherapy: An escalating dose of 3 million IU 3 times/week for 1 week, then 9 million IU 3 times/week for 1 week, then 18 million IU 3 times/week thereafter for 3- 12 month SC or IM i) 2 MIU SC or IM 3 times a week ii) Patient more than 18 years: 3 - 9 MIU 3 - 5 times a week or daily depending on response iii) Patient more than 18 For the treatment of years. Initially escalating i) Hairy cell leukaemia dose to 18-36 MIU SC/IM for ii) Chronic myelogenous 10-12 weeks. Maintenance: leukaemia up to 36 MIU 3 times weekly Interferon Alpha - 2a 4.5 L03AB04000P3002 iii) AIDS related Kaposi's iv) 2.5-5 MIU/m2 SC 3 times 802. A* MIU Injection XX Sarcoma weekly for 4-6 month. iv) Chronic hepatitis B CHILD: up to 10 MIU/m2 v) Chronic hepatitis C BSA vi) Advanced renal cell v) 3 MIU for 12 months carcinoma vi) As an adjunct to cytotoxic chemotherapy: An escalating dose of 3 million IU 3 times/week for 1 week, then 9 million IU 3 times/week for 1 week, then 18 million IU 3 times/week thereafter for 3- 12 month SC or IM

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) 2 MIU/m2 SC or IM 3 times a week ii) 4 - 5 MIU/m2 SC daily. Treatment must be discontinued after 8 to 12 weeks of treatment if at least a partial haematological remission or a clinically meaningful cytoreduction has For the treatment of not been achieved i) Hairy cell leukaemia iii) Patient > 18 years : 30 ii) Chronic myelogenous MIU/m2 SC or IM three times leukaemia a week until disease Interferon Alpha 2b 3 MIU L03AB05000P3001 iii) AIDS related Kaposi's progression or maximal 803. A* Injection XX sarcoma response has been achieved iv) Chronic hepatitis B after 16 weeks of treatment. v) Chronic hepatitis C iv) 5 MIU daily or 10 MIU vi) Advanced renal cell three times a week for 16 carcinoma weeks. CHILD : 3 MIU/m2 three times a week for the first week of therapy followed by dose escalation to 6 MIU/m2 (maximum of 10MIU) three times a week SC for a total duration of 16 to 24 weeks v) 3 MIU SC or IM 3 times a week. i) Relapsing-remitting multiple sclerosis (RRMS): Reduction of frequency and degree of severity of clinical relapses in ambulatory patients characterized by at least two attacks of neurological dysfunction over the preceding two year Interferon beta -1b L03AB08000P4001 0.25 mg (8 MIU) by SC 804. A* period, followed by 250mcg (8MIU) Injection XX injection every other day complete or incomplete recovery ii) Secondary progressive multiple sclerosis (SPMS):Reduction of frequency and severity of clinical relapses and for slowing the progression of disease Multiple sclerosis of the L03AB07000P5001 relapsing remitting type with 805. Interferon Beta-1a 22 mcg A* 22 mcg 3 times weekly XX 2 or more relapses within the last 2 years

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Multiple sclerosis of the L03AB07000P5002 relapsing remitting type with 806. Interferon Beta-1a 44 mcg A* 44 mcg 3 times weekly XX 2 or more relapses within the last 2 years V08AA03000P3001 According to the procedure 807. Iodamide Injection A For hysterosalpingography XX and route of administration i) Pre-operative treatment of Iodine and Potassium H03CA00200L9901 i) 1 ml daily in divided doses 808. B thyrotoxicosis Iodide Solution XX ii) 2 - 3 ml daily ii) Thyrotoxicosis crisis X-ray contrast medium for cardioangiography, cerebral angiography, peripheral arteriography, abdominal Iodixanol 320 mg I/ml V08AB09000P3001 Depending on type of 809. A angiography, uroloraphy, Injection XX examination venography, CT enhancement, lumbar, thoracic and cervical myelography X-ray contrast medium for use in adults and children for cardioangiography, arteriography, urography, phlebography and CT- enhancement. Lumbar, thoracic, cervical myelography and computed V08AB02000P3001 Dose depending on the route 810. Iohexol Injection A tomography of the basal XX and procedure cisterns, following subarachnoid injection. Arthrography, endoscopic retrograde pancreatography (ERCP), herniography, hysterosalpingography, sialography and studies of the gastrointestinal tract i) Neuroradiology : myeloradiculography, cisternography and ventriculography ii) Angiograph : cerebral For angiography and cardiac arteriography, thoracic cases- dose depending on aortography, abdominal the route and procedure. For aortography, V08AB04000P3001 selected vascular 811. Iopamidol Injection A angiocardiography, XX examination - bottles of 30 selective visceral ml and 100 ml; dose arteriography, peripheral depending on the route and arteriography, venography, procedure digital subtraction angiography (DSA), DSA of cerebral arteries, DSA of peripheral arteries, DSA of abdominal arteries

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber iii) Urography : intravenous urography iv) Contrast enhancement in CT Scanning, arthrography, fistulography i) For angiography, urography, aortography and Iopromide 300mg the visualization of body injection (623 mg of V08AB05000P3001 cavities ii) Contrast Dose depending on the route 812. A iopromide with 300 mg of XX enhancement during and procedure iodine per mL) computerized tomography iii) To check functioning of a dialysis shunt i) For angiography, urography, aortography and the visualization of body Iopromide 370mg cavities injection (769 mg of V08AB05000P3002 Dose depending on the route 813. A ii) Contrast enhancement iopromide with 370 mg of XX and procedure during computerized iodine per mL) tomography iii) To check functioning of a dialysis shunt Only for treatment of : i) Patients with ischaemic heart disease who develop extrasystole with salbutamol or terbutaline ADULT : 500 mcg up to 4 ii) Patients with chronic Ipratropium Bromide times daily. CHILD 5 - 12 R03BB01320A300 bronchitis who have airway 814. 0.0125% Nebulising B years : 125 - 250 mcg up to 4 1XX obstruction and who do not Solution (125 mcg/ml) times daily, 12 years : 250 - respond to salbutamol or 500 mcg up to 4 times daily terbutaline. Reversible airways obstruction, particularly in chronic obstructive pulmonary disease Only for treatment of : i) Patients with ischaemic heart disease who develop extrasystole with salbutamol or terbutaline ADULT : 500 mcg up to 4 ii) Patients with chronic Ipratropium Bromide times daily. CHILD 5 - 12 R03BB01320A300 bronchitis who have airway 815. 0.025% Nebulising B years : 125 - 250 mcg up to 4 2XX obstruction and who do not Solution (250 mcg/ml) times daily, 12 years : 250 - respond to salbutamol or 500 mcg up to 4 times daily terbutaline. Reversible airways obstruction, particularly in chronic obstructive pulmonary disease

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Acute attacks : 1 unit dose vial. In severe cases not Management of reversible relieved by 1 unit dose vial, 2 Ipratropium Bromide 0.5 R03AK04320A300 bronchospasm associated unit dose vials may require, 816. mg and Salbutamol 2.5 B 1XX with obstructive airway patient should consult a mg per UDV diseases doctor immediately. Maintenance : 1 unit dose vial 3 - 4 times daily ADULT & CHILD more than 6 years; Acute asthma 2 Management of symptoms puffs. Severe cases: if in chronic obstructive breathing has not noticeably Ipratropium Bromide 20 airway disorders with improved after 5 mins, 2 R03AK03986A210 817. mcg and Fenoterol 50 B reversible bronchospasm further puffs may be taken. 1XX mcg/dose Inhaler such as bronchial asthma Intermittent and long-term and chronic bronchitis with treatment 1-2 puffs for each or without emphysema administration, up to max 8 puffs/day (average: 1-2 puffs three times daily) ADULT and ELDERLY : 2 Management of reversible Ipratropium Bromide 20 inhalations 4 times daily. R03AK04320A100 bronchospasm associated 818. mcg and Salbutamol base B Maximum : 12 inhalations 1XX with obstructive airway 100 mcg/dose Inhalation daily. CHILD under 12 years diseases not recommended Only for treatment of : i) Patients with chronic 20 - 40 mcg 3 - 4 times daily. bronchitis who have airway In the early treatment, up to obstruction and who do not 80 mcg 3 - 4 times daily. Ipratropium Bromide 20 R03BB01320A100 respond to Salbutamol or 819. B CHILD up to 6 years : 20 mcg/dose Inhalation 1XX Terbutaline mcg 3 times daily, 6 - 12 ii) Patients with ischaemic years : 20 - 40 mcg 3 times heart disease who develop daily extrasystole with Salbutamol or Terbutaline Irbesartan 150 mg and Hypertension in patients C09DA04000T100 820. Hydrochlorothiazide 12.5 A/KK who cannot tolerate ACE 1 tablet daily 3XX mg Tablet inhibitors because of cough Hypertension, diabetic nephropathy (in patients C09CA04000T100 821. Irbesartan 150 mg Tablet A/KK who cannot tolerate ACE 150 mg to 300 mg daily 1XX inhibitors because of cough) Irbesartan 300 mg & Hypertension in patients C09DA04000T100 822. Hydrochlorothiazide 12.5 A/KK who cannot tolerate ACE 1 tablet daily 1XX mg Tablet inhibitors because of cough Hypertension, diabetic nephropathy (in patients C09CA04000T100 823. Irbesartan 300 mg Tablet A/KK who cannot tolerate ACE 150 mg to 300 mg daily 2XX inhibitors because of cough)

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Only for patients with colorectal cancer who: In combination therapy (for i) have relapsed within 6 previously untreated months after the end of patients): 180 mg/m2 once adjuvant chemotherapy with every 2 weeks as an IV 5-fluorouracil-based regime infusion over 90 mins ii) have progressive disease followed by infusion with Irinotecan HCl Trihydrate L01XX19110P3002 despite 5-fluorouracil 824. A* folinic acid and 5-fluorouracil. 20 mg/ml Injection XX chemotherapy for advanced In monotherapy (for disease previously treated patients): iii) good performance status 350 mg/m2 administered as (WHO of 2 or less) The an intravenous infusion over treatment must be given in 90 minutes period once a tertiary oncology centre or every 3 weeks have clearance in writing by an oncologist Only for patients with colorectal cancer who: In combination therapy (for i) have relapsed within 6 previously untreated months after the end of patients): 180 mg/m2 once adjuvant chemotherapy with every 2 weeks as an IV 5-fluorouracil-based regime infusion over 90 mins ii) have progressive disease followed by infusion with Irinotecan HCl Trihydrate L01XX19110P3001 despite 5-fluorouracil 825. A* folinic acid and 5-fluorouracil. 40 mg/2 ml Injection XX chemotherapy for advanced In monotherapy (for disease previously treated patients): iii) good performance status 350 mg/m2 administered as (WHO of 2 or less) The an intravenous infusion over treatment must be given in 90 minutes period once a tertiary oncology centre or every 3 weeks have clearance in writing by an oncologist Treatment of iron deficiency Individualised dosage. anaemia: ADULT and ELDERLY: a) where there is a clinical Cumulative dose is to be need for rapid iron supply; administered in single doses Iron (III) hydroxide b) in patients who cannot of 100 - 200 mg of iron 2 - 3 B03AC02250P300 826. sucrose complex 20mg/ml B tolerate oral iron therapy or times weekly depending on 1XX solution for injection who are non-compliant; Hb level. By IV drip infusion, c) in active inflammatory slow IV injection or directly bowel disease where oral into the venous limb of the iron preparations are dialyser. Total cumulative ineffective. dose: 1000 mg

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Dosage and duration of therapy are dependent upon the extent of iron deficiency. Manifest iron deficiency: 1 chewable tablet two to three times daily until a Treatment of latent and Iron (III)-hydroxide normalization of the manifest iron deficiency and polymaltose complex hemoglobin value is B03AD04250T2001 prevention of iron and folic 827. (IPC) 100mg iron and A/KK achieved. Afterwards the XX acid deficiency before, 0.35mg folic acid therapy should be continued during after pregnancy chewable tablet with 1 chewable tablet daily (during lactation) at least until the end of pregnancy to replenish the iron stores. Latent iron deficiency and prevention of iron and folic acid deficiency: 1 chewable tablet daily An initial test dose of 0.5 ml should be given over the desired route. For severe Iron Dextran 50 mg Fe/ml B03AC06000P300 Severe iron deficiency 828. B iron deficiency anaemia, 1-2 Injection 1XX anaemia ml daily given by deep IM. Dosage is individualized according to total iron deficit i) Induction- Initiate at a concentration of 0.5 % i) Induction and ii) Maintenance- 1 - 2.5 % in N01AB06000L5001 829. Isoflurane Liquid B ii) Maintenance of oxygen or nitrous oxide XX anaesthesia mixture. 0.5 - 0.75 % with oxygen and nitrous oxide for Caesarian section i) & ii) ADULT 5-8mg/kg daily J04AC01000T1001 i) Tuberculosis 830. Isoniazid 100 mg Tablet B (Max 300mg) or 15-20mg/kg XX ii)Tuberculous meningitis biweekly (max 1200mg) i) & ii) ADULT 5-8mg/kg daily J04AC01000T1002 i) Tuberculosis 831. Isoniazid 400 mg Tablet B (Max 300mg) or 15-20mg/kg XX ii)Tuberculous meningitis biweekly (max 1200mg) If given as IM: Initially 0.2 mg (1 ml of 1:5000 solution), followed by 0.02-1 mg depending on clinical response. If given as SC: 0.2 Complete heart block (third- mg (1 ml of 1:5000 solution), degree artrioventricular Isoprenaline HCl 0.2 C01CA02110P300 followed by 0.15-0.2 mg 832. B block) not responding to mg/ml Injection 1XX depending on clinical atropine, while waiting for response. If given as IV : 1-2 cardiac pacing mg in 500 ml of dextrose 5%, infused at a rate of 0.5-2 ml/min while the patient's EKG is being monitored. The dose should be titrated to

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber produce the desired clinical response If given as IM: Initially 0.2 mg (1 ml of 1:5000 solution), followed by 0.02-1 mg depending on clinical response. If given as SC: 0.2 mg (1 ml of 1:5000 solution), Complete heart block (third- followed by 0.15-0.2 mg degree artrioventricular Isoprenaline HCl 1 mg/5 C01CA02110P300 depending on clinical 833. B block) not responding to ml Injection 2XX response. If given as IV : 1-2 atropine, while waiting for mg in 500 ml of dextrose 5%, cardiac pacing infused at a rate of 0.5-2 ml/min while the patient's EKG is being monitored. The dose should be titrated to produce the desired clinical response 2-10 mg/hour IV infusion Treatment for angina Isosorbide Dinitrate 1 C01DA08221P300 after dilution, higher doses 834. A pectoris and left ventricular mg/ml Injection 1XX up to 20 mg/hour may be failure required Prophylaxis and treatment i) 30 - 120 mg daily in divided Isosorbide Dinitrate 10 mg C01DA08221T100 for: doses 835. B Tablet 1XX i) Angina ii) 40 - 160 mg, up to 240 mg ii) Left ventricular failure if required Isosorbide Mononitrate 50 C01DA14221C200 Prophylaxis and treatment 836. A 50 mg daily mg SR Capsule 1XX of angina pectoris Initiate at 30 mg for 1st 2-4 days to avoid headache. Isosorbide-5-Mononitrate C01DA14221T500 Prophylaxis and treatment 837. A Usual dose: 60 mg once 30 mg SR Tablet 1XX of angina pectoris daily, may be increased to 120 mg once daily Isosorbide-5-Mononitrate C01DA14221T500 Prophylaxis and treatment 60mg once daily, increase to 838. A 60 mg SR Tablet 2XX of angina pectoris 120 mg daily 0.5-1 mg/kg of body weight per day (in two divided doses) for 15 to 20 weeks; the maximum recommended dose is 2mg/kg of body Only for treatment of weight per day. After about 4 i) Severe nodulo-cystic weeks, therefore, dosage for acne Isotretinoin 10 mg D10BA01000C100 the maintenance treatment 839. A* ii) Acne conglobata Capsule 1XX should be adjusted within the iii) Acne fulminans iv) range 0f 0.1-1mg/kg daily to Severe acne vulgaris failing meet individual need. conventional treatment. Treatment usually lasts a total of 16 weeks. There should be an interval of at least 8 weeks before re- starting treatment.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber 0.5-1 mg/kg of body weight per day (in two divided doses) for 15 to 20 weeks; the maximum recommended Only for treatment of i) dose is 2mg/kg of body Severe nodulo-cystic acne weight per day. After about 4 ii) Acne conglobata iii) Acne weeks, therefore, dosage for Isotretinoin 20 mg D10BA01000C100 fulminans iv) Severe acne the maintenance treatment 840. A* Capsule 2XX vulgaris failing conventional should be adjusted within the treatment range 0f 0.1-1mg/kg daily to WARNING: THIS DRUG IS meet individual need. TERATOGENIC Treatment usually lasts a total of 16 weeks. There should be an interval of at least 8 weeks before re- starting treatment. Treatment of gastrointestinal symptoms of functional, non-ulcer dyspepsia (chronic gastritis) A03FA00110T1001 i.e sensation of bloating, 50 mg 3 times daily before 841. Itopride HCl 50 mg Tablet A* XX early satiety, upper meal abdominal pain or discomfort, anorexia, heartburn, nausea and vomiting i) 200 mg daily for 1 week. If no response after 1 week, continue treatment for another week Treatment of: i) oral and/or ii) 100 - 200 mg twice daily oesophageal candidiasis Itraconazole 10 mg/ml J02AC02000L9901 for 2 weeks. If no response 842. A* ii) fluconazole resistant Oral Solution XX after 2 weeks, continue and/or oesophageal treatment for another 2 candidiasis weeks. The 400 mg daily dose should not be used for more than 14 days if there are no signs of improvement i) 200 mg once daily for 7 i) Dermatomycosis days including pityriasis ii) 100 mg daily for 15 days versicolor iii) 200 mg twice daily for 7 ii) Oral candidiasis days Itraconazole 100 mg J02AC02000C1001 iii) Palmar tinea manus and iv) 200mg twice daily for 1 843. A/KK Capsule XX plantar tinea pedis week per month for 2 months iv) Fingernail v) 200 mg twice daily for 1 onychomycosis week per month for 3 months v) Toenail onychomycosis vi)200 mg morning and vi) Vulvovaginal candidiasis evening for 1 day or 200 mg once daily for 3 days

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Symptomatic treatment of chronic stable angina pectoris in patients with normal sinus rhythm, who have a contraindication or intolerance to beta blockers ii) Treatment of coronary artery disease. Symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm. Ivabradine is indicated : - in Initial dose 5 mg twice daily. patients unable to tolerate May increase dose after 3-4 or with a contraindication to weeks to 7.5 mg twice daily C01EB17110T1001 the use of beta-blockers - or depending on response. 844. Ivabradine 5 mg Tablet A* XX in combination with beta- ELDERLY, initial dose 2.5 blockers in patients mg twice daily and titrate to a inadequately controlled with maximum of 7.5 mg twice an optimal beta-blocker daily dose and whose heart rate is > 60 bpm. Treatment of chronic heart failure. Ivabradine is indicated in chronic heart failure NYHA II to IV class with sinus rhythm and whose heart rate is ≥75bpm, in combination with standard beta-blocker therapy or when beta- blocker therapy is contraindicated or not tolerated.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Symptomatic treatment of chronic stable angina pectoris in patients with normal sinus rhythm, who have a contraindication or intolerance to beta blockers ii) Treatment of coronary artery disease. Symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm. Ivabradine is indicated : - in Initial dose 5 mg twice daily. patients unable to tolerate May increase dose after 3-4 or with a contraindication to weeks to 7.5 mg twice daily C01EB17110T1002 the use of beta-blockers - or depending on response. 845. Ivabradine 7.5 mg Tablet A* XX in combination with beta- ELDERLY, initial dose 2.5 blockers in patients mg twice daily and titrate to a inadequately controlled with maximum of 7.5 mg twice an optimal beta-blocker daily dose and whose heart rate is > 60 bpm. Treatment of chronic heart failure. Ivabradine is indicated in chronic heart failure NYHA II to IV class with sinus rhythm and whose heart rate is ≥75bpm, in combination with standard beta-blocker therapy or when beta- blocker therapy is contraindicated or not tolerated. i) ADULT: 1 - 2 g daily IM in i) Treatment of gonorrhoea 1 - 2 equally divided doses. and neonatal meningitis CHILD: 30 - 50 mg/kg/day in ii) Treatment of TB patients J01GB04183P4001 1 - 2 divided doses 846. Kanamycin 1 g Injection A* who require reserved XX ii) ADULT: 2 g daily IM in 2 second line drugs but have equally divided doses twice a no pre-existing renal week or 1 g once daily 3 complications days a week IV Initially, 1-4.5 mg/kg IV, a Sole anaesthetic for short dose of 2 mg/kg produces procedures or induction of Ketamine 10 mg/ml N01AX03110P300 anesth for 5-10 mins. IM 847. B anaesthesia in certain types Injection 1XX Initially, 6.5-13 mg/kg IM, a of patients (e.g in shock dose of 10 mg/kg produces states) anesth for 12-25 mins. IV Initially, 1-4.5 mg/kg IV, a Sole anaesthetic for short Ketamine 50 mg/ml N01AX03110P300 dose of 2 mg/kg produces 848. B procedures or induction of Injection 2XX anesthesia for 5-10 mins. IM anaesthesia in certain types Initially, 6.5-13 mg/kg IM, a

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber of patients (e.g in shock dose of 10 mg/kg produces states) anesthesia for 12-25 mins.

Apply twice weekly for 2 - 4 Ketoconazole 2% D01AC08000L5201 849. A/KK Resistant dandruff only weeks. Prophylaxis: Once Shampoo XX every 1 - 2 weeks i) 200 mg with meal once i) Pityriasis versicolor daily for 10 days Ketoconazole 200 mg J02AB02000T1001 ii) Systemic mycosis (other ii) 200 - 400 mg daily for 4 850. A/KK Tablet XX skin mycoses) weeks - 6 months iii) Nail infections iii) 200 - 400 mg daily for 6 - 12 months. As a short term treatment M02AA10000G300 for traumatic lesions, Apply onto affected areas 2- 851. Ketoprofen 2.5% Gel A 1XX sprains, tendinitis, oedema, 4 times daily up to 10 days. bruises 200mg in the morning or Ketoprofen 200 mg Slow M01AE03000C200 Pain and inflammation in evening. Should be taken 852. A/KK Release Capsule 2XX rheumatic disease with food: Take immediately after meals. Treatment of signs & symptoms of arthritis deformans, periarthritis humero-scapularis, Ketoprofen 30 mg M02AA10000M700 Apply 1 plaster to the 853. A tendinitis, peritendinitis, Transdermal Plaster 1XX affected area twice daily sore muscle, swelling, pain resulting from trauma (eg. contusion, distorsion, sprain). By deep IM into gluteal To be used only in muscle, 50-100 mg every 4 Ketoprofen 50 mg/ml M01AE03000P300 854. A* treatment of acute hours. Maximum 200 mg in Injection 1XX inflammatory conditions 24 hours for up to 3 days. Child not recommended Prophylaxis and reduction of i) Ocular itching due to inflammation and associated allergic conjunctivitis symptoms following ocular Ketorolac Tromethamine S01BC05239D200 ii) Prophylaxis and 855. A surgery: 1 drop 3 times daily 0.5% Eye drops 1XX reduction of inflammation starting 24 hours pre- and associated symptoms operatively and continuing up following ocular surgery to 3 weeks post-operatively. ADULT : 60mg as a single dose via IM inj or 30mg as a Short term management of Ketorolac Tromethamine M01AB15239P300 single IV dose. Alternatively, 856. A* moderate to severe 30 mg/ml Injection 1XX 30mg every 6 hr via IM or IV postoperative pain admin up to a max of 120mg daily.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber ADULT: 100 mg (50 mg in elderly) daily with food, increased at intervals of 14 Labetalol HCl 100 mg C07AG01110T100 Hypertension (including in days to usual dose of 200 857. B Tablet 1XX pregnancy) mg twice daily, up to 800 mg twice daily (3 - 4 divided doses if higher dose). Max: 2.4 g daily ADULT: 100 mg (50 mg in elderly) daily with food, increased at intervals of 14 Labetalol HCl 200 mg C07AG01110T100 Hypertension (including in days to usual dose of 200 858. B Tablet 2XX pregnancy) mg twice daily, up to 800 mg twice daily (3 - 4 divided doses if higher dose). Max: 2.4 g daily ADULT: 20mg injected slowly for at least 2 min, followed by 40-80mg dose Labetalol HCl 5 mg/ml C07AG01110P300 859. B Hypertension crisis every 10 min, if necessary Injection 1XX upto 300 mg. Patient should remain supine during and 3 hr after the procedure. Atrophic vaginitis : 1 vaginal tablet daily for 6-12 days followed by a maintenance dose of 1 vaginal tablet for 1- 2 days per week Restoration i) Atrophic vaginitis due to therapy: 1-2 vaginal tablet estrogen deficiency during daily for 6-12 days menopause and post- Administration The vaginal menopause, or as co- tablets should be inserted medication to systemic Lactobacillus acidophilus deeply into the vagina in the hormone replacement 100 million viable cells G03CC06953T100 evenings before bedtime. 860. A/KK therapy and estriol 0.03mg vaginal 1XX In cases of a very dry vagina, ii) Restoration of the tablet vaginal tablet can be Lactobacillus flora after moistened with 1 or 2 drops local and/or systemic of water before insertion into treatment with anti-infective the vagina. agents or chemotherapeutic During menstruation, agents treatment should be interrupted and resumed afterwards Should not use vaginal douches or rinses during treatment i) ADULT 15 ml twice daily adjusted to patient's need. Lactulose 3.35 g/5 ml A06AD11000L5001 i) Constipation CHILD 0.5 ml/kg/dose once 861. C+ Liquid XX ii) Hepatic encephalopathy or twice daily ii) 30-50 ml 3-4 times daily, dose adjusted to produce 2-3

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber soft stools daily. CHILD 1 ml/kg/dose 3-4 times daily ADULT: 150 mg twice daily or 300 mg once daily. HIV infection in combination Lamivudine 10 mg/ml Oral J05AF05000L9901 INFANT under 1 month: 2 862. A* with other antiretroviral Solution XX mg/kg twice daily. CHILD 3 agents month or over: 4 mg/kg twice daily. Maximum 300 mg daily Adult: 100 mg once daily. For Management of chronic patients with hepatitis B infection concomitant HIV infection: Lamivudine 100 mg J05AF05000T1001 associated with evidence of 863. A* 300 mg once daily or in 2 Tablet XX hepatitis B viral replication divided doses. Child: >2 yr: 3 and active liver mg/kg once daily. Max: 100 inflammation mg/day. ADULT: 150 mg twice daily or 300 mg once daily. HIV infection in combination Lamivudine 150 mg J05AF05000T1002 INFANT under 1 month: 2 864. A/KK with other antiretroviral Tablet XX mg/kg twice daily. CHILD 3 agents month or over: 4 mg/kg twice daily. Maximum 300 mg daily i) Adjunctive or monotherapy for partial seizures and generalised tonic-clonic seizures not satisfactorily controlled with i) Up to 200 mg daily in Lamotrigine 100 mg N03AX09000T1002 other antiepileptic drugs 865. A single or divided dosage Tablet XX ii) Prevention of mood ii) 25- 200 mg daily episodes in adult 18 years and above with bipolar disorder, predominately by preventing depressive episodes Lamotrigine 25 mg N03AX09000T2001 Add-on therapy in 25 mg daily - 50 mg twice 866. Dispersible/Chewable A XX intractable partial seizures daily Tablet a) Add-on therapy in patients not taking Valproate: week 1 and 2: 2 mg/kg/day twice daily, week 3 and 4: 5 mg/kg/day twice daily. Maintenance: 5 - 15 Lamotrigine 5 mg mg/kg/day twice daily b) N03AX09000T2002 Management of seizures in 867. Dispersible/Chewable A Add-on therapy in patients XX children aged 2 - 12 years Tablet taking Valproate or other anti-epileptic drugs, week 1 and 2: 0.2 mg/kg/day as a single dose (children less than 25 kg may take 5 mg on alternate days), week 3 and 4: 0.5 mg/kg/day as a single

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber dose. Maintenance dose: 1 - 5 mg/kg/day once daily or twice daily i) Adjunctive or monotherapy for partial seizures and generalised tonic-clonic seizures not satisfactorily controlled with i) Up to 200 mg daily in N03AX09000T1001 other antiepileptic drugs 868. Lamotrigine 50 mg Tablet A single or divided dosage XX ii) Prevention of mood ii) 25- 200 mg daily episodes in adult 18 years and above with bipolar disorder, predominately by preventing depressive episodes i) 30mg daily in the morning for up to 4 weeks (duodenal ulcer) or up to 8 weeks (gastric ulcer). Maintenance: 15mg/day. ii) 30mg OD in the morning for up to 8 weeks if not i) Peptic ulcer disease healed. Maintenance: 15mg ii) Reflux oesophagitis OD. iii) Zollinger-Ellison Lansoprazole 30 mg A02BC03000T1001 iii) Initially 60mg OM & adjust 869. A* Syndrome Tablet XX as required. Daily doses iv) For eradication of >120mg should be given in 2 Helicobacter pylori in divided doses. combination with antibiotic iv) 30 mg twice daily in combination with any of the 2 antibiotics (clarithromycin 500 mg twice daily , amoxicillin 1 g twice daily or metronidazole 400 mg twice daily) for 1-2 weeks Phosphate binding agent Initial: 750 to 1500 mg/day in for the treatment of divided doses with meals, hyperphosphataemia in then titrate in increments of Lanthanum Carbonate V03AE03130T2004 dialysis patients with 870. A* 750 mg/day at intervals of 2 1000mg Chewable Tablet XX sustained hypercalcaemia to 3 weeks. Maintenance: of more than three months 1500-3000 mg/day in divided and secondary doses. Max: 3750 g/day hyperparathyroidism Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I 0.58 mg/kg of body weight Laronidase 2.9 mg/5ml A16AB05000P3001 871. A* (MPS I) and for patients administered once-weekly as Injection XX with the Scheie form who an intravenous infusion have moderate to severe symptoms

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) 5,000 iu/m2 for 10 days during induction, 10,000 iu/m2 also used with high i) Acute lymphoblastic dose methotrexate rescue in L-Asparaginase 10,000 IU L01XX02000P3001 872. A* leukemia consolidation phase of acute Injection XX ii) Non-hodgkin's lymphoma lymphoblastic leukemia ii) CHILD: 5,000 - 25,000 iu/m2 per dose depending on protocol For reduction of Intraocular Pressure (IOP) in patients Latanoprost 0.005% and with Open-angle Glaucoma S01ED51990D200 1 drop in the affected eye(s) 873. timolol maleate 0.5% eye A* (OAG) and Ocular 4XX once daily drops Hypertension (OH) who are insufficiently responsive to topical beta-blocker. The recommended dosage is one drop (1.5 µg) in the Reduction of elevated affected eye(s) once daily in Latanoprost 0.005% Eye S01EE01000D200 intraocular pressure in the evening. If more than one 874. A* Drops 1XX patients with open-angle topical ophthalmic drug is glaucoma being used, the drugs should be administered at least five (5) minutes apart Loading dose: 100 mg once i) Persistent active L04AA13000T1001 daily for 3 days. 875. Leflunomide 10 mg Tablet A* rheumatoid arthritis XX Maintenance: 10-20 mg once ii) Active psoriatic arthritis daily Loading dose: 100 mg once i) Persistent active L04AA13000T1002 daily for 3 days. 876. Leflunomide 20 mg Tablet A* rheumatoid arthritis XX Maintenance: 10-20 mg once ii) Active psoriatic arthritis daily. Recommended starting dose: 25 mg once daily on days 1 to 21 of repeated 28 In combination with day cycle with dexamethesone is indicated dexamethasone 40 mg once Lenalidomide 10 mg L04AX04000C1002 for the treatment of multiple daily on days 1 to 4, 9 to 12 877. A* Capsule XX myeloma patients who have and 17 to 20 of each 28 day received at least one prior cycle for the first 4 cycles of therapy therapy, thereafter dexamethasone 40 mg once daily on day 1 to 4 every 28 day cycle Recommended starting In combination with dose: 25 mg once daily on dexamethesone is indicated days 1 to 21 of repeated 28 Lenalidomide 15 mg L04AX04000C1003 for the treatment of multiple day cycle with 878. A* Capsule XX myeloma patients who have dexamethasone 40 mg once received at least one prior daily on days 1 to 4, 9 to 12 therapy and 17 to 20 of each 28 day cycle for the first 4 cycles of

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber therapy, thereafter dexamethasone 40 mg once daily on day 1 to 4 every 28 day cycle Recommended starting dose: 25 mg once daily on days 1 to 21 of repeated 28 In combination with day cycle with dexamethesone is indicated dexamethasone 40 mg once Lenalidomide 25 mg L04AX04000C1004 for the treatment of multiple daily on days 1 to 4, 9 to 12 879. A* Capsule XX myeloma patients who have and 17 to 20 of each 28 day received at least one prior cycle for the first 4 cycles of therapy therapy, thereafter dexamethasone 40 mg once daily on day 1 to 4 every 28 day cycle Recommended starting dose: 25 mg once daily on days 1 to 21 of repeated 28 In combination with day cycle with dexamethesone is indicated dexamethasone 40 mg once Lenalidomide 5 mg L04AX04000C1001 for the treatment of multiple daily on days 1 to 4, 9 to 12 880. A* Capsule XX myeloma patients who have and 17 to 20 of each 28 day received at least one prior cycle for the first 4 cycles of therapy therapy, thereafter dexamethasone 40 mg once daily on day 1 to 4 every 28 day cycle i) Treatment of hormone responsive metastatic or locally advance breast cancer after failure of tamoxifen ii) Adjunct for node positive postmenopausal women L02BG04000T1001 881. Letrozole 2.5 mg Tablet A* with early breast cancer 2.5 mg once daily XX (positive or unknown oestrogen or positive progesterone receptor status / receptor status) who have received 5 years of adjuvant tamoxifen therapy Leucovorin Calcium V03AF03390T1001 Treatment of folic acid 15 mg every 6 hours for the 882. (Calcium Folinate) 15 mg A XX antagonist overdose next 48 - 72 hours Tablet

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) 200mg/m2 by slow IV injection over a minimum 3 minutes, followed by 5- Fluorouracil or 20mg/m2 IV i) Biochemical modulator for followed by 5-Fluorouracil. In 5-Fluorouracil in the both cases, treatment is treatment of colorectal repeated daily for 5 days; Leucovorin Calcium cancer V03AF03237P3001 may repeat at 4-week 883. (Calcium Folinate) 3 mg A ii) As rescue for high dose XX intervals for 2 courses then Injection methotrexate 4- to 5-week intervals iii) Megaloblastic anaemias ii) 15 mg (approximately due to deficiency of folic 10mg/m2) every 6 hours for acid 10 doses, starting 24 hours after the beginning of the methotrexate infusion iii) Up to 1 mg daily i) 200mg/m2 by slow IV injection over a minimum 3 minutes, followed by 5- Fluorouracil or 20mg/m2 IV followed by 5-Fluorouracil. In both cases, treatment is repeated daily for 5 days; i) Biochemical modulator for may repeat at 4-week 5-Fluorouracil in the intervals for 2 courses then treatment of colorectal Leucovorin Calcium 4- to 5-week intervals V03AF03237P3002 cancer 884. (Calcium Folinate) 50 mg A ii) 15 mg (approximately XX ii) As rescue for high dose Injection 10mg/m2) every 6 hours for methotrexate 10 doses, starting 24 hours iii) Gestational trophoblastic after the beginning of the disease methotrexate infusion iii) 6 - 12 mg exactly 30 hours after each dose of methotrexate. In EMA-CO regime for high risk gestational trophoblastic disease, use 30 mg IM i) Endometriosis Leuprolide Acetate 11.25 L02AE02122P5002 885. A* ii) Hormonal therapy in 11.25 mg every 3 months mg Injection XX advanced prostate cancer i) 3.75 mg monthly for 3 - 6 i) Endometriosis Leuprolide Acetate 3.75 L02AE02122P5001 months 886. A* ii) Hormonal therapy in mg Injection XX ii) 3.75 mg IM or SC injection advanced prostate cancer monthly

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) ADULTS and ADOLESCENT (from 16 years): Starting dose: 250 mg twice daily, Increase dose to 500 mg twice daily i) Monotherapy therapy in after 2 week. Dose can be the treatment of partial further increased by 250 mg onset seizures with or twice daily every 2 weeks without secondary depending upon the clinical generalization in patients response. Max: 1500 mg from age 16 years of age twice daily. with newly diagnosed ii) ADULT more than 18 epilepsy years and ADOLESCENT ii) Adjunctive treatment in (12 to 17 years) more than or partial onset seizures with equal to 50 kg: Initially 500 or without secondary Levetiracetam 100 mg/ml N03AX14000P300 mg twice daily may be 887. A* generalization in adults and Injection 1XX increased up to 1500 mg children from 4 years of age twice daily. Dose changes with epilepsy; juvenile can be made in 500 mg twice myoclonic epilepsy and daily increments or idiopathic generalized tonic decrements 2 to 4 weekly. clonic epilepsy from 12 CHILD (4 to 11 years) and years of age. To be initiated ADOLESCENT (12 to 17 when conventional IV years) less than 50 kg : antiepileptic drugs failed to Initially 10 mg/kg twice daily, achieve control, or oral form may be increased up to 30 is temporarily not feasible in mg/kg twice daily. Dose seizure emergencies changes should not exceed increments or decrements of 10 mg/kg twice daily every 2 weeks. CHILD more than or equal to 50 kg: Adult dose CHILD: 4-11 years and adolescent (12-17 years) As adjunctive therapy in the less than 50 kg: Initially 10 treatment of partial onset mg/kg twice daily, may be Levetiracetam 100 mg/ml N03AX14000L9901 seizures with or without increased up to 30 mg/kg 888. A* Oral Solution XX secondary generalization in twice daily. Dose changes adults and children from 4 should not exceed years of age with epilepsy increments or decrements of 10 mg/kg two times daily twice weekly

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Monotherapy ADULTS and ADOLESCENT (from 16 years) : Starting dose: 250 mg twice daily, Increase dose to 500 mg twice daily after 2 week. Dose can be further increased by 250 mg i) Monotherapy therapy in twice daily every 2 week the treatment of partial depending upon the clinical onset seizures with or response. Max: 1500 mg without secondary twice daily. generalization in patients ii) ADULT more than 18 from age 16 years of age years and ADOLESCENT with newly diagnosed (12-17 years) more than or epilepsy equal to 50 kg: Initially 500 Levetiracetam 250 mg N03AX14000T1001 ii) Adjunctive treatment in mg twice daily may be 889. A* Tablet XX partial onset seizures with increased up to 1500 mg or without secondary twice daily. Dose changes generalization in adults and can be made in 500 mg twice children from 4 years of age daily increments or with epilepsy; juvenile decrements 2-4 weekly. myoclonic epilepsy and CHILD (4-11 years) and idiopathic generalized tonic ADOLESCENT (12-17 years) clonic epilepsy from 12 less than 50 kg : Initially 10 years of age mg/kg twice daily, may be increased up to 30 mg/kg twice daily. Dose changes should not exceed increments or decrements of 10 mg/kg twice daily every 2 weeks. CHILD more than or equal to 50 kg: Adult dose i) Monotherapy ADULTS and i) Monotherapy therapy in ADOLESCENT (from 16 the treatment of partial years) : Starting dose: 250 onset seizures with or mg twice daily, Increase without secondary dose to 500 mg twice daily generalization in patients after 2 week. Dose can be from age 16 years of age further increased by 250 mg with newly diagnosed twice daily every 2 week epilepsy depending upon the clinical Levetiracetam 500 mg N03AX14000T1002 ii) Adjunctive treatment in response. Max: 1500 mg 890. A* Tablet XX partial onset seizures with twice daily. or without secondary ii) ADULT more than 18 generalization in adults and years and ADOLESCENT children from 4 years of age (12-17 years) more than or with epilepsy; juvenile equal to 50 kg: Initially 500 myoclonic epilepsy and mg twice daily may be idiopathic generalized tonic increased up to 1500 mg clonic epilepsy from 12 twice daily. Dose changes years of age can be made in 500 mg twice daily increments or

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber decrements 2-4 weekly. CHILD (4-11 years) and ADOLESCENT (12-17 years) less than 50 kg : Initially 10 mg/kg twice daily, may be increased up to 30 mg/kg twice daily. Dose changes should not exceed increments or decrements of 10 mg/kg twice daily every 2 weeks. CHILD more than or equal to 50 kg: Adult dose Surgical anesthesia: Lumber epidural: 10 - 20 ml (50 - 150 mg) , caesarean section : 15 Production of local or - 30 ml (75 - 150 mg), regional anesthesia for Levobupivacaine 5mg/ml N01BB10110P300 intrathecal: 3 ml (15 mg), 891. A surgery and obstetrics, and Injection 1XX peripheral nerve block : 1 - for postoperative pain 40 ml, management ilioinguinal/iliohypogastric block. CHILD : 0.25 - 0.5 ml/kg (1.25-2.5 mg/kg) Symptomatic treatment of Children above 12 years and Levocetirizine allergic rhinitis (including R06AE09110T1001 adults: 5 mg orally once daily 892. Dihydrochloride 5 mg A* persistent allergic rhinitis) XX (Swallow whole, do not Tablet and chronic idopathic chew/crush). urticaria Initially 1 cap tds. Max initial dose: 6 caps/day. Patients previously on immediate- release Levodopa/Benserazide Levodopa 100 mg and N04BA02977T4001 preparations: Initially dose 893. Benserazide 25 mg A* Parkinson's Disease XX should substitute every Dispersible Tablet 100mg of Levodopa with 1 controlled-released cap, given at same dosage frequency as before. Increase every 2-3 days. Patients not receiving Levodopa before, initially 100 - 125 mg 3 - 4 times daily adjusted according to response. Maintenance: 0.75 Levodopa 100 mg and N04BA02000T1001 894. B Parkinson's disease - 2 g in divided doses. In Carbidopa 25 mg Tablet XX patients previously treated with Levodopa the dose should be about 20 - 25% of the dose previously being taken

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Initial: 100/25 mg 1-2 times/day, increase every 3- 4 days until therapeutic effect, optimal dosage: 400/100 mg to 800/200 Levodopa 100 mg, N04BA02977C100 mg/day divided into 4-6 895. Benserazide 25 mg HBS B Parkinson's Disease 1XX doses. Dose: 200/50 mg capsule used only when maintenance therapy is reached and not to exceed levodopa 1000-1200 mg/benserazide 250-300 mg per day The optimum daily dosage must be determined by careful titration of levodopa in each patient. The daily dose should preferably be optimised using 1 of the 4 available tablet strengths (50/12.5/200mg, 100/25/200mg, 150/37.5/200mg or 200/50/200mg levodopa/carbidopa/entacap one). Patients should be instructed to take only 1 tablet/dose administration. While the experience with total daily dosage >200 mg Levodopa 100 mg, carbidopa is limited, the Carbidopa 25 mg and N04BA03977T1002 Idiopathic Parkinson's 896. A* maximum recommended Entacapone 200 mg XX disease daily dose of entacapone is Tablet 2000 mg and therefore the maximum dose, for the strengths of 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg, is 10 tablets/day. Ten (10) tablets of the strength 150/37.5/200 mg equals carbidopa 375 mg/day. Therefore, using a maximum recommended daily dose of carbidopa 375 mg, the maximum daily dose of 200/50/200 mg is 7 tablets per day. The maximum total daily levodopa dose administered should not exceed 1500 mg.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber The optimum daily dosage must be determined by careful titration of levodopa in each patient. The daily dose should preferably be optimised using 1 of the 4 available tablet strengths (50/12.5/200mg, 100/25/200mg, 150/37.5/200mg or 200/50/200mg levodopa/carbidopa/entacap one). Patients should be instructed to take only 1 tablet/dose administration. While the experience with total daily dosage >200 mg Levodopa 150 mg, carbidopa is limited, the Carbidopa 37.5 mg and N04BA03977T1003 Idiopathic Parkinson's 897. A* maximum recommended Entacapone 200 mg XX disease daily dose of entacapone is Tablet 2000 mg and therefore the maximum dose, for the strengths of 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg, is 10 tablets/day. Ten (10) tablets of the strength 150/37.5/200 mg equals carbidopa 375 mg/day. Therefore, using a maximum recommended daily dose of carbidopa 375 mg, the maximum daily dose of 200/50/200 mg is 7 tablets per day. The maximum total daily levodopa dose administered should not exceed 1500 mg. Initial: 100/25 mg 1-2 times/day, increase every 3- 4 days until therapeutic effect, optimal dosage: 400/100 mg to 800/200 Levodopa 200 mg, N04BA02977T1001 mg/day divided into 4-6 898. B Parkinson's Disease Benserazide 50 mg Tablet XX doses. Dose: 200/50 mg used only when maintenance therapy is reached and not to exceed levodopa 1000-1200 mg/benserazide 250-300 mg per day

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber The optimum daily dosage must be determined by careful titration of levodopa in each patient. The daily dose should preferably be optimised using 1 of the 4 available tablet strengths (50/12.5/200mg, 100/25/200mg, 150/37.5/200mg or 200/50/200mg levodopa/carbidopa/entacap one). Patients should be instructed to take only 1 tablet/dose administration. While the experience with total daily dosage >200 mg Levodopa 200 mg, carbidopa is limited, the Carbidopa 50 mg & N04BA03977T1004 Idiopathic Parkinson's 899. A* maximum recommended Entacapone 200 mg XX disease daily dose of entacapone is Tablet 2000 mg and therefore the maximum dose, for the strengths of 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg, is 10 tablets/day. Ten (10) tablets of the strength 150/37.5/200 mg equals carbidopa 375 mg/day. Therefore, using a maximum recommended daily dose of carbidopa 375 mg, the maximum daily dose of 200/50/200 mg is 7 tablets per day. The maximum total daily levodopa dose administered should not exceed 1500 mg. Patients not receiving Levodopa before, initially 100 - 125 mg 3 - 4 times daily adjusted according to response. Maintenance: 0.75 Levodopa 250 mg and N04BA02000T1002 900. B Parkinson's disease - 2 g in divided doses. In Carbidopa 25 mg Tablet XX patients previously treated with Levodopa the dose should be about 20 - 25% of the dose previous being taken

189 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber The optimum daily dosage must be determined by careful titration of levodopa in each patient. The daily dose should preferably be optimised using 1 of the 4 available tablet strengths (50/12.5/200mg, 100/25/200mg, 150/37.5/200mg or 200/50/200mg levodopa/carbidopa/entacap one). Patients should be instructed to take only 1 tablet/dose administration. While the experience with total daily dosage >200 mg Levodopa 50 mg, carbidopa is limited, the Carbidopa 12.5 mg & N04BA03977T1001 Idiopathic Parkinson's 901. A* maximum recommended Entacapone 200 mg XX disease daily dose of entacapone is Tablet 2000 mg and therefore the maximum dose, for the strengths of 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg, is 10 tablets/day. Ten (10) tablets of the strength 150/37.5/200 mg equals carbidopa 375 mg/day. Therefore, using a maximum recommended daily dose of carbidopa 375 mg, the maximum daily dose of 200/50/200 mg is 7 tablets per day. The maximum total daily levodopa dose administered should not exceed 1500 mg. Adult dose: 1 drop a time 3 For the treatment of times daily. The dosage may bacterial conjunctivitis Levofloxacin 0.5% S01AX19000D200 be adjusted according to the 902. A* caused by susceptible ophthalmic solution 1XX patient's symptoms. Route of strains of the designated administration: ophthalmic microorganisms. use only. Levofloxacin 250 mg J01MA12000T1001 Community acquired 903. A* 500 mg daily for 7 - 14 days Tablet XX pneumonia Levofloxacin 500 mg J01MA12000P3001 Community Acquired 904. A* 500 mg daily for 7 - 14 days Injection XX Pneumonia Levofloxacin 500 mg J01MA12000T1002 Community acquired 905. A* 500 mg daily for 7 - 14 days Tablet XX pneumonia

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Emergency contraception within 72 hours of 1.5 mg as a single dose as unprotected sexual soon as possible after coitus Levonorgestrel 1.5 mg G03AC03000T100 906. A* intercourse for the female [preferably within 12 hours Tablet 1XX victim of sexual violence to but no later than after 72 prevent unwanted hours] pregnancy Levonorgestrel 150 mcg 1 tablet daily for 21 days G03AA07954T100 907. and Ethinyloestradiol 30 C+ Contraception from first day of the cycle, 1XX mcg Tablet followed by 7 tab free days i) & ii):One unit intrauterine device to be inserted into the uterine cavity within 7 days of the onset of menstruation or immediately after first i) Contraception (Initial trimester abortion. Levonorgestrel 52 mg G02BA03000P100 release rate of 20 mcg/24 908. A* Postpartum insertion should Intrauterine System 1XX hours). be postponed until 6 weeks ii) Idiopathic menorrhagia after delivery.Can be inserted at any time of amenorrheic woman. One unit IUD is effective for 5 years Start at low dose and increase at 2-4 weeks interval. Adult: Initially, 50- 100 mcg/day may increase by 25-50 mcg at approximately 3 to 4 weeks intervals until the thyroid deficiency is corrected. Levothyroxine Sodium H03AA01520T1001 909. B Hypothyroidism Maintenance: 100-200 100 mcg Tablet XX mcg/day. CHILD; 0 - 3 months: 10 - 15 mcg/kg/day; 3 - 6 months: 8 - 10 mcg/kg/day; 6 - 12 months: 6 - 8 mcg/kg/day; 1 - 5 years: 5 - 6 mcg/kg/day; 6 - 12 years: 4 - 5 mcg/kg/day; more than 12 years: 2 -3 mcg/kg/day

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Start at low dose and increase at 2-4 weeks interval. Usual recommended dose for i) Treatment of benign euthyroid goitre: 75- 200mcg. ii) Prophylaxis of relapse after surgery for euthyroid goitre: 75-200mcg iii) Substitution therapy in hypothyroidism: ADULT Levothyroxine Sodium 25 H03AA01152T1003 Initially, 25-50mcg/day. 910. B Hypothyroidism mcg Tablet XX Maintenance: 100- 200mcg/day. CHILDREN Initially 12.5-50mcg/day, Maintenance: 100- 150mcg/m2 body surface area iv) Concomitant supplementation during anti- thyroid drug treatment of hyperthyroidism: 50-100mcg v) Suppression therapy in thyroid cancer: 150-300mcg Start at low dose and increase at 2-4 weeks interval. Usual recommended dose for i) Treatment of benign euthyroid goitre: 75- 200mcg. ii) Prophylaxis of relapse after surgery for euthyroid goitre: 75-200mcg iii) Substitution therapy in hypothyroidism: ADULT Levothyroxine Sodium 50 H03AA01520T1002 Initially, 25-50mcg/day. 911. B Hypothyroidism mcg Tablet XX Maintenance: 100- 200mcg/day. CHILDREN Initially 12.5-50mcg/day, Maintenance: 100- 150mcg/m2 body surface area iv) Concomitant supplementation during anti- thyroid drug treatment of hyperthyroidism: 50-100mcg v) Suppression therapy in thyroid cancer: 150-300mcg Used for painless venepunctures, radial artery cannulations before Apply a thick layer under Lidocaine 25mg and N01BB52974G100 extradural/spinal and other 912. A occlusive dressing at least 1 Prilocaine 25mg Cream 1XX regional blocks in children hour before the procedure above 1 year old and adults. Also used in chronic renal failure patients for

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber insertion of A-V fistulas and shunts for haemodialysis. Indicated for the symptomatic relief of neuropathic pain associated with previous herpes zoster 1 patch /day (Adults & infection (post-herpetic elderly. Cover the painful neuralgia, PHN). area once daily for up to 12 Lidocaine Medicated N01BB02110M600 Restrictions: hr w/in 24-hr period. 913. A* Plaster 5% w/w 1XX i) For elderly patients with Subsequent plaster-free polymedication status interval: At least 12 hr. Not whom certain treatment more than 3 plasters should was contraindicated or not be used at the same time) tolerated. ii) Prescribed by pain specialist only. For surface anaesthesia in Lignocaine 10 % w/w N01BB02110A400 dental practice, in 914. B Spray to affected part Spray 1XX otorhinolaryngology and paracentesis Lignocaine 2 % with For local anaesthesia By infiltration: 0.5 - 1 ml; not N01BB52974P300 915. Adrenaline (1:80,000) B including infiltration, nerve to exceed 7 mg/kg body 1XX Injection and plexus blocks weight Use for endotracheal tubes and instruments, painful procedures in the ear, nose and throat, burns, wounds, Apply to affected area 10 N01BB02110G400 916. Lignocaine 2% Jelly B abrasions, lacerations; mins before catheterization, 1XX catheterisation of the male etc and female urethra and for symptomatic treatment of cystitis and urethritis As 2% soln: For pain: 300 For post-tonsilectomy, sore mg rinsed and ejected for throat, dumping syndrome, mouth and throat pain; or hiccough, reflux vomiting, gargled and swallowed if Lignocaine 2% Viscous N01BB02110L5001 painful lesions of the mouth, 917. A necessary for pharyngeal Solution XX cardiospasm, pain. Not to be used more instrumentation of the frequently than every 3 hr. respiratory and digestive Max (topical oral soln): 2.4 tract g/day.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Adult Male Instil 20 mL slowly into the urethra until it reaches external sphincter, proximal to the prostrate. Subsequently, apply To provide local compression at the corona anaesthesia and lubrication for several mins. Fill the during catheterization, length of the urethra w/ the exploration by sound and remaining gel. Sounding Lignocaine 2% with N01BB52974G300 other endourethral procedure or cytoscopy Instill 918. B Chlorhexidine 0.05% Gel 1XX operations and 40 mL (in 3-4 portions) into examinations, cytoscopy the insertion area then allow and symptomatic treatment 5-10 mins for anaesth to take of painful cystitis and effect. Adult Female Prior to urethritis urological procedure, instill 5- 10 mL in small portions to fill the whole urethra & allow anaesth to take effect in 3-5 mins.Childn <12 yr Up to 6 mg/kg. For anaesthesia of mucous Bronchoscopy, 2 - 3 ml with membranes of the suitable spray; biopsy in N01BB02110L5002 oropharyngeal, tracheal and mouth, 3 - 4 ml with suitable 919. Lignocaine 4 % Solution B XX bronchial areas eg. in spray or swab (with laryngoscopy and adrenaline if necessary); bronchoscopy maximum 7.5 ml 50-100 mg IV as a bolus, Lignocaine HCl Ventricular tachycardia and repeated after 5 minutes if C01BB01110P300 920. (Lidocaine) 100 mg/ml B ventricullar fibrillation. To be necessary. Maintenance : 1- 2XX Injection diluted before use 4 mg/min by IV infusion under ECG monitoring Local anesthesia : ADULT Maximum: 100 mg; CHILD Local anesth by infiltration Maximum: 3 mg/kg Cardiac IV regional anesthesia and arrhythmias : ADULT 50-100 nerve block. Emergency mg IV. Maximum: 200-300 Lignocaine HCl N01BB02110P300 921. B management of ventricular mg/hour; CHILD Loading (Lidocaine) 2% Injection 1XX arrhythmias particularly dose: 0.5-1 mg/kg IV after myocardial infarction repeated if necessary up to and cardiac surgery 3-5 mg/kg followed by a continuous infusion of 10-50 mcg/kg/min 50-100 mg IV as a bolus, Lignocaine HCl Ventricular tachycardia and repeated after 5 minutes if C01BB01110P300 922. (Lidocaine) 20 mg/ml B ventricullar fibrillation. To be necessary. Maintenance : 1- 1XX Injection diluted before use 4 mg/min by IV infusion under ECG monitoring

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber According to patients weight and nature of procedures, maximum 200mg. For most obstetric procedures, the Local or regional Lignocaine HCl 1% N01BB02110P300 preparation is diluted to 923. C+ anaesthesia for episiotomy Injection 2XX 0.5%, which gives the repairs maximum effect with the least toxicity. [lignocaine 1%, 1 part and normal saline or sterile distilled water, 1 part] Preparation of nasal mucosa for surgery (eg. Cautery to Little?s area), Adults and children over 12 aid the treatment of acute years : 5 squirts per nostril. nose bleeds and removal of Children: 8 to 12 years 3 Lignocaine HCl 5% and foreign bodies from the N01BB02984A410 squirts per nostril, 4 to 8 924. Phenylephrine HCl 0.5% A* nose, topical anaesthesia of 1XX years 2 squirts per nostril, 2 Nasal Spray the pharynx prior to direct to 4 years 1 squirt per nostril. or indirect laryngoscopy, Doses are to be topical anaesthesia and administered once only. local vasoconstriction prior to endoscopy of the upper airways Lignocaine, Aluminium C05AX03931G500 Anorectal pain, pruritis, Apply once or twice daily. 925. Acetate, Zinc Oxide and A/KK 1XX inflammation and irritation Not for prolonged use Hydrocortisone Ointment Lignocaine, Aluminium 1 suppository to be used Acetate, Zinc Oxide and C05AX03931S200 Anorectal pain, pruritis, 926. B once or twice daily. Not for Hydrocortisone 1XX inflammation and irritation prolonged use Suppository FUKKM restriction: As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. - Management of diabetes Adults: 5 mg once daily. in patients with renal failure When linagliptin is added to A10BH05000T1001 where metformin, the dose of 927. Linagliptin 5 mg tablet A* XX metformin/sulphonylurea is metformin should be contraindicated/untolerated maintained and linagliptin and elderly with multiple co administered concomitantly. morbidities that always experience hypoglycemia with other antidiabetic. Not to be used in diabetic patient whose HBA1c is more than 9%. MRSA patient with severe ADULT: 600 mg twice daily Linezolid 2 mg/ml J01XX08000P3001 sepsis requiring intensive for 10 - 14 days. CHILD: 10 928. A* Injection XX care and not clinically mg/kg 3 times daily. responding to vancomycin PREMATURE NEONATES

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber less than 7 days: 10 mg/kg twice daily

MRSA patients with severe CHILD: 10 mg/kg 3 times Linezolid 20 mg/ml J01XX08000L8001 sepsis requiring intensive daily. PREMATURE 929. A* Suspension XX care and not clinically NEONATES less than 7 responding to vancomycin days: 10 mg/kg twice daily ADULT: Above 12 years 600 MRSA patient with severe mg every 12 hours for 10-14 J01XX08000T1001 sepsis requiring intensive days. CHILD :10 mg/kg 3 930. Linezolid 600 mg Tablet A* XX care and not clinically times daily. PREMATURE responding to vancomycin. NEONATES less than 7 days: 10 mg/kg twice daily ADULT 10-30 ml daily at night but should not be taken A06AA01000L5001 931. Liquid Paraffin C Constipation immediately before going to XX bed. CHILD not recommended i) Prophylaxis and treatment Dose depends on the of acute mania and preparation used. Doses hypomania episodes Lithium Carbonate 300 N05AN01121T100 should be adjusted to 932. A ii) Prophylaxis of manic mg Tablet 1XX produce a serum-lithium depression in bipolar illness concentration of 0.4-1 or bipolar depression and mmol/l. recurrent depression Acute diarrhoea: ADULT: 4 mg stat, followed by 2 mg after each unformed stool Adjunct to rehydration in (up to 5 days). Usual 6- 8 mg Loperamide 2 mg A07DA03110C100 acute diarrhoea in adult 933. B daily. Max: 16 mg daily. Capsule 1XX also in chronic diarrhoea in Chronic diarrhoea: Initially 4- adult 8 mg daily in divided doses, adjust according to response. Max: 16 mg daily Adult: (Therapy-naive patients) 400/100 mg bd or 800/200 mg once daily; (Therapy-experienced As second line protease patients): 400/100 mg bd. Lopinavir 100 mg and J05AE06964T1002 inhibitor if intolerant to 934. A Concomitant therapy Ritonavir 25 mg Tablet XX indinavir/ ritonavir as part of (efavirenz, nevirapine, HAART regimen. amprenavir, fosamprenavir or nelfinavir) 400/100 mg bd. Children >40 kg or w/ BSA >1.4 m2 as adult dose. Adult: (Therapy-naive As second line protease patients) 400/100 mg bd or Lopinavir 200 mg and J05AE06964T1001 inhibitor if intolerant to 800/200 mg once daily; 935. A Ritonavir 50 mg Tablet XX indinavir/ ritonavir as part of (Therapy-experienced HAART regimen patients): 400/100 mg bd. Concomitant therapy

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber (efavirenz, nevirapine, amprenavir, fosamprenavir or nelfinavir) 400/100 mg bd. Children >40 kg or w/ BSA >1.4 m2 as adult dose.

Tab Adult Therapy-naive patients 400/100 mg bd or 800/200 mg once daily. Therapy-experienced patients 400/100 mg bd. Concomitant therapy (efavirenz, nevirapine, Management of patients amprenavir, fosamprenavir with asymptomatic and or nelfinavir) 400/100 mg bd. Lopinavir 80mg/Ritonavir J05AE06964L9901 symptomatic (early or Can be used w/ no dose 936. 20mg (per ml) Oral A XX advanced) HIV Infection adjustment. Childn >40 kg or Solution with CD4 cell counts <50 w/ BSA >1.4 m2 Adult dose. cubic mm Oral Soln Childn 6 mth-12 yr, 15-40 kg 10/2.5 mg/kg bd; 7 to <15 kg 12/3 mg/kg bd. Max: 5 mL bd in childn >40 kg. W/ efavirenz or nevirapine 15-45 kg 11/2.75 mg/kg bd; 7 to <15 kg 13/3.25 mg/kg. ADULT and CHILD over 6 Allergic rhinitis, chronic R06AX13000L9001 years : 10 mg once daily. 937. Loratadine 1 mg/ml Syrup A urticaria and other allergic XX CHILD 2 - 6 years: 5 mg dermatological disorders once daily ADULT and CHILD over 6 R06AX13000T1001 Allergic rhinitis and allergic years 10 mg once daily. 938. Loratadine 10 mg Tablet B XX dermatoses CHILD 2 - 6 years: 5 mg once daily Loratadine 5 mg and For treatment of allergic R01BA52988T1001 ADULT and CHILD over 12 939. Pseudoephedrine A/KK rhinitis and allergic XX years 1 tablet twice daily Sulphate 120 mg Tablet dermatoses i) 1 - 4 mg increase to 10 mg daily in divided doses. N05BA06000T1001 i) Severe anxiety ELDERLY (or delibitated) 940. Lorazepam 1 mg Tablet A/KK XX ii) Insomnia half adult dose ii) 1 - 2 mg at bedtime Not recommended in children

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Hypertension: Usual starting and maintenance dose: 50 mg once daily. Maximum increasing the dose to 100 Patients intolerant of ACE mg once daily. Patients with inhibitors, only in the intravascular volume- treatment of depletion starting dose of 25 C09CA01500T100 i) Hypertensive patient with 941. Losartan 50 mg Tablet A/KK mg once daily. Renal 1XX left ventricular hypertrophy protection in Type 2 diabetic ii) Hypertension in diabetics patients with proteinuria and with proteinuria or hypertension, starting dose: nephropathy 50 mg once daily, may be increased to 100 mg once daily based on blood pressure response Fixed dose combination is not indicated for initial therapy. i. Usual starting & maintenance dose: 1 tab of losartan & HCTZ 50/12.5 mg once daily. May be increased to 2 tab of losartan & HCTZ 50/12.5 mg or 1 tab of losartan & HCTZ 100/25mg once daily if blood pressure remain uncontrolled after Hypertension in patients about 3 weeks of Losartan Potassium 100 who cannot tolerate ACE C09DA01935T100 combination therapy with 942. mg & Hydrochlorothiazide A* inhibitors because of cough, 4XX losartan & HCTZ 50/12.5mg. 25 mg Tablet hypertensive patient with Max: 1 tab of losartan & left ventricular hypertrophy HCTZ 100/25mg once daily or 2 tab of Losartan & HCTZ 50/12.5 mg once daily. ii. Usual starting dose: 50 mg losartan once daily, may be titrated with a combination of losartan 50mg & HCTZ 12.5 mg, maybe substituted with losartan 100mg & HCTZ 12.5mg, followed by losartan 100 mg & HCTZ 25 mg once daily.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Fixed dose combination is not indicated for initial therapy. i. Usual starting & maintenance dose: 1 tab of losartan & HCTZ 50/12.5 mg once daily. May be increased to 2 tab of losartan & HCTZ 50/12.5 mg or 1 tab of losartan & HCTZ 100/25mg once daily if blood pressure remain uncontrolled after Hypertension in patients Losartan Potassium 100 about 3 weeks of who cannot tolerate ACE mg and C09DA01935T100 combination therapy with 943. A* inhibitors because of cough, Hydrochlorothiazide 12.5 3XX losartan & HCTZ 50/12.5mg. hypertensive patient with mg Tablet Max: 1 tab of losartan & left ventricular hypertrophy HCTZ 100/25mg once daily or 2 tab of Losartan & HCTZ 50/12.5 mg once daily. ii. Usual starting dose: 50 mg losartan once daily, may be titrated with a combination of losartan 50mg & HCTZ 12.5 mg, maybe substituted with losartan 100mg & HCTZ 12.5mg, followed by losartan 100 mg & HCTZ 25 mg once daily. Patients intolerant of ACE inhibitors, only in the treatment of: Usual starting dose: 50 mg Losartan Potassium 100 C09CA01500T100 i) Hypertensive patient with 944. A/KK once daily. May be increased mg Tablet 2XX left ventricular hypertrophy to 100 mg once daily. ii) Hypertension in diabetics with proteinuria or nephropathy Hypertension in patients 1 tablet once daily, may Losartan Potassium 50 who cannot tolerate ACE increase to maximum dose mg and C09DA01935T100 945. A/KK inhibitors because of cough, losartan 100 mg/ Hydrochlorothiazide 12.5 1XX hypertensive patient with hydrochlorothiazide 25 mg mg Tablet left ventricular hypertrophy once daily Inflammatory skin Magnesium Sulphate 45% D11AX05183G600 946. C conditions such as boils Apply under dressing Paste 1XX and carbuncles

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Mild hypomagnesemia (ADULT): 1gm magnesium sulphate (8mEq) IM every 6 hours for 4 doses. Severe hypomagnesemia (ADULT): 0.25 g/kg IM over 4 hours. Alternative dose of 5g may i) Treatment and be given by slow intravenous prophylaxis of acute infusion over 3 hours hypomagnesaemia ii) Toxemia of pregnancy: An Magnesium Sulphate 50% B05XA05183P3001 ii) Prevention and treatment initial intravenous dose of 947. C Injection XX of life-threatening seizures 4gm of magnesium sulphate in the treatment of toxemias is recommended. Followed of pregnancy (pre- by an intramuscular dose of eclampsia and eclampsia) 4-5gm into each buttock. This may be followed by a dose of 4-5gm into alternate buttocks every 4 hours as needed. Alternatively, the initial dose IV dose may be followed by an infusion of 1- 2gm/hr Magnesium Trisilicate A02AA10912L2101 10-20 ml 3-4 times daily 948. C Heartburn, dyspepsia Mixture XX before meals ADULT 1-2 tablet to be chewed up to 6 times a day Magnesium Trisilicate A02AA10912T1001 949. C Heartburn, dyspepsia before meals. CHILD over 6 Tablet XX years one tablet to be taken 3-4 times a day As a buffering agent for reconstituting didanosine powder for oral DDI should be mixed with administration so as to Magnesium, Aluminium water and diluted with the V07AB00900L8001 prevent acid degradation of 950. Hydroxide and C appropriate dose of antacids XX didanosine which is used Simethicone Suspension to a final concentration of 10 for the treatment of mg per ml paediatric patients (more than 6 months old) with symptomatic HIV infection Wet hair, apply shampoo and work up lather. Leave for 15 P03AX03000L5201 951. Malathion 1 % Shampoo C+ Lice infestation minutes and rinse, comb. XX Repeat if necessary after 7 - 9 days 0.25- 2 g/kg IV of a 15% to 25% solution over 30-60 Mannitol 10% Injection B05BC01000P300 952. A Cerebral oedema minutes. Safety and efficacy (10 g/100 ml) 1XX not established in children under 12 years of age

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber 0.25- 2 g/kg IV of a 15% to 25% solution over 30-60 Mannitol 20% Injection B05BC01000P300 953. A Cerebral oedema minutes. Safety and efficacy (20 g/100 ml) 2XX not established in children under 12 years of age The vaccine should be For active immunization reconstituted only with the against measles and rubella diluent supplied (sterile water in infants, children, for injection) using a sterile adolescents and young syringe and needle. With adults at risk. Immunization gentle shaking the dried cake of susceptible non-pregnant is easily dissolved. After adolescent and adult reconstitution the vaccines Measles and Rubella females is indicated if should be used immediately. Virus Vaccine Live, J07BD52963P4002 certain precautions are A single dose of 0.5ml 954. C Attenuated (Freeze-dried) XX observed. The vaccine can should be administered by 10 doses/vial be safely and effectively deep SC injection into the given simultaneously with anterolateral aspect of upper DTP, DT, TT, Td, BCG, thigh in infants and upper Polio Vaccine (OPV and arm in older children. If the IPV), Haemophilus vaccines is not used influenza type B, Hepatitis immediately then it should be B, Yellow fever vaccine and stored in the dark at 20C and vitamin A supplementation. 80C for no longer than 6 hours. Prophylaxis against measles and to prevent By SC or IM injection, 0.5 ml Measle's Vaccine J07BD01000P4001 955. C+ development of infection (if as a single dose at 12 - 15 Injection (10 doses) XX given within 72 hours of months of age contact) Measles, Mumps and For immunisation of Subcutaneous or by J07BD52963P4001 956. Rubella (MMR) Vaccine C+ children against measles, intramuscular injection, 0.5 XX Injection (Single Dose) mumps and rubella ml Mebeverine HCl 135 mg A03AA04110T1002 957. B Irritable bowel syndrome 135 mg 3 times daily Tablet XX Meclozine HCl 25 mg and R06AE55919T1001 Nausea and vomiting of 1 - 2 tablet 2 - 3 times daily 958. B Pyridoxine 50 mg Tablet XX pregnancy in severe cases 1 tablet 3 times daily. The Mecobalamin 500 mcg M09AX00000T100 dosage should be adjusted 959. B Peripheral neuropathies Tablet 1XX according to age of patient and severity of symptoms i) 5-10 mg daily for 5-10 days started anytime during cycle i) Secondary amenorrhoea ii) 5-10 mg daily for 5-10 Medroxyprogesterone G03DA02122T100 ii) Abnormal uterine days on day 16-21 of 960. B Acetate 10 mg Tablet 2XX bleeding due to hormonal menstrual cycle. Optimum imbalance secretory transformation 10 mg daily for 10 days from day 16 of the cycle

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Breast carcinoma, Medroxyprogesterone L02AB02122T1002 961. A endometrial carcinoma, 200-500 mg orally daily Acetate 100 mg Tablet XX renal carcinoma i) 5-10 mg daily for 5-10 days started anytime during cycle i) Secondary amenorrhoea ii) 5-10 mg daily for 5-10 Medroxyprogesterone G03DA02122T100 ii) Abnormal uterine days on day 16-21 of 962. B Acetate 5 mg Tablet 1XX bleeding due to hormonal menstrual cycle. Optimum imbalance secretory transformation 10 mg daily for 10 days from day 16 of the cycle Medroxyprogesterone Prevention of pregnancy G03AC06122P300 150mg to be administered 963. Acetate 50 mg/ml B and to provide long term 1XX once every 3 month Injection contraception Breast carcinoma, Medroxyprogesterone L02AB02122T1001 964. A endometrial carcinoma, 200-500 mg orally daily Acetate 500 mg Tablet XX renal carcinoma ADULT: 250 - 500 mg 3 times daily after meals. CHILD over 6 months: 6.5 - Mefenamic Acid 250 mg M01AG01000C100 965. B Mild to moderate pain 25 mg/kg daily 3 - 4 times Capsule 1XX daily for not longer than 7 days except in juvenile arthritis ADULT: 250 - 500 mg 3 times daily after meals. CHILD over 6 months: 6.5 - Mefenamic Acid 250 mg M01AG01000T100 966. B Mild to moderate pain 25 mg/kg daily 3 - 4 times Tablet 1XX daily for not longer than 7 days except in juvenile arthritis Treatment of malaria : ADULT and CHILD 25 mg/kg usually given over 2-3 days. Prophylaxis of malaria : ADULT 250 mg once a Mefloquine HCl 250 mg P01BC02110T1001 For multi-drug resistant 967. A* week. CHILD over 5 kg : 5 Tablet XX cases of malaria only mg/kg once a week; prophylaxis should start 1-3 weeks before departure and continue for 4 weeks after last exposure i) initially 7.5 mg daily. May Only for patients not be increased to 15 mg daily responding to other NSAIDs ii) initially 15 mg daily. May M01AC06000T100 968. Meloxicam 7.5 mg Tablet A/KK in the treatment of be reduced to 7.5 mg daily. 1XX i) painful osteoarthritis Maximum 15 mg daily. Child ii) rheumatoid arthritis under 12 years not recommended

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Multiple myeloma i) 8 - 10 mg/m2 for 4 days ii) Neuroblastoma, every 4 weeks L01AA03000T1001 969. Melphalan 2 mg Tablet A rhabdomyosarcoma ii) 10 - 35 mg/m2 once every XX iii) Recurrent month For dose regimes, neuroblastoma (palliative) refer to protocols 200 mg/ m2 IV infusions in High dose conditioning divided doses for Day 1 to L01AA03000P4001 therapy for stem cell 970. Melphalan 50 mg Injection B day 3 followed by IV XX transplantation in multiple infusions of autologous stem myeloma cells Adult Initially 5 mg/day on the 1st week, 5mg twice a day on the 2nd week, then As monotherapy or as 15 mg/day (10mg in the adjunctive therapy with morning and 5mg in the Memantine HCI 10 mg N06DX01110T100 cholinesterase inhibitors for 971. A* evening) on the 3rd week. Tablet 1XX the symptomatic treatment From the 4th week on, of patients with moderate to continue treatment with severe Alzheimer's disease. maintenance dose of 20 mg/day (10mg twice a day). Max: 20 mg/day. Adult Initially 5 mg/day on the 1st week, 5mg twice a day on the 2nd week, then As monotherapy or as 15 mg/day (10mg in the adjunctive therapy with morning and 5mg in the Memantine HCl 20 mg N06DX01110T100 cholinesterase inhibitors for 972. A* evening) on the 3rd week. Tablet 2XX the symptomatic treatment From the 4th week on, of patients with moderate to continue treatment with severe Alzheimer's disease. maintenance dose of 20 mg/day (10mg twice a day). Max: 20 mg/day. Immunisation against meningococcal diseases Meningococcal A, C, Y, W J07AH04000P4001 Prophylaxis: 0.5 ml 973. B caused by Neisseria 135 Vaccine Injection XX intramuscular injection. meningitis Group A, Group C, Group Y or Group W-135 Treatment of infertility Menotrophin 150 IU where clomifene has fail or Injection (Follicle G03GA02954P400 stimulation of follicle growth SC or IM injection according 974. Stimulating Hormone 150 A* 2XX as part of an assisted to patients response IU and Luteinizing reproductive technology Hormone 150 IU) (ART) Treatment of infertility Menotrophin 75 IU where clomifene has fail or Injection (Follicle G03GA02954P400 stimulation of follicle growth SC or IM Injection according 975. Stimulating Hormone 75 A* 1XX as part of an assisted to patient's response IU and Luteinizing reproductive technology Hormone 75 IU) (ART)

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber The recommended initial dose of MENOPUR is 75- 150 IU daily. The subsequent dosing should be adjusted Anovulation in women who according to individual Menotrophin, Highly have been unresponsive to patient response. Purified 75 IU Injection treatment with clomiphene Adjustments in dose should (Follicle Stimulating G03GA02954P400 976. A* citrate or stimulation of not be made more frequently Hormone 75 IU and 3XX follicle growth as part of an than every 7 days. The Luteinizing Hormone 75 assisted reproductive recommended dose IU) technology (ART) increment is 37.5 IU per adjustment and should not exceed 75 IU. The maximum daily dose should not be higher than 225 IU. Menthol 1.6% in Industrial R01AX30000A990 Decongestion of the upper 977. Methylated Spirit C As directed for local use 1XX respiratory tract Inhalation Adult: Single site in the jaw: Mepivacaine HCl 2% with For local anaesthesia 36 mg (1.8ml). Entire oral N01BB53974P300 978. Adrenaline (1:100,000) B including infiltration and cavity: 180 mg (9 ml). Max: 1XX Injection nerve blocks 400 mg (20 ml) per single dental procedure For dental local Adult: Single site in the jaw: anaesthesia including 54 mg (1.8 ml). Entire oral Mepivacaine HCl 3% N01BB03110P300 infiltration and nerve blocks 979. B cavity: 270 mg (9 ml). Max: Injection 1XX on patients in whom 400 mg (13.3 ml) per single adrenalin might be dental procedure contraindicated Leukaemia adults: 2.5mg/kg or 80-00mg/m2 p.o per day, given as a single dose. To be increased at the end of 4 i) Langerhan's cell weeks, If necessary, up to histocytosis 5mg/kg p.o per day. ii) Acute lymphoblastic Mercaptopurine 50 mg L01BB02000T1001 Maintainance dosage are 980. A leukaemia Tablet XX 1.5mg/kg -2.5mg/kg p.o per iii) Acute promyelocytic day Children age 5 and leukaemia APML older: Induction: (maintenance) 2.5mg/kg/day p.o once daily. Maintanance dose: 1.5mg/kg -2.5mg.kg p.o once daily or 70-100mg/m2 p.o once daily. i. Emperical treatment for presume infections in ADULT: 0.5g - 1g 8 hourly patients (adult and children) CHILD: (aged 3 months and J01DH02000P4002 with febrile neutropenia, 981. Meropenem 1 g Injection A* over): 10-40mg/kg 8 hourly, if XX used as monotherapy or in body weight over 50kg, adult combination with anti-virals dosage should be used or antifungal agent ii. Septicaemia

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber iii. Serious infections in renal impaired patients i. Emperical treatment for presume infections in patients (adult and children) ADULT: 0.5g - 1g 8 hourly with febrile neutropenia, CHILD: (aged 3 months and Meropenem 500 mg J01DH02000P4001 used as monotherapy or in 982. A* over): 10-40mg/kg 8 hourly, if Injection XX combination with anti-virals body weight over 50kg, adult or antifungal agent dosage should be used ii. Septicaemia iii. Serious infections in renal impaired patients Ulcerative colitis : 1 g suppository insert rectally once daily at bedtime. The dose may be increased to 500 mg 3 times daily if the response is inadequate after 2 weeks of therapy. To Inflammatory bowel disease Mesalazine 1 g A07EC02259S200 achieve maximum benefit, it 983. A of ulcerative colitis and Suppository 2XX is recommended that the Crohn's disease. suppository be retained in the rectum for a minimum of 1 to 3 hours or longer. The usual course of therapy, depending upon response, may last from 3 to 6 weeks. CHILD not recommended Ulcerative colitis : 1 g suppository insert rectally once daily at bedtime. The dose may be increased to 500 mg 3 times daily if the response is inadequate after 2 weeks of therapy. To Inflammatory bowel disease Mesalazine 250 mg A07EC02259S200 achieve maximum benefit, it 984. A of ulcerative colitis and Suppository 1XX is recommended that the Crohn's disease. suppository be retained in the rectum for a minimum of 1 to 3 hours or longer. The usual course of therapy, depending upon response, may last from 3 to 6 weeks. CHILD not recommended ADULT: 250 - 500 mg 3 - 4 Inflammatory bowel disease times daily for 3 - 6 weeks. Mesalazine 250mg MR A07EC02259T1001 985. A of ulcerative colitis and CHILD up 2 years with Tablet XX Crohn's disease. Crohn's disease: 20 - 30 mg/daily in divided doses

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber ADULT: 250 - 500 mg 3 - 4 Inflammatory bowel disease times daily for 3 - 6 weeks. Mesalazine 500mg MR A07EC02259T1002 986. A of ulcerative colitis and CHILD up 2 years with Tablet XX Crohn's disease. Crohn's disease: 20 - 30 mg/daily in divided doses Inflammatory bowel disease 60 ml (4g) at bedtime, Mesalazine 6.67% w/w A07EC02259G200 987. A of ulcerative colitis and retained overnight, Enema 1XX Crohn's disease. approximately 8 hours IV injection at a dosage of 20% of the corresponding oxazaphosphorine dose at For prevention of urotoxic the times 0 hour effects of (concurrently with the Mesna 100 mg/ml V03AF01520P3001 988. A oxazaphosphorines e.g. oxazaphosphorine), 4 hours Injection XX ifosfamide and and 8 hours thereafter. cyclophosphamide CHILD: Dose given at greater frequency (e.g. 6 times) and a shorter intervals (e.g. 3 hours) Initial dose:1.25 mg/250 mg As second-line therapy ORALLY once daily; titrate in when diet, exercise and increments of 1.25 mg/250 initial treatment with Metformin 500 mg and mg per day every 2 A10BD02926T1001 sulphonylurea or metformin 989. Glibenclamide 2.5 mg B weeks,2.5 mg/500 mg to 5 XX do not result in adequate Tablet mg/500 mg ORALLY twice glycemic control in patients daily; titrate in increments of with type 2 diabetes 5 mg/500 mg up to MAX 20 mellitus mg/2000 mg once daily Diabetes mellitus who 500 mg once daily. Maximum Metformin HCl 500 mg A10BA02110T5001 experienced gastrointestinal 990. A/KK dose 2000 mg once daily Extended Release Tablet XX side effects with normal with evening meal metformin Initial: 500mg orally twice daily with food. Maintenance: Metformin HCl 500 mg A10BA02110T1001 Titrate in 500mg increments 991. B Diabetes mellitus Tablet XX weekly, doses up to 2000 mg daily may be divided into 2 equal doses. Diabetes mellitus who 500 mg once daily. Maximum Metformin HCl 750 mg A10BA02110T5003 experienced gastrointestinal 992. A/KK dose 2000 mg once daily Extended Release Tablet XX side effects with normal with evening meal metformin Initial 10-20mg per day, increasing by 10-20mg per N07BC02110L9001 Detoxification treatment of 993. Methadone 5mg/ml Syrup A/KK day until there are no signs XX narcotic addiction of withdrawal or intoxication. Usual dose 40-60mg/day

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) 50 mg/m2 once every 3 weeks in combination with other drugs (for this dose, use the 50 mg preparation) ii) 50 mg IV Day 1, 3, 5, 9 every 3 weeks. For high risk gestational trophoblastic disease, use 100 mg/m2 as part of EMA-CO regime iii) High dose regimes: 500 - 3000 mg/m2 per dose may be used, employing the 500 mg preparations. CHILD: Central nervous system prophylaxis for acute leukaemia 2 gm/m2 over 24 i) Solid tumours hours with folinic acid ii) Gestational trophoblastic Methotrexate 1000mg L01BA01520P3005 rescue, 3 doses for B-cell 994. A disease Injection XX lineage. 4 doses for T- iii) Acute leukaemias, lineage all every 3 weeks. lymphomas Relapse acute lymphoblastic leukaemia (ALL): 1 gm/m2 over 36 hours with folinic acid rescue every 3 weeks for 9 doses, maintenance: 50 mg/m2 every 2 weeks. B-cell lymphoma: 3 gm/m2 over 3 hours with folinic acid rescue for three doses. Methotrexate level monitoring recommended when using high dose regimens. THE 500 MG STRENGTH IS NOT FOR INTRATHECAL USE i) ADULT: 20 mg/m2 weekly. CHILD: 20 - 30 mg/m2 weekly according to protocol i) Acute lymphoblastic ii) Relapsed acute leukaemia and acute lymphoblastic leukaemia promyelocytic leukemia (ALL): 100 mg/m2/day for 5 (maintenance) days 6 weekly according to Methotrexate 2.5 mg L01BA01000T1001 ii) Extensive plaque protocol 995. A Tablet XX psoriasis, erythrodermic iii) Dose used by psoriasis, pustular dermatologist: 5 - 25 mg psoriasis, Reiter's weekly. Liver biopsy after syndrome, connective cumulative dose of 1.5 gram tissue disease and repeat liver biopsy with additional gram received. Maximum cumulative dose is 4 gram. Monitor full blood

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber count (FBC), renal and liver function iv) Rheumatoid arthritis, psoriatic arthropathy: dose used by rheumatologist: 2.5 mg/week orally starting dose, increasing to 7.5 - 20 mg/weekly

i) 50 mg/m2 once every 2 - 3 weeks in combination with other drugs ii) 50 mg IV Day 1, 3, 5, 9 every 3 weeks. For high risk gestational trophoblastic disease, use 100 mg/m2 as part of EMA-CO regime iii) High dose regimes: 500 - 3000 mg/m2 per dose may be used, employing the 500 mg preparations. CHILD: Central nervous system prophylaxis for acute i) Solid tumours leukaemia 2 gm/m2 over 24 ii) Gestational trophoblastic hours with folinic acid disease rescue, 3 doses for B-cell iii) Acute lineage. 4 doses for T- Methotrexate 50 mg L01BA01520P3001 996. A leukaemia/lymphomas iv) lineage all every 3 weeks. Injection XX Rheumatoid arthritis, Relapse acute lymphoblastic psoriatic arthropathy, leukaemia (ALL): 1 gm/m2 severe/erythrodermic over 36 hours with folinic psoriasis acid rescue every 3 weeks for 9 doses, maintenance: 50 mg/m2 every 2 weeks. B-cell lymphoma: 3 gm/m2 over 3 hours with folinic acid rescue for three doses. Methotrexate level monitoring recommended when using high dose regimens. The 500 mg strength is not for intrathecal (IT) use. Dosage for intrathecal treatment and prophylaxis in leukaemia: less than 1 year: 5 mg, 1 - 2

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber years: 7.5 mg, 2 - 3 years: 10 mg, more than 3 years: 12.5 mg. IT preparation must be clearly stated/verified. ENSURE THAT PREPARATION IS SUITABLE FOR INTRATHECAL USE iv) Dose used by rheumatologist: 10 - 15 mg IM injection or oral weekly. Dose used by dermatologist: 10 - 25 mg IM injection weekly

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) 50 mg/m2 once every 3 weeks in combination with other drugs (for this dose, use the 50 mg preparation) ii) 50 mg IV Day 1, 3, 5, 9 every 3 weeks. For high risk gestational trophoblastic disease, use 100 mg/m2 as part of EMA-CO regime iii) High dose regimes: 500 - 3000 mg/m2 per dose may be used, employing the 500 mg preparations. CHILD: Central nervous system prophylaxis for acute leukaemia 2 gm/m2 over 24 i) Solid tumours hours with folinic acid ii) Gestational trophoblastic Methotrexate 500 mg/20 L01BA01520P3002 rescue, 3 doses for B-cell 997. A disease ml Injection XX lineage. 4 doses for T- iii) Acute leukaemias, lineage all every 3 weeks. lymphomas Relapse acute lymphoblastic leukaemia (ALL): 1 gm/m2 over 36 hours with folinic acid rescue every 3 weeks for 9 doses, maintenance: 50 mg/m2 every 2 weeks. B-cell lymphoma: 3 gm/m2 over 3 hours with folinic acid rescue for three doses. Methotrexate level monitoring recommended when using high dose regimens. THE 500 MG STRENGTH IS NOT FOR INTRATHECAL USE Apply 0.1% lotion to area to Repigmenting agent in be exposed to the UVA light ( D05AD02000L6001 vitiligo in conjuction with 998. Methoxsalen 1% Lotion A need to dilute the 1% lotion XX controlled doses of UVA or to 0.1% lotion, otherwise the sunlight skin will burn) 0.2 - 0.6 mg/kg/body weight. For repigmentation of larger Protection before exposure Methoxsalen 10 mg D05BA02000C100 lesions (greater than 6 cm 999. A to sunlight, psoriasis and Capsule 1XX sq): 20 mg/day 2 hours vitiligo before exposure. Take with food or milk

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Treatment of anaemia associated with chronic renal failure in the following circumstances: i)Patients who require 2 or more Non Erythropoiesis subcutaneous Stimulating Agent (ESA)- erythropoietin injections per treated patients : 0.6 mcg/kg, week and need to travel to once every two weeks (IV or obtain the injections. SC). When the Hb is >11g/dl, Methoxy Polyethylene ii)Patients who are on high administration can be Glycol-epoetin Beta 100 B03XA03000P5001 1000. A* doses of subcutaneous reduced to once monthly mcg/0.3 ml Injection in XX erythropoietin injections eg. using the dose equal to twice Prefilled Syringe 6000 units or more per time the previous two weekly and require more than 1 dose. ESA-treated patients : injection of conventional 120-360 mcg once monthly erythropoietin per time. or 60-180 mcg every two iii)Patients who require 2 or weeks. more erythropoietin injections per week and where compliance is an issue. Treatment of anaemia associated with chronic renal failure in the following circumstances: i) Patients who require 2 or Non Erythropoiesis more subcutaneous Stimulating Agent (ESA)- erythropoietin injections per treated patients : 0.6 mcg/kg, week and need to travel to once every two weeks (IV or obtain the injections. SC). When the Hb is >11g/dl, Methoxy Polyethylene ii) Patients who are on high administration can be Glycol-epoetin Beta 120 B03XA03000P5005 1001. A* doses of subcutaneous reduced to once monthly mcg/0.3 ml Injection in XX erythropoietin injections eg. using the dose equal to twice Prefilled Syringe 6000 units or more per time the previous two weekly and require more than 1 dose. ESA-treated patients : injection of conventional 120-360 mcg once monthly erythropoietin per time. or 60-180 mcg every two iii) Patients who require 2 or weeks. more erythropoietin injections per week and where compliance is an issue.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Treatment of anaemia associated with chronic renal failure in the following circumstances: i) Patients who require 2 or Non Erythropoiesis more subcutaneous Stimulating Agent (ESA)- erythropoietin injections per treated patients : 0.6 mcg/kg, week and need to travel to once every two weeks (IV or obtain the injections. SC). When the Hb is >11g/dl, Methoxy Polyethylene ii) Patients who are on high administration can be Glycol-epoetin Beta 150 B03XA03000P5006 1002. A* doses of subcutaneous reduced to once monthly mcg/0.3 ml Injection in XX erythropoietin injections eg. using the dose equal to twice Prefilled Syringe 6000 units or more per time the previous two weekly and require more than 1 dose. ESA-treated patients : injection of conventional 120-360 mcg once monthly erythropoietin per time. or 60-180 mcg every two iii) Patients who require 2 or weeks more erythropoietin injections per week and where compliance is an issue Treatment of anaemia associated with chronic renal failure in the following circumstances: i) Patients who require 2 or Non Erythropoiesis more subcutaneous Stimulating Agent (ESA)- erythropoietin injections per treated patients : 0.6 mcg/kg, week and need to travel to once every two weeks (IV or obtain the injections. SC). When the Hb is >11g/dl, Methoxy Polyethylene ii) Patients who are on high administration can be Glycol-epoetin Beta 200 B03XA03000P5007 1003. A* doses of subcutaneous reduced to once monthly mcg/0.3 ml Injection in XX erythropoietin injections eg. using the dose equal to twice Prefilled Syringe 6000 units or more per time the previous two weekly and require more than 1 dose. ESA-treated patients : injection of conventional 120-360 mcg once monthly erythropoietin per time. or 60-180 mcg every two iii) Patients who require 2 or weeks. more erythropoietin injections per week and where compliance is an issue.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Treatment of anaemia associated with chronic renal failure in the following circumstances: i) Patients who require 2 or Non Erythropoiesis more subcutaneous Stimulating Agent (ESA)- erythropoietin injections per treated patients : 0.6 mcg/kg, week and need to travel to once every two weeks (IV or obtain the injections. SC). When the Hb is >11g/dl, Methoxy Polyethylene ii) Patients who are on high administration can be Glycol-epoetin Beta 50 B03XA03000P5002 1004. A* doses of subcutaneous reduced to once monthly mcg/0.3 ml Injection in XX erythropoietin injections eg. using the dose equal to twice Prefilled Syringe 6000 units or more per time the previous two weekly and require more than 1 dose. ESA-treated patients : injection of conventional 120-360 mcg once monthly erythropoietin per time. or 60-180 mcg every two iii) Patients who require 2 or weeks more erythropoietin injections per week and where compliance is an issue. Treatment of anaemia associated with chronic renal failure in the following circumstances: i) Patients who require 2 or Non Erythropoiesis more subcutaneous Stimulating Agent (ESA)- erythropoietin injections per treated patients : 0.6 mcg/kg, week and need to travel to once every two weeks (IV or obtain the injections. SC). When the Hb is >11g/dl, Methoxy Polyethylene ii) Patients who are on high administration can be Glycol-epoetin Beta 75 B03XA03000P5004 1005. A* doses of subcutaneous reduced to once monthly mcg/0.3 ml Injection in XX erythropoietin injections eg. using the dose equal to twice Prefilled Syringe 6000 units or more per time the previous two weekly and require more than 1 dose. ESA-treated patients : injection of conventional 120-360 mcg once monthly erythropoietin per time. or 60-180 mcg every two iii) Patients who require 2 or weeks more erythropoietin injections per week and where compliance is an issue Relief of minor aches and pains of muscles and joints To be massage well to the Methyl Salicylate 25% M02AC00260G500 1006. C+ associated with simple affected area, 3 - 4 times Ointment 1XX backache, arthritis and daily. rheumatic conditions.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Adult: 250 mg 2 - 3 times daily, gradually increased at intervals of 2 or more days, maximum; 3 g/day. Elderly: initially 125 mg twice daily, increased gradually, Methyldopa 250 mg C02AB01110T1001 1007. B Hypertension maximum; 2 g daily. Child: Tablet XX Initially, 10 mg/kg or 300 mg/m2 daily in 2-4 divided doses; increase as necessary. Max: 65 mg/kg, 2 g/m2 or 3 g daily, whichever is least. Adult and children: 1 to 2 mg/kg (0.1 to 0.2 mL/kg of a For treatment of idiopathic Methylene Blue 1% V03AB17100P3001 1% solution) IV very slowly 1008. B and drug-induced Injection XX over 5 minutes. This dosage methaemoglobinemia can be repeated if necessary after one hour. CHILD over 6 years, initially 5 mg 1 - 2 times daily, increased if necessary at weekly intervals by 5 - 10 mg daily to maximum of 60 mg Attention deficit Methylphenidate HCl 10 N06BA04110T1001 daily in divided doses; 1009. A hyperactivity disorder mg Tablet XX discontinue if no response (ADHD) after 1 month, also suspend periodically to assess child's condition (usually finally discontinued during or after puberty) CHILD over 6 years: Individualize dosage, to be taken once daily in the morning. Dose may be adjusted in increments to a maximum of 54 mg/day, at Methylphenidate HCl 18 Attention deficit weekly interval. Patient new N06BA04110T5002 1010. mg Extended-release A* hyperactivity disorder to methylphenidate: starting XX Tablet (ADHD) dose 18 mg once daily; adults 18mg or 36mg once daily. Patient currently using methylphenidate: 18 - 36 mg. Maximum 54 mg/day. Discontinue if no response after 1 month 20 mg once daily to be taken Attention deficit Methylphenidate HCl 20 N06BA04110C200 in the morning. Dosage be 1011. A* hyperactivity disorder mg LA Capsule 3XX adjusted in increments to a (ADHD) maximum of 60 mg/day

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber CHILD over 6 years: Individualize dosage, to be taken once daily in the morning. Dose may be adjusted in increments to a maximum of 54 mg/day, at Methylphenidate HCl 36 Attention deficit weekly interval. Patient new N06BA04110T5003 1012. mg Extended-release A* hyperactivity disorder to methylphenidate: starting XX Tablet (ADHD) dose 18 mg once daily; adults 18mg or 36mg once daily. Patient currently using methylphenidate: 18 - 36 mg. Maximum 54 mg/day. Discontinue if no response after 1 month 20 mg once daily to be taken Attention deficit Methylphenidate HCl N06BA04110C200 in the morning. Dosage be 1013. A* hyperactivity disorder 40mg LA Capsule 2XX adjusted in increments to a (ADHD) maximum of 60 mg/day i) Intramuscular administration: anti- inflammatory treatment, i. Intramuscular route treatment of hematological a) Asthma: may be used in and oncological disorders, place of a short burst of oral endocrine disorders steroids in vomiting or non- ii) Intrasynovial, adherent patients. The periarticular, intrabursal or recommended dose is 80- soft tissue administration: 120mg intramuscularly as a Indicated as adjunctive one-dose therapy for short term b) Adrenogenital syndrome: administration in : Synovitis 40mg every two weeks of osteoarthritis, rheumatoid c) Rheumatoid arthritis arthritis, acute and (maintenance): 40-120mg subacute bursitis, acute weekly gouty arthritis, epicondylitis, d) Dermatologic lesions Methylprednisolone H02AB04134P300 1014. A* acute nonspecific (acute severe dermatitis, Acetate 40mg injection 1XX tenosynovitis, post- chronic contact dermatitis, traumatic osteoarthritis seborrheic dermatitis): 40- iii) Intralesional use in 120mg weekly for 1-4 weeks alopecia areata, discoid ii. Intraarticular route lupus erythematosus; Recommended dose is 4 to keloids, localized 80 milligrams, depending hypertrophic, infiltrated upon the size of the joint. inflammatory lesions of Injections may be repeated granuloma annulare, lichen at intervals of 1 to 5 or more planus, psoriatic plaques, weeks in chronic cases lichen simplex chronicus iii.Intralesional route 20 to 60 (neurodermatitis) milligrams *Restricted to patients methylprednisolone acetate experiencing side effects injected into the lesion with triamcinolone acetonide

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Suppression of inflammatory and allergic disorders, cerebral oedema, Methylprednisolone 15 - 30 mg/kg daily. Large H02AB04520P400 immunosuppression 1015. Sodium Succinate 0.5 g A doses may be repeated 4 - 6 1XX treatment of haematological Injection hourly for up to 48 hours and oncological disorders, treatment of shock states and endocrine disorders Suppression of inflammatory and allergic disorders, cerebral oedema, Methylprednisolone 15 - 30 mg/kg daily. Large H02AB04520P400 immunosuppression 1016. Sodium Succinate 1 g A doses may be repeated 4 - 6 2XX treatment of haematological Injection hourly for up to 48 hours and oncological disorders, treatment of shock states and endocrine disorders i) CHILD over 5 years: 2.5 - 5 i) Dyspepsia, flatulence, ml 3 times daily. 3 - 5 years 2 hiatus hernia, peptic ml 2 - 3 times daily. 1 - 3 ulceration, reflux years: 1 ml 2 - 3 times daily. oesophagitis, gastritis, Under 1 year: 1 ml 2 times Metoclopramide HCl 1 A03FA01110L9001 1017. B duodenitis, cholelithiasis, daily mg/ml Syrup XX nausea, vomiting ii) Single dose given 10 ii) Promote bowel transit minutes before examination. during diagnostic CHILD over 5 years: 2.5 - 5 procedures ml. Between 3 - 5 years: 2 ml. Under 1 year: 1 ml i) ADULT over 20 years: 10 mg 3 times daily. ADULT i) Dyspepsia, flatulence, between 12 - 20 years: 5 mg hiatus hernia, peptic 3 times daily. CHILD under ulceration, reflux 12 years: 0.12 mg/kg/dose 6 oesophagitis, gastritis, Metoclopramide HCl 10 A03FA01110T1001 - 12 hourly 1018. B duodenitis, cholelithiasis, mg Tablet XX ii) Single dose 5 - 10 minutes nausea, vomiting before examination; ADULT ii) Promote bowel transit and CHILD over 15 years: 10 during diagnostic - 20 mg; CHILD less than 15 procedures years: 0.12 mg/kg/dose 6 - 12 hourly i) ADULT over 20 years: 10 mg 3 times daily. ADULT i) Dyspepsia, flatulence, between 12 - 20 years: 5 mg hiatus hernia, peptic 3 times daily. CHILD under ulceration, reflux 12 years: 0.12 mg/kg/dose 6 oesophagitis, gastritis, Metoclopramide HCl 5 A03FA01110P3001 - 12 hourly 1019. B duodenitis, cholelithiasis, mg/ml Injection XX ii) Single dose 5 - 10 minutes nausea, vomiting before examination; ADULT ii) Promote bowel transit and CHILD over 15 years: 10 during diagnostic - 20 mg; CHILD less than 15 procedures years: 0.12 mg/kg/dose 6 - 12 hourly

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Adult: 5-10 mg daily, increased if necessary to 20 Oedema in congestive mg daily. Max: 80 mg in 24 C03BA08000T1002 cardiac failure, nephrotic 1020. Metolazone 2.5 mg Tablet A* hr. Elderly: Initially, 2.5 XX syndrome and impaired mg/day or every other day. renal function Should be taken with food. Take after breakfast. Hypertension: Initially 100 mg to maximum 400 mg daily, Angina: 50 mg - 100 Hypertension, angina, Metoprolol Tartrate 100 C07AB02123T1002 mg in 2 - 3 times daily. 1021. B myocardial infarction, mg Tablet XX Myocardial infarction: 200 arrhythmias mg daily in divided doses. Arrythmias: 50 mg - 300 mg in 2 - 3 times daily Hypertension: Initially 100 mg to maximum 400 mg daily, Angina: 50 mg - 100 Hypertension, angina, Metoprolol Tartrate 50 mg C07AB02123T1001 mg in 2 - 3 times daily. 1022. B myocardial infarction, Tablet XX Myocardial infarction: 200 arrhythmias mg daily in divided doses. Arrythmias: 50 mg - 300 mg in 2 - 3 times daily Anaerobic infections Adult: As a 1-g suppository 8 hrly for 3 days, then 12 hrly. Substitute oral therapy as soon as possible. May be unsuitable for initiating therapy in severe infections. Child: <1 yr: 125 mg; 1-5 yr: Metronidazole 0.5 g P01AB01000S2001 250 mg; 5-10 yr: 500 mg. All 1023. B Anaerobic infection Suppository XX doses to be given 8 hrly for 3 days, then 12 hrly thereafter. May be unsuitable for initiating therapy in severe infections. Prophylaxis of postoperative anaerobic bacterial infections Adult: 1 g 8 hrly starting 2 hr before surgery.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Anaerobic bacterial infections Adult: Initially, 800 mg followed by 400 mg 8 hly for about 7 days. Other recommended doses: 500 mg 8 hrly or 7.5 mg/kg 6 hrly (max: 4 g in 24 hr). Child: 7.5 mg/kg 8 hrly. Elderly: Use lower end of adult dose recommendations. Do not admin as a single dose. Prophylaxis of postoperative anaerobic bacterial infections Metronidazole 200 mg P01AB01000T1001 Adult: 400 mg by mouth 8 1024. B Anaerobic infection Tablet XX hrly in the 24 hr prior to surgery followed postoperatively by IV or rectal admin until oral therapy is possible. Other sources recommend that oral doses be initiated only 2 hr prior to surgery and that number of doses for all admin routes be limited to a total of 4. Elderly: Dose reduction may be necessary. Tab: Should be taken with food. Metronidazole 200 mg/5 P01AB01000L8001 CHILD: 7.5 mg/kg 3 times 1025. B Anaerobic infection ml Suspension XX daily for 7 days ADULT: 500 mg IV infusion 8 hourly. CHILD: 7.5 mg/kg body weight every 8 hours. Metronidazole 500 J01XD01000P9901 Neonates: 15mg/kg LD, 1026. A Anaerobic infections mg/100 ml Injection XX followed by 7.5mg/kg every 12 hourly. 1 month to 18 years: 7.5mg/kg (maximum 500mg) every 8 hours.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Dosage for adults, adolescents ≥ 16 years of age and the elderly for the treatment of invasive candidiasis: - Body weight > 40kg: 100mg/day* - Body weight ≤ 40kg: 2mg/kg/day* *If the patient?s response is inadequate, e.g. persistence of cultures or if clinical condition does not improve, Treatment of invasive the dose may be increased candidiasis, including to 200 mg/day in patients Micafungin Sodium 50mg J02AX05520P4101 candidemia in adults when weighing > 40kg or 1027. Powder for Solution for A* XX intolerance or resistance to 4mg/kg/day in patients Infusion Amphotericin B or weighing ≤ 40kg. Treatment Fluconazole. duration for invasive candidiasis: The treatment duration of candida infection should be a minimum of 14 days. The antifungal treatment should continue for at least one week after two sequential negative blood cultures have been obtained and after resolution of clinical signs and symptoms of infection. i) Fungal infections: Tinea pedis, Tinea corporis, Tinea capitis and other dermatophyte infections Apply sparingly and rub caused by Trichophyton gently onto affected area 1-2 D01AC02221G100 1028. Miconazole 2% Cream B and Epidermophyton times daily continuing for 14 1XX species days after lesions have ii) Antifungal agent that has healed been in various candida infections including vaginal candidiasis Miconazole Nitrate 2% D01AC02221F200 Skin infections caused by Dust powder over infected 1029. A Powder 1XX dermatophytes or Candida area 1 - 2 times daily Usual sedative range 2.5 - 7.5 mg (about 70 mcg/kg by Pre-operative sedation, IV injection over 30 induction of general seconds). Premedication by Midazolam 5 mg/5 ml N05CD08110P300 anaesthesia, premedication IM injection 70 - 100 mcg/kg 1030. A Injection 1XX and sedation in ICU and 30 -60 minutes before sedation for minor surgery; ELDERLY: 1 - 1.5 procedures mg/kg. Induction: Induction by slow IV infusion 200 - 300 mcg/kg (ELDERLY 100 - 200

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber mcg/kg. CHILD over 7 years 150 - 200 mcg/kg); Maximum: 0.35mg/kg. Sedation in ICU 0.03 - 0.2 mg/kg/hour Usual sedative range 2.5 - 7.5 mg (about 70 mcg/kg by IV injection over 30 seconds). Premedication by IM injection 70 - 100 mcg/kg Pre-operative sedation, 30 -60 minutes before induction of general surgery; ELDERLY: 1 - 1.5 Midazolam 5 mg/ml N05CD08110P300 anaesthesia, premedication 1031. A mg/kg. Induction: Induction Injection 2XX and sedation in ICU and by slow IV infusion 200 - 300 sedation for minor mcg/kg (ELDERLY 100 - 200 procedures mcg/kg. CHILD over 7 years 150 - 200 mcg/kg); Maximum: 0.35mg/kg. Sedation in ICU 0.03 - 0.2 mg/kg/hour ADULT: Usually 7.5 - 15 mg at bedtime; or for premedication, 30 - 60 N05CD08253T100 Pre and post-operative 1032. Midazolam 7.5 mg Tablet A/KK minutes before the 1XX sedation procedure. For ELDERLY, debilitated or impaired liver/kidney function: 7.5 mg Minocycline 100 mg J01AA08110C1002 As second-line treatment 1033. A* 100 mg daily 6 - 18 months Capsule XX for leprosy only Minocycline 50 mg J01AA08110C1001 As second-line treatment 1034. A* 100 mg daily 6 - 18 months Capsule XX for leprosy only ADULTS and CHILD above 12 years old: Initially 5 mg daily in single or divided doses (elderly 2.5 mg). May C02DC01000T100 1035. Minoxidil 5 mg Tablet A* Severe hypertension increase by 5 - 10 mg daily 1XX at intervals of 3 or more days until optimum control is achieved. Maximum 50 mg daily Initially 15 mg daily at bedtime increased according to response up to 45 mg Mirtazapine 15 mg N06AX11000T4001 daily as a single dose at 1036. A* Major depression Orodispersible Tablet XX bedtime or in 2 divided doses. CHILD and ADOLESCENT under 18 years not recommended

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Initially 15 mg daily at bedtime increased according to response up to 45 mg Mirtazapine 30 mg N06AX11000T4002 daily as a single dose at 1037. A* Major depression Orodispersible Tablet XX bedtime or in 2 divided doses. CHILD and ADOLESCENT under 18 years not recommended Mitomycin C 0.002% Eye S01AX00000D200 Pterygium, conjunctival 1 - 2 drops several times a 1038. A Drops 3XX tumour, glaucoma surgery day Mitomycin C 0.02% Eye S01AX00000D200 Pterygium, conjunctival 1 - 2 drops several times a 1039. A Drops 1XX tumour, glaucoma surgery day Mitomycin C 0.04% Eye S01AX00000D200 Pterygium, conjunctival 1 - 2 drops several times a 1040. A Drops 2XX tumour, glaucoma surgery day i) 10 - 20 mg/m2 body i) Gastrointestinal, lung, surface area (BSA) given as breast, cervical cancers a single dose through a ii) Bladder tumours running IV infusion repeated iii) Opthalmological every 6 - 8 weeks. The whole conditions: conjunctival schedule may be repeated squamous neoplasia, Mitomycin-C 10 mg L01DC03000P4001 depending on the bone 1041. A* squamous cell carcinoma of Injection XX marrow conjunctiva, trabeculectomy ii) 10 - 40 mg daily or every chronic lymphocytic other day (intravesical) leukaemia, chronic iii) 0.4 mg topically as a myelogenous leukaemia. single application for Gastric, colorectal, lung opthalmological conditions, cancer duration: 1 to 3 minutes 10 - 12 mg/m2 IV daily for 3 days, in combination with other cytotoxic agents. Refer to protocol. CHILD: 5 - 10 Acute leukaemia, elderly mg/m2 daily for 3 - 5 days patients with acute myeloid according to protocol. Mitoxantrone 20 mg/10ml L01DB07110P3001 leukaemia (AML), Treatment of acute 1042. A* Injection XX relapsed/resistant acute leukaemia, ADULT: 8 - 12 leukaemia, non-Hodgkin's mg/m2/day once daily for 4 - lymphoma (NHL) 5 days. CHILD more than 2 years: same as adult dose. CHILD 2 years: 0.4 mg/kg/day once daily for 3 - 5 days Mixed Gas-Gangrene Prophylactic: 25,000 units IM J06AA05000P3001 1043. Antitoxin 25,000 units/5 B Mixed gas-gangrene or IV. Therapeutic: Not less XX ml Injection than 75,000 units IV Initially 300 mg daily in divided doses. Gradually to Moclobemide 150 mg N06AG02000T100 Treatment of depressive 1044. A* increase up to 600 mg daily Tablet 1XX syndrome in divided doses depending on response. Usual range

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber 150 - 600 mg daily. Not recommended in children For primary volume replacement in hypovolaemia, peri- Modified Fluid Gelatin 4% B05AA06905P9901 operative stabilization of the ADULT 500 - 1500 ml given 1045. B Injection XX circulation, haemodilution, as IV infusion extracorporeal circulation (haemodialysis and heart- lung machine) Administered by intravenous For primary volume infusion only. Total dosage replacement in and rate of infusion depend hypovolaemia, peri- Modified Polypeptides upon the amount of blood B05AA10905P9901 operative stabilization of the 1046. (Polygeline) 3.5% B loss and hemodynamic XX circulation, haemodilution, Injection parameters. The usual dose extracorporeal circulation is 500 to 1000 milliliters (mL), (haemodialysis and heart- with total dosage not to lung machine) exceed 2500 mL daily i) As secondary prophylaxis SC or IV 250 mcg/m2/day. and therapeutic use against Initiation: 24 to 72 hours after chemotherapy induced Molgramostim 300 mcg L03AA03000P4002 chemotherapy. Duration: 1047. A* leucopenia according to Injection XX Until a clinically adequate clinician's discretion neutrophil recovery is ii) Haemopoietic stem cell achieved transplantation (HSCT) Apply thin layer to the Steroid responsive affected skin areas once dermatosis and vitiligo. daily until the lesion heals or Mometasone Furoate D07AC13139G100 Used where a potent for a duration of 3 weeks 1048. A* 0.1% Cream 1XX steroid is required for short whichever is duration not more than 6 sooner.Massage gently and weeks thoroughly until the medication disappears. ADULT and CHILD over 12 years: 100 mcg/day (2 sprays) to each nostril once daily. Maximum 200 mcg (4 Mometasone Furoate 50 R01AD09139A410 sprays) once daily. Reduce 1049. mcg Aqueous Nasal A* Allergic rhinitis 1XX to 50 mcg (1 spray) once Spray daily when control achieved. CHILD 6 - 12 years old: 50 mcg (1 spray) to each nostril once daily

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber 45 ml diluted with half a glass (120 ml) of water, followed by one full glass (240 ml) of water to be taken depending on the time of the procedure. For morning procedure, 45 ml dilute with half glass of water should be taken at 7 am and the Bowel cleansing prior to second 45 ml at 7 pm on the Monobasic Sodium A06AG01162L5001 colonoscopy, radiological day before the procedure. 1050. Phosphate 48%, Dibasic A XX examination or bowel For afternoon procedure, the Sodium Phosphate 18% surgery first dose should be taken at 7 pm on the day before and the second dose at 7 am on the day of the procedure. Solid food must not be taken during the preparation period; clear fluids or water can be taken liberally. Not recommended for use in children Chronic treatment of asthma and relief of CHILD more than 15 years Montelukast Sodium 10 R03DC03520T100 symptoms of seasonal 1051. A/KK and ADULT: 10 mg daily at mg Tablet 1XX allergic rhinitis for children bedtime more than 15 years and adults Asthmatics, not controlled on high dose inhaled corticosteroids more than 12 months - 5 years: 1 Montelukast Sodium 4 mg R03DC03520F100 1052. A* 1600 mcg/day and with co- packet of 4mg oral granules Oral Granules 1XX morbid allergic disorders. daily at bedtime Chronic treatment of asthma Asthmatics, not controlled on high dose inhaled corticosteroids more than CHILD 6 - 14 years: One 5 Montelukast Sodium 5 mg R03DC03520T200 1053. A* 1600 mcg/day and with co- mg chewable tablet daily at Tablet 1XX morbid allergic disorders. bedtime Chronic treatment of asthma For use in management of 5-20 mg or more regularly Morphine HCl 10 mg/5 ml N02AA01110L9901 moderate to severe pain 1054. B every 4 hours as needed in Solution XX especially that associated terminal pain with neoplastic disease Prolonged relief of severe 10 - 60 mg 12 hourly pain associated with intervals, depend upon the Morphine Sulphate 10 mg N02AA01183T5001 neoplastic disease; assists severity of the pain. Children 1055. A Controlled Release Tablet XX in procuring sleep where (more than 1 year of age) sleeplessness is due to with severe cancer pain: 0.2 pain or shock - 0.8mg/kg 12 hourly.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber 5-10 mg every four hours. Morphine Sulphate 10 mg N02AA01183T6002 Relief of moderate to 1056. A* The dose may be increased Immediate Release Tablet XX severe pain (cancer patient) according to needs Morphine Sulphate 10 mg N02AA01183S200 Relief of severe chronic 15 - 30 mg regularly every 4 1057. A* Suppository 1XX pain (cancer patient) hours ADULT: 5-20mg SC or IM every 4 hours in terminal For moderate to severe pain CHILD: Up to 1 month: Morphine Sulphate 10 N02AA01183P300 pain especially that 1058. B 0.15 mg/kg body weight; 1 - mg/ml Injection 1XX associated with neoplastic 12 months: 0.2 mg/kg body disease weight; 1 - 5 years: 2.5 - 5 mg ; 6 - 12 years: 5 - 10 mg Morphine Sulphate 20 mg N02AA01183S200 Relief of severe chronic 15 - 30 mg regularly every 4 1059. A* Suppository 2XX pain (cancer patient) hours Prolonged relief of severe pain associated with 10 - 60 mg 12 hourly Morphine Sulphate 30 mg N02AA01183T5002 neoplastic disease; assists 1060. A intervals, depend upon the Controlled Release Tablet XX in procuring sleep where severity of the pain sleeplessness is due to pain or shock Morphine Sulphate 30 mg N02AA01183S200 Relief of severe chronic 15 - 30 mg regularly every 4 1061. A* Suppository 3XX pain (cancer patient) hours 5-10 mg every four hours. Morphine Sulphate 5 mg N02AA01183T6001 Relief of moderate to 1062. A* The dose may be increased Immediate Release Tablet XX severe pain (cancer patient) according to needs Prolonged relief of severe 10 - 60 mg 12 hourly pain associated with intervals, depend upon the Morphine Sulphate 60 mg N02AA01183T5003 neoplastic disease; assists severity of the pain. Children 1063. A Controlled Release Tablet XX in procuring sleep where (more than 1 year of age) sleeplessness is due to with severe cancer pain: 0.2 pain or shock - 0.8mg/kg 12 hourly. CHILD more than 1 year and Treatment of conjunctivitis Moxifloxacin 0.5% S01AX22110D200 ADULT: 1 drop to affected 1064. A* caused by susceptible Ophthalmic Solution 1XX eye(s) 3 times daily for 7 organism days Second line therapy for Severe Community Acquired Pneumonia (CAP) IV or Oral: 400 mg once patients with co-morbidity or daily. The recommended with recent antibiotic Moxifloxacin 400 mg J01MA14110P3001 total treatment duration for 1065. A* therapy, suspected Injection XX sequential administration infections of resistant (intravenous followed by oral pathogens including therapy) is 7 to 14 days Streptococcus pneumoniae, Haemophilus influenzae & Mycoplasma pneumoniae.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Second line therapy for Severe Community Acquired Pneumonia (CAP) IV or Oral: 400 mg once patients with co-morbidity or daily. The recommended with recent antibiotic Moxifloxacin 400mg J01MA14110T1001 total treatment duration for 1066. A* therapy, suspected Tablet XX sequential administration infections of resistant (intravenous followed by oral pathogens including therapy) is 7 to 14 days Streptococcus pneumoniae, Haemophilus influenzae & Mycoplasma pneumoniae. For prevention and A11BA00901D500 INFANT less than 1 year: 1 1067. Multivitamin Drops B treatment of vitamin 1XX ml daily deficiencies Initially 2 - 4 pairs IV 4 - 8 hourly, reducing to 1 pair IV For prevention and A11BA00901P3001 daily. For less serious cases, 1068. Multivitamin Injection B treatment of vitamin XX 1 pair IV 1 - 2 times daily or deficiencies based on individual requirements For prevention and A11BA00901L9001 CHILD 5 ml daily or based 1069. Multivitamin Syrup C+ treatment of vitamin XX on manufacturer deficiencies For prevention and A11BA00901T1001 1 - 2 tablets daily or based 1070. Multivitamin Tablet B treatment of vitamin XX on individual requirements deficiencies Skin infection by Staphylococcus aureus Adults and child over 1 year, D06AX09000G100 (including MRSA), 1071. Mupirocin 2% Cream A apply up to 3 times daily for 1XX Staphylococcus epidermidis up to 10 days and beta-haemolytic streptococcus ADULT and CHILD: Apply up D06AX09000G500 1072. Mupirocin 2% Ointment A For MRSA infections only to three times daily for up to 1XX 10 days i) Renal transplant rejection: ADULT: 1 g twice daily. i) Prophylaxis of acute CHILD (3 months and older): organ rejection in patients 600 mg/m(2)/dose, twice receiving allogenic renal, daily; maximum daily dose, 2 cardiac and hepatic g/10 mL. Cardiac transplant Mycophenolate Mofetil L04AA06236C1001 transplant 1073. A* rejection: 1.5 g twice daily. 250 mg Capsule XX ii) Used with steroids for Hepatic transplant rejection: induction and maintenance 1.5 g twice daily of severe lupus nephritis ii) Induction phase: 2 - 3 resistant or intolerant to g/day for up to 6 months. cyclophosphamide therapy Maintenance phase: dose gradually tapers to 1 g/day

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Renal transplant rejection: ADULT: 1 g twice daily. i) Prophylaxis of acute CHILD (3 months and older): organ rejection in patients 600 mg/m(2)/dose, twice receiving allogenic renal, daily; maximum daily dose, 2 cardiac and hepatic g/10 mL. Cardiac transplant Mycophenolate Mofetil L04AA06236T1002 transplant 1074. A* rejection: 1.5 g twice daily. 500 mg tablet XX ii) Used with steroids for Hepatic transplant rejection: induction and maintenance 1.5 g twice daily of severe lupus nephritis ii) Induction phase: 2 - 3 resistant or intolerant to g/day for up to 6 months. cyclophosphamide therapy Maintenance phase: dose gradually tapers to 1 g/day Prophylaxis of acute transplant rejection in adult Mycophenolate Sodium L04AA06520T1001 patients receiving allogenic 1075. A* 720 mg twice daily 180mg Tablet XX renal transplant in combination with ciclosporin and corticosteroids Prophylaxis of acute transplant rejection in adult Mycophenolate Sodium L04AA06520T1002 patients receiving allogenic 1076. A* 720 mg twice daily 360mg Tablet XX renal transplant in combination with ciclosporin and corticosteroids Perioperative analgesia, for Nalbuphine HCl 10 mg/ml N02AF02110P3001 10 - 20 mg SC, IM or IV 1077. B relief of moderate to severe Injection XX every 3 - 6 hours pain For the complete/partial reversal of narcotic depression including 0.005 - 0.01 mg/kg body respiratory depression weight repeated at intervals Naloxone HCl 0.02 mg/ml V03AB15110P3001 1078. B induced by opioids such as of 2 - 3 minutes according to Injection XX natural and synthetic the patient's needs by IM, IV narcotics. Diagnosis of or SC suspected acute opioids overdosage For the complete/partial reversal of narcotic depression including Initially 0.4 - 2 mg IV respiratory depression Naloxone HCl 0.4 mg/ml V03AB15110P3002 repeated at intervals of 2 - 3 1079. B induced by opioids such as Injection XX minutes according to natural and synthetic patient's needs narcotics. Diagnosis of suspected acute opioids overdosage Initial 25 mg may be Adjunct in relapse increased to 50 mg. Naltrexone HCl 50 mg N07BB04110T1001 prevention treatment in Maintenance: 350 mg 1080. A Tablet XX detoxified formerly opioid- weekly; administered as 50 dependant patients mg daily. Dosing interval may be lengthened to

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber improve compliance; 100 mg on alternate days or 150 mg every third day ADULT: 25 - 50 mg every 3 Nandrolone Decanoate 25 A14AB01135P3001 weeks by IM. CHILD over 2 1081. A Anabolic therapy mg/ml Injection XX years: 25 - 50 mg every 3 to 4 weeks i) 0.5 - 1 g daily in 2 divided i) Rheumatic arthritis, doses osteoarthritis and ii) 750 mg initially then 250 M01AE02000T100 ankylosing spondylitis 1082. Naproxen 250 mg Tablet A/KK mg 8 hourly 1XX ii) Acute gout iii) 500 mg initially then 250 iii) Muscular skeletal mg every 6 - 8 hour as disorder, dysmenorrhoea required i) Rheumatic arthritis, osteoarthritis and alkylosing spondylitis Naproxen Sodium 275 mg M01AE02520T100 550 mg- 1100 mg in two 1083. A ii) Acute gout Tablet 1XX divided doses iii) Muscular skeletal disorder and dysmenorrhoea Apply sparingly to affected D06AX04256G100 Infections of the skin due to 1084. Neomycin 0.5% Cream B area up to 3 times daily (For 1XX susceptible organisms short term use, 1 - 2 weeks) Treatment of the following conditions where bacterial infection is present or likely Apply sparingly to affected Neomycin 0.5% in to occur: eczemas, prurigo D07CC01947G100 area 2 - 3 times daily. (May 1085. Betamethasone 17- B nodularis, psoriasis 1XX cause sensitisation to Valerate 0.01% Cream (excluding widespread neomycin. Use with caution) plaque psoriasis), neurodermatoses, anal and genital intertrigo Treatment of the following conditions where bacterial infection is present or likely Apply sparingly to affected Neomycin 0.5% in to occur: eczemas, prurigo D07CC01947G500 area 2 to 3 times daily. (May 1086. Betamethasone 17- B nodularis, psoriasis 1XX cause sensitisation to Valerate 0.01% Ointment (excluding widespread Neomycin. Use with caution) plaque psoriasis), neurodermatoses, anal and genital intertrigo Treatment of the following conditions where bacterial infection is present or likely Apply sparingly to affected Neomycin 0.5% in to occur: eczemas, prurigo D07CC01947G100 area 2 - 3 times daily (May 1087. Betamethasone 17- A nodularis, psoriasis 2XX cause sensitisation to Valerate 0.1% Cream (excluding widespread neomycin. Use with caution) plaque psoriasis), neurodermatoses, anal and genital intertrigo

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Treatment of the following conditions where bacterial infection is present or likely Apply sparingly to affected Neomycin 0.5% in to occur: eczemas, prurigo D07CC01947G500 area 2 to 3 times daily. (May 1088. Betamethasone 17- A nodularis, psoriasis 2XX cause sensitisation to Valerate 0.1% Ointment (excluding widespread neomycin. Use with caution) plaque psoriasis), neurodermatoses, anal and genital intertrigo Apply sparingly to affected D06AX04256G500 Infections of the skin due to 1089. Neomycin 0.5% Ointment B area up to 3 times daily (For 1XX susceptible organisms short term use, 1- 2 weeks) 1 - 2 drops in the affected Neomycin with Polymyxin S01AA30990D200 Eye infections that require a eye 2 - 4 times daily. In 1090. B Sulphate and A 1XX broad spectrum antibiotic severe infections : 1 - 2 Gramicidin Eye Drops drops every 15 - 30 minutes i) ADULT: 1 - 2.5 mg at suitable intervals by SC, IM or IV. Usual total daily dose 5 - 20 mg. CHILD: 200 - 500 mcg at suitable intervals i) Myasthenia gravis Neostigmine throughout the day. N07AA01183P300 ii) Reversal of non- 1091. Methylsulphate 2.5 mg/ml B NEONATE: 50 - 250 mcg 2XX depolarising neuromuscular Injection every 4 hours blockade ii) By IV injection over 1 minute, 50 - 70 mcg/kg (maximum 5 mg) after or with atropine sulphate 0.6 - 1.2 mg ADULT: 4 - 6.5 mg/kg/day IM or IV in 2 - 3 equally divided doses for 7 - 14 days. Netilmicin Sulphate 100 J01GB07183P3002 Maximum: 7.5 mg/kg/day. 1092. A Systemic infections mg/2 ml Injection XX CHILD: 5 - 7.5 mg/kg/day 8 - 12 hourly depending on gestation and age. Maximum: 7.5 mg/kg/day ADULT: 4 - 6.5 mg/kg/day IM or IV in 2 - 3 equally divided doses for 7 - 14 days. Netilmicin Sulphate 150 J01GB07183P3003 Maximum: 7.5 mg/kg/day. 1093. A Systemic infections mg/2 ml Injection XX CHILD: 5 - 7.5 mg/kg/day 8 - 12 hourly depending on gestation and age. Maximum: 7.5 mg/kg/day ADULT: 4 - 6.5 mg/kg/day IM or IV in 2 - 3 equally divided Netilmicin Sulphate 50 J01GB07183P3001 doses for 7 - 14 days. 1094. A Systemic infections mg/2 ml Injection XX Maximum: 7.5 mg/kg/day. CHILD: 5 - 7.5 mg/kg/day 8 - 12 hourly depending on

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber gestation and age. Maximum: 7.5 mg/kg/day

Combined with other antiretrovirals: 200 mg once daily for the 1st 14 days; up to 200 mg twice daily if rash Treatment of HIV-1 does not develop. Re- J05AG01000T1001 infection in combination 1095. Nevirapine 200 mg Tablet A/KK introduce at a lower dose for XX with other antiretroviral the 1st 14 days if treatment agents is interrupted for >7 days,necessitate reintroduction at a lower dose for the first 14 days. The total daily dose should not exceed 400mg. Nevirapine may be dosed in paediatric patients either by body surface area (BSA) or by body weight. i) By BSA using the Mosteller formula: the recommended oral dose for paediatric Treatment of HIV-1 patients of all ages is 150 Nevirapine 50mg/5ml Oral J05AG01000L8001 infection in combination 1096. A/KK mg/m2 once daily for 2 Suspension XX with other antiretroviral weeks followed by 150 agents mg/m2 twice daily thereafter. ii) By body weight: -<8 years of age: 4 mg/kg once daily for 2 weeks followed by 7 mg/kg twice daily thereafter. -≥8 years: 4 mg/kg once daily for 2 weeks followed by 4 mg/kg twice daily thereafter. Adult over 18 years old: 15 mg patch on waking (usually in the morning) and remove For the treatment of 16 hours later (usually at tobacco dependence by bedtime) for 8 weeks, then relieving nicotine withdrawal 10 mg patch daily for 2 Nicotine 10 mg/ 16 hour N07BA01000M700 1097. A/KK symptoms, thereby weeks followed by one 5 mg Transdermal Patch 5XX facilitating smoking patch daily for another 2 cessation in smokers weeks. Apply to dry non- motivated to quit. hairy skin site. Application limited to 16 hours in a 24-hr period in each case. Review at 3 months.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber For the treatment of tobacco dependence by relieving nicotine withdrawal Apply 1 patch daily for 24 Nicotine 14mg/24 hour N07BA01000M700 1098. A/KK symptoms, thereby hours as in the product Transdermal Patch 2XX facilitating smoking leaflet cessation in smokers motivated to quit. Adult over 18 years old: 15 mg patch on waking (usually in the morning) and remove For the treatment of 16 hours later (usually at tobacco dependence by bedtime) for 8 weeks, then relieving nicotine withdrawal 10 mg patch daily for 2 Nicotine 15 mg/ 16 hour N07BA01000M700 1099. A/KK symptoms, thereby weeks followed by one 5 mg Transdermal Patch 6XX facilitating smoking patch daily for another 2 cessation in smokers weeks. Apply to dry non- motivated to quit. hairy skin site. Application limited to 16 hours in a 24-hr period in each case. Review at 3 months. For the treatment of tobacco dependence by Smokes ≤ 20 sticks/day, relieving nicotine withdrawal chew 2mg gum. Smokes ≥ N07BA01000M990 1100. Nicotine 2 mg Gum A/KK symptoms, thereby 20 sticks/day,chew 4 mg 1XX facilitating smoking gum. (MAX 24 pieces /day cessation in smokers for up to 12 week.) motivated to quit. For the treatment of tobacco dependence by relieving nicotine withdrawal Apply 1 patch daily for 24 Nicotine 21mg/24 hour N07BA01000M700 1101. A/KK symptoms, thereby hours as in the product Transdermal Patch 3XX facilitating smoking leaflet. cessation in smokers motivated to quit. For the treatment of tobacco dependence by Smokes ≤ 20 sticks/day, relieving nicotine withdrawal chew 2mg gum. Smokes ≥ N07BA01000M990 1102. Nicotine 4 mg Gum A/KK symptoms, thereby 20 sticks/day,chew 4 mg 2XX facilitating smoking gum. (MAX 24 pieces /day cessation in smokers for up to 12 week.) motivated to quit. For the treatment of tobacco dependence by relieving nicotine withdrawal Apply 1 patch daily for 24 Nicotine 7mg/24 hour N07BA01000M700 1103. A/KK symptoms, thereby hours as in the product Transdermal Patch 1XX facilitating smoking leaflet. cessation in smokers motivated to quit.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber The patch should be apply to an intact area of the skin upon waking up in the morning and removed at bedtime. Heavy smoker(those smoking 15 or more cigarettes in a 24-hour period) are recommended to start at Step 1 with 25mg/16 hours patch and use one patch daily for 8 weeks. Gradual weaning from the patch should then be initiated. One 15mg/16hours patch should be daily for 2 weeks followed by one 10mg/16 hours patch daily for 2 weeks. Light smokers (those smoking less than 15 For the treatment of cigarettes in a 24-hour tobacco dependence by period) are recommended to relieving nicotine craving start at Step 2 (15mg/16hours and withdrawal symptoms patch) for 8 weeks and Nicotine Transdermal NO7BA01000M700 1104. A/KK thereby facilitating smoking decrease the dose to Step 3 Patch 25mg/16 hours. 7XX cessation in smokers (10mg/16hours) for the final 4 motivated to quit. Advice weeks. Heavy smoker Light and support normally smoker Dose Regimen improve the success rate. Duration Dose Regimen Duration Step 1 25mg/16hr patch First 8 weeks Step 2 15mg/16hr patch Next 2 weeks Step 2 15mg/16hr patch First 8 weeks Step 3 10mg/16hr patch Last 2 weeks Step 3 10mg/16hr patch Last 4 weeks Combination therapy Highly dependent smokers, smokers who experience ?breakthrough? cravings or those who have failed with single NRT treatment, can use a flexible smoking cessation format, in combination with the patch for fast relief of cravings. Prophylactic: 15 - 30 mg For prophylaxis and daily. Therapeutic: 50 - 250 Nicotinic Acid 50 mg A11HA01000T1001 1105. B treatment of Vitamin B3 mg daily. Maximum single Tablet XX deficiency dose: 200 mg. Maximum dose in 24 hours: 800 mg

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber 100 - 200 mg 3 times daily, gradually increased over 2 - 4 weeks to 1 - 2 g 3 times daily with or after meals. Nicotinic Acid 500 mg C10AD02000T100 CHILD: 100 - 250 mg/day in 1106. B Hyperlipidaemia Tablet 1XX 3 divided doses with meals, increase 100 mg/day weekly or 250 mg/day every 2 - 3 weeks as tolerated. Maximum: 10 mg/kg/day 10 - 30 mg 3 times daily. C08CA05000C100 1107. Nifedipine 10 mg Capsule B Hypertension Maximum: 120 - 180 mg per 1XX day Initial dose of 10 mg twice daily. Usual range 10 - 30 C08CA05000T100 mg 3 times daily. Maximum: 1108. Nifedipine 10 mg Tablet B Hypertension 1XX 120 - 180 mg per day. Elderly: Dose reduction may be necessary. For the treatment of adult patients with newly 300mg twice daily. Dose diagnosed Philadelphia adjustments or L01XE08110T1001 1109. Nilotinib 150mg capsule A* chromosome positive modifications:For XX chronic myelogenous neutropenia & leukemia in the chronic thrombocytopenia phase (CP). Treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in adults who: 400 mg twice daily, 12 hours i) Failed imatinib ie no L01XE08110C1001 apart. No food should be 1110. Nilotinib 200 mg Capsule A* cytogenic response and no XX taken two hours before and 1 haematological response by hour after taking the dose 12 months ii) Have molecular resistance to Imatinib as shown by molecular mutation studies iii) Are intolerant to Imatinib IV infusion of 1 mg/hour for a Prophylaxis & treatment of period of 2 hours (about 15 ischaemic neurological mcg/kg/hour). IV therapy Nimodipine 10 mg/50 ml C08CA06000P990 deficits caused by cerebral 1111. A* should be started no later Infusion Solution 1XX vasospasm following than 4 days after subarachnoid haemorrhage haemorrhage & continue for of aneurysmal origin up to 10 - 14 days

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Prophylaxis & treatment of ischaemic neurological C08CA06000T100 deficits caused by cerebral 360 mg daily in divided 1112. Nimodipine 30 mg Tablet A* 1XX vasospasm following doses for 7 days subarachnoid haemorrhage of aneurysmal origin 5 - 10 mg at bedtime. ELDERLY or debilitated 2.5 - N05CD02000T100 1113. Nitrazepam 5 mg Tablet B Epilepsy (infantile spasms) 5 mg. CHILD not 1XX recommended. Increasing slowly according to response Acute uncomplicated urinary tract infections Adult: 50-100 mg 4 times daily for 7 days. Dual-release preparation: 100 mg bid. Child: >3 mth Nitrofurantoin 100 mg J01XE01000T1002 Uncomplicated lower and older children: 3 mg/kg 1114. B Tablet XX urinary tract infections daily in 4 divided doses. Prophylaxis of uncomplicated urinary tract infections Adult: 50-100 mg at bedtime. Child: >3 mth and older children: 1 mg/kg once daily. Number of factor IX units required = body weight (kg) x desired factor IX increase (% or units/dL) x reciprocal of Treatment and prophylaxis observed recovery (units/kg Nonacog alfa 1000 IU B02BD09000P400 of bleeding in patients with per units/dL). Average dose 1115. A* injection 3XX haemophilia B (congenital for secondary prophylaxis for factor IX deficiency) previously treated adult patients (PTP) was 40 units/kg (range 13 to 78 units/kg) at intervals of 3 to 4 days Number of factor IX units required = body weight (kg) x desired factor IX increase (% or units/dL) x reciprocal of Treatment and prophylaxis observed recovery (units/kg Nonacog alfa 2000 IU B02BD09000P400 of bleeding in patients with per units/dL). Average dose 1116. A* injection 4XX haemophilia B (congenital for secondary prophylaxis for factor IX deficiency) previously treated adult patients (PTP) was 40 units/kg (range 13 to 78 units/kg) at intervals of 3 to 4 days

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Number of factor IX units required = body weight (kg) x desired factor IX increase (% or units/dL) x reciprocal of Treatment and prophylaxis observed recovery (units/kg Nonacog alfa 250 IU B02BD09000P400 of bleeding in patients with per units/dL). Average dose 1117. A* injection 1XX haemophilia B (congenital for secondary prophylaxis for factor IX deficiency) previously treated adult patients (PTP) was 40 units/kg (range 13 to 78 units/kg) at intervals of 3 to 4 days Number of factor IX units required = body weight (kg) x desired factor IX increase (% or units/dL) x reciprocal of Treatment and prophylaxis observed recovery (units/kg Nonacog alfa 500 IU B02BD09000P400 of bleeding in patients with per units/dL). Average dose 1118. A* injection 2XX haemophilia B (congenital for secondary prophylaxis for factor IX deficiency) previously treated adult patients (PTP) was 40 units/kg (range 13 to 78 units/kg) at intervals of 3 to 4 days Noradrenaline Acid Septic shock and shock Infuse and titrate to desired Tartrate (Norepinephrine C01CA03123P300 1119. A where peripheral vascular pressure response. Range: Bitartrate) 1 mg/ml 1XX resistance is low 0.05 - 0.5 mcg/kg/minute Injection 1 tablet daily starting on the Norethisterone 0.35 mg G03AC01000T100 1120. C+ Contraception first day of the menstrual Tablet 1XX bleeding By deep IM injection only. First injection is within first 5 days of the cycle. The next 3 Norethisterone Enanthate G03AC01257P300 1121. B Contraception injections are given at 8 200 mg/ml Injection 1XX weeks interval after which the injection interval should be extended to 12 weeks ADULT and CHILD more Superficial infections of the than 1 year : 1-2 drops 4 Norfloxacin 0.3% Eye S01AX12000D200 eye (Pseudomonas times daily. First day : 1 - 2 1122. A* Drops 1XX aeruginosa and MRSA) and drops two hourly during its adnexae waking hours (depending on severity) Apply liberally to affected area twice daily or as Prevention and treatment of required. After lesion has Nystatin 100,000 units/g D01AA01000G100 cutaneous infections disappeared continue 1123. C Cream 1XX caused by Candida treatment for 10 days to albicans prevent relapses. Nail infection: Cut nails as short as possible. Apply cream

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber once daily until growth of new nail has set in Apply liberally to affected area twice daily or as required. After lesion has Prevention and treatment of disappeared continue cutaneous or Nystatin 100,000 units/g D01AA01000G500 treatment for 10 days to 1124. C mucocutaneous infections Ointment 1XX prevent relapses. Nail caused by Candida infection: Cut nails as short albicans as possible. Apply cream once daily until growth of new nail has set in Prevention and treatment of NEWBORN: 50,000-100,000 candidiasis of the skin and units daily. CHILD up to 5 mucous membranes, years: 100,000 -500,000 Nystatin 100,000 units/ml A07AA02000L8001 protection against candidas 1125. B units 6 hourly. CHILD up to Suspension XX overgrowth during 6-12 years and ADULT: antimicrobial /corticosteroid 500,000-1,000,000 units 3 to therapy and as selective 4 times daily decontamination regimens Prevention and treatment of candidiasis of the skin and ADULT: 500,000 -1,000,000 mucous membranes, units 6 hourly, according to Nystatin 500,000 units A07AA02000T1001 protection against candidas 1126. B severity of infections. CHILD: Tablet XX overgrowth during 100,000-500,000 units 6 antimicrobial /corticosteroid hourly therapy and as selective decontamination regimens i) Acromegaly ii) Treatment of patients with symptoms associated with gastro-entero- pancreatic endocrine tumours i, ii and iii) Initially 0.005 - 0.1 iii) Carcinoid tumours with mg SC 1 - 2 times daily, features of the carcinoid increase gradually up to 0.1 - syndrome, VIPomas, 0.2 mg 3 times daily Octreotide 0.05 mg/ml H01CB02122P300 glucagonomas, iv) 0.1 mg 3 times daily for 7 1127. A Injection 2XX gastrinomas/Zollinger- consecutive days, starting on Ellison syndrome, the day of operation, at least GRFomas, insulinomas 1 hour before laparotomy iv) Prevention of v) 25 mcg/hour for 5 days by complications following continous IV infusion pancreatic surgery v) Emergency management of bleeding gastro- eosophageal varices in patients with cirrhosis

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Acromegaly ii) Treatment of patients with symptoms associated with gastro-entero- pancreatic endocrine tumours i, ii and iii) Initially 0.005 - 0.1 iii) Carcinoid tumours with mg SC 1 - 2 times daily, features of the carcinoid increase gradually up to 0.1 - syndrome, VIPomas, 0.2 mg 3 times daily Octreotide 0.1 mg/ml H01CB02122P300 glucagonomas, iv) 0.1 mg 3 times daily for 7 1128. A Injection 1XX gastrinomas/Zollinger- consecutive days, starting on Ellison syndrome, the day of operation, at least GRFomas, insulinomas 1 hour before laparotomy iv) Prevention of v) 25 mcg/hour for 5 days by complications following continous IV infusion pancreatic surgery v) Emergency management of bleeding gastro- eosophageal varices in patients with cirrhosis i) Adjunctive treatment for active acromegaly (second/third line therapy in whom surgery or radiotherapy is inappropriate or ineffective- based on level of growth hormone and high IGF-1 and residual pituitary tumor). ii) Treatment of symptoms associated with functional Octreotide Acetate 20 mg H01CB02122P200 10 - 30 mg every 4 weeks as 1129. A* gastro-entero-pancreatic Injection 1XX deep intragluteal injection endocrine tumours. iii) Carcinoid tumours with features of the carcinoid syndrome, VIPomas, Glucagonomas, Gastrinomas/Zollinger- Ellison syndrome, Insulinomas, for pre- operative control of hypoglycemia and for maintenance therapy, GRFomas.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Adjunctive treatment for active acromegaly (second/third line therapy in whom surgery or radiotherapy is inappropriate or ineffective- based on level of growth hormone and high IGF-1 and residual pituitary tumor). ii) Treatment of symptoms associated with functional Octreotide Acetate 30 mg H01CB02122P200 10 - 30 mg every 4 weeks as 1130. A* gastro-entero-pancreatic Injection 2XX deep intragluteal injection endocrine tumours. iii) Carcinoid tumours with features of the carcinoid syndrome, VIPomas, Glucagonomas, Gastrinomas/Zollinger- Ellison syndrome, Insulinomas, for pre- operative control of hypoglycemia and for maintenance therapy, GRFomas. Acute otitis media with CHILD: 1 - 12 years: 5 drops tympanostomy tubes, twice daily for 10 days. Ofloxacin 0.3% Otic S02AA00000D100 chronic suppurative otitis ADULT and CHILD over 12 1131. A/KK Solution 1XX media with perforated years: 6 - 10 drops twice tympanic membranes and daily and remain in the ear otitis externa about 10 minutes i) As second-line treatment of leprosy ii) As second-line treatment i) 400 mg/day J01MA01000T1001 for tuberculosis and 1132. Ofloxacin 100 mg Tablet A ii) 400 mg twice daily XX multidrug resistant iii) 200 mg twice daily tuberculosis (MDR-TB) iii) Sequential therapy for UTI and pyelonephritis 200 mg IV twice daily for 3 - 5 days followed with 200 mg Ofloxacin 200 mg J01MA01000P4001 Sequential therapy for UTI 1133. A tablet twice daily for 3 - 5 Injection XX and pyelonephritis days as maintenance dose (if necessary) i) Acute and maintenance i) 5 - 10 mg once daily, treatment of schizophrenia increase to 10 mg once daily and other psychoses where within 5 - 7 days, adjust by 5 Olanzapine 10 mg N05AH03000T400 positive and or negative - 10 mg/day at 1 week 1134. A* Disintegrating Tablet 2XX symptoms are prominent intervals, maximum 20 ii) Short-term use for acute mg/day mania episodes associated ii) 10 - 15 mg once daily, with Bipolar 1 disorder increase by 5 mg/day at

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber intervals of not less than 24 hours. Maintenance 5 - 20 mg/day; maximum 20 mg/day

i) 5 - 10 mg once daily, increase to 10 mg once daily i) Acute and maintenance within 5 - 7 days, adjust by 5 treatment of schizophrenia - 10 mg/day at 1 week and other psychoses where intervals, maximum 20 N05AH03000T100 positive and or negative mg/day 1135. Olanzapine 10 mg Tablet A* 2XX symptoms are prominent ii) 10 - 15 mg once daily, ii) Short-term use for acute increase by 5 mg/day at mania episodes associated intervals of not less than 24 with Bipolar 1 disorder hours. Maintenance 5 - 20 mg/day; maximum 20 mg/day i) 5 - 10 mg once daily, increase to 10 mg once daily i) Acute and maintenance within 5 - 7 days, adjust by 5 treatment of schizophrenia - 10 mg/day at 1 week and other psychoses where intervals, maximum 20 N05AH03000T100 positive and or negative mg/day 1136. Olanzapine 5 mg Tablet A* 1XX symptoms are prominent ii) 10 - 15 mg once daily, ii) Short-term use for acute increase by 5 mg/day at mania episodes associated intervals of not less than 24 with Bipolar 1 disorder hours. Maintenance 5 - 20 mg/day; maximum 20 mg/day i) 5 - 10 mg once daily, increase to 10 mg once daily i) Acute and maintenance within 5 - 7 days, adjust by 5 treatment of schizophrenia - 10 mg/day at 1 week and other psychoses where intervals, maximum 20 Olanzapine 5mg N05AH03000T400 positive and or negative mg/day 1137. A* Disintegrating Tablet 1XX symptoms are prominent ii) 10 - 15 mg once daily, ii) Short-term use for acute increase by 5 mg/day at mania episodes associated intervals of not less than 24 with Bipolar 1 disorder hours. Maintenance 5 - 20 mg/day; maximum 20 mg/day S02DC00000D100 3 - 4 drops 3 - 4 or as 1138. Olive Oil Ear Drops C Impacted wax softener 1XX directed Indicated as a maintenance Olodaterol HCL bronchodilator treatment in R03AC19110A300 1139. 2.5mcg/puff, solution for A* patients with chronic 5 mcg (2 puffs) once daily. 1XX inhalation obstructive pulmonary disease (COPD).

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Temporary prevention of Olopatadine hydrochloride S01GX09110D200 One drop in each affected 1140. A* ocular itching due to allergic ophthalmic solution 0.2% 2XX eye once a day conjunctivitis i) Adult & adolescent ≥12 yr, 150-375 mg SC every 2-4 wk, according to body wt & i) For adults and baseline serum total IgE adolescents (≥12 years), level.. For subcutaneous for severe persistent administration only. Do not allergic asthma whose administer by the symptoms are inadequately intravenous or intramuscular controlled with inhaled route. corticosetroids ii) Appropriate dose and ii) For Children (6 to <12 dosing frequency of years of age): As add-on omalizumab is determined by therapy to improve asthma baseline IgE (IU/ml), control with severe measured before the start of Omalizumab 150 mg R03DX05000P300 persistent allergic asthma treatment, and body weight 1141. (powder and solvent for A* 1XX who have positive skin test (kg). Prior to initial dosing, solution) or in vitro reactivity to a patients should have their perennial aero allergen and IgE level determined for their frequent daytime symptoms dose assignment. Based on or night-time awakenings these measurements 150- and who have had multiple 375mg in 1 -3 injections may documented severe asthma be needed for each exacerbations despite daily administration. Patients high-dose inhaled whose baseline IgE levels or corticosteroids, plus a long- body weight in kilograms are acting inhaled beta 2 outside the limits of the agonist dosing table should not be given omalizumab. For subcutaneous administration only. i)20 - 80 mg 1 - 2 times daily up to 8 - 12 weeks ii)20 mg twice daily in Only for : combination with any of the 2 i) Reflux oesophagitis antibiotics (clarithromycin ii) For eradication of 500 mg twice daily, Helicobacter pylori infection amoxicillin 1 g twice daily or Omeprazole 10 mg A02BC01000C100 1142. A/KK iii) Benign peptic ulcer not metronidazole 400 mg twice Capsule 1XX responding to conventional daily)for 1 - 2 weeks therapy iii) 20 mg once daily for 4 - 6 iv) Zollinger-Ellison weeks Syndrome iv) ADULT: 20 - 120 mg once daily adjusted according to the patient's response. CHILD 0.4 - 0.8 mg/kg/day

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i)20 - 80 mg 1 - 2 times daily up to 8 - 12 weeks ii)20 mg twice daily in Only for : combination with any of the 2 i) Reflux oesophagitis antibiotics (clarithromycin ii) For eradication of 500 mg twice daily, Helicobacter pylori infection amoxicillin 1 g twice daily or Omeprazole 20 mg A02BC01000C100 1143. A/KK iii) Benign peptic ulcer not metronidazole 400 mg twice Capsule 2XX responding to conventional daily)for 1 - 2 weeks therapy iii) 20 mg once daily for 4 - 6 iv) Zollinger-Ellison weeks iv) ADULT: 20 - 120 Syndrome mg once daily adjusted according to the patient's response. CHILD 0.4 - 0.8 mg/kg/day Only for : i) Reflux oesophagitis ii) For eradication of i) 40 mg IV once daily when Helicobacter pylori infection Omeprazole 40 mg A02BC01000P400 oral therapy is inappropriate 1144. A* iii) Benign peptic ulcer not Injection 1XX ii) 40- 160 mg by IV in single responding to conventional or divided doses therapy iv) Zollinger-Ellison Syndrome i)8 mg given by IV infusion over 15 minutes or by IM immediately before treatment followed by 8 mg orally every 12 hours for up to 5 days. CHILD 5 mg/m2 body surface IV over 15 minutes immediately before i)Prevention of nausea and chemotherapy followed by 4 vomiting induced by mg orally every 12 hours for Ondansetron 2 mg/ml A04AA01110P3001 chemotherapy and up to 5 days 1145. A Injection XX radiotherapy ii)Prevention : 4 mg given by ii)Postoperative nausea and IV at induction of vomiting anaesthesia. CHILD over 2 years, 100 mcg/kg (max 4mg) by slow IV before, during or after induction of anaesthesia. Treatment of postoperative: 4 mg by IM or slow. CHILD over 2 years 100 mcg/kg (maximum 4mg) by slow IV

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) 8 mg 1 - 2 hours before treatment then 8 mg every 12 hours for up to 5 days. CHILD, treatment by infusion followed by 4 mg by mouth i) Prevention of nausea and every 12 hours for up to 5 vomiting induced by days A04AA01110T1001 chemotherapy and 1146. Ondansetron 4 mg Tablet A ii) Prevention of XX radiotherapy postoperative nausea and ii) Postoperative nausea vomiting, 16 mg 1 hour and vomiting before anaesthesia or 8 mg 1 hour before anaesthesia followed by 8 mg at intervals of 8 hours for a further 2 doses i) 8 mg 1 - 2 hours before treatment then 8 mg every 12 hours for up to 5 days. CHILD, treatment by infusion followed by 4 mg by mouth i) Prevention of nausea and every 12 hours for up to 5 vomiting induced by days A04AA01110T1002 chemotherapy and 1147. Ondansetron 8 mg Tablet A ii) Prevention of XX radiotherapy postoperative nausea and ii) Postoperative nausea vomiting, 16 mg 1 hour and vomiting before anaesthesia or 8 mg 1 hour before anaesthesia followed by 8 mg at intervals of 8 hours for a further 2 doses i) 8 mg given by IV infusion over 15 minutes or by IM immediately before treatment followed by 8 mg orally every 12 hours for up to 5 days. CHILD 5 mg/m2 body surface IV over 15 minutes immediately before i) Prevention of nausea and chemotherapy followed by 4 vomiting induced by mg orally every 12 hours for Ondansetron 8 mg/4ml A04AA01110P3002 chemotherapy and up to 5 days 1148. A Injection XX radiotherapy ii) Prevention : 4 mg given by ii) Postoperative nausea IV at induction of and vomiting anaesthesia. CHILD over 2 years, 100 mcg/kg (max 4mg) by slow IV before, during or after induction of anaesthesia. Treatment of postoperative: 4 mg by IM or slow. CHILD over 2 years 100 mcg/kg (maximum 4mg) by slow IV

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber ADULT: 200 - 400 ml ( 1 - 2 sachets ) for every loose motion. CHILD: 200 ml (1 sachet) for every loose Replacement of fluid and A07CA00905F2101 motion. In severe 1149. Oral Rehydration Salt C electrolytes loss in XX dehydration 100 ml/kg for 3 - diarrhoea 4 hours. INFANT: 1 - 1.5 times their usual feed volume (50 ml per stool for small infant) Initially 150 mg daily in Orphenadrine 100 mg M03BC01110T100 1150. A Painful muscle spasm divided doses. Maximum: Tablet 1XX 400 mg daily Manual reprocessing, at least 12 minute immersion time at room temperature (20 High level disinfectant for degree celcius) is required. Ortho-phthalaldehyde V07AV00000L9909 sensitive endoscopes or 1151. A Automatic endoscope 0.55% Solution XX semi-critical reusable reprocessor, at least 5 medical devices minute immersion time at a minimum of 25 degree celcius is required i) For treatment of patients Children with body weight with suspected or confirmed more than 40kg is influenza and severe recommended to be dosed as disease (requiring adults. The following weight hospitalization or evidence adjusted dosing regimens are of lower respiratory tract recommended for children Oseltamivir 60mg/5ml oral J05AH02000L8001 infection). 1152. A/KK aged one year and older for suspension. XX ii) For treatment of patients duration of five days: with suspected or confirmed a) ≤15 kg: 30mg twice daily; influenza and with co- b) >15kg to 23kg:45mg twice morbidity and associated daily; with increased risk of c) >23kg to 40kg: 60mg twice influenza complications. Not daily to be used as prophylaxis.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Recommended dose in adults and adolescents ≥ 13 years of age and body weight >40kg is 75mg twice daily for 5 days. No dose adjustment is necessary for patients with creatinine clearance above 60 ml/min. Dose recommendations for renal impairment patients as follows: a) Creatinine clearance of >30-60 mL/min: 30 mg twice daily for 5 days; b) Creatinine clearance of 10- 30 ml/min: 30 mg of once i) For treatment of patients daily for 5 days; with suspected or confirmed c) In patients undergoing influenza and severe routine hemodialysis an initial disease (requiring dose of 30 mg can be hospitalization or evidence administered prior to the start of lower respiratory tract of dialysis if influenza J05AH02000C1001 infection). symptoms develop during the 1153. Oseltamivir 75mg capsule. A/KK XX ii) For treatment of patients 48 hours between dialysis with suspected or confirmed sessions. To maintain plasma influenza and with co- concentrations at a morbidity and associated therapeutic level, a dose of 30 with increased risk of mg should be administered influenza complications. Not after every hemodialysis to be used as prophylaxis. session. d) For peritoneal dialysis a dose of 30 mg administered prior to the start of dialysis followed by further 30 mg doses administered every 5 days is recommended for treatment. Dosing recommendation cannot be provided for patients with end-stage renal disease (creatinine clearance of <10 ml/min) not undergoing dialysis. No dose adjustment needed in patients with hepatic impairment and the elderly.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Only for patients with colorectal cancer who: i) have relapsed within 6 months after the end of adjuvant chemotherapy with 5-fluorouracil-based regime ii) have progressive disease Oxaliplatin 50 mg L01XA03000P4001 despite 5-fluorouracil 85 mg/m2 IV repeated every 1154. A* Injection XX chemotherapy for advanced 2 weeks disease iii) good performance status (WHO of 2 or less). The treatment must be given in a tertiary oncology centre or have clearance in writing by an oncologist ADULT: Initially 5 mg 2 - 3 times daily increased if For the relief of symptoms necessary to maximum 5 mg of bladder instability 4 times daily. ELDERLY: associated with voiding in Initially 2.5 - 3 mg twice daily, patients with uninhibited increased to 5 mg twice daily Oxybutynin Chloride 5 mg G04BD04110T100 1155. A* neurogenic or reflex according to response and Tablet 1XX neurogenic bladder (ie tolerance. CHILD over 5 urgency, frequency, urinary years, neurogenic bladder leakage, urge incontinence, instability: 2.5 - 3 mg twice dysuria) daily increased to 5 mg twice daily to maximum 3 times daily i) As a second line drug in the management of opioid responsive, moderate to severe chronic cancer pain Initially 5 mg every 4 to 6 ii) As a step-down analgesic hours, increased if necessary Oxycodone HCl 10 mg N02AA05110C100 drug in post-operative according to severity of pain, 1156. Immediate Release A* 2XX procedures (Initiated by usual max. 400 mg daily, but Capsules palliative medicine some patients may require physicians, oncologists, higher doses anaesthesiologists, haematologists and pain specialists only) Management of moderate ADULT, ELDERLY and to severe chronic cancer CHILDREN more than 18 pain non-responsive to years, opioid-naive patients: morphine (in accordance 10 mg 12 hourly. Renal or Oxycodone HCl 10 mg N02AA05110T5001 1157. A* with WHO step-wise ladder hepatic impairment: 5 mg 12 Prolonged Release Tablet XX of chronic pain hourly. Titrate dose carefully, management) [Initiated by as frequently as once a day if Chronic Pain Specialist necessary, to achieve pain only] relief

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) As a second line drug in the management of opioid responsive, moderate to severe chronic cancer pain Initially 5 mg every 4 to 6 ii) As a step-down analgesic hours, increased if necessary Oxycodone HCl 20 mg N02AA05110C100 drug in post-operative according to severity of pain, 1158. Immediate Release A* 3XX procedures (Initiated by usual max. 400 mg daily, but Capsules palliative medicine some patients may require physicians, oncologists, higher doses anaesthesiologists, haematologists and pain specialists only) Management of moderate ADULT, ELDERLY and to severe chronic cancer CHILDREN more than 18 pain non-responsive to years, opioid-naïve patients: morphine (in accordance 10 mg 12 hourly. Renal or Oxycodone HCl 20 mg N02AA05110T5002 1159. A* with WHO step-wise ladder hepatic impairment: 5 mg 12 Prolonged Release Tablet XX of chronic pain hourly. Titrate dose carefully, management) as frequently as once a day if [Initiated by Chronic Pain necessary, to achieve pain Specialist only] relief Management of moderate to severe chronic cancer pain non-responsive to Initially, 10 mg every 12 morphine hours, increased if necessary Oxycodone HCl 40 mg N02AA05110T5003 (Initiated by palliative according to severity of pain, 1160. A* Prolonged Release Tablet XX medicine physicians, usual max. 200 mg every 12 oncologists, hours, but some patients anaesthesiologists, may require higher doses haematologists and pain specialists only) i) As a second line drug in the management of opioid responsive, moderate to severe chronic cancer pain Initially 5 mg every 4 to 6 ii) As a step-down analgesic hours, increased if necessary Oxycodone HCl 5 mg drug in post-operative N02AA05110C100 according to severity of pain, 1161. Immediate Release A* procedures 1XX usual max. 400 mg daily, but Capsules (Initiated by palliative some patients may require medicine physicians, higher doses oncologists, anaesthesiologists, haematologists and pain specialists only) Adults over 18 years: The For the treatment of following starting doses are moderate to severe pain in recommended. A gradual patients with cancer and Oxycodone Hydrochloride N02AA05110P300 increase in dose may be 1162. A* post-operative pain. For the 10 mg/ml Injection 1XX required if analgesia is treatment of severe pain inadequate or if pain severity requiring the use of a strong increases. IV Bolus: Dilute to opioid. 1 mg/ml in 0.9% saline, 5%

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber dextrose or water for injections. Administer a bolus dose of 1 to 10 mg slowly over 1-2 minutes. Doses should not be administered more frequently than every 4 hours. IV Infusion: Dilute to 1 mg/ml in 0.9% saline, 5% dextrose or water for injections. A starting dose of 2 mg/hour is recommended. IV PCA: Dilute to 1 mg/ml in 0.9% saline, 5% dextrose or water for injections. Bolus doses of 0.03 mg/kg should be administered with a minimum lock-out time of 5 minutes. SC Bolus: Use as 10 mg/ml concentration. A starting dose of 5 mg is recommended, repeated at 4-hourly intervals as required. SC Infusion: Dilute in 0.9% saline, 5% dextrose or water for injections if required. A starting dose of 7.5 mg/day is recommended in opioid naïve patients, titrating gradually according to symptom control. Cancer patients transferring from oral oxycodone may require much higher doses (see below). Transferring patients between oral and parenteral oxycodone: The dose should be based on the following ratio: 2 mg of oral oxycodone is equivalent to 1 mg of parenteral oxycodone. It must be emphasised that this is a guide to the dose required.Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Adults and paediatric patients from 18 years of age: The usual starting dose for opioid-naïve patients or The management of patients presenting with moderate to severe chronic moderate to severe chronic pain unresponsive to non- pain uncontrolled by weaker Oxycodone Hydrochloride narcotic analgesics. The opioids is one tablet 10mg and Naloxone N02AA55900T1002 opioid antagonist naloxone 10mg/5mg at 12 hourly 1163. A* Hydrochloride Dihydrate XX in the fixed combination is intervals, or one tablet 5mg Tablet added to counteract and/or 5mg/2.5mg 12-hourly for prevent opioid-induced patients with mild hepatic constipatio. For pain impairment and patients with specialist only renal impairment. The dose should then be cautiously titrated, as frequently as every 1-2 days if necessary, to achieve pain relief. Adults, elderly and children over 12 years: Usual starting dose for opioid-naive patients or patients presenting with moderate to severe pain uncontrolled by weaker opioids (especially if Management of moderate they are receiving concurrent to severe chronic cancer sedatives, muscle relaxants pain non-responsive to or other CNS medicines) is morphine in accordance 10mg 12 hourly. The dose with WHO step-wise ladder should then be carefully Oxycodone Hydrochloride N02AA05110T5301 of chronic pain titrated with longitudinal 1164. 10mg Controlled Release A* XX management. (Initiated by patient monitoring, assessing Tablet palliative medicine whether the pain is opioid physicians, oncologists, responsive and providing the anaesthesiologists, patient significant pain relief. haematologists and pain Patients with renal or hepatic specialists only) impairment: The recommended adult starting dose should be reduced by 1/3 to 1/2, and each patient should be titrated to adequate pain control according to their clinical situation.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Adults and paediatric patients from 18 years of age: The usual starting dose for opioid-naïve patients or The management of patients presenting with moderate to severe chronic moderate to severe chronic pain unresponsive to non- pain uncontrolled by weaker Oxycodone Hydrochloride narcotic analgesics. The opioids is one tablet 20mg and Naloxone N02AA55900T1003 opioid antagonist naloxone 10mg/5mg at 12 hourly 1165. A* Hydrochloride Dihydrate XX in the fixed combination is intervals, or one tablet 10mg Tablet added to counteract and/or 5mg/2.5mg 12-hourly for prevent opioid-induced patients with mild hepatic constipatio. For pain impairment and patients with specialist only renal impairment. The dose should then be cautiously titrated, as frequently as every 1-2 days if necessary, to achieve pain relief. Adults, elderly and children over 12 years: Usual starting dose for opioid-naive patients or patients presenting with moderate to severe pain uncontrolled by weaker opioids (especially if Management of moderate they are receiving concurrent to severe chronic cancer sedatives, muscle relaxants pain non-responsive to or other CNS medicines) is morphine in accordance 10mg 12 hourly. The dose with WHO step-wise ladder should then be carefully Oxycodone Hydrochloride N02AA05110T5302 of chronic pain titrated with longitudinal 1166. 20mg Controlled Release A* XX management. (Initiated by patient monitoring, assessing Tablet palliative medicine whether the pain is opioid physicians, oncologists, responsive and providing the anaesthesiologists, patient significant pain relief. haematologists and pain Patients with renal or hepatic specialists only) impairment: The recommended adult starting dose should be reduced by 1/3 to 1/2, and each patient should be titrated to adequate pain control according to their clinical situation.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Adults and paediatric patients from 18 years of age: The usual starting dose for opioid-naïve patients or The management of patients presenting with moderate to severe chronic moderate to severe chronic pain unresponsive to non- pain uncontrolled by weaker Oxycodone Hydrochloride narcotic analgesics. The opioids is one tablet 40mg and Naloxone N02AA55900T1004 opioid antagonist naloxone 10mg/5mg at 12 hourly 1167. A* Hydrochloride Dihydrate XX in the fixed combination is intervals, or one tablet 20mg Tablet added to counteract and/or 5mg/2.5mg 12-hourly for prevent opioid-induced patients with mild hepatic constipation. For pain impairment and patients with specialist only renal impairment. The dose should then be cautiously titrated, as frequently as every 1-2 days if necessary, to achieve pain relief. Adults, elderly and children over 12 years: Usual starting dose for opioid-naive patients or patients presenting with moderate to severe pain uncontrolled by weaker opioids (especially if Management of moderate they are receiving concurrent to severe chronic cancer sedatives, muscle relaxants pain non-responsive to or other CNS medicines) is morphine in accordance 10mg 12 hourly. The dose with WHO step-wise ladder should then be carefully Oxycodone Hydrochloride N02AA05110T5303 of chronic pain titrated with longitudinal 1168. 40mg Controlled Release A* XX management (Initiated by patient monitoring, assessing Tablet palliative medicine whether the pain is opioid physicians, oncologists, responsive and providing the anaesthesiologists, patient significant pain relief. haematologists and pain Patients with renal or hepatic specialists only) impairment: The recommended adult starting dose should be reduced by 1/3 to 1/2, and each patient should be titrated to adequate pain control according to their clinical situation.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Adults and paediatric patients from 18 years of age: The usual starting dose for opioid-naïve patients or The management of patients presenting with moderate to severe chronic moderate to severe chronic pain unresponsive to non- pain uncontrolled by weaker Oxycodone Hydrochloride narcotic analgesics. The opioids is one tablet 5 mg and Naloxone N02AA55900T1001 opioid antagonist naloxone 10mg/5mg at 12 hourly 1169. A* Hydrochloride Dihydrate XX in the fixed combination is intervals, or one tablet 2.5mg Tablet added to counteract and/or 5mg/2.5mg 12-hourly for prevent opioid-induced patients with mild hepatic constipation. For pain impairment and patients with specialist only renal impairment. The dose should then be cautiously titrated, as frequently as every 1-2 days if necessary, to achieve pain relief. Newborn (up to 4 weeks): 1 Acute cold, paranasal Oxymetazoline HCI R01AA05110D600 drop. Infant (1 - 12 month): 1 1170. A* sinusitis, syringitis, otitis 0.01% Nasal Drops 3XX - 2 drop. Doses to be given media. twice or three times daily Oxymetazoline HCl 1 - 2 drops twice daily in R01AA05110D600 Acute colds, paranasal 1171. 0.025% (Paediatric) Nasal A/KK each nostril for child more 1XX sinusitis and otitis media Drops than 1 year Oxymetazoline HCl 2 - 3 sprays into each nostril R01AA05110A410 Acute colds, paranasal 1172. 0.025% (Paediatric) Nasal A twice daily for child more 1XX sinusitis and otitis media Spray than 1 year Oxymetazoline HCl 0.05% R01AA05110D600 Acute colds, paranasal 1 - 2 drops twice daily in 1173. A/KK (Adult) Nasal Drops 2XX sinusitis and otitis media each nostril 2 - 3 sprays into each nostril Oxymetazoline HCl 0.05% R01AA05110A410 Acute colds, paranasal 1174. A twice daily, maximum 6 (Adult) Nasal Spray 2XX sinusitis and otitis media sprays per nostril/day ADULT and CHILD: 1 - 5 mg/kg daily in one daily Anaemias caused by the dose. Usual effective dose 1 Oxymetholone 50 mg A14AA05000T1001 administration of myelotoxic 1175. A - 2 mg/kg/day, given for a Tablet XX drugs, treatment of AIDS- minimum trial of 3 - 6 months wasting syndrome because response may be delayed Conjunctivitis, dacryocystitis, Oxytetracycline with blepharoconjunctivitis, S01AA30947G510 Apply into the conjunctival 1176. Polymyxin B Sulphate B keratitis, trachoma, 1XX sac 4 times daily Eye Ointment blepharitis, pre-op prophylaxis against infection

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber IV: 0.5 - 1 milliunits/minute; gradually increase dose in increments of 1 - 2 milliunits/minute until desired contraction pattern is Oxytocin 10 units/ml H01BB02000P300 1177. B Induction of labour established; dose may be Injection 1XX decreased after desired frequency of contractions is reached and labor has progressed to 5 - 6 cm dilation i) 1 ml IM, may be repeated after 2 hours. Should not i) Prevention and treatment exceed 3 ml within 24 hours Oxytocin 5 units & of post partum ii) For routine management G02AC01900P300 1178. Ergometrine Maleate 0.5 C+ haemorrhage of third stage of labour, 1 ml 1XX mg/ml Injection ii) Management of third IM following delivery of the stage of labour anterior shoulder or immediately after delivery of the child i) Treatment of recurrent breast cancer, after failure i) 175 mg/m2 IV over 3 hours of anthracycline-based every 3 weeks chemotherapy ii) 175 mg/m2 IV over 3 hour ii) Primary adjuvant therapy followed by cisplatin 75 in advanced ovarian cancer mg/m2 in every 3 weeks or Paclitaxel 100 mg/16.6 ml L01CD01000P3002 1179. A* in combination with cisplatin 135 mg/m2 IV over 24 hours Injection XX iii) Treatment of locally followed by cisplatin 75 advanced or metastatic mg/m2 every 3 weeks non-small cell lung cancer iii) 135 mg/m2 IV over 24 (NSCLC) in chemonaive hours followed by cisplatin patients in combination with 75 mg/m2 every 3 weeks platinum compounds i) Treatment of recurrent breast cancer, after failure i) 175 mg/m2 IV over 3 hours of anthracycline-based every 3 weeks ii) 175 mg/m2 chemotherapy ii) Primary IV over 3 hour followed by adjuvant therapy in cisplatin 75 mg/m2 in every 3 advanced ovarian cancer in weeks or 135 mg/m2 IV over Paclitaxel 30 mg/5 ml L01CD01000P3001 1180. A* combination with cisplatin 24 hours followed by Injection XX iii) Treatment of locally cisplatin 75 mg/m2 every 3 advanced or metastatic weeks iii) 135 mg/m2 IV over non-small cell lung cancer 24 hours followed by (NSCLC) in chemonaive cisplatin 75 mg/m2 every 3 patients in combination with weeks platinum compounds

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Initiation: Deltoid IM 150 mg eq on Day1, followed by deltoid IM 100 mg eq on one week later. Maintenance: Monthly dose of 75 mg eq ( Second or third line Paliperidone 100 mg this can be increased or N05AX13000P200 treatment of acute and 1181. Prolonged Release A* decreased based on 4XX maintenance treatment of Injection individual patient?s schizophrenia in adults tolerability and/or efficacy). These monthly maintenace dose can be administered in either the deltoid or gluteal muscle Initiation: Deltoid IM 150 mg eq on Day1, followed by deltoid IM 100 mg eq on one week later. Maintenance: Monthly dose of 75 mg eq ( Second or third line Paliperidone 150 mg this can be increased or N05AX13000P200 treatment of acute and 1182. Prolonged Release A* decreased based on 5XX maintenance treatment of Injection individual patient?s schizophrenia in adults tolerability and/or efficacy). These monthly maintenace dose can be administered in either the deltoid or gluteal muscle ADULT 6 mg once daily in the morning, adjusted if necessary; usual range 3 -12 Paliperidone 3 mg mg daily. Renal impairment N05AX13000T5001 Second or third line 1183. Extended Released A* (creatinine clearance XX treatment of schizophrenia Tablet between 10-50 mL/min) 3 mg once daily. Avoid if creatinine clearance less than 10mL/min Initiation: Deltoid IM 150 mg eq on Day1, followed by deltoid IM 100 mg eq on one week later. Maintenance: Monthly dose of 75 mg eq ( Second or third line Paliperidone 50 mg this can be increased or N05AX13000P200 treatment of acute and 1184. Prolonged Release A* decreased based on 2XX maintenance treatment of Injection individual patient?s schizophrenia in adults tolerability and/or efficacy). These monthly maintenace dose can be administered in either the deltoid or gluteal muscle

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber ADULT 6 mg once daily in the morning, adjusted if necessary; usual range 3 -12 Paliperidone 6 mg mg daily. Renal impairment N05AX13000T5002 Second or third line 1185. Extended Released A* (creatinine clearance XX treatment of schizophrenia Tablet between 10-50 mL/min) 3 mg once daily. Avoid if creatinine clearance less than 10mL/min Initiation: Deltoid IM 150 mg eq on Day1, followed by deltoid IM 100 mg eq on one week later. Maintenance: Second or third line Monthly dose of 75 mg eq ( Paliperidone 75 mg N05AX13000P200 treatment of acute and this can be increased or 1186. Prolonged Release A* 3XX maintenance treatment of decreased based on Injection schizophrenia in adults individual patient's tolerability and/or efficacy). These monthly maintenace dose can be administered in either the deltoid or gluteal muscle ADULT 6 mg once daily in the morning, adjusted if necessary; usual range 3 -12 Paliperidone 9 mg mg daily. Renal impairment N05AX13000T5004 Second or third line 1187. Extended Released A* (creatinine clearance XX treatment of schizophrenia Tablet between 10-50 mL/min) 3 mg once daily. Avoid if creatinine clearance less than 10mL/min For the prevention of serious lower respiratory Palivizumab 100mg J06BB16000P3001 tract disease caused by 15 mg/kg IM once a month 1188. A* Injection XX respiratory syncytial virus during season of RSV risk (RSV) in paediatric patients at high risk of RSV disease Dose depends on the initial Hypercalcaemia of Pamidronate Disodium 30 M05BA03520P300 serum calcium levels. Doses 1189. A* malignancy (tumour - mg Injection 1XX range from a single infusion induced hypercalcaemia) of 30 - 90 mg Dose depends on the initial Hypercalcaemia of Pamidronate Disodium 90 M05BA03520P300 serum calcium levels. Doses 1190. A* malignancy (tumour - mg Injection 2XX range from a single infusion induced hypercalcaemia) of 30 - 90 mg Treatment of pancreatic exocrine insufficiency due Initially 1 - 2 capsules with Pancreatin 150 mg A09AA02000C100 to conditions such as cystic 1191. A/KK each meal. May increase to Capsule 1XX fibrosis, chronic pancreatitis 5 - 15 capsules daily and non-pancreatic diseases

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber ADULT: Initially 50 - 100 mcg/kg IV, then 10 - 20 mcg/kg as required. CHILD > Muscle relaxant as an Pancuronium Bromide 2 M03AC01320P300 2 YEARS: Initially 60 - 100 1192. B adjunct to general mg / ml lnjection 1XX mcg/kg then 10 - 20 mcg/kg. anaesthesia Intensive care, by IV, 60 mcg/kg every 60 - 90 minutes 40 mg twice daily until oral Pantoprazole 40 mg A02BC02000P300 Bleeding peptic ulcer and administration can be 1193. A* Injection 1XX acute stress ulceration resumed. CHILD not recommended i) 40 mg twice daily in combination with any of the 2 antibiotics (Clarithromycin i) Helicobacter pylori 500 mg twice daily, eradication Amoxicillin 1 g twice daily or ii) Peptic ulcer disease Metronidazole 400 mg twice iii) Erosive and non-erosive daily) for 1-2 weeks Pantoprazole 40 mg A02BC02000T1001 1194. A/KK reflux oesophagitis (GERD ii) 40 mg daily for 2 - 4 weeks Tablet XX and NERD) iii) 20 - 40 mg daily on iv) Zollinger-Ellison morning for 4 weeks Syndrome v) Prevention of iv) Initially 80 mg daily, dose NSAID induced gastropathy can be titrated up or down as needed. v) 20 mg daily. CHILD not recommended Relief of cerebral and peripheral ischaemia ADULT: 30 - 120 mg may be Papaverine HCl 120 A03AD01110P300 associated with arterial repeated every 3 hours as 1195. A mg/10ml Injection 2XX spasm and myocardial necessary. CHILD: 6 mg/kg ischaemia complicated by daily in 4 divided doses arrhythmias Body Weight (BW) ≤ 10kg: 7.5mg/kg, max: 30mg/kg BW >10kg to ≤ 33kg: 15mg/kg, max 60mg/kg not exceeding 2g BW >33kg to ≤ 50kg: Paracetamol 10mg/ml in N02BE01000P310 Mild to moderate pain and 15mg/kg, max 60mg/kg not 1196. 100ml Solution for IV A 1XX pyrexia exceeding 3g BW >50kg Infusion (with risk of hepatotoxicity): 1g, max 3g BW >50kg (without risk of hepatotoxicity): 1g, max 4g OR as in the product leaflet CHILD: up to 1 year: 60 - 120 mg. 1 - 5 years: 120 - 240 mg. 6 - 12 years: 240 - Paracetamol 120 mg/5 ml N02BE01000L9001 Mild to moderate pain and 1197. C+ 480 mg per dose. Repeat Syrup XX pyrexia every 4 - 6 hours when necessary. Maximum of 4 doses in 24 hours

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber CHILD: 6 - 12 years: 250 - 500 mg per dose. Repeat Paracetamol 250 mg/5 ml N02BE01000L9002 Mild to moderate pain and 1198. C+ every 4 - 6 hours when Syrup XX pyrexia necessary. Maximum of 4 doses in 24 hours ADULT & CHILDREN more than 12 years old: 500mg - 1g every 4-6 hours CHILD 6 - 12 years : 250 - 500 mg; 1 - 5 years : 125 - 250 mg; 3 - Symptomatic relief of fever 11 months : 80 mg inserted Paracetamol 125 mg N02BE01000S200 and post operative pain every 4 - 6 hours if 1199. C+ Suppository 2XX whom cannot tolerate oral necessary, maximum 4 preparations. doses in 24 hours. INFANTS under 3 months should not be given Paracetamol unless advised by doctor; a dose of 10 mg/kg (5 mg/kg if jaundiced) is suitable. ADULT & CHILDREN more than 12 years old: 500mg - 1g every 4-6 hours CHILD 6 - 12 years : 250 - 500 mg; 1 - 5 years : 125 - 250 mg; 3 - Symptomatic relief of fever 11 months : 80 mg inserted Paracetamol 250 mg N02BE01000S200 and post operative pain every 4 - 6 hours if 1200. B Suppository 1XX whom cannot tolerate oral necessary, maximum 4 preparations. doses in 24 hours. INFANTS under 3 months should not be given Paracetamol unless advised by doctor; a dose of 10 mg/kg (5 mg/kg if jaundiced) is suitable. ADULT: 500 - 1000 mg every Paracetamol 500 mg N02BE01000T1001 Mild to moderate pain and 1201. C+ 4 - 6 hours, maximum of 4 g Tablet XX pyrexia daily Occlusion or partial Paradichlorobenzene, S02DA30900D100 occlusion of the external 1202. Turpentine Oil and B Instill 5 drops into the ears 1XX auditory meatus by soft wax Chlorbutol Ear Drops or wax plug Paraffin Mole Alba (White D02AC00000G500 1203. C Xerosis and ichthyosis Apply to the affected area Soft Paraffin) 1XX D02AC00000G500 1204. Paraffin Mole Flava C Xerosis and ichthyosis Apply to the affected area 2XX The usual intramuscular dose of paraldehyde for status epilepticus is 0.15 to N05CC05000P300 1205. Paraldehyde Injection C Status epilepticus 0.3 milliliter/kilogram, a 1XX moderate additional dose (0.05 milliliter/kilogram) may be necessary. The dose may

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber be repeated in 2 to 6 hours and no more than 5 milliliters should be administered in one site

40 mg followed by 20 or 40 mg every 6 to 12 hours, as Management of post required. Use limited to two Parecoxib Sodium 40mg M01AH04520P300 operative pain in the 1206. A* days only with a maximum Injection 1XX immediate post operative dose of 80 mg/day. Reduce setting only the initial dose by 50% in elderly less than 50 kg Recommended dose is 800 mg ORALLY once daily. For treatment of advanced Should be taken without food Pazopanib Hydrochloride L01XE11110T1001 1207. A* and/or metastatic renal cell (at least one hour before or 200 mg Tablet XX carcinoma (RCC) two hours after meal). The dose should not exceed 800 mg. Recommended dose is 800 mg ORALLY once daily. For treatment of advanced Should be taken without food Pazopanib Hydrochloride L01XE11110T1002 1208. A* and/or metastatic renal cell (at least one hour before or 400 mg Tablet XX carcinoma (RCC) two hours after meal). The dose should not exceed 800 mg. Administered as a slow (one hour) intravenous perfusion, Infections due to gram- Pefloxacin 400 mg J01MA03196P3001 after diluting the contents of 1209. A positive and gram-negative Injection XX the 400 mg in 250 ml 5% pathogens glucose (two perfusions daily, morning and evening) i) Infections due to gram- positive and gram-negative ADULT i) 800 mg/day in 2 J01MA03000T1001 pathogens 1210. Pefloxacin 400 mg Tablet A divided doses XX ii) Uncomplicated UTI, ii) 800 mg stat chancroid gonococcal urethritis

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Adults (≥18 years): One 6 mg dose (a single pre-filled syringe) of pegfilgrastim for each chemotherapy cycle, administered as a subcutaneous injection Reduction in the duration of approximately 24 hours neutropenia, the incidence following cytotoxic of febrile neutropenia and chemotherapy. Renal the incidence of infection as impairment: manifested by febrile Pharmacokinetics of Pegfilgrastim Pre-filled neutropenia in patients L03AA13000P5001 pegfilgrastim is not expected 1211. Syringe 6 mg/0.6 ml (10 A* treated with cytotoxic XX to be affected by renal mg/ml) chemotherapy for impairment. Hepatic malignancy (with the impairment: exception of chronic Pharmacokinetics of myeloid leukaemia and pegfilgrastim is not expected myelodysplastic to be affected by hepatic syndromes) impairment. Paediatric population: Insufficient data to recommend the use of pegfilgrastim in children and adolescents under 18 years of age. i) Combination therapy with Ribavirin: ADULT: SC 1.5 mcg/kg/week CHILD and ADOLESCENT (3-17 yr): SC Treatment of: Peginterferon Alfa-2b 80 L03AB10000P5002 60 mcg/m2/week for 24-48 1212. A* i) Chronic Hepatitis C mcg Injection XX weeks Monotherapy: ii) Chronic Hepatitis B ADULT: SC 1 mcg/kg/week for 24 weeks to 1 year ii) SC 1.0 - 1.5 mcg/kg once weekly for 52 weeks i) Chronic hepatitis C usually in combination with ribavirin (Important to i) 180 mcg weekly SC with establish hepatitis C virus ribavirin 800 mg daily for 24 (HCV) genotype and viral weeks in patients in load where combination genotype 2 and 3 and 180 treatment is advocated) mcg weekly SC with ribavirin ii) For the treatment of both (1000 - 1200 mg) for 48 Peginterferon Alpha-2a L03AB11000P5002 1213. A* HbeAg-positive and HbeAg- weeks for those with 135 mcg Prefilled Syringe XX negative chronic hepatitis B genotype 1 and 4. 135 mg with compensated liver dose may be used for disease and evidence of patients who cannot tolerate viral replication who are not the 180 mcg dose responding or tolerating oral ii) 180 mcg weekly SC for 48 antiviral therapy (Initiated weeks by Hepatologist and Gasteroenterologist only)

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Chronic hepatitis C usually in combination with ribavirin (Important to i) 180 mcg weekly with establish hepatitis C virus ribavirin 800 mg daily for 24 (HCV) genotype and viral weeks in patients in load where combination genotype 2 and 3 and 180 treatment is advocated) mcg weekly with ribavirin ii) For the treatment of both (1000 - 1200 mg) for 48 Peginterferon Alpha-2a L03AB11000P5001 1214. A* HbeAg-positive and HbeAg- weeks for those with 180 mcg Prefilled Syringe XX negative chronic hepatitis B genotype 1 and 4. 135 mg with compensated liver dose may be used for disease and evidence of patients who cannot tolerate viral replication who are not the 180 mcg dose responding or tolerating oral ii) 180 mcg subcutaneously antiviral therapy (Initiated once a week for 48 weeks by Hepatologist and Gasteroenterologist only) i) Monotherapy: SC at a dose of 0.5 or 1 mcg/kg once weekly for at least 6 months. Combination therapy: 1.5 Pegylated Interferon Treatment of: L03AB10000P5003 mcg/kg/week SC in 1215. Alpha -2b 100 mcg A* i) Chronic Hepatitis C XX combination with ribavirin Injection ii) Chronic Hepatitis B capsules. ii) 1-1.5 mcg/kg once weekly for at least 24 weeks and up to 52 weeks. i) Monotherapy: SC at a dose of 0.5 or 1 mcg/kg once weekly for at least 6 months. Pegylated Interferon Treatment of: Combination therapy: 1.5 L03AB10000P5004 1216. Alpha -2b 120 mcg A* i) Chronic Hepatitis C mcg/kg/week SC in XX Injection ii) Chronic Hepatitis B combination with ribavirin capsules. ii) 1-1.5 mcg/kg once weekly for at least 24 weeks and up to 52 weeks. i) Monotherapy: SC at a dose of 0.5 or 1 mcg/kg once weekly for at least 6 months. Pegylated Interferon Treatment of: Combination therapy: 1.5 L03AB10000P5005 1217. Alpha -2b 150 mcg A* i) Chronic Hepatitis C mcg/kg/week SC in XX Injection ii) Chronic Hepatitis B combination with ribavirin capsules. ii) 1-1.5 mcg/kg once weekly for at least 24 weeks and up to 52 weeks. i) Monotherapy: SC at a dose of 0.5 or 1 mcg/kg once Treatment of: weekly for at least 6 months. Pegylated Interferon L03AB10000P5001 1218. A* i) Chronic Hepatitis C Combination therapy: 1.5 Alpha-2b 50 mcg Injection XX ii) Chronic Hepatitis B mcg/kg/week SC in combination with ribavirin capsules. ii) 1-1.5 mcg/kg

258 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber once weekly for at least 24 weeks and up to 52 weeks.

50 mg/m2 IV every 4 weeks for as long as the disease does not progress & patient continues to tolerate i) For patients with treatment.For doses <90 mg: platinum-resistant ovarian dilute in 250 ml Dextrose 5 % cancer where the disease in Water. For doses >90 mg: relapses within 6 months dilute in 500 ml Dextrose 5 % after completion of the initial in Water. To minimize the platinum-based risk of infusion reactions, the chemotherapy initial dose is administered at ii) For patients with a rate no greater than 1 Pegylated Liposomal platinum-sensitive ovarian mg/minute. Renal L01DB01110P3003 1219. Doxorubicin HCl 20 A* cancer where the disease impairment: No dose XX mg/vial responds to first-line adjustment required in platinum-based therapy but patients with creatinine relapses 12 months or more clearance 30-156 ml/min, no after completion of the initial pharmacokinetic data are platinum based available in patients with chemotherapy. As third line creatinine clearance of less therapy for very selected than 30 ml/min. Hepatic patients. (Gyne Oncology impairment: At initiation of Specialist only) therapy: Bilirubin 1.2 - 3.0 mg/dl, the first dose is reduced by 25 %, Bilirubin > 3.0 mg/dl, the first dose is reduced by 50 %. Initial therapy 500 mg/m(2) In combination with IV over 10 minutes on day 1, Cisplatin for the 2nd line followed 30 minutes later by treatment of patients with cisplatin 75 mg/m(2) infused Pemetrexed Disodium L01BA04016P3002 locally advanced or IV over 2 hours; repeat cycle 1220. A* 100 mg Injection XX metastatic non small cell every 21-days. Prior lung cancer (NSCLC) other chemotherapy : 500 mg/m(2) than predominantly IV, as a single-agent, over 10 squamous cell histology minutes on day 1 of each 21- day cycle In combination with Initial therapy 500 mg/m(2) Cisplatin for the 2nd line IV over 10 minutes on day 1, treatment of patients with followed 30 minutes later by Pemetrexed Disodium L01BA04016P3001 locally advanced or cisplatin 75 mg/m(2) infused 1221. A* 500 mg Injection XX metastatic non small cell IV over 2 hours; repeat cycle lung cancer (NSCLC) other every 21-days. Prior than predominantly chemotherapy : 500 mg/m(2) squamous cell histology IV, as a single-agent, over 10

259 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber minutes on day 1 of each 21- day cycle

Only for the treatment of 4 mg/kg once daily by slow Pentamidine Isethionate P01CX01198P300 1222. A* pneumonia due to IV infusion for at least 14 300 mg Injection 1XX Pneumocytosis carinii days Pentoxifylline 400 mg C04AD03000T100 1223. A/KK Peripheral vascular disease 400 mg 2 - 3 times daily Tablet 1XX High level disinfectant or Immersion time based on Peracetic Acid and V07AV00000L9906 1224. A sterilant for heat labile manufacturer Hydrogen Peroxide XX endoscopes recommendation Essential hypertension, for Perindopril 4 mg and patients whose blood One tablet daily, preferably C09BA04900T1001 1225. Indapamide 1.25 mg A/KK pressure is insufficiently taken in the morning and XX Tablet controlled by perindopril before a meal. alone. i) 4 mg as single dose, may be increased to a single 8 mg dose. ELDERLY: Start treatment with 2 mg dose. In renal insufficiency, dose should be adapted according to creatinine clearance ii) Single starting oral dose of i) Hypertension 2 mg should be increased to C09AA04000T1001 ii) Congestive heart failure a single 4 mg once BP 1226. Perindopril 4 mg Tablet B XX iii) Stable coronary artery acceptability has been disease demonstrated iii) 4 mg once daily for 2 weeks, may be increased to 8 mg once daily. ELDERLY: 2 mg once daily for 1 week, then 4 mg once daily for the following week, may be increased up to 8 mg once daily

260 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) 4 mg as single dose, may be increased to a single 8 mg dose. ELDERLY: Start treatment with 2 mg dose. In renal insufficiency, dose should be adapted according to creatinine clearance ii) Single starting oral dose of i) Hypertension 2 mg should be increased to C09AA04000T1002 ii) Congestive heart failure a single 4 mg once BP 1227. Perindopril 8 mg Tablet B XX iii) Stable coronary artery acceptability has been disease demonstrated iii) 4 mg once daily for 2 weeks, may be increased to 8 mg once daily. ELDERLY: 2 mg once daily for 1 week, then 4 mg once daily for the following week, may be increased up to 8 mg once daily Peritoneal Dialysis For chronic renal disease B05DB00908H200 Dose depending on clinical 1228. Solution (1.5% Dextrose 5 B requiring dialysis and for 1XX cases Litres) acute renal failure Peritoneal Dialysis For chronic renal disease B05DB00908H200 Dose depending on clinical 1229. Solution (4.25% Dextrose, B requiring dialysis and for 2XX cases 2 Litres) acute renal failure As a once replacement for a single glucose exchange as part of a continuous Administered as a single ambulatory peritoneal daily exchange for the long dialysis (CAPD) or dwell in continuous Peritoneal Dialysis with B05DB00908H200 automated peritoneal ambulatory peritoneal 1230. A* 7.5% Icodextrin Solution 3XX dialysis (APD) regimen for dialysis or automated the treatment of chronic peritoneal dialysis. The renal failure, particularly for recommended dwell time is 8 patients who have lost ultra to 16 hours filtration on glucose solutions Apply lotion onto clean towel dried hair ensuring every strand comes in contact with P03AC04000L6002 For topical treatment of 1231. Permethrin 1% w/v Lotion. B lotion for at least 10 minutes. XX head lice. Rinse completely. Re-apply after 10 days to ensure total recovery. Apply thoroughly to all body P03AC04000L6001 parts. Leave on for 8 - 14 1232. Permethrin 5% w/v Lotion A/KK Treatment of scabies XX hours. Not recommended for children less than 2 years old

261 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber ADULT: Initially 4 mg 3 times daily adjusted according to Perphenazine 4 mg N05AB03000T1001 Schizophrenia and other response, maximum 24 mg 1233. B Tablet XX psychoses daily. ELDERLY: 1/4 to 1/2 adult dose. CHILD not recommended ADULT: 0.5 - 2 mg/kg SC or For relief of moderate to IM every 3 - 4 hours if severe pain (medical and necessary. CHILD: by IM 0.5 Pethidine HCl 100 mg/2 N02AB02110P300 1234. B surgical), pre-anaesthetic - 2 mg/kg. Up to 1 year : 1- 2 ml Injection 2XX medication and obstetrical mg/kg weight IM, 1 - 5 years analgesia : 12.5 - 25 mg IM, 6 - 12 years: 25 - 50 mg IM ADULT: 0.5 - 2 mg/kg SC or For relief of moderate to IM every 3 - 4 hours if severe pain (medical and necessary. CHILD: by IM 0.5 Pethidine HCl 50 mg/ml N02AB02110P300 1235. B surgical), pre-anaesthetic - 2 mg/kg. Up to 1 year : 1- 2 Injection 1XX medication and obstetrical mg/kg weight IM, 1 - 5 years analgesia : 12.5 - 25 mg IM, 6 - 12 years: 25 - 50 mg IM ADULT: 60 - 180 mg daily Phenobarbitone 30 mg N03AA02000T1002 1236. B Epilepsy on. CHILD: Up to 8 mg/kg Tablet XX daily ADULT: 10 mg/kg IV at a rate of not faster than 100 mg/minute. Initial maximum dose does not exceeding 1 gm. Daily maintenance of 1 - Phenobarbitone Sodium N03AA02520P300 1237. B Status Epilepticus 4 mg/kg/day. CHILD: 10 - 20 200 mg/ml Injection 1XX mg/kg/dose loading dose, followed by repeated doses at 10 mg/kg/dose (strictly in ICU setting). Maintenance 5 - 8 mg/kg/day D08AE03000L5001 1238. Phenol 80% w/w Liquid C As disinfectant Use in various dilutions XX Hypertensive episodes 1 mg/kg daily over at least 2 Phenoxybenzamine HCl C04AX02110P300 1239. A* associated with hours into large vein. Do not 100 mg/2 ml Injection 1XX phaeochromocytoma repeat within 24 hours. i) ADULT: 500 - 750 mg 6 hourly.CHILD; up to 1 year: 62.5 mg, 1 - 5 years: 125 i) Treatment or prophylaxis mg, 6 - 12 years: 250 mg 6 of infections caused by Phenoxymethyl Penicillin J01CE02500T1001 hourly 1240. C susceptible organisms 125 mg Tablet XX ii) ADULT: 125 - 250 mg ii) Prophylactic, rheumatic twice daily. CHILD: 25 - 50 fever mg/kg in divided doses every 6 - 8 hours. Maximum: 3 g/day

262 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber CHILD: Up to 1 year: 62.5 Treatment or prophylaxis of Phenoxymethyl Penicillin J01CE02500F2101 mg 6 hourly; 1 - 5 years: 125 1241. C infections caused by 125 mg/5 ml Syrup XX mg 6 hourly; 6 - 12 years: susceptible organisms 250 mg 6 hourly i) ADULT: 500 - 750 mg 6 hourly.CHILD; up to 1 year: 62.5 mg, 1 - 5 years: 125 i) Treatment or prophylaxis mg, 6 - 12 years: 250 mg 6 of infections caused by Phenoxymethyl Penicillin J01CE02500T1002 hourly 1242. C susceptible organisms 250 mg Tablet XX ii) ADULT: 125 - 250 mg ii) Prophylactic, rheumatic twice daily. CHILD: 25 - 50 fever mg/kg in divided doses every 6 - 8 hours. Maximum: 3 g/day Mydriasis and vasoconstriction: 1 drop of 2.5% or 10% solution, repeated in one hour if necessary. Chronic mydriasis: 1 drop of a 2.5% For pupillary dilation in or 10% solution 2 - 3 times a uveitis, for refraction without day. Uveitis with posterior Phenylephrine HCI 2.5% S01FB01110D2001 1243. B cyclopegic. For fundoscopy synechiae (treatment) or Eye Drops XX and other diagnostic synechiae, posterior procedures (prophylaxis): 1 drop of a 2.5% or 10% solution, repeated in one hour if necessary, not to exceed three times a day. Treatment may be continued the following day, if necessary Mydriasis and vasoconstriction: 1 drop of 2.5% or 10% solution, repeated in one hour if necessary. Chronic mydriasis: 1 drop of a 2.5% For pupillary dilation in or 10% solution 2 - 3 times a uveitis, for refraction without day. Uveitis with posterior Phenylephrine HCl 10% S01FB01110D2002 1244. B cyclopegic. For fundoscopy synechiae (treatment) or Eye Drops XX and other diagnostic synechiae, posterior procedures (prophylaxis): 1 drop of a 2.5% or 10% solution, repeated in one hour if necessary, not to exceed three times a day. Treatment may be continued the following day, if necessary

263 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber ADULT and CHILD more than 6 years: 300-400 mg/day in 3 - 4 divided doses before meals. Maximum: 600 Phenytoin Sodium 100 N03AB02520C100 1245. B Epilepsy mg/day. CHILD: Initially 5 mg Capsule 2XX mg/kg/day in 2 - 3 divided doses. Maintenance: 4 - 8 mg/kg/day. Maximum: 300 mg/day ADULT: Patients with no previous treatment may be started on 1 teaspoonful or 5 mL (125 milligrams) 3 times daily. It is then individualized to the patient. An increase to 5 teaspoonfuls (625 Phenytoin Sodium 125 N03AB02520L8001 milligrams) may be made if 1246. B Epilepsy mg/5ml Suspension XX necessary. CHILD: Initially 5 mg/kg/day in 2 - 3 divided doses. Maintenance: 4 - 8 mg/kg/day. Maximum: 300 mg/day. Children over 6 years and adolescents may require the minimum adult dose (300mg/day). ADULT and CHILD more than 6 years: 300-400 mg/day in 3 - 4 divided doses before meals. Maximum: 600 Phenytoin Sodium 30 mg N03AB02520C100 1247. B Epilepsy mg/day. CHILD: Initially 5 Capsule 1XX mg/kg/day in 2 - 3 divided doses. Maintenance: 4 - 8 mg/kg/day. Maximum: 300 mg/day i) Status epilepticus: ADULT 10 - 15 mg/kg by slow IV. Maximum 50 mg/minute. Maintenance: 100 mg orally/IV every 6 - 8 hours. Phenytoin Sodium N03AB02520P300 1248. B Status epilepticus CHILD 15 - 20 mg/kg by slow 50mg/ml lnjection 1XX IV. Maximum: 1 - 3 mg/kg/minute ii) Neurosurgery 100 - 200 mg IM approximately at 4 hourly interval Phosphate Solution For supplemental ionic B05XA09902L5001 According to the needs of the 1249. containing Sodium Acid A phosphorus for correction of XX patient Phosphate 1.936 g /15 ml hypophosphataemia 2 capsules to be taken orally, Phyllanthus Niruri Extract HA05BA5999C100 1250. A/KK Liver tonic 3 times a day, before or after 250 mg Capsule 1XX meals

264 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber S01EB01110D200 Miotics in chronic open- 1251. Pilocarpine 1% Eye Drops B 1 drop 1 - 4 times a day 1XX angle glaucoma S01EB01110D200 Miotics in chronic open- 1252. Pilocarpine 2% Eye Drops B 1 drop 1 - 4 times a day 2XX angle glaucoma S01EB01110D200 Miotics in chronic open- 1253. Pilocarpine 4% Eye Drops B 1 drop 1 - 4 times a day 3XX angle glaucoma Adult and children more than 12 years: 4.5g 6 hourly, for Piperacillin 4 g & Febrile neutropenia, lower J01CR05961P3001 neutropenia adult and 1254. Tazobactam 500 mg A* respiratory tract infection XX children more than 50kg: Injection and severe sepsis 4.5g 6 hourly. Children less than 50kg: 90mg/kg 6 hourly ADULT: 100 - 150 mg/kg IM/IV in divided doses. Increase to 200 - 300 mg/kg in severe infections & at least Piperacillin Sodium 4 g J01CA12520P4002 Infections due to 16 g in life-threatening 1255. A Injection XX Pseudomonas aeruginosa infections. Single dose over 2 g: IV route only. Maximum: 24 g/day. CHILD: 50-75 mg/kg/dose every 6 - 8 hourly 30 - 160 mg/kg/day orally or N06BX03000P300 Treatment of cerebral parenterally 2 times daily or 1256. Piracetam 1 g Injection A* 1XX functional impairment 3 to 4 times daily. Maximum: 24 g/day Initially 7.2 g daily in 2 - 3 Mild cognitive impairment, divided doses, increased post concussional head according to response by 4.8 N06BX03000T1001 1257. Piracetam 1.2 g Tablet A* syndrome, head injury g daily every 3 - 4 days to XX disorder, chronic vertigo maximum of 20 g daily. and myoclonus CHILD under 16 years not recommended Children with learning 30 - 160 mg/kg/day orally. To N06BX03000L5001 disability, progressive be given 2 times daily or 3 - 1258. Piracetam 20% Solution A* XX myoclonic epilepsy and 4 times daily. Maximum 24 hypoxia g/day As monotherapy: 150 - 250 mg as 3 - 5 divided doses N04BC08000T500 daily. As combination with L- 1259. Piribedil 50 mg Tablet A* Parkinson disease 1XX dopa therapy: 50 - 150 mg daily (50 mg per 250 mg of L-dopa) i) 20 mg daily, maintenance i) Rheumatoid arthritis, 10 - 30 mg daily, in single or osteoarthritis, ankylosing divided doses M01AC01000C100 spondylitis ii) 40 mg daily in single or 1260. Piroxicam 10 mg Capsule A/KK 1XX ii) Acute musculoskeletal divided doses for 2 days, disorders then 20 mg daily for 7 - 14 iii) Acute gout days iii) 40 mg initially, then 40 mg

265 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber daily in single or divided doses for 4 - 6 days

Starting with 0.5mg daily, the dosage should be progressively increased. The average maintenance dosage is 1.5mg daily in N02CX01253T100 Prophylactic treatment of 1261. Pizotifen 0.5 mg Tablet B divided doses or as a single 1XX vascular headache dose at night. Max dose: 4.5 mg/day and 3 mg/dose. Child: >2 yr: Up to 1.5 mg daily in divided doses. Max dose: 1 mg/dose. Primary injection: 1 single Prevention of injection (0.5 ml) only. pneumococcal infections in Booster: Must not be given high risk subjects from the Pneumococcal Vaccine J07AL01000P3001 within 5 years except in very 1262. A age of 2 years including (Polyvalent) XX high risk patient who patient with a history of received the vaccine while splenectomy or scheduled under immunosuppressive splenectomy treatment Apply 2 - 3 drops carefully to lesion after protecting surrounding area with Podophyllum 10 - 20% D06BB04000L7001 1263. B External anogenital warts vaseline. Wash off after 6 Paint XX hours or if feel burning sensation and repeat 2 - 3 times weekly or once weekly Local treatment of cervical and vaginal inflammation and tissue damage eg. For cauterization, undiluted discharge due to bacterial, once or twice weekly whilst Policresulen 360 mg/g G01AX03900L9901 trichomonal and fungal 1264. A for vaginal douches, to be Concentrate XX infections, protrusions of diluted 1 part concentrate to endocervical mucosa 5 parts of water (erosion), haemostasis following biopsy or excision of uterine polyps Two drops (0.1 ml). Primary immunization: 1 oral dose at Poliomyelitis Oral Live J07BF02000D5001 Immunisation against 1265. C+ 3,4 & 5 month of age. Vaccine (10 Doses) XX poliomyelitis Booster doses at 1-4 years & 7 years.

266 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber The usual dose of potassium citrate is 30 - 60 mEq/day orally in 3 or 4 doses with meals or within 30 minutes A12BA02955L9001 For treatment of calcium 1266. Polycitra Syrup C after meals. ADULT: 15 ml 3 XX and uric acid stones times daily well diluted with water. CHILD 5-15 ml 3 times daily, after meals and at bedtime. 1 sachet dissolved in 1 L of water. 2-3 L of oral solution are required. When morning Bowel cleansing prior to surgery is planned, the oral colonoscopy, radiological solution is given in the late Polyethylene Glycol A06AD15000F2101 examination or colonic afternoon the day prior. If 1267. A /Macrogol 4000 Powder XX surgery. Suitable for surgery is scheduled in patients with heart failure or afternoon, the oral solution renal failure should be given on the same day for ingestion to be completed three hours before surgery 3 drops 3 - 4 times daily. External auditory meatus and Polymyxin B Sulphate Treatment of bacterial canal to be thoroughly 10,000 U, Neomycin S02CA03991D100 infection and inflammation cleansed and dried before 1268. Sulphate 5 mg and B 1XX of the external auditory each application but soap Hydrocortisone 10 mg Ear meatus should not be used as the Drops antibiotics may be inactivated by it Prophylaxis of invasive Prophylaxis of invasive fungal infections in the fungal infections: 200mg following adult patients: (5ml) three times a day. The i. Patient receiving duration of therapy is based remission-induction on recovery from chemotherapy for acute neutropenia or myelogenous leukemia immunosuppression. For (AML) or myelodysplastic patients with acute syndrome (MDS) expected myelogenous leukemia or to result in prolonged myelodysplastic syndromes, Posaconazole 40mg/ml J02AC04000L8001 neutropenia and who are at 1269. A* prophylaxis with Oral Suspension XX high risk of developing posaconazole should start invasive fungal infections. several days before the ii. Haematopoietic stem cell anticipated onset of transplant (HSCT) neutropenia and continue 7 recipients who are days after the neutrophil undergoing high-dose count rises above immunosuppressive 500cell/mm3. Increasing the therapy for graft versus host total daily dose above 800mg disease and who are at does not further enhance the high risk of developing exposure to posaconazole. invasive fungal infections.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Dosage depends on the age, weight, clinical and biological Potassium Chloride (acid-base balance) Prevention and treatment of 0.15% w/v & Sodium A06AD10921L9902 conditions of the patient and 1270. B potassium, sodium and Chloride 0.9% w/v XX concomitant therapy. chloride depletion Injection Maximum recommended dose of potassium is 2 to 3 mmol/kg/24hr By slow IV infusion depending on the deficit or For the correction of severe the daily maintenance Potassium Chloride 1 B05XA01100P3001 hypokalaemia and when 1271. B requirements. 1 g diluted in g/10 ml Injection XX sufficient potassium cannot 500 ml normal saline or be taken by mouth glucose and given slowly over 2 - 3 hours Potassium Chloride 1 A12BA01100L2101 1 g once or twice daily until 1272. C Potassium depletion g/15 ml Mixture XX serum potassium is restored ADULT: 2 - 3 tablets daily. For the treatment and Potassium Chloride 600 A12BA01100T5001 Severe deficiency: 9 - 12 1273. B specific prevention of mg SR Tablet XX tablets daily or according to hypokalaemia the needs of the patient ADULT: 15-30 ml well diluted with water. CHILD up to 1 year: 2.5 ml 3 times daily; 1 - Potassium Citrate 3 g/10 A12BA02955L2101 For systemic or urine 5 years: 5 ml 3 times daily; 6 1274. C ml and Citric Acid Mixture XX alkalinization - 12 years: 10 ml 3 times daily. To be taken well diluted with water, after meals and at bedtime. Potassium Dihydrogen B05XA06170P3001 For treatment of Up to 10mmol phosphate 1275. A Phosphate Injection XX hypophosphataemia administered over 12 hours Pre-operative management H03CA00200L2101 ADULT and CHILD: 50 - 250 1276. Potassium Iodide Mixture B of hyperthyroidism and XX mg 3 times daily thyrotoxicosis Cleansing and deodorising Potassium Permanganate D08AX06362L9901 As soaks or wet dressing 1 - 1277. C+ suppurative eczematous 1:10,000 Solution XX 3 times daily or as required reactions and wounds Cleansing and deodorising Potassium Permanganate D08AX06362L9902 As a bath once to twice daily 1278. C suppurative eczematous 1:20,000 Solution XX or as required reactions and wounds Skin operation prior to To be applied undiluted in Povidone Iodine 10% D08AG02000L990 surgery, in cleansing open pre-operative skin 1279. (equivalent to 1% iodine) B 2XX wounds, as an antiseptic for disinfection and general Solution operative wounds infections antisepsis. Spread 5 ml over both hands and rub thoroughly for about Povidone Iodine 7.5% D08AG02000L990 As preoperative scrub for 5 minutes. Rinse thoroughly. 1280. (equivalent to 0.75% B 1XX hands and skin Repeat if desired. Pre- iodine) Scrub operative use on patient: Apply scrub and rub

268 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber thoroughly for about 5 minutes. Rinse off using a sterile gauze saturated with water

Adult: Used in combination with atropine. Admin atropine via IM/IV inj and repeat as needed until patient shows signs of atropine toxicity. Maintain atropinisation for at least 48 hr. As soon as the effects of atropine are observed, 1-2 g of pralidoxime (chloride, iodide or mesilate) may be given via Antidote in the treatment of IM/IV inj. Repeat dose after 1 organophosphorus hr, then every 8-12 hr, if insecticide poisoning and in necessary. In severe Pralidoxime 25 mg/ml V03AB04000P3002 1281. B the control of overdosage poisoning, continuous Injection XX by anticholinergic drugs infusion of 200-500 mg/hr used in the treatment of may be given, titrated myasthenia gravis according to response. Alternatively, pralidoxime chloride may be given at an initial dose of 30 mg/kg via IV infusion over 20 minutes or IV inj over 5 minutes, followed by IV infusion at 8 mg/kg/hr. Max: 12 g/24 hr. Child: As mesilate: 20-60 mg/kg. Renal impairment: Dose adjustment may be required. Dose escalation: 0.125 mg 3 times daily on week 1 then 0.25 mg 3 times daily week 2 then 0.5 mg 3 times daily on week 3. Increase by 0.75 mg at weekly intervals if needed Treatment for signs and up to maximum of 4.5 symptoms of advanced Pramipexole mg/day. Patient on levodopa: N04BC05110T100 idiopathic Parkinson's 1282. Dihydrochloride 0.125 mg A* Reduce dose. Renal 1XX disease. It may be used as Tablet impairment: In patient with monotherapy or in creatinine clearance < combination with levodopa 20ml/min, the daily dose of pramipexole should be started at 0.125 mg daily instead of 0.25mg and the maximum dose should not > 1.5 mg daily 269 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Dose escalation: 0.125 mg 3 times daily on week 1 then 0.25 mg 3 times daily week 2 then 0.5 mg 3 times daily on week 3. Increase by 0.75 mg at weekly intervals if needed Treatment for signs and up to maximum of 4.5 symptoms of advanced Pramipexole mg/day. Patient on levodopa: N04BC05110T100 idiopathic Parkinson's 1283. Dihydrochloride 1 mg A* Reduced dose. Renal 2XX disease. It may be used as Tablet impairment: In patient with monotherapy or in creatinine clearance < combination with levodopa 20ml/min, the daily dose of pramipexole should be started at 0.125 mg daily instead of 0.25mg and the maximum dose should not > 1.5 mg daily Dose escalation: 0.375 mg/day on week 1, 0.75 mg/day on week 2, 1.5 mg/day on week 3. Increase Treatment for signs and by 0.75 mg at weekly symptoms of advanced intervals if needed up to a Pramipexole N04BC05110T500 idiopathic Parkinson's max of 4.5 mg/day. Patient 1284. Dihydrochloride Extended A 1XX disease. It may be used as on l-dopa: reduce dose. Release 0.375mg Tablet monotherapy or in Renal Impairment: CrCl 30- combination with levodopa 50 mL/min Initially 0.375 mg every other day. May be increased by 0.375 mg at weekly intervals to max 2.25 mg/day Dose escalation: 0.375 mg/day on week 1, 0.75 mg/day on week 2, 1.5 mg/day on week 3. Increase Treatment for signs and by 0.75 mg at weekly symptoms of advanced intervals if needed up to a Pramipexole N04BC05110T500 idiopathic Parkinson's max of 4.5 mg/day. Patient 1285. Dihydrochloride Extended A 3XX disease. It may be used as on l-dopa: reduce dose. Release 1.5mg Tablet monotherapy or in Renal Impairment: CrCl 30- combination with levodopa 50 mL/min Initially 0.375 mg every other day. May be increased by 0.375 mg at weekly intervals to max 2.25 mg/day

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Co-administered with aspirin, is indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndromes who are to be managed Initiate treatment with a with percutaneous coronary single 60mg oral loading intervention (PCI) as dose. Continue at 10mg/5mg Prasugrel HCl 10 mg B01AC22110T1002 1286. A* follows: STEMI with or once daily with or without Tablet XX without diabetes, UA and food. Patients should also NSTEMI with diabetes, age take aspirin (75 mg - 325 <75yrs old, weight >60kg, mg) daily. without history of TIA stroke and clinically suspected clopidogrel resistance subset. (Only to be used in Cardiology Centre as third line treatment/ adjunctive therapy). 10 - 20 mg once daily. Maximum: 40 mg daily. In Hypercholesterolaemia and patients concomitantly taking coronary heart disease cyclosporine, with or without intolerant or not responsive Pravastatin Sodium 20 C10AA03520T1001 other immunosuppressive 1287. A/KK to other forms of therapy. In mg Tablet XX drugs: Initial dose is health clinics, Pravastatin is 10mg/day and titration to restricted to HIV patients on higher doses should be HAART. performed with caution. Maximum dose 20mg/day. Initially 0.5 mg 2 - 3 times daily, the initial dose on retiring to bed at night; C02CA01110T100 1288. Prazosin HCl 1 mg Tablet B Hypertension increased to 1 mg 2 - 3 times 1XX daily after 3 - 7 days: further increased if necessary to maximum 20 mg daily Initially 0.5 mg 2 - 3 times daily, the initial dose on retiring to bed at night; C02CA01110T100 1289. Prazosin HCl 2 mg Tablet B Hypertension increased to 1 mg 2 - 3 times 2XX daily after 3 - 7 days: further increased if necessary to maximum 20 mg daily Initially 0.5 mg 2 - 3 times daily, the initial dose on retiring to bed at night; C02CA01110T100 1290. Prazosin HCl 5 mg Tablet B Hypertension increased to 1 mg 2 - 3 times 3XX daily after 3 - 7 days: further increased if necessary to maximum 20 mg daily

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Vitamin and mineral Pre/Post Natal Vitamin & A11AA03903C100 1 capsule daily or based on 1291. C+ supplement for use during Mineral Capsule 1XX individual requirements pregnancy and lactation Vitamin and mineral Pre/Post Natal Vitamin & A11AA03903T1001 1 tablet daily or based on 1292. C+ supplement for use during Mineral Tablet XX individual requirements pregnancy and lactation i) 5 - 25 mg daily in divided doses i) Replacement therapy for ii) 10 - 20 mg/m2 body primary and secondary surface daily in divided Prednisolone 3 mg/5 ml H02AB06000L9001 1293. B adrenocortical insufficiency doses Syrup XX ii) Adrenogenital syndrome iii) ADULT: 5 - 60 mg daily. iii) Other therapy CHILD: 0.5 - 2 mg/kg/day in divided doses every 6 - 8 hours or as a single daily i) 5 - 25 mg daily in divided doses i) Replacement therapy for ii) 10 - 20 mg/m2 body primary and secondary surface daily in divided H02AB06000T1001 1294. Prednisolone 5 mg Tablet B adrenocortical insufficiency doses XX ii) Adrenogenital syndrome iii) ADULT: 5 - 60 mg daily. iii) Other therapy CHILD: 0.5 - 2 mg/kg/day in divided doses every 6 - 8 hours or as a single daily i) Initially, 75 mg twice daily. May be increased to 150 mg twice daily after 3-7 days. i) Second line treatment of Max: 600 mg/day after an neuropathic pain in patients Pregabalin 150 mg N03AX16000C100 additional 7-day interval 1295. A* who do not response to first Capsules 2XX ii) Initially, 75 mg twice daily. line drugs May be increased to 150 mg ii) Fibromyalgia twice daily within 1 week or 225 mg twice daily. Max: 450 mg/day i) Initially, 75 mg twice daily. May be increased to 150 mg twice daily after 3-7 days. i) Second line treatment of Max: 600 mg/day after an neuropathic pain in patients Pregabalin 75 mg N03AX16000C100 additional 7-day interval 1296. A* who do not response to first Capsule 1XX ii) Initially, 75 mg twice daily. line drugs May be increased to 150 mg ii) Fibromyalgia twice daily within 1 week or 225 mg twice daily. Max: 450 mg/day i) 15 mg daily for 14 days, increased to higher doses or i) Treatment of malaria longer course if resistance in Primaquine 7.5 mg base P01BA03162T1001 ii) Prophylaxis together with P.vivax occurs. 1297. B Tablet XX a schizonticide such as ii) ADULT: 30 mg once chloroquine weekly. CHILD: 0.5 mg once weekly Child: 250 mcg/kg daily for 14 days. Should be

272 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber taken with food. Take with meals to avoid GI discomfort.

ADULT: Initially 1 tablet daily in the evening, increasing by 1 tablet every 4 - 7 days to 3 N03AA03000T1001 1298. Primidone 250 mg Tablet B Epilepsy - 4 tablets daily. Maximum XX dosage: 1.5 g daily in divided doses. CHILD: 6 - 8 years: Up to 1/2 adult dose Hyperuricemia associated with gout and gouty arthritis Probenecid 500 mg M04AB01000T100 (for cases allergic to 500 mg to 1000 mg twice 1299. A Tablet 1XX allopurinol or serum uric daily acid not controlled by allopurinol alone) ADULT: 300,000 - 900,000 units (300 - 900 mg) IM daily. Procaine Benzylpenicillin Treatment of infections due J01CE09702P4001 CHILD: Up to 1 year: 150 mg 1300. Aqueous 3 mega units (3 B to Penicillin G-sensitive XX IM daily. 1 - 5 years: 300 mg g) Injection organisms IM daily. 6 - 12 years: 600 mg IM daily ADULT: 300,000 - 900,000 units (300 - 900 mg) IM daily. Treatment of infections due Procaine Penicillin J01CE09702P4002 CHILD: Up to 1 year: 150 mg 1301. B to Penicillin G-sensitive Fortified 4 MU Injection XX IM daily. 1 - 5 years: 300 mg organisms IM daily. 6 - 12 years: 600 mg IM daily Adult: Monotherapy: Initially, 50 mg/day, increased by 50 mg daily to 250-300 mg daily in divided doses. Continue doses until max response is achieved or appearance of signs of toxicity. Procarbazine HCl 50 mg L01XB01110C1001 Maintenance: 50-150 mg/day 1302. A Lymphomas Capsule XX or 1-2 mg/kg daily until a cumulative dose of at least 6 g. Combination Therapy: 100 mg/m2 on days 1-14 of each 4- or 6-wk cycle. Child: Initially, 50 mg/m2 daily, up to 100 mg/m2 adjust according to response.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Nausea and vomiting Adult: As maleate or mesilate: 20 mg, further doses are given if needed. Recommended buccal dose: As maleate: 3-6 i) Severe nausea and mg bid. Vertigo Adult: As Prochlorperazine Maleate N05AB04253T1002 vomiting 1303. B maleate or mesilate: 15-30 5mg Tablet XX ii) Vertigo/labyrinthine mg daily, given in divided disorders doses. May reduce gradually to 5-10 mg daily. Recommended buccal dose: 3-6 mg bid. May be taken with or without food. Deep IM injection, 12.5 mg i) Severe nausea and Prochlorperazine repeated if necessary after 6 N05AB04253P300 vomiting 1304. Mesylate 12.5 mg/ml B hours and then followed by 1XX ii) Vertigo/labyrinthine Injection an oral dose. Not disorders recommended in children i) Initial dose 2.5mg TDS, increasing by 2.5-5mg/day at i) All forms of Parkinson's intervals of 2 or 3 days until disease (idiopathic the optimum clinical paralysis agitants), post- response is achieved. Usual encephalitis and maintenance dose: 15- arteriosclerosis 30mg/day. Max: 60mg/day Procyclidine HCl 5 mg/ ml N04AA04110P300 ii) To control troublesome ii) Initial dose 2.5mg TDS, 1305. B Injection 1XX extrapyramidal symptoms increasing by 2.5mg daily induced by neuroleptic until symptoms are relieved. drugs including pseudo- Usual maintenance dose: 10- parkinsonism, acute 30mg/day. IV Emergency: 5- dystonic reactions and 10 mg. IM Emergency: 5-10 akathisia mg as a single dose, may repeat after 20 mins if needed. Max: 20 mg/day. Oral route: On average for progesterone insufficiency, the daily dose of progesterone is 200-300mg per day; one capsule after Progesterone 100 mg G03DA04000C100 Supplementation of the breakfast and one to two 1306. A* capsule 1XX luteal phase. capsules at bedtime. Vaginal route: 4 to 6 capsules (in 2 to 3 divided doses) per day starting from the day of the HCG injection until the 12th week of pregnancy. 90 mg intravaginally daily Progesterone 8% Vaginal G03DA04000G300 Treatment of infertility due 1307. A* from day of egg retrieval till Gel 1XX to inadequate luteal phase pregnancy established Oedema and inflammation M09AB00000T100 1308. Prolase Tablet B in conjunction with other 2 tablet 4 times daily 1XX physical or

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber chemotherapeutic measures By deep IM: ADULT: 25 - 50 mg, maximum 100 mg. CHILD 5 - 10 years : 6.25 - Promethazine HCl 25 R06AD02110P300 1309. B Allergic conditions 12.5 mg. By slow IV: 25 - 50 mg/ml Injection 1XX mg in a solution of 2.5 mg/ml in water for injection. Maximum 100 mg CHILD 2 - 5 years: 5 - 15 mg Promethazine HCl 5 mg/5 R06AD02110L9001 1310. B Allergic conditions daily 5 - 10 years : 10 - 25 ml Syrup XX mg daily Deep anaesthesia:1 or 2 drops in the (eyes) every 5 to 10 minutes for 3 to 5 doses. For minor surgical Proparacaine HCI 0.5% S01HA04110D200 Topical anaesthesia in procedures: instill 1 to 2 1311. B Ophthalmic Drops 1XX ophthalmic procedures drops every 5 to 10 minutes for 1 to 3 doses. Tonometry and/or tonography procedure: 1 to 2 drops in each eye before procedure. Treatment of urinary ADULT: 15 mg twice daily to incontinence, urgency and 3 times daily, increase to 4 frequency in neurogenic times daily if required. Max Propiverine HCl 15 mg G04BD06110T100 detrusor overactivity 1312. A* dose: 60 mg daily. CHILD Tablet 1XX (detrusor hyperreflexia) and more than 5 years: 0.2 to 0.4 in idiopathic detrusor mg/kg per day in 2 divided overactivity (overactive doses bladder) Adult: Induction: 20- 40 mg by injection or infusion every 10 sec. Usual dose: 1.5-2.5 mg/kg. Maintenance: 4-12 mg/kg/hr or intermittent bolus inj of 20-50 mg. Child: >8 yr: Induction dose of 2.5 mg/kg. Maintenance dose: 9-15 Induction & maintenance of mg/kg/hr by IV infusion or Propofol 10mg/ml (1%) N01AX10000P990 general anaesthesia. intermittent bolus inj. Elderly: 1313. A* Injection 1XX Sedation of ventilated ICU Including neurosurgical and patients debilitated patients: Infuse at a rate of 20 mg every 10 sec. Maintenance: 3-6 mg/kg/hr. Usual dose needed: 1-1.5 mg/kg. Duration of use : Can be administered for a maximum period of 7 days. Sedation: 0.3 - 4 mg/kg/hour up to 3 days

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Adult: IV Induction and maintenance of general anesth Induction: 40 mg every 10 sec. Maintenance: 4-12 mg/kg/hr or intermittent Induction & maintenance of boluses of 20-50 mg. Propofol 20mg/ml (2%) N01AX10000P990 general anaesthesia. Sedation In diagnostic and 1314. emulsion for injection of A* 2XX Sedation of ventilated ICU surgical procedures: Initial: infusion patients 6-9 mg/kg/hr by infusion. Maintenance: 1.5-4.5 mg/kg/hr. For ventilated patients: 0.3-4 mg/kg/hr. Monitor lipid concentrations if duration of sedation >3 days. Slow IV injection in a dose of 1 mg over 1 minute, repeated if necessary every 2 minutes until a maximum of Propranolol HCl 1 mg/ml C07AA05110P300 Arrhythmias and 10 mg has been given in 1315. A Injection 1XX thyrotoxicosis crisis conscious patients and 5 mg in patients under anaesthesia. CHILD: 25 - 50 mcg/kg slow IV with appropriate monitoring Dysrythmias, tachycardia, Propranolol HCl 10 mg C07AA05110T1001 hypertrophic obstructive 1316. B 10 - 40 mg 3 - 4 times daily Tablet XX cardiomyopathy (For cardiologist only) i) Initially 80 mg twice daily increased as required to a usual range of 160 - 320 mg daily. CHILD: Initial doses of 1 mg/kg in divided doses, can be increased to 2 - 4 mg/kg/day in divided doses ii) Initial dose of 40 mg 2 - 3 times daily. Maintenance 120 i) Hypertension - 240 mg daily ii) Angina iii) 40mg 4 times daily for 2 - iii) Myocardial infarct Propranolol HCl 40 mg C07AA05110T1002 3 days then 80 mg twice 1317. B iv) Cardiac arrhythmia Tablet XX daily, beginning 5 - 21 days v) Portal hypertension after infarction vi) Migraine iv) 10 - 40 mg 3 - 4 times vii) Thyrotoxicosis daily v) Initially 40 mg twice daily. The dose may be increased as required up to 160 mg twice daily vi) Initial prophylaxis dose: 40 mg 2 - 3 times daily. The dose may be increased at weekly intervals up to 160

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber mg daily vii) Adjunct: 10 - 40 mg 3 - 4 times daily. CHILD: Arrythmias, thyrotoxicosis: 0.25 - 0.5 mg/kg 3 - 4 times daily as required

ADULT Initially 300-450mg in 8 hourly intervals (can be given up to 600-900mg/daily) until symptoms are controlled in 1-2 months. Maintenance Propylthiouracil 50 mg H03BA02000T1001 50-150mg daily for at least 1318. B Hyperthyroidism Tablet XX 12-18 months. CHILDREN 6- 10 years: 50-150mg. CHILDREN > 10 years: 150- 300mg daily. All doses are to be given in 3 divided doses daily. Taken with food. 5 ml slow IV injected over 10 minutes. If administered within 15 minutes of heparin dose, 1 mg will neutralise approximately 100 units of Heparin overdose and heparin. If longer time has following cardiac or arterial elapsed, less protamine is surgery or dialysis required. Not more than 50 Protamine Sulphate 10 V03AB14183P3001 1319. B procedures when required mg should be injected at any mg/ml Injection XX to neutralize the effects of one time. The dose is heparin administered during dependent on the amount extracorporeal circulation and type of heparin to be neutralised, its route of administration and the time elapsed since it was last given and blood coagulation studies.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Trophic lesions in patients with arterial occlusive disease and with chronic Protein Free D03AX00000G400 venous insufficiency, burn 1320. Haemodialysate 10% A Apply 3 - 5 times daily 1XX injuries, impaired wound Jelly healing, decubitus ulcers and skin ulcer caused by irradiation Eyes disorders e.g. burns, Protein Free scalds, ulcers, prevention S01XA20000G300 1321. Haemodialysate 20% Eye A and treatment of radiation Instill 1 drop 3 - 4 times daily 1XX Gel dermatitis, traumatic and ischaemic wound Trophic lesions in patients with arterial occlusive disease and with chronic Protein Free D03AX00000G500 venous insufficiency, burn 1322. Haemodialysate 5% A Apply 3 - 5 times daily 1XX injuries, impaired wound Ointment healing, decubitus ulcers and skin ulcer caused by irradiation Painful and inflammatory affliction on the oral Protein Free mucosa, gums and lips, D03AX00000G600 Apply to lesions 3 - 5 times 1323. Haemodialysate Dental A teething pain, denture 1XX daily Adhesive Paste pressure sores, oral and maxillofacial surgery and dressing after scaling ADULT and CHILD : 2 years Pyrantel Pamoate 125 mg P02CC01127T100 and older - single dose 1324. C Intestinal nematodes Tablet 1XX 10mg/kg body weight once. Maximum 1 g ADULT and CHILD : 2 years Pyrantel Pamoate 250 mg P02CC01127T100 and older - single dose 1325. C Intestinal nematodes Tablet 2XX 10mg/kg body weight once. Maximum 1 g Adult: 20-40mg/kg daily (max 1500mg) or 50mg/kg Pyrazinamide 500 mg J04AK01000T1001 1326. B Tuberculosis biweekly (max 2000mg). Tablet XX Children: 20-30mg/kg daily or 30-40mg/kg thrice weekly. ADULT: 30 - 120 mg at suitable intervals throughout the day, total daily dose 0.3 - Pyridostigmine Bromide N07AA02320T1001 1327. B Myasthenia gravis 1.2 g. CHILD up to 6 years 60 mg Tablet XX initially 30 mg, 6 - 12 years initially 60 mg, usual total daily dose 30 - 360 mg

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Pyridoxine-dependent i) INFANT 4 mg/kg daily for convulsions in infant short periods ii) Sideroblastic anaemia ii) 100 - 400 mg daily in iii) B6-deficient anaemia in divided doses Pyridoxine HCl 10 mg A11HA02110T1001 adult iii) ADULT 20 - 50 mg up to 3 1328. C+ Tablet XX iv) Prophylaxis to peripheral times daily neuritis in isoniazid therapy iv) Prophylaxis 10 mg daily, v) Nausea and vomiting of therapeutic 50 mg 3 times pregnancy and irradiation daily sickness v) 20 - 100 mg daily i) Pyridoxine-dependent i) INFANT 4 mg/kg daily for convulsions in infancy short periods ii) Sideroblastic anaemia ii) 100 - 400 mg daily in iii) B6-deficient anaemia in divided doses Pyridoxine HCl 50 mg/2 A11HA02110P300 adult iii) ADULT 20 - 50 mg up to 3 1329. B ml Injection 1XX iv) Prophylaxis to peripheral times daily neuritis in isoniazid therapy iv) Prophylaxis 10 mg daily, v) Nausea and vomiting of therapeutic 50 mg 3 times pregnancy and irradiation daily sickness v) 20 - 100 mg daily i) Initial titration schedule over 4 days: 25 mg twice daily on Day 1, increase in steps of 25 - 50 mg 2 to 3 times daily on Days 2 and 3 to reach target dose of 300 - 400 mg daily by Day 4, given in 2 - 3 divided doses. Institute further dose adjustments, if indicated, at intervals of 2 days or more, i) Schizophrenia in steps of 25 - 50 mg twice ii) Short term treatment of daily acute manic episodes ii) 100 mg (Day 1), 200 mg associated with bipolar I (Day 2), 300 mg (Day 3) & Quetiapine Fumarate 100 N05AH04138T100 disorder, either 400 mg (Day 4). Further 1330. mg Immediate Release A* 2XX monotherapy or adjunct to dosage adjustments up to Tablet lithium or divalproex 800 mg/day by Day 6 should iii) Treatment of depressive be in increments of not more episodes associated with than 200 mg/day. Adjust bipolar disorder dose within the range of 200 - 800 mg/day depending on clinical response and tolerability of the patient. Usual effective dose range: 400 - 800 mg/day iii) 50 mg ORALLY once a day on Day 1, then 100 mg once daily on Day 2, then 200 mg once daily on Day 3, then 300 mg once daily on Day 4 (all doses given at

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber bedtime); patients requiring higher doses should receive 400 mg on Day 5, increased to 600 mg on Day 8 (week 1)

i) & ii) 300 mg once daily on Day 1 then 600 mg on Day 2. Maintenance dose: 400 to 800 mg once daily. Maximum dose: 800 mg daily i)Schizophrenia iii) 50 mg on Day 1, 100 mg ii) Moderate to severe on Day 2, 200 mg on Day 3 Quetiapine Fumarate 200 N05AH04138T500 manic episodes in bipolar and 300 mg on Day 4. 1331. mg Extended Release A* 2XX disorder Recommended daily dose is Tablet iii) Major depressive 300 mg. May be titrated up to episodes in bipolar disorder 600 mg daily. In elderly or hepatic impairment:Start with 50mg/ day, may be increased in increments of 50mg /day to an effective dose. i) Initial titration schedule over 4 days: 25 mg twice daily on Day 1, increase in steps of 25 - 50 mg 2 to 3 times daily on Days 2 and 3 to reach target dose of 300 - 400 mg daily by Day 4, given in 2 - 3 divided doses. i) Schizophrenia Institute further dose ii) Short term treatment of adjustments, if indicated, at acute manic episodes intervals of 2 days or more, associated with bipolar I Quetiapine Fumarate 200 in steps of 25 - 50 mg twice N05AH04138T100 disorder, either 1332. mg Immediate Release A* daily 4XX monotherapy or adjunct to Tablet ii) 100 mg (Day 1), 200 mg lithium or divalproex (Day 2), 300 mg (Day 3) & iii) Treatment of depressive 400 mg (Day 4). Further episodes associated with dosage adjustments up to bipolar disorder 800 mg/day by Day 6 should be in increments of not more than 200 mg/day. Adjust dose within the range of 200 - 800 mg/day depending on clinical response and tolerability of the patient. Usual effective dose range:

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber 400 - 800 mg/day iii) 50 mg ORALLY once a day on Day 1, then 100 mg once daily on Day 2, then 200 mg once daily on Day 3, then 300 mg once daily on Day 4 (all doses given at bedtime); patients requiring higher doses should receive 400 mg on Day 5, increased to 600 mg on Day 8 (week 1)

i) & ii) 300 mg once daily on Day 1 and 600 mg on Day 2. Maintenance dose: 400 - 800 i) Schizophrenia mg once daily. Maximum ii) Moderate to severe Quetiapine Fumarate 300 dose: 800 mg daily N05AH04138T500 manic episodes in bipolar 1333. mg Extended Release A* iii) 50 mg on Day 1, 100 mg 3XX disorder Tablet on Day 2, 200 mg on Day 3 iii) Major depressive and 300 mg on Day 4. episodes in bipolar disorder Recommended daily dose is 300 mg. May be titrated up to 600 mg daily i) & ii) 300 mg once daily on Day 1 and 600 mg on Day 2. Maintenance dose: 400 - 800 i) Schizophrenia mg once daily. Maximum ii) Moderate to severe Quetiapine Fumarate 400 dose: 800 mg daily N05AH04138T500 manic episodes in bipolar 1334. mg Extended Release A* iii) 50 mg on Day 1, 100 mg 4XX disorder Tablet on Day 2, 200 mg on Day 3 iii) Major depressive and 300 mg on Day 4. episodes in bipolar disorder Recommended daily dose is 300 mg. May be titrated up to 600 mg daily

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) & ii) 300 mg once daily on Day 1 then 600 mg on Day 2. Maintenance dose: 400 to 800 mg once daily. Maximum dose: 800 mg daily. i) Schizophrenia iii) 50 mg on Day 1, 100 mg ii) Moderate to severe on Day 2, 200 mg on Day 3 Quetiapine Fumarate 50 N05AH04138T500 manic episodes in bipolar and 300 mg on Day 4. 1335. mg Extended Release A* 1XX disorder Recommended daily dose is Tablet iii) Major depressive 300 mg. May be titrated up to episodes in bipolar disorder 600 mg daily. In elderly or hepatic impairment: Start with 50mg/ day, may be increased in increments of 50mg /day to an effective dose. By slow intravenous infusion (over 4 hours). ADULT : 20 mg/kg followed by 10 mg/kg every 8 hours. CHILD : 20 mg/kg followed by 10 mg/kg Quinine Dihydrochloride P01BC01110P300 Severe and complicated 1336. B every 12 hours, initial dose 600 mg/2 ml Injection 1XX malaria should be half in patients who have received quinine, quinidine or mefloquine during the previous 12 or 24 hours 300 - 600 mg daily. Treatment : 1.2 - 2 g daily in divided doses. CHILDS less than 1 year : 100 - 200 mg Quinine Sulphate 300 mg P01BC01183T1001 Severe and complicated daily, 1 - 3 years : 200 - 300 1337. B Tablet XX malaria mg daily, 4 - 6 years: up to 500 mg daily, more than 7 years : up to 1 g daily. All above doses are given for 7 days in 2 - 3 divided doses i) Treatment and i) 10-20 mg daily for 4-8 maintenance of erosive or weeks, maintenance 10-20 Rabeprazole Sodium 20 A02BC04520T1001 ulcerative 1338. A* mg daily mg Tablet XX gastroesophageal reflux ii) 20 mg daily at morning for disease (GERD) up to 4-8 weeks ii) Duodenal ulcers Prophylaxis: 3 dose (1 ml each) schedule on D0, D7 and D28. Booster dose after Rabies Human Diploid Pre-exposure and post- every 2 - 3 years. Post J07BG01000P4001 1339. Cell Vaccine (Lyophilised) B exposure vaccination exposure prophylaxis: use XX Injection against rabies after attack of a potential rabid animal: 1 dose on D0, D3, D7, D14 and D28. In previously vaccinated

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber individuals 2 doses on D0 and D3

Prevention and treatment of Raloxifene HCl 60 mg G03XC01110T100 1340. A* postmenopausal 1 tablet daily Tablet 1XX osteoporosis Raltgeravir combination with other antiretroviral agents is indicated for the 400mg administered orally, treatment of HIV-1 infection twice daily with or without J05AX08500T1001 1341. Raltegravir 400 mg tablet A* in patients who are food, to be given XX contraindicated to boosted combination with other Protease Inhibitor or who antiretroviral agent. are intolerant to boosted Protease Inhibitor. i) Hypertension: Initially 2.5 mg once daily, increased at intervals of 1 - 2 weeks to i) Hypertension and maximum 10 mg once daily; congestive heart failure ii) Congestive heart Post-myocardial infarction failure:Initially 1.25 mg once iii) Reducing risk of daily. Max: 10 mg/day ii) C09AA05000T1001 1342. Ramipril 2.5 mg Tablet A myocardial infarction, stroke Initially 2.5 mg twice daily for XX or cardiovascular death in 2 days then increased to diabetics or patients with maximum 5 mg twice daily iii) increased cardiovascular Initially 1.25 - 2.5 mg once risks daily, increased to 5 mg once daily after 1 week, maximum dose: 10 mg once daily after 3 weeks i) Hypertension: Initially 2.5 mg once daily, increased at intervals of 1 - 2 weeks to i) Hypertension and maximum 10 mg once daily; congestive heart failure ii) Congestive heart Post-myocardial infarction failure:Initially 1.25 mg once iii) Reducing risk of daily. Max: 10 mg/day C09AA05000T1002 1343. Ramipril 5 mg Tablet A myocardial infarction, stroke ii) Initially 2.5 mg twice daily XX or cardiovascular death in for 2 days then increased to diabetics or patients with maximum 5 mg twice daily increased cardiovascular iii) Initially 1.25 - 2.5 mg once risks daily, increased to 5 mg once daily after 1 week, maximum dose: 10 mg once daily after 3 weeks

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Treatment of Neovascular (wet) Age-Related Macular Degeneration (ARMD). ii) Treatment of visual 0.5 mg (0.05ml) as a single impairment due to diabetic intravitreal Injection.Interval macular edema (DME). between 2 doses should not iii) Treatment of visual be shorter than 1 month, impairment due to macular then monitor for visual acuity edema secondary to retinal Ranibizumab 10 mg/ml S01LA04000P3001 monthly. Treatment is given 1344. A* vein occlusion (RVO). Intravitreal Injection XX monthly & continued until iv) Treatment of visual max visual acuity is impairment due to choroidal achieved, confirmed by neovascularization (CNV) stable visual acuity for 3 secondary to pathologic consecutive monthly myopia (PM). assessments. Note: Indication ii) and iii) approved to be used by retinal specialist only (PFUKKM 1/2015) i) 150 mg twice daily (at morning and night) or 300 mg on night for 4-8 weeks. i) Benign gastric and Maintenance: 150-300 mg on duodenal ulcer ii) Reflux night A02BA02110T1001 oesophagitis 1345. Ranitidine 150 mg Tablet B ii) 150 mg twice daily or 300 XX iii) Non-ulcer dyspepsia mg on night for 8-12 weeks iv) Zollinger-Ellison iii) 150 mg daily or twice daily Syndrome iv) 150 mg and may be increased as necessary to 6 g/day Ranitidine 150 mg/10 ml A02BA02110L9001 CHILD 2-4 mg/kg 2 times 1346. B Peptic ulcer disease Syrup XX daily. Maximum 300 mg daily i) ADULT: Slow IV injection of 50 mg diluted to 20 ml and given over at least 2 minutes. i) Benign gastric/ duodenal May be repeated every 6-8 ulceration, reflux hours or IV infusion at rate of oesophagitis, Zollinger 25 mg/hour for 2 hours, may Ranitidine 25 mg/ml A02BA02110P3001 1347. B Ellison Syndrome be repeated at 6-8 hours Injection XX ii) Stress ulcer prophylaxis intervals or IM. CHILD: 1 in post-operative and high mg/kg/dose 6-8 hourly. risk patients ii) Initial slow IV injection of 50 mg, then continuous infusion of 125-250 mcg/kg/hour i) 150 mg twice daily (at i) Benign gastric and morning and night) or 300 duodenal ulcer mg on night for 4-8 weeks. A02BA02110T1002 ii) Reflux oesophagitis 1348. Ranitidine 300 mg Tablet B Maintenance: 150-300 mg on XX iii) Non-ulcer dyspepsia night iv) Zollinger-Ellison ii) 150 mg twice daily or 300 Syndrome mg on night for 8-12 weeks

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber iii) 150 mg daily or twice daily iv) 150 mg and may be increased as necessary to 6 g/day

For IV use only. ADULT: Induction:Bolus infusion: 1µg/kg over 30-60 seconds; Continuous infusion: 0.5- 1µg/kg/min; Maintenance: Continuous infusion: 0.025 to 2 µg/kg/min. CHILD (1-12 years of age): Induction: Insufficient data; Neonates: IV infusion 0.4-1.0 i) As an analgesic agent for mcg/kg/minute depending on use during induction and/or the anaesthetic method and maintenance of general adjust according to patient anaesthesia during surgical response, supplemental IV procedures including inj of 1 mcg/kg dose may be cardiac surgery. given. 1-12 yr: initially 0.1-1 ii) Continuation of analgesia mcg/kg by IV inj over at least Remifentanil 5 mg N01AH06110P400 into the immediate post- 30 seconds (excluded if not 1349. A* Injection 1XX operative period under needed), followed by IV close supervision, during infusion 0.05-1.3 transition to longer acting mcg/kg/minute depending on analgesia. the anaesthetic method and iii) Provision of analgesia adjust according to patient and sedation in response, supplemental IV mechanically ventilated bolus inj may be admin intensive care patients. during infusion. 12-18 yr: 0.1- 1 mcg/kg IV inj over at least 30 seconds (excluded if not needed), followed by IV infusion of 0.05-2 mcg/kg/minute depending on anaesthetic method and adjust according to patient response, supplemental IV bolus inj may be admin during infusion.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber ADULT (more than 18 years old): 50mg/kg/day Recommended: Body weight: ≤ 75kg should receive 1000mg daily as two 200mg capsules in the morning and three 200mg capsules in the evening Body For the treatment of chronic weight: >75kg should receive J05AB04000C1001 1350. Ribavirin 200 mg Capsule A* hepatitis C (in combination 1200mg as three 200mg XX with interferon alfa-2a/2b) capsules in the morning and three 200mg capsules in the evening Genotype 1,4: 48 weeks Genotype: 24 weeks duration should be individualized in accordance with the baseline characteristics of the disease. For prevention and CHILD: 2.5-10 mg/day in A11HA04000T1001 1351. Riboflavine 3 mg Tablet C treatment of riboflavine divided doses. ADULT: 5-30 XX deficiency mg/day in divided doses CHILD: 20 mg/kg body Rifampicin 100 mg/5 ml J04AB02000L9001 weight daily in 1 - 2 doses. 1352. A Tuberculosis and leprosy Syrup XX Up to 1 year: 10 mg/kg body weight in a single daily dose i) ADULT: 450 - 600 mg as a single morning dose. CHILD: 10 - 20 mg/kg body weight daily in 1 - 2 doses. Directly i) Tuberculosis observed therapy (DOT): 10 Rifampicin 150 mg J04AB02000C1001 ii) Leprosy 1353. B mg/kg twice weekly or 3 Capsule XX iii) Prophylaxis for times/week. Maximum: 600 meningococcal meningitis mg ii) 600 mg/day iii) 600 mg twice daily for 2 days Patient more than or 71 kg: 5 Rifampicin 150 mg, tab/day, 55 -70 kg: 4 tab/day, Isoniazid 75 mg & J04AM05000T1001 Initial phase (2 months) of 1354. B 38-54 kg: 3 tab/day, 30-37 Pyrazinamide 400 mg XX tuberculosis treatment kg: 2 tab/day. To be taken as Tablet a single dose Rifampicin 150 mg, Treatment of both ADULT: 30 - 37 kg: 2 tablets Isoniazid 75 mg, pulmonary and daily, 38 - 54 kg: 3 tablets J04AM06000T1001 1355. Pyrazinamide 400 mg & B extrapulmonary daily, 55 - 70 kg: 4 tablets XX Ethambutol HCl 275 mg tuberculosis, in the daily, more than 70 kg: 5 Tablet intensive treatment phase tablets daily For pulmonary tuberculosis 30-37kg: 2 tablets once daily, in which organisms are 38-54kg: 3 tablets once daily, Rifampicin 150mg + J04AM02000T1001 1356. B susceptible in continuation 55-70kg: 4 tablets once daily, Isoniazid 75mg tablet XX phase treatment for 4 Above 70kg: 5 tabs once months daily

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Tuberculosis ADULT: Daily doses: 10mg/kg/day Body weight doses: 10-15/kg/day CHILD: 10 - 20 mg/kg body weight daily in 1 - 2 doses. Maximum daily dose : 600mg Directly observed therapy (DOT): 10 mg/kg twice i) Tuberculosis weekly or 3 times/week. Rifampicin 300 mg J04AB02000C1002 ii) Leprosy Maximum: 600 mg 1357. B Capsule XX iii) Prophylaxis for ii) Leprosy: ADULT: 600 meningococcal meningitis mg/day CHILDREN: 10mg/kg iii) Prophylaxis for meningococcal meningitis: ADULT: 600 mg twice daily for 2 days CHILDREN: 10mg/kg twice daily for 2 days INFANT: 5mg/kg twice daily for 2 days" Rifampicin: 600 mg once monthly, Dapsone: 100 mg Rifampicin, Dapsone & J04AM02961T9901 For the treatment of leprosy daily, Clofazimine: 300 mg 1358. B Clofazimine XX and tuberculosis once monthly and 50 mg daily (or 100 mg on alternate days) Ringers Solution As a source of electrolytes (contained sodium B05XA30905P6001 and water for According to the needs of the 1359. chloride, potassium B XX hydration/replenishing of patient chloride and calcium chloride chloride) ADULT : 2 mg in 1 - 2 divided doses on first day then 4 mg in 1 - 2 divided doses on 2nd day then 6 mg in 1 - 2 divided doses on 3rd day (slower titration appropriate in some patients); usual range 4 - 8 N05AX08000T1001 Psychoses and mg daily; dose above 10 mg 1360. Risperidone 1 mg Tablet B XX schizophrenia daily only if benefit outweigh risk (maximum 16 mg daily). Elderly (or in hepatic or renal impairment): initially 0.5 mg twice daily increased in steps of 0.5 mg twice daily to 1 - 2 mg twice daily. Not recommended in children under 15 years

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber ADULT: 2 mg in 1 - 2 divided doses on 1st day then 4 mg in 1 - 2 divided doses on 2nd day then 6 mg in 1 - 2 divided doses on 3rd day (slower titration appropriate in some patients); usual range 4 - 8 mg daily; dose Risperidone 1 mg/ml Oral N05AX08000L5001 Psychoses and above 10 mg daily only if 1361. A Solution XX schizophrenia benefit outweighs risk (maximum 16 mg daily). Elderly (or in hepatic or renal impairment): initially 0.5 mg twice daily increased in steps of 0.5 mg twice daily to 1-2 mg twice daily. Not recommended in children under 15 years ADULT : 2 mg in 1 - 2 divided doses on first day then 4 mg in 1 - 2 divided doses on 2nd day then 6 mg in 1 - 2 divided doses on 3rd day (slower titration appropriate in some patients); usual range 4 - 8 N05AX08000T1002 Psychoses and mg daily; dose above 10 mg 1362. Risperidone 2 mg Tablet B XX schizophrenia daily only if benefit outweigh risk (maximum 16 mg daily). Elderly (or in hepatic or renal impairment): initially 0.5 mg twice daily increased in steps of 0.5 mg twice daily to 1 - 2 mg twice daily. Not recommended in children under 15 years Treatment of acute and chronic schizophrenic psychosis and other 25 mg IM every 2 weeks. psychotic conditions, in Dose increments (if required) Risperidone 25 mg N05AX08000P300 1363. A* which positive and negative to 37.5 mg or 50 mg can be Injection (Long Acting) 1XX symptoms are prominent. It considered after a minimum also alleviates affective of 4 weeks on each dosage symptoms associated with schizophrenia Treatment of acute and chronic schizophrenic 25 mg IM every 2 weeks. psychosis and other Dose increments (if required) Risperidone 37.5 mg N05AX08000P300 1364. A* psychotic conditions, in to 37.5 mg or 50 mg can be Injection (Long Acting) 2XX which positive and negative considered after a minimum symptoms are prominent. It of 4 weeks on each dosage also alleviates affective

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber symptoms associated with schizophrenia

Treatment of acute and chronic schizophrenic psychosis and other 25 mg IM every 2 weeks. psychotic conditions, in Dose increments (if required) Risperidone 50 mg N05AX08000P300 1365. A* which positive and negative to 37.5 mg or 50 mg can be Injection (Long Acting) 3XX symptoms are prominent. It considered after a minimum also alleviates affective of 4 weeks on each dosage symptoms associated with schizophrenia IV 0.05 mg/min to be gradually increased by 0.05 mg/min every 10-15 minutes. Ritodrine HCl 50 mg/5 ml G02CA01110P300 Prevention of preterm 1366. A IM injection: 10 mg 4-6 Injection 1XX labour hourly. Continue treatment for 12-48 hours after ceased contraction Progressive or advanced ADULT: (Single PI) initially HIV infection in combination 300 mg twice daily, increase with other antiretroviral by 100 mg twice daily agents. Criteria for use: a) J05AE03000C1001 increments to 600 mg twice 1367. Ritonavir 100 mg Capsule A* Clinical AIDS XX daily. (Dual PI) Initially b) CD4 less than 350 cells 200mg BD, then increase by or 100mg BD & reaching c) Viral load more than 400mg BD within 2 wk. 10,000 copies/ml Progressive or advanced ADULT: 400 - 600 mg twice HIV infection in combination daily. CHILD: >1 month, with other antiretroviral initiate at dise of 25mg/m2 agents. Criteria for use: a) Ritonavir 80 mg/ml J05AE03000L9901 twice daily, titrate dose 1368. A* Clinical AIDS Solution XX upward every 2-3 days by b) CD4 less than 350 cells 50mg/m2 twice daily or (maximum dose 600mg twice c) Viral load more than daily) 10,000 copies/ml

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) 375 mg/m2 BSA i) Treatment of patients with administered as an IV relapsed or chemo-resistant infusion through a dedicated low grade or follicular B-cell line once weekly for 4 weeks Non-Hodgkin's lymphoma ii) Combination with CHOP ii) Adjunctive therapy with (cyclophosphamide, combination chemoagents doxorubicin, prednisone and for aggressive Non-Hodgkin vincristine) as 375 mg/m2 Lymphoma iii) Severe BSA on day 1 of each active rheumatoid arthritis chemotherapy cycle for 8 Rituximab 10 mg/ml L01XC02000P3001 with inadequate response 1369. A* cycles after IV administration Injection XX or intolerance to other of the glucocorticoid disease-modifying anti- component of CHOP. rheumatic drugs (DMARDs) iii) 1000 mg IV infusion including one or more followed by a second 1000 tumour necrosis factor mg IV infusion two weeks (TNF) inhibitor therapies iv) later iv) 375mg/m2 BSA once Maintenance in relapsed/ every 3 months until disease refractory follicular progression or for a lymphoma after response to maximum period of two induction therapy years. 10 mg once daily. Initial dose should be taken 6 to 10 hour Prevention of venous post-surgery provided that thromboembolism in Rivaroxaban 10 mg B01AX06000T1001 haemostasis has been 1370. A* patients undergoing elective Tablet XX established. Duration of hip or knee replacement treatment: Major hip surgery surgery 5 weeks. Major knee surgery 2 weeks i) Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as Congestive heart failure (CHF), hypertension, age ≥ 75 yrs, diabetes mellitus, i) 20mg once daily or 15mg prior stroke or transient once daily (for patients with ischaemic attack. moderate renal impairment Rivaroxaban 15 mg B01AX06000T1002 ii) Treatment of deep vein (creatinine clearance 30-49 1371. A* Tablet XX thrombosis (DVT), and ml/min) prevention of recurrent DVT Dosage: ii) & (iii) 15mg BD and pulmonary embolism for 21 days, followed by (PE) following an acute 20mg OD. DVT in adults. iii) Treatment of Pulmonary Embolism (PE), and prevention of recurrent DVT and pulmonary embolism (PE) following an acute PE in adults.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as Congestive heart failure (CHF), hypertension, age ≥ 75 yrs, diabetes mellitus, i)20mg once daily or 15mg prior stroke or transient once daily (for patients with ischaemic attack. moderate renal impairment Rivaroxaban 20 mg B01AX06000T1003 ii) Treatment of deep vein (creatinine clearance 30-49 1372. A* Tablet XX thrombosis (DVT), and ml/min) prevention of recurrent DVT Dosage (ii) & (iii)15mg BD for and pulmonary embolism 21 days, followed by 20mg (PE) following an acute OD. DVT in adults. iii) Treatment of Pulmonary Embolism (PE), and prevention of recurrent DVT and pulmonary embolism (PE) following an acute PE in adults. Initial dose 1.5 mg 2 times For psychiatrists and daily, may increase by 1.5 neurologists only. Mild to mg 2 times daily every 2 Rivastigmine 1.5 mg N06DA03123C100 moderately severe weeks to maximum of 6 mg 2 1373. A* Capsule 1XX dementia associated with times daily. If treatment is Alzheimer's or Parkinson's interrupted for several days, disease should be reinitiated at the lowest daily dose Initial dose 1.5 mg 2 times daily. May be increased after a minimum of 2 weeks of For psychiatrists and treatment to 3 mg 2 times neurologists only. Mild to daily. Subsequently to 4.5 Rivastigmine 2 mg/ml N06DA03123L9901 moderately severe 1374. A* mg 2 times daily, up to Oral Solution XX dementia associated with maximum of 6 mg 2 times Alzheimer's or Parkinson's daily. If treatment is disease interrupted for several days, should be reinitiated at the lowest daily dose Initial dose 1.5 mg 2 times For psychiatrists and daily, may increase by 1.5 neurologists only. Mild to mg 2 times daily every 2 Rivastigmine 3 mg N06DA03123C100 moderately severe weeks to maximum of 6 mg 2 1375. A* Capsule 2XX dementia associated with times daily. If treatment is Alzheimer's or Parkinson's interrupted for several days, disease should be reinitiated at the lowest daily dose

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Initial dose 1.5 mg 2 times For psychiatrists and daily, may increase by 1.5 neurologists only. Mild to mg 2 times daily every 2 Rivastigmine 4.5 mg N06DA03123C100 moderately severe weeks to maximum of 6 mg 2 1376. A* Capsule 3XX dementia associated with times daily. If treatment is Alzheimer's or Parkinson's interrupted for several days, disease should be reinitiated at the lowest daily dose Initial, 4.6 mg/24 hr patch Mild to moderately severe TOPICALLY once daily; after Rivastigmine 4.6mg/24hr N06DA03123M700 dementia associated with a minimum of 4 weeks and 1377. A* Transdermal Patch 1XX Alzheimer's or Parkinson's good tolerability, increase the disease dose to 9.5 mg/24 hr patch once daily Initial dose 1.5 mg 2 times For psychiatrists and daily, may increase by 1.5 neurologists only. Mild to mg 2 times daily every 2 Rivastigmine 6 mg N06DA03123C100 moderately severe weeks to maximum of 6 mg 2 1378. A* Capsule 4XX dementia associated with times daily. If treatment is Alzheimer's or Parkinson's interrupted for several days, disease should be reinitiated at the lowest daily dose Initial, 4.6 mg/24 hr patch Mild to moderately severe TOPICALLY once daily; after Rivastigmine 9.5 mg/24hr N06DA03123M700 dementia associated with a minimum of 4 weeks and 1379. A* Transdermal Patch 2XX Alzheimer's or Parkinson's good tolerability, increase the disease dose to 9.5 mg/24 hour patch once daily i) Mild to moderately severe dementia associated with Alzheimer's or Parkinson's disease. Initial, 4.6mg/24 hours patch ii) Severe dementia of the TOPICALLY once daily, after Alzheimer's type: - Patient a minimum of 4 weeks of with mild to moderately treatment and if well severe dementia (currently tolerated, this increased to Rivastigmine Transdermal N03DA03123M700 1380. A* on lower strength of 9.5mg/24 hours or Patch 13.3mg/24 hours 3XX rivastigmine patch) and 13.3mg/24 hours (individual developed to severe responses to rivastigmine dementia. - Use as second may vary and some patients line/alternative option if the may derive additional benefit first line medication with from higher doses) oral tablet failed or patients are not able to tolerate the oral medication.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Adult: Initially, 600 mcg/kg by inj. Higher doses of 1 mg/kg may be used for intubation during rapid sequence induction of anaesthesia. Maintenance: 150 mcg/kg by inj (may reduce to 75-100 mcg/kg if inhalational anaesthesia is used) or by infusion at a rate of 300-600 mcg/kg/hr. Doses should be based on lean body weight As an adjunct to general for obese patients weighing anaesthesia to facilitate >30% above the ideal body endotracheal intubation, to weight. Child: Infants and provide skeletal muscle Rocuronium Bromide 10 M03AC09320P300 children >1 mth: Initially, 600 1381. A* relaxation during surgery mg/ml Injection 1XX mcg/kg by inj. Maintenance: and to facilitate mechanical 150 mcg/kg by inj or by ventilation in adults, infusion at a rate of 300-600 children and infants from 3 mcg/kg/hr, maintenance months of age doses may be required more frequently than in adult patients. Elderly: Reduced maintenance doses: 75-100 mcg/kg. Renal impairment: Initially, 600 mcg/kg by inj. Maintenance: 75-100 mcg/kg. Hepatic impairment: or biliary tract disease: Initially, 600 mcg/kg by inj. Maintenance: 75-100 mcg/kg. ADULT: Initially 2 mg once daily for the 1st week. May be increased by 2 mg at ≥1 week intervals. Max: 24 mg/day. Switching from ropinirole immediate- realease to prolonged- Treatment of idiopathic release tablet; dose of Parkinson?s disease. It ropinirole prolonged release Ropinirole HCI 2 mg N04BC04110T500 1382. A* may be used as tablet should be based on Extended Release Tablet 3XX monotherapy or in the total daily dose of combination with levodopa ropinirole immediate-release tab the patient was taking. Tablets should be taken at a similar time each day with or without food, must be swallowed whole and must not be chewed, crushed or divided.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber ADULT: Initially 2 mg once daily for the 1st week. May be increased by 2 mg at ≥1 week intervals. Max: 24 mg/day. Switching from ropinirole immediate- realease to prolonged- Treatment of idiopathic release tablet; dose of Parkinson?s disease. It ropinirole prolonged release Ropinirole HCI 4 mg N04BC04110T500 1383. A* may be used as tablet should be based on Extended Release Tablet 4XX monotherapy or in the total daily dose of combination with levodopa ropinirole immediate-release tab the patient was taking. Tablets should be taken at a similar time each day with or without food, must be swallowed whole and must not be chewed, crushed or divided. 0.25 mg 3 times daily Parkinson disease in gradually increasing till younger patients and Ropinirole HCl 0.25 mg N04BCO4110T100 adequate response obtained 1384. A* patients with dyskinesias, Tablet 1XX up to a maximum of 24 especially peak dose mg/day. Most patients need dyskinesias 3-9 mg/day 0.25 mg 3 times daily Parkinson disease in gradually increasing till younger patients and Ropinirole HCl 1 mg N04BCO4110T100 adequate response obtained 1385. A* patients with dyskinesias, Tablet 2XX up to a maximum of 24 especially peak dose mg/day. Most patients need dyskinesias 3-9 mg/day Dose adjusted according to patient physical status and nature of procedure. i) Lumbar epidural: 15-25 ml of 7.5 mg/ml solution; Caesarean section, 15-20 ml i) Surgical anaesthaesia of 7.5 mg/ml solution in Ropivacaine HCl 2 mg/ml N01BB09110P300 1386. A* including obstetrics incremental doses ( max . Injection 1XX ii) Acute pain management total dose 150 mg). ii) lumbar epidural: 10-20 ml of 2mg/ml solution followed by 10-15 ml of 2 mg/ml solution at interval at of least 30 minutes. Labour pain 6-10 ml/hour of 2mg/ml solution

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Dose adjusted according to patient physical status and nature of procedure. i) Lumbar epidural: 15-25 ml of 7.5 mg/ml solution; Caesarean section, 15-20 ml i) Surgical anaesthaesia of 7.5 mg/ml solution in Ropivacaine HCl 7.5 N01BB09110P300 1387. A* including obstetrics incremental doses ( max . mg/ml Injection 2XX ii) Acute pain management total dose 150 mg). ii) lumbar epidural: 10-20 ml of 2mg/ml solution followed by 10-15 ml of 2 mg/ml solution at interval at of least 30 minutes. Labour pain 6-10 ml/hour of 2mg/ml solution Initially 5-10 mg once daily (5mg in patients with pre- disposing factors to myopathy), increased if necessary at intervals of at least 4 weeks to 20 mg once daily, increased after further 4 weeks to 40 mg daily ONLY in severe Dyslipidaemia not hypercholesterolemia with Rosuvastatin 10 mg C10AA07390T1002 responsive to atorvastatin 1388. A* high cardiovascular risk. Tablet XX 40 mg or equivalent doses Patient of Asian origin, of other statins patients on concomitant ciclosporin/fibrate and patients with risk factors for myopathy/rhabdomyolysis (including personal/family history of muscular disorders/toxicity), the maximum dose should be 20 mg daily Initially 5-10 mg once daily (5mg in patients with pre- disposing factors to myopathy), increased if necessary at intervals of at least 4 weeks to 20 mg once Dyslipidaemia not daily, increased after further Rosuvastatin 20 mg C10AA07390T1003 responsive to atorvastatin 4 weeks to 40 mg daily 1389. A* Tablet XX 40 mg or equivalent doses ONLY in severe of other statins hypercholesterolemia with high cardiovascular risk. Patient of Asian origin, patients on concomitant ciclosporin/fibrate and patients with risk factors for myopathy/rhabdomyolysis

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber (including personal/family history of muscular disorders/toxicity), the maximum dose should be 20 mg daily

A single daily dose should be initiated at 4mg/24 h and For stage IV Parkinson Rotigotine 2 mg per 24 N04BC09000M700 then increased in weekly 1390. A* Disease with peak hour Transdermal Patch 1XX increments of 2mg/24 h to an dyskinesia effective dose up to a maximal dose of 16mg/24 hr. A single daily dose should be initiated at 4mg/24 h and For stage IV Parkinson Rotigotine 4 mg per 24 N04BC09000M700 then increased in weekly 1391. A* Disease with peak hour Transdermal Patch 2XX increments of 2mg/24 h to an dyskinesia effective dose up to a maximal dose of 16mg/24 hr. A single daily dose should be initiated at 4mg/24 h and For stage IV Parkinson Rotigotine 6 mg per 24 N04BC09000M700 then increased in weekly 1392. A* Disease with peak hour Transdermal Patch 3XX increments of 2mg/24 h to an dyskinesia effective dose up to a maximal dose of 16mg/24 hr. A single daily dose should be initiated at 4mg/24 h and For stage IV Parkinson Rotigotine 8 mg per 24 N04BC09000M700 then increased in weekly 1393. A* Disease with peak hour Transdermal Patch 4XX increments of 2mg/24 h to an dyskinesia effective dose up to a maximal dose of 16mg/24 hr. Rubella Virus Vaccine J07BJ01000P3001 Immunization against 1394. C 0.5 ml SC as a a single dose Injection (Single injection) XX rubella (German measles) For the treatment of The recommended starting disease-related dose is 15 mg twice daily for splenomegaly or symptoms patients with a platelet count in adult patients with between 100,000/mm3 and primary myelofibrosis (also 200,000/mm3 and 20 mg known as chronic idiopathic twice daily for patients with a L01XE18162T1002 1395. Ruxolitinib 15mg tablet A* myelofibrosis), post- platelet count of XX polycythemia vera >200,000/mm3. There is myelofibrosis or post- limited information to essential thrombocythemia recommend a starting dose myelofibrosis. Place in for patients with platelet therapy: To be used as 3rd counts between 50,000/mm3 line after hydroxyurea and and <100,000/mm3. The

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber other best available maximum recommended treatment such as danazol starting dose in these and S.C. Interferon patients is 5 mg twice daily and the patients should be titrated cautiously.

The recommended starting For the treatment of dose is 15 mg twice daily for disease-related patients with a platelet count splenomegaly or symptoms between 100,000/mm3 and in adult patients with 200,000/mm3 and 20 mg primary myelofibrosis (also twice daily for patients with a known as chronic idiopathic platelet count of myelofibrosis), post- >200,000/mm3. There is L01XE18162T1003 polycythemia vera limited information to 1396. Ruxolitinib 20mg tablet A* XX myelofibrosis or post- recommend a starting dose essential thrombocythemia for patients with platelet myelofibrosis. Place in counts between 50,000/mm3 therapy: To be used as 3rd and <100,000/mm3. The line after hydroxyurea and maximum recommended other best available starting dose in these treatment such as danazol patients is 5 mg twice daily and S.C. Interferon and the patients should be titrated cautiously. The recommended starting For the treatment of dose is 15 mg twice daily for disease-related patients with a platelet count splenomegaly or symptoms between 100,000/mm3 and in adult patients with 200,000/mm3 and 20 mg primary myelofibrosis (also twice daily for patients with a known as chronic idiopathic platelet count of myelofibrosis), post- >200,000/mm3. There is L01XE18162T1001 polycythemia vera limited information to 1397. Ruxolitinib 5mg tablet A* XX myelofibrosis or post- recommend a starting dose essential thrombocythemia for patients with platelet myelofibrosis. Place in counts between 50,000/mm3 therapy: To be used as 3rd and <100,000/mm3. The line after hydroxyurea and maximum recommended other best available starting dose in these treatment such as danazol patients is 5 mg twice daily and S.C. Interferon and the patients should be titrated cautiously. Asthma and other 2 ml may be inhaled up to 4 Salbutamol 0.5 % R03AC02183A300 conditions associated with times daily over a period of 3 1398. B Inhalation Solution 1XX reversible airways minutes per inhalation (0.5 obstruction ml diluted in 2.5 ml of normal

297 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber saline by inhalation over 5 to 15 minutes)

500 mcg by SC/IM injection 4 hourly or 250 mcg by slow Asthma and other IV. If required, by IV infusion, Salbutamol 0.5 mg/ml R03CC02183P300 conditions associated with 1399. A initially 5 mcg/min adjusted Injection 1XX reversible airways according to response and obstruction heart rate, usually in the range 3 - 20 mcg/min Asthma and other ADULT : 100 - 200 mcg up to Salbutamol 100 mcg/dose R03AC02183A100 conditions associated with 3 - 4 times daily. CHILD : 1400. B Inhalation 1XX reversible airways 100 mcg increased to 200 obstruction mcg if necessary CHILD 2 - 6 years : 1 - 2 mg Asthma and other 3 - 4 times daily, 6 - 12 years R03CC02183T100 conditions associated with : 2 mg 3 - 4 times daily. 1401. Salbutamol 2 mg Tablet B 1XX reversible airways CHILD over 12 years and obstruction ADULT : 2 - 4 mg 3 - 4 times daily Asthma and other CHILD 2 - 6 years : 1 - 2 mg Salbutamol 2 mg/5 ml R03CC02183L900 conditions associated with 1402. B 3 - 4 times daily, 6 - 12 years Syrup 1XX reversible airways : 2 mg 3 -4 times daily obstruction CHILD : 100 - 200 mcg. Asthma and other Maintenance : 100 - 200 mcg Salbutamol 200mcg/dose R03AC02183A200 conditions associated with 2 - 4 times daily. ADULT : 1403. B Inhaler 1XX reversible airways 100 - 400 mcg. Maitenance : obstruction 100 - 400 mcg 2 - 4 times daily Infusions containing 5 mg in 500ml (10 mcg/ml) at the rate of 10 - 45 mcg/min increased at intervals of 10 minutes until evidence of Prevention of Salbutamol 5 mg/5 ml R03CC02183P300 patient response as shown 1404. A* uncomplicated premature Injection 2XX by reduction of strength, labour only frequency or duration of contractions; maintain rate for 1 hour after contractions have stopped, then gradually reduce by 50% every 6 hours

298 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) ADULT, acute attack 1-2 g 4 times daily until remission occurs (if necessary corticosteroids may also be given), reducing to a maintenance dose of 500 mg 4 times daily, CHILD over 2 i) Treatment of years, acute attack 40-60 Salicylazosulphapyridine inflammatory bowel disease mg/kg daily, maintenance A07EC01000T1001 1405. (Sulfasalazine) 500 mg A/KK of ulcerative colitis and dose 20-30 mg/kg daily XX Tablet Crohn's disease ii) ADULT, initially; 0.5-1 ii) Rheumatoid arthritis g/day, increase weekly to maintenance dose of 2 g/day in 2 divided doses, maximun 3 g/day. CHILD over 6 years, juvenile rheumatoid arthritis: 30-50 mg/kg/day in 2 divided doses up to a maximum of 2 g/day Salicylic Acid 1 - 2% in D07XA01952G500 Apply sparingly to affected 1406. Hydrocortisone 1% B Seborrhoeic capitis 1XX areas 1-2 times daily Ointment Seborrhoeic dermatitis, Salicylic Acid 2 - 10% D01AE12000G100 scalp psoriasis and Apply sparingly to the 1407. C Cream 1XX hyperkeratotic skin affected area 2-3 times daily conditions Seborrhoeic dermatitis, Salicylic Acid 2 - 10% D01AE12000G500 scalp, psoriasis and Apply sparingly to the 1408. C Ointment 1XX hyperkeratotic skin affected area 2-3 times daily disorders Seborrhoeic dermatitis, Apply sparingly to the D01AE12000L6001 scalp, psoriasis and affected area 2-3 times daily. 1409. Salicylic Acid 2 % Lotion B XX hyperkeratotic skin Wash with cleanser 2 - 3 conditions times per day Apply daily and protect surrounding skin (eg with soft Salicylic Acid 20% D01AE12000G500 1410. C Plantar warts paraffin or specially designed Ointment 2XX plaster) ,may need to continue up to 3 months Apply the paste liberally and Salicylic Acid, Starch, D01AE12952G600 1411. C Use as a protective or base carefully to the lesions twice Zinc Oxide Paste 1XX daily Regular treatment of ADULT and CHILD more Salmeterol 25 mcg and R03AK06989A210 reversible obstructive than 12 years : 1 - 2 puff 1412. Fluticasone Propionate A* 2XX airway diseases including twice daily. CHILD over 4 125 mcg Inhalation asthma. years : 1 puff twice daily

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Regular treatment of reversible obstructive ADULT and CHILD more airway diseases including than 12 years : 2 puff twice Salmeterol 25mcg and R03AK06989A210 asthma in children, where daily. CHILD over 4 years : 2 1413. Fluticasone Propionate A* 4XX use of lower dose of a puff twice daily No data on 50mcg Inhalation combination (bronchodilator use for children aged under 4 and inhaled corticosteroids) years. is appropriate. i) Regular treatment of reversible obstructive i) ADULT and CHILD more airways diseases including than 12 years : 1 puff twice Salmeterol 50 mcg and asthma R03AK06989A210 daily. 1414. Fluticasone Propionate A/KK ii) For the regular treatment 1XX ii) For COPD: Dose is one 250 mcg Inhalation of chronic obstructive inhalation 50/250mcg to pulmonary disease (COPD) 50/500mcg twice daily. including chronic bronchitis and emphysema i) Regular treatment of reversible obstructive airways diseases including i) ADULT and CHILD more Salmeterol 50 mcg and R03AK06989A210 asthma than 12 years : 1 puff twice 1415. Fluticasone Propionate A* 6XX ii) Chronic obstructive daily 500 mcg Inhalation pulmonary disease ii) ADULT 1 puff twice daily including chronic bronchitis and emphysema FUKKM restriction: As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. i) As add on therapy in type 2 diabetes patients inadequately controlled on Recommended starting dose metformin monotherapy and maintenance dose in and high risk of patients with normal renal hypoglycaemia, especially function and mild renal elderly patients with co- insufficiency (CrCl more than A10BH03000T1001 1416. Saxagliptin 2.5 mg Tablet A/KK morbidities. 50 ml/min) is 5 mg once XX ii) As add on therapy in type daily. For patients with 2 diabetes patients moderate to severe renal inadequately controlled with insufficiency (CrCl less than a sulphonylure and or equal to 50 ml/min) dose intolerant/contraindicated is 2.5 mg once daily for metformin therapy iii) As add on therapy in type 2 diabetes patients inadequately controlled on metformin and sulphonylurea combination therapy iv) In patients with renal

300 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber failure where metformin contraindicated Not to be used in patients with HbA1c > 8% on single/combination OAD, as insulin initiation is preferred.

The recommended starting dose of in patients who need 5mg of saxagliptin and who are not currently treated with metformin is 5mg saxagliptin/500 mg metformin extended-release once daily with gradual dose escalation to reduce the FUKKM restriction: As gastrointestinal side effects add-on therapy for patient due to metformin. In patients who failed therapy and/or treated with metformin, the contraindicated/unable to dose of should provide tolerate metformin and/or metformin at the dose Saxagliptin 2.5mg and sulphonylurea. A10BD10926T1001 already being taken, or the 1417. Metformin HCl 1000mg A - Indicated as an adjunct to XX nearest therapeutically Extended-Release Tablet diet and exercise to appropriate dose. Patients improve glycemic control in who need 2.5mg saxagliptin adults with type 2 diabetes in combination with mellitus when treatment metformin extended-release with both saxagliptin and may be treated with metformin is appropriate. 2.5mg/1000mg. Patients who need 2.5mg saxagliptin who are either metformin naive or who require a dose of metformin higher than 1000mg should use the individual components. Max daily recommended dose is 5mg/2000mg.

301 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber FUKKM restriction: As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. i) As add on therapy in type 2 diabetes patients inadequately controlled on metformin monotherapy and high risk of hypoglycaemia, especially elderly patients with co- morbidities. ii) As add on therapy in type 2.5-5mg once daily. Patients 2 diabetes patients with CrCl < 50ml/min, and A10BH03000T1002 1418. Saxagliptin 5 mg Tablet A/KK inadequately controlled with when coadministered with XX a sulphonylure and strong CYP450 3A4/5 intolerant/contraindicated inhibitors: 2.5mg OD for metformin therapy iii) As add on therapy in type 2 diabetes patients inadequately controlled on metformin and sulphonylurea combination therapy iv) In patients with renal failure where metformin contraindicated Not to be used in patients with HbA1c > 8% on single/combination OAD, as insulin initiation is preferred. The recommended starting dose of in patients who need 5mg of saxagliptin and who FUKKM restriction: As are not currently treated with add-on therapy for patient metformin is 5mg who failed therapy and/or saxagliptin/500 mg contraindicated/unable to metformin extended-release tolerate metformin and/or once daily with gradual dose Saxagliptin 5mg and sulphonylurea. escalation to reduce the A10BD10926T1002 1419. Metformin HCl 1000mg A - Indicated as an adjunct to gastrointestinal side effects XX Extended-Release Tablet diet and exercise to due to metformin. In patients improve glycemic control in treated with metformin, the adults with type 2 diabetes dose of should provide mellitus when treatment metformin at the dose with both saxagliptin and already being taken, or the metformin is appropriate. nearest therapeutically appropriate dose. Patients who need 2.5mg saxagliptin in combination with

302 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber metformin extended-release may be treated with 2.5mg/1000mg. Patients who need 2.5mg saxagliptin who are either metformin naive or who require a dose of metformin higher than 1000mg should use the individual components. Max daily recommended dose is 5mg/2000mg.

The recommended starting dose of in patients who need 5mg of saxagliptin and who are not currently treated with metformin is 5mg saxagliptin/500 mg metformin extended-release once daily with gradual dose escalation to reduce the FUKKM restriction: As gastrointestinal side effects add-on therapy for patient due to metformin. In patients who failed therapy and/or treated with metformin, the contraindicated/unable to dose of should provide tolerate metformin and/or metformin at the dose Saxagliptin 5mg and sulphonylurea. A10BD10926T1003 already being taken, or the 1420. Metformin HCl 500 mg A - Indicated as an adjunct to XX nearest therapeutically Extended-Release Tablet diet and exercise to appropriate dose. Patients improve glycemic control in who need 2.5mg saxagliptin adults with type 2 diabetes in combination with mellitus when treatment metformin extended-release with both saxagliptin and may be treated with metformin is appropriate. 2.5mg/1000mg. Patients who need 2.5mg saxagliptin who are either metformin naive or who require a dose of metformin higher than 1000mg should use the individual components. Max daily recommended dose is 5mg/2000mg.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber For treatment of shock due to burns, crushing injuries, abdominal emergencies and where there is a predominant loss of plasma ADULT 12.5-25 g (250-500 Selected Plasma Protein B05AA02000P3001 fluids and red blood cells, ml) by IV. CHILD usual dose 1421. B 5 g/100 ml Injection XX emergency treatment of 33 ml/kg body weight at rate shock due to haemorrhage of 5-10 ml/min and in infants and small children in the initial therapy of shock due to dehydration and infection Only for treatment of late 5 mg twice daily at breakfast Selegiline HCl 5 mg N04BD01110T100 1422. A* stage Parkinsonism with on and lunch. Maximum 10 Tablet 1XX and off phenomenon mg/day Dandruff: apply 5-10 mL topically twice weekly for 2 weeks, then 1-4 times per month, as needed, leave on for 2-3 min, then rinse Selenium Sulphide 2.5% D11AC03180L5201 Dandruff, seborrheic thoroughly. Seborrheic 1423. A/KK Shampoo XX dermatitis of scalp dermatitis of scalp: apply 5- 10 mL topically twice weekly for 2 weeks, then 1-4 times per month, as needed, leave on for 2-3 min, then rinse thoroughly Depression, obsessive- compulsive disorder: 50 mg/day, may increase in steps of 50mg at weekly Major depression, interval, max:200mg/day. Sertraline HCI 50 mg N06AB06110T1001 obsessive-compulsive Panic disorder: Initially 25 1424. B Tablet XX disorder (OCD), panic mg/day. After 1 week, disorder increase dose to 50 mg/day. All dose changes should be made at intervals of more than 1 week, max: 200 mg/day Control of hyperphosphatemia in adult patients receiving haemodialysis and Starting dose is one or two peritoneal dialysis. 800mg tablets three times Restriction: Sevelamer per day with meals. Adjust by V03AE02121T1001 1425. Sevelamer 800mg Tablet A* carbonate 800mg tablet one tablet per meal in two XX should be used in context of weeks interval as needed to multiple therapeutic obtain serum phosphorus approach which include target (1.13 to 1.78mmol/L). calcium supplement, 1, 25- hydroxy Vitamin D3 or one of its analogues to control

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber the development of renal bone disease.

i) Adult: Given via a calibrated vaporiser: Up to 5% v/v with oxygen or a mixture of oxygen and To be used only for nitrous oxide. Child: Given N01AB08000L5001 i) induction and 1426. Sevoflurane Liquid A* via a calibrated vaporiser: Up XX ii) maintenance of to 7% v/v. anaesthesia ii) Adult: 0.5-3% v/v with or without nitrous oxide. Child: 0.5-3% v/v with or without nitrous oxide. ADULTS ≥ 18 years: The recommended dose is 20mg three times a day. Tablets should be taken approximately 6 to 8 hours apart with or without food. ELDERLY (≥65 years): Dosage adjustments are not required in elderly patients. Clinical efficacy as measured Treatment of adult patients by 6-minute walk distance with pulmonary arterial could be less in elderly hypertension classified as patients. WHO functional class II and IMPAIRED RENAL III, to improve exercise FUNCTION: Initial dose Sildenafil Citrate 20 mg G04BE03136T100 capacity. Efficacy has been 1427. A* adjustments are not required Film-coated Tablet 4XX shown in primary in patients with renal pulmonary hypertension impairment, including severe and pulmonary renal impairment (creatinine hypertension associated clearance <30ml/min). A with connective tissue downward dose adjustment disease. to 20 mg twice daily should be considered after a careful benefit-risk assessment only if therapy is not well- tolerated. IMPAIRED HEPATIC FUNCTION: Initial dose adjustments are not required in patients with hepatic impairment (Child-Pugh

305 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber class A and B). A downward dose adjustment to 20mg twice daily should be considered after a careful benefit-risk assessment only if therapy is not well- tolerated.

D08AL01221L6001 Apply undiluted to affected 1428. Silver Nitrate 0.5% Lotion B Use as antiseptic XX area for a limited period Prevention and treatment of infections in severe burns, Burns: Apply 3 mm thick Silver Sulfadiazine 1% D06BA01199G100 leg ulcers where infections layer twice daily with sterile 1429. B Cream 1XX may prevent healing and for applicator. Leg ulcer: apply the prophylaxis of infections at least 3 times a week in skin grafting Hypercholesterolaemia and C10AA01000T1001 coronary heart disease 10 - 20 mg once daily. 1430. Simvastatin 10 mg Tablet B XX intolerant or not responsive Maximum: 80 mg daily to other forms of therapy Hypercholesterolaemia and C10AA01000T1002 coronary heart disease 10 - 20 mg once daily. 1431. Simvastatin 20 mg Tablet B XX intolerant or not responsive Maximum: 80 mg daily to other forms of therapy Hypercholesterolaemia and C10AA01000T1003 coronary heart disease 10 - 20 mg once daily. 1432. Simvastatin 40 mg Tablet B XX intolerant or not responsive Maximum: 80 mg daily to other forms of therapy

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber FUKKM Restriction: As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. - Management of diabetes ADULT over 18 years, 100 in patients with renal failure mg once daily: 100mg once A10BH01000T1003 where daily CrCl ≥ 30 to < 1433. Sitagliptin 100 mg Tablet A* XX metformin/sulphonylurea is 50ml/min: 50mg once daily contraindicated/untolerated CrCl < 30 ml/min: 25mg once and elderly with multiple co- daily morbidities that always experience hypoglycemia with other antidiabetic. Not to be used in diabetic patient whose HbA1c is more than 9%. FUKKM restriction: As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. - Management of diabetes ADULT over 18 years, 100 in patients with renal failure mg once daily: 100mg once A10BH01000T1001 where daily CrCl ≥ 30 to < 1434. Sitagliptin 25 mg Tablet A* XX metformin/sulphonylurea is 50ml/min: 50mg once daily contraindicated/untolerated CrCl < 30 ml/min: 25mg once and elderly with multiple co daily morbidities that always experience hypoglycemia with other antidiabetic. Not to be used in diabetic patient whose HbA1c is more than 9%.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber FUKKM restriction: As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. i) Type 2 diabetes patients, especially the elderly, with multiple co-morbidities that always experience hypoglycaemia with other 50 mg/500 mg twice daily. Sitagliptin 50 mg and antidiabetics who are The recommended maximum A10BD07926T1003 1435. Metformin HCl 1000 mg A* inadequately controlled on daily dose is 100 mg XX Tablet metformin or sitagliptin sitagliptin plus 2000 mg alone or already being metformin treated with the combination of sitagliptin and metformin. ii) Newly diagnosed type 2 diabetes patients with high baseline HbA1c and multiple co-morbidities who may experience hypoglycaemia with other antidiabetics. FUKKM restriction: As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. i) Type 2 diabetes patients, especially the elderly, with multiple co-morbidities that always experience hypoglycaemia with other 50 mg/500 mg twice daily. Sitagliptin 50 mg and antidiabetics who are The recommended maximum A10BD07926T1001 1436. Metformin HCl 500 mg A* inadequately controlled on daily dose is 100 mg XX Tablet metformin or sitagliptin sitagliptin plus 2000 mg alone or already being metformin treated with the combination of sitagliptin and metformin. ii) Newly diagnosed type 2 diabetes patients with high baseline HbA1c and multiple co-morbidities who may experience hypoglycaemia with other antidiabetics.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber FUKKM restriction: As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. i) Type 2 diabetes patients, especially the elderly, with multiple co-morbidities that always experience hypoglycaemia with other 50 mg/500 mg twice daily. Sitagliptin 50 mg and antidiabetics who are The recommended maximum A10BD07926T1002 1437. Metformin HCl 850 mg A* inadequately controlled on daily dose is 100 mg XX Tablet metformin or sitagliptin sitagliptin plus 2000 mg alone or already being metformin treated with the combination of sitagliptin and metformin. ii) Newly diagnosed type 2 diabetes patients with high baseline HbA1c and multiple co-morbidities who may experience hypoglycaemia with other antidiabetics. FUKKM restriction: As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. - Management of diabetes ADULT over 18 years, 100 in patients with renal failure mg once daily: 100mg once A10BH01000T1002 where daily CrCl ≥ 30 to < 1438. Sitagliptin 50 mg Tablet A* XX metformin/sulphonylurea is 50ml/min: 50mg once daily contraindicated/untolerated CrCl < 30 ml/min: 25mg once and elderly with multiple co daily morbidities that always experience hypoglycemia with other antidiabetic. Not to be used in diabetic patient whose HbA1c is more than 9%. Treatment of symptoms of gastro-oesophageal reflux Sodium Alginate 1000 eg. acid regurgitation, mg/10 ml & Potassium A02BX13915L8001 heartburn, indigestion due Adult, elderly & children ≥12 1439. A* Bicarbonate 200 mg/10 ml XX to the reflux of stomach year: 5-10 mL. Suspension contents not responding to conventional antacids or as an addition to PPI when PPI

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber alone fails to control the symptoms Depend on the type of Sodium and Meglumine V08AA01993P3002 procedure and the degree 1440. Diatrizoate 58-60% B For IV pyelography XX and extent of contrast Injection required i) 3 g in every 2 hours until i) Relief of discomfort in Sodium Bicarbonate 1 A02AH00131L2102 urinary pH exceeds 7 1441. B mild urinary tract g/15 ml Mixture XX ii) Maintenance of alkaline ii) Alkalinisation of urine urine 5-10 g daily For acceleration of excretion in drug IV infusion of 2 - 5 mmol/kg intoxication (where Sodium Bicarbonate 4.2% B05XA02131P3001 body weight over a period of 1442. B excretion of the drug into (0.5 mmol/ml) Injection XX 4 - 8 hours or according to the urine is accelerated by the needs of the patients elevated urine pH) and for acidosis Sodium Bicarbonate 5% S02DC00131D100 To soften the impacted ear 1443. C 2-3 drops 3-4 times daily w/v Ear Drops 1XX wax For acceleration of excretion in drug intoxication (where According to the needs of the Sodium Bicarbonate 8.4% B05XA02131P3002 1444. B excretion of the drug into patient. In severe shock due (1 mmol/ml) Injection XX the urine is accelerated by to cardiac arrest: 50 ml by IV elevated urine pH) and for acidosis Sodium Bicarbonate and A02AH00912L2101 Heartburn, for rapid relief of ADULT 10-20 ml 3 times 1445. Magnesium Carbonate C XX dyspepsia daily Compound Mixture CHILD up to 1 year 5 ml; up Sodium Bicarbonate A02AH00131L2101 Heartburn for rapid relief of 1446. C to 1-5 years 10 ml in 4 to 6 Mixture (Paediatric) XX dyspepsia divided doses For relieving of discomfort in mild urinary tract infection, symptomatic relief Sodium Bicarbonate, of dysuria to enchance the 4 - 8 g (1- 2 sachets) Citric Acid, Sodium Citrate B05CB10955M400 action to certain antibiotics dissolved in a glass of cold 1447. B and Tartaric Acid - 4 g per 1XX especially some water 4 times daily as sachet sulphonamides. In gout as prescribed urinary alkalinizers to prevent cystallisation of urates Bowel cleansing before colonic surgery, colonoscopy or radiological ADULT 133 ml (1 bottle) Sodium Biphosphate A06AG01162G200 examination to ensure the administered rectally. CHILD 1448. 16%, Sodium Phosphate A 1XX bowel is free of solid more than 2 years half the 6% Rectal Solution contents. It is not to be adult dose (66.6ml) used for treatment of constipation

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber 45 ml diluted with half a glass (120 mL) of water, followed by one full glass (240 mL) of water. Timing of doses is dependent on the time of the procedure. For morning procedure, first dose Bowel cleansing before should be taken at 7 a.m. colonic surgery, and second at 7 p.m. on day colonoscopy or radiological Sodium Biphosphate before the procedure. For A06AG01162L9901 examination to ensure the 1449. 16%, Sodium Phosphate A afternoon procedure, first XX bowel is free of solid 6% Solution dose should be taken at 7 contents. It is not to be p.m. on day before and used for treatment of second dose at 7 a.m. on constipation day of the procedure. Solid food should not be taken during the bowel preparation period. However clear fluids or water can be taken liberally. CHILD under 12 years not recommended For replenishing fluid and Sodium Chloride 0.18% energy and for restoring or B05XA03904P6001 According to the needs of the 1450. with Dextrose 10% B maintaining the XX patient Injection concentration of sodium and chloride ions For replenishing fluid and Sodium Chloride 0.18% energy and for restoring or B05XA03904P6004 According to the needs of the 1451. with Dextrose 4.23% B maintaining the XX patient Injection concentration of sodium and chloride ions For replenishing fluid and 100 - 1000 ml by IV or Sodium Chloride 0.45% B05XA03100P6001 for restoring / maintaining 1452. B according to the needs of the Injection XX the concentration of sodium patient and chloride ions For replenishing fluid and Sodium Chloride 0.45% energy and for restoring or B05XA03904P6002 According to the needs of the 1453. with Dextrose 10% B maintaining the XX patient Injection concentration of sodium and chloride ions For replenishing fluid and Sodium Chloride 0.45% energy and for restoring or B05XA03904P6005 According to the needs of the 1454. with Dextrose 5% B maintaining the XX patient Injection concentration of sodium and chloride ions Sodium Chloride 0.9% S01XA03000D200 1455. C Irrigation of conjunctival sac 1 - 2 drops every 3 - 4 hours Eye Drops 1XX For replenishing fluid and 100 - 1000 ml by IV or Sodium Chloride 0.9% B05XA03100P6002 for restoring/maintaining the 1456. C+ according to the needs of the Injection XX concentration of sodium patient and chloride ions

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber For replenishing fluid and Sodium Chloride 0.9% energy and for restoring or B05XA03904P6003 According to the needs of the 1457. with Dextrose 5% C+ maintaining the XX patient Injection concentration of sodium and chloride ions Addition of sodium electrolyte in parenteral Sodium Chloride 20% B05XA03100P9902 According to the needs of the 1458. B nutrition bags especially in Injection XX patient paediatrics or neonates with restricted fluid allowance Sodium Chloride 3% B05XA03100P9901 Acute dilutional According to the needs of the 1459. B Injection XX hyponatraemia patient Labelling of erythrocytes for Sodium Chromate V09GX00143L9901 Usual dose range : 10 - 200 1460. A* the investigation of (Chromium-51) Solution XX microcuries IV by IV injection haemotological disorders Dose depending on clinical cases. Usually, 30 ml given Prophylaxis for aspiration Sodium Citrate 0.3 M B05CB02136L9901 10- 60 minutes before 1461. B pneumonitis (use as an oral Solution XX anaesthesia prior to elective solution) cesarean surgery is an effective antacid Sterile solution for irrigation Sodium Citrate 3.8% B05CB02136H300 Dose depending on clinical 1462. B or washout of infected Solution 1XX cases bladder Citrates and citric acid solutions are used to correct the acidosis of certain renal tubular ADULT 10 - 20 ml. CHILD up disorders to treat metabolic to 1 year 2.5 ml tds; 1-5 year Sodium Citrate, Citric Acid B05CB02136L2101 1463. B acidosis for long-term urine 5 ml tds; 6-12 years 10 ml Mixture 3 g/10 ml XX alkalinization for prevention tds. To be taken well diluted and treatment of uric acid with water and calcium kidney stones and as nonparticulate neutralizing buffers Prevention and treatment of allergic conjunctivitis Sodium Cromoglycate 2% S01GX01520D200 including seasonal and 1464. A/KK 1 or 2 drops 4 times daily Eye Drops 1XX perennial allergic conjunctivitis and vernal keratoconjunctivitis Sodium V07AV00000T1001 Low and medium level 1465. Dichloroisocyanurate 2.5 C 50 - 10,000 ppm av chlorine XX disinfectant g Tablet Sodium V07AV00000T1002 Low and medium level 1466. Dichloroisocyanurate 5 g C 50 - 10,000 ppm av chlorine XX disinfectant Tablet Skin infections caused by Sodium Fusidate 2% D06AX01520G500 staphylococci, streptococci, Apply to affected area 2 - 3 1467. A Ointment 1XX corynebacterium times daily minutissumun and other

312 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber sodium fusidate-sensitive organisms

Adults: The recommended dosage is individual. The recommended daily dosage of phosphate during intravenous nutrition would normally be 10-20mmol. This Indicated in adult patients can be met by using 10-20ml Sodium glycerophosphate and infants as a of sodium glycerophosphate B05XA14171P3001 1468. for addition into infusion A supplement in intravenous to the infusion solution or to XX solution, 20ml vial nutrition to meet the the admixture for which requirement of phosphate. compatibility has been proved. Infants: The recommended dosage is individual. The recommended dose for infants and neonates is 1.0- 1.5 mmol/kg bodyweight/day. Sodium Hypochlorite V07AV00000L9903 Low-level disinfectant and Antiseptic: less than 0.5%. 1469. C Solution XX antiseptic Disinfectant: 5% Sodium Iodide (Iodide- V09FX03200P3001 Used in the determination 1470. A* 5 - 50 millicuries 131) Injection XX of various thyroid functions Sodium Iodide (Iodine- V09FX03200C1001 Determination of various 5 - 10 milicuries (5 mCi for 1471. A* 131) Capsule XX thyroid functions whole body scan) Sodium Iodide (Iodine- V10XA01200C100 i) Thyrotoxicosis i) 2 - 30 millicuries 1472. 131) Capsule A* 1XX ii) Thyroid carcinoma ii) 80 - 300 millicuries (Therapeutic) Sodium Iodide (Iodine- V10XA01200L9901 i) Thyrotoxicosis i) 5-25 millicuries 1473. A* 131) Solution XX ii) Thyroid carcinoma ii) 30-150 millicuries Adult: 300 mg sodium nitrite IV over 3 minutes followed after 5 minutes with 12.5g sodium thiosulphate IV administered over 10 minutes. CHILD: 4 - 10 mg/kg of sodium nitrite (max: 300 mg) followed by 400 mg/kg of sodium thiosulfate, Sodium Nitrite 30 mg/ml V03AB08220P3001 1474. B For cyanide poisoning as a 25 or 50% solution Injection XX (max: 12.5 g). Methaemoglobin concentration should not exceed 30-40%. If symptoms of cyanide toxicity recur, the doses of nitrite and thiosulfate may be repeated after 30 min at half the initial doses.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) By IV infusion, initially 0.5- 1.5 mcg/kg/min, then adjusted before increasement of 0.5 mcg/kg/min every 5 mins i) Hypertensive crisis within range 0.5-8 ii) Controlled hypotension mcg/kg/min (lower doses in Sodium Nitroprusside 10 C02DD01520P300 1475. A during anaesthesia in order patients already receiving mg/ml Injection 1XX to reduce bleeding in other antihypertensives); surgical procedures stop if marked response not obtained with max dose in 10 minutes. Use only in infusion with 5 % Dextrose IV. ii) By IV infusion, max: 1.5 mcg/kg/min Polycythemia vera, chronic Initially 5 millicuries, follow if myeloid and chronic necessary by a dose of not Sodium Phosphate V10XX01162P3001 1476. A* lymphocytic leukaemia and more than 3 or 4 millicurie at (Phosphorus-32) Injection XX palliative treatment of bone intervals of not less than 2 metastases months ADULT : Oral : 15 g 1 - 4 times/day. Rectal : 30 g in Treatment and prevention 100 ml 2% methylcellulose of hyperkalaemia and 100 ml water as a daily associated with anuria or Sodium Polystyrene V03AE01520F2101 retention enema. Retain for 9 1477. A severe oliguria, in dialysis Sulphonate Powder XX hours followed by non- patients or those on sodium cleansing enema. prolonged peritoneal CHILD : 1 g/kg in 1 - 4 doses dialysis in acute hyperkalemia. Maintenance : 0.5 g/kg/daily 0.5-2 mL into the submucosal layer at the base Sclerotherapy of of the oesophageal varix or Sodium Tetradecyl C05BB04183P300 oesophageal varices, the haemorrhoid; several 1478. A* Sulphate 1 % Injection 1XX haemorrhoids and varicose injections may be given at veins different sites, max. total injected 10-15 mL of 1% per treatment 0.5-2 mL into the submucosal layer at the base Sclerotherapy of of the oesophageal varix or Sodium Tetradecyl C05BB04183P300 oesophageal varices, the haemorrhoid, several 1479. A* Sulphate 3 % Injection 2XX haemorrhoids and varicose injections may be given at veins different sites, max. total injected 10-15 mL of 1% per treatment Apply to all affected parts of Fungicides. For the Sodium Thiosulphate 10- D01AE00181L9901 the body and face with a 1480. C treatment of pityriasis 20% Solution XX brush after a bath once daily versicolor or twice daily or 3 times daily

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Adult: To be given after 300 mg of sodium nitrite has been admin over 5-20 min: 12.5 g of sodium thiosulfate (50 ml of a 25% solution or 25 ml of a 50% solution) given over 10 min. Methaemoglobin concentration should not exceed 30-40%. If symptoms of cyanide toxicity recur, the doses of nitrite and thiosulfate may be repeated Sodium Thiosulphate 500 V03AB06181P3001 after 30 min at half the initial 1481. B For cyanide poisoning mg/ml Injection XX doses. Child: To be given after 4-10 mg/kg of sodium nitrite (max: 300 mg) has been admin: 400 mg/kg of sodium thiosulfate, as a 25 or 50% solution (max: 12.5 g). Methaemoglobin concentration should not exceed 30-40%. If symptoms of cyanide toxicity recur, the doses of nitrite and thiosulfate may be repeated after 30 min at half the initial doses. i) Epilepsy: ADULT: Initially 600 mg/day in 2 - 3 divided doses, dose may be increased by 200 mg at 3- day intervals to max 2.5 g/day. Usual maintenance dose: 1-2 g/day (20-30 mg/kg/day). CHILD: More than 20 kg. Initially 400 mg/day with spaced i) Epilepsy increases until control is ii) Treatment and Sodium Valproate 200 mg N03AG01520T100 achieved (usually 20-30 1482. B prevention of mania Tablet 1XX mg/kg/day), dose may be associated with bipolar increased to 35 mg/kg/day. disorders Less than 20 kg 20 mg/kg/day, in severe cases the dose may be increased provided plasma concentration can be monitored. ii) Treatment and prevention of mania associated with bipolar disorders: Adults: The recommended initial dose is

315 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber 1000mg/day. The dose should be increased as rapidly as possible to achieve the lowest therapeutic dose, which produces the desired clinical effects. The recommended maintenance dosage for the treatment of bipolar disorder is between 1000mg and 2000mg daily. In exceptional cases, the dose may be increased to not more than 3000mg daily.

ADULT: Initially 600 mg/day; dose may be increased by 200 mg at 3-day intervals to max 2500 mg/day. Usual maintenance dose: 1000- 2000 mg/day (20-30 mg/kg/day). CHILD: More Sodium Valproate 200 N03AG01520L900 than 20 kg. Initially 400 1483. B Epilepsy mg/5 ml Syrup 1XX mg/day with spaced increases until control is achieved (usually 20-30 mg/kg/day), dose may be increased to 35 mg/kg/day. Less than 20 kg, 20 mg/kg/day. Severe cases: 50 mg/kg daily ADULT and CHILD above 10 years: 10 to 15 mg/kg/day IV, may increase 5 to 10 Sodium Valproate 400 mg N03AG01520P400 mg/kg/week to achieve 1484. B Status epilepticus Injection 1XX optimal clinical response (Maximum 60 mg/kg/day or less with a therapeutic range of 50 to 100 mcg/mL) Symptomatic treatment of 5mg od. Dose can be Solifenacin Succinate 5 G04BD08000T100 urge incontinence and/or 1485. A* increased to 10mg if mg Tablet 1XX increased urinary frequency necessary. and urgency as may occur

316 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber in patients with overactive bladder syndrome.

i) Growth failure due to inadequate endogenous i) 0.7-1 mg/m2/day or 0.025- growth hormone. 0.035 mg/kg/day SC/IM. ii) Growth failure in girls due Somatropin 10 mg (30IU) H01AC01000P500 ii) 1.4 mg/m2/day or 0.045- 1486. A* to gonadal dysgenesis Injection 2XX 0.05 mg/kg/day SC. (Turner syndrome). iii) 0.035 mg/kg/day or 1 iii) Growth failure in short mg/m2/day SC children born small gestational age (SGA) i) Growth failure due to inadequate endogenous i) 0.7-1 mg/m2/day or 0.025- growth hormone 0.035 mg/kg/day SC/IM ii) Growth failure in girls due Somatropin 12 mg (36IU) H01AC01000P300 ii) 1.4 mg/m2/day or 0.045- 1487. A* to gonadal dysgenesis Injection 2XX 0.05 mg/kg/day SC (Turner syndrome) iii) 0.035 mg/kg/day or 1 iii) Growth failure in short mg/m2/day SC children born small gestational age (SGA) i) Growth failure due to growth hormone i) 0.7-1 mg/m2/day or 0.025- insufficiency 0.035 mg/kg/day SC/IM ii) Growth failure in girls due Somatropin 5mg (15IU) H01AC01000P300 ii) 1.4 mg/m2/day or 0.045- 1488. A* to gonadal dysgenesis Injection 4XX 0.05 mg/kg/day SC (Turner syndrome) iii) 0.035 mg/kg/day or 1 iii) Growth failure in short mg/m2/day SC children born small gestational age(SGA) i) Growth failure due to growth hormone i) 0.7-1 mg/m2/day or 0.025- insufficiency 0.035 mg/kg/day SC/IM ii) Growth failure in girls due Somatropin 8 mg (24IU) H01AC01000P300 ii) 1.4 mg/m2/day or 0.045- 1489. A* to gonadal dysgenesis Injection 3XX 0.05 mg/kg/day SC (Turner syndrome) iii) 0.035 mg/kg/day or 1 iii) Growth failure in short mg/m2/day SC children born small gestational age(SGA) Supraventricular and ventricular arrhythmias Adult: Initially, 80 mg/day as single or in 2 divided doses, increased gradually every 2- C07AA07110T1002 1490. Sotalol HCl 160 mg Tablet A* Ventricular tachyarrythmias 3 days. Usual dose: 160-320 XX mg/day in 2 divided doses. Life-threatening ventricular arrhythmias Adult: Initially, 80 mg bid, increased gradually every 3 days to

317 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber 240-320 mg/day in divided doses if needed. Maintenance: 160-320 mg/day in divided doses. Max: 480-640 mg in divided doses.

Supraventricular and ventricular arrhythmias Adult: Initially, 80 mg/day as single or in 2 divided doses, increased gradually every 2- 3 days. Usual dose: 160-320 mg/day in 2 divided doses. Life-threatening ventricular C07AA07110T1001 1491. Sotalol HCl 80 mg Tablet A* Ventricular tachyarrythmias arrhythmias Adult: Initially, XX 80 mg bid, increased gradually every 3 days to 240-320 mg/day in divided doses if needed. Maintenance: 160-320 mg/day in divided doses. Max: 480-640 mg in divided doses. ADULT: 100 - 200 mg daily Oedema and ascites in in divided doses. Increase to Spironolactone 25 mg C03DA01000T100 1492. B cirrhosis of the liver, 400 mg if required. CHILD: Tablet 1XX congestive heart failure initially 3 mg/kg daily in divided doses Infant: 0 - 13 days old: 0.5 mg/kg/dose twice daily. HIV infection, in Infant 14 days and older and Stavudine 1 mg/ml J05AF04000L5001 1493. A* combination with other weighing less than 30 kg: 1 Solution XX antiretrovirals mg/kg twice daily; more than 30 kg and <60kg: 30 mg twice daily ADULT more than 60 kg: 40 HIV infection, in mg twice daily; less than 60 J05AF04000C1001 1494. Stavudine 30 mg Capsule A/KK combination with other kg: 30 mg twice daily. CHILD XX antiretrovirals <30kg: 1mg/kg twice daly; >30kg refer to adult dosage Fixed dose triple therapy for treatment of HIV infection in Stavudine 30 mg, adults once patients have SLN 30: 30-60 kg 1 tablet J05AR07964T1001 1495. Lamivudine 150 mg & A/KK been stabilized on the twice daily. SLN 40 ≥60 kg 1 XX Nevirapine 200 mg Tablet maintenance regimen of tablet twice daily nevirapine 200 mg twice daily and have

318 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber demonstrated adequate tolerability to nevirapine

ADULT more than 60 kg: 40 HIV infection, in mg twice daily; less than 60 J05AF04000C1002 1496. Stavudine 40 mg Capsule A* combination with other kg: 30 mg twice daily. CHILD XX antiretrovirals <30kg: 1mg/kg twice daly; >30kg refer to adult dosage Fixed dose triple therapy for treatment of HIV infection in adults once patients have Stavudine 40 mg, been stabilized on the SLN 30: 30-60 kg 1 tablet J05AR07964T1002 1497. Lamivudine 150 mg & A* maintenance regimen of twice daily. SLN 40 ≥60 kg 1 XX Nevirapine 200 mg Tablet nevirapine 200 mg twice tablet twice daily daily and have demonstrated adequate tolerability to nevirapine Myocardial infarction: 1,500,000 units over 30 - 60 minutes. Pulmonary embolism: 250,000 units by Streptokinase 1,500,000 B01AD01000P400 Acute myocardial infarction, 1498. A* IV infusion over 30 minutes, IU Injection 1XX acute pulmonary embolism then 100,000 units every hour for up to 12-72 hours with monitoring of clotting factors ADULT: 15 mg/kg daily; max: 1 g daily. Reduce max daily dose to 500-750 mg in patients >40 yr. As part of an intermittent therapy: 25-30 mg/kg/day 2-3 times/wk; Streptomycin Sulphate 1 J01GA01183P4001 max: 1.5 g/dose. Not >120 g 1499. B Tuberculosis g Injection XX over the course of treatment should be given unless there are no other treatment options. Child: 20-40 mg/kg (max: 1 g) daily or 25-30 mg/kg (max: 1.5 g) 2-3 times wkly. Treatment of postmenopausal Strontium Ranelate 2 g M05BX03000F100 osteoporosis to reduce risk 1500. A* 2 g sachet once daily Granules 1XX of vertebral and hip fractures when biphosphonates are

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber contraindicated or not tolerated

High level disinfection for Succindialdehyde 11% & Immersion time is based on V07AV00000L9907 endoscopes, 1501. Dimethoxytetrahydrofuran A manufacturers XX ultrasonicprobes, 3% recommendation anaesthesia equipment etc i) 2 g twice daily or 1 g 4 times daily for 4-6 weeks or i) Benign gastric and in resistant cases up to 12 A02BX02000T1001 1502. Sucralfate 1 g Tablet A duodenal ulceration weeks (maximum 8 g daily) XX ii) Stress ulcer prophylaxis ii) 1 g 6 times daily (maximum 8 g daily). CHILD not recommended 2 mg/kg sugammadex is recommended, if spontaneous recovery has Indicated for reversal of occurred up to at least the neuromuscular blockade reappearance of second induced by rocuronium and twitch tension of the train-of- vecuronium in selective four (T2). 4 mg/kg patient group: obese, Sugammadex 100 mg/ml V03AB35000P3001 sugammadex is 1503. A* elderly, underlying Injection XX recommended if recovery cardiovascular disease. For has reached at least 1- 2 pediatric population, post-tetanic counts (PTC). sugammadex is For immediate reversal recommended for routine following administration of reversal rocuronium a dose of 16 mg/kg sugammadex is recommended Chloroquine resistant falciparum malaria acute attack Adult: Per tab contains pyrimethamine 25 mg and sulfadoxine 500 mg: 2-3 tabs as a single dose. Do not Treatment of Plasmodium repeat for at least 7 days. falciparum malaria in Child: Pyrimethamine 25mg patients in whom + Sulfadoxine 500mg Sulfadoxine 500 mg and P01BD51981T1001 chloroquine resistance is (Tablet): <2 yr (5-10 kg): 1/2 1504. Pyrimethamine 25 mg B XX suspected and malaria (half) tab as a single dose; 2- Tablet prophylaxis for travellers to 5 yr (>10-20 kg): 1 tab as a areas where chloroquine- single dose; 5-10 yr (< 20-30 resistant malaria is endemic kg): 1 1/2 (one and half) tab as a single dose; 10-14 yr (> 30-45 kg): 2 tab as a single dose. Do not repeat for at least 7 days. Renal impairment: Dose reduction may be needed. Severe:

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber contra-indicated. Hepatic impairment: Dose reduction may be needed. Severe: contra-indicated.

Mild to moderate infections: more than 2months: 8 - Sulphamethoxazole 200 12mg Trimethoprim/kg/day J01EE01961L8001 Infections caused by 1505. mg & Trimethoprim 40 B divided every 12hours. XX susceptible pathogens mg/5ml Suspension Serious Infections: 15-20mg Trimethoprim/kg/day divided every 6hours. i) ADULT: 960 mg twice daily increased to 1.44 g twice daily in severe infections. CHILD: 36 mg/kg daily in 2 divided doses increased to 54 mg/kg/day in severe infections i) Severe or complicated ii) Treatment: ADULT & infections when oral therapy CHILD over 4 weeks: 120 is not feasible mg/kg/day PO/IV infusion in Sulphamethoxazole 400 ii) Treatment and J01EE01961P3001 2 - 4 divided doses for 14 1506. mg & Trimethoprim 80 mg A prophylaxis of XX days. Prophylaxis: ADULT: Injection pneumocystis carinii 960 mg once daily or 960 mg pneumonia (PCP) in on alternate days (3 times a immunocompromised week) or 960 mg twice daily patients on alternate days (3 times a week). CHILD 6 weeks - 5 months: 120 mg twice daily on 3 consecutive days or 7 days per week; 6 months - 5 years: 240 mg; 6 - 12 years: 480 mg

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) ADULT: 1 - 3 tablets twice daily ii) Treatment: ADULT & CHILD over 4 weeks: 120 i) Severe or complicated mg/kg/day in 2 - 4 divided infections due to doses for 14 days. susceptible infection Prophylaxis: ADULT: 960 mg Sulphamethoxazole 400 ii) Treatment and once daily or 960 mg on J01EE01961T1001 1507. mg & Trimethoprim 80 mg B prophylaxis of alternate days (3 times a XX Tablet pneumocystis carinii week) or 960 mg twice daily pneumonia (PCP) in on alternate days (3 times a immunocompromised week). CHILD; 6 weeks - 5 patients months: 120 mg twice daily on 3 consecutive days or 7 days per week; 6 months - 5 years: 240 mg; 6 - 12 years: 480 mg When used in scalp disorders, a small amount of cream should be rubbed gently into the roots of the hair. When used in skin Sulphur 2% & Salicylic D10AB02951G100 Acne vulgaris and 1508. C disorders, the cream should Acid 2% Cream 1XX seborrhoeic dermatitis be applied sparingly to the affected area. Apply once daily or until noticeable improvement, then once or twice a week 200-400 mg twice daily; 800 mg daily in predominantly negative symptoms and 2.4 Acute and chronic g daily in mainly positive N05AL01000T1001 1509. Sulpiride 200 mg Tablet B schizophrenia, chronic symptoms. Elderly, lower XX delusional psychoses initial dose; increased gradually according to response. Child under 14 years not recommended Sumatriptan 100 mg N02CC01000T100 Treatment of acute 50 mg per attack and not 1510. A/KK Tablet 2XX migraine attacks more than 300 mg daily Sumatriptan 50 mg Fast N02CC01000T500 Treatment of acute 50 mg per attack and not 1511. A Disintegrating Tablet 1XX migraine attacks more than 300 mg daily N02CC01000T100 Treatment of acute 50 mg per attack and not 1512. Sumatriptan 50 mg Tablet A/KK 1XX migraine attacks more than 300 mg daily 6 mg given by SC as soon as possible after onset. Dose Treament of acute migraine may be repeated once after Sumatriptan 6 mg/0.5 ml N02CC01000P500 1513. A attacks and cluster not less than 1 hour if Injection 1XX headache needed. Max. 12 mg in 24 hours. Child not recommended

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Apply to exposed areas at least 30 minutes prior to solar exposure; reapply after Sunscreen 5 - 20% w/w D02BA02000G100 1514. B Photodermatitis swimming, prolonged Cream 1XX perspiration and after 2 hours of continuos sun exposure Intravenous: Muscle relaxant in general anaesthesia Adult: As chloride: single dose of 0.3-1.1 mg/kg injected; supplementary doses of 50- 100% of the initial dose may be given at 5-10 min intervals. Max dose (repeated IV injection or Suxamethonium Chloride M03AB01100P300 Muscle relaxant as an continuous infusion): 500 1515. B 50 mg/ml lnj 1XX adjunct to anaesthesia mg/hr Child: As chloride: <1 yr: 2 mg/kg; 1-12 yr: 1 mg/kg. Intramuscular: Muscle relaxant in general anaesthesia Adult: As chloride: 3-4 mg/kg. Max total dose: 150 mg Child: As chloride: <1 yr: Up to 4-5 mg/kg; ≥1 yr: Up to 4 mg/kg. Max dose: 150 mg. Diagnostic test for investigation of adrenocortical insufficiency Adult: As plain preparation: Measure plasma cortisol concentration immediately before and exactly 30 min after IM/IV inj of 250 mcg. Post-inj rise in plasma cortisol concentration ≥200 nmol/l (70 mcg/l) if normal Diagnostic test to Synthetic ACTH adrenocortical function. As H01AA02000P300 differentiate primary adrenal 1516. (Tetracosactrin Acetate) A depot preparation (if 1XX from secondary (pituitary) 250 mcg/ml Injection inconclusive results with adrenocortical insufficiency plain preparation): Measure plasma cortisol concentration before and exactly 30 min, 1, 2, 3, 4 and 5 hr after an IM inj of 1 mg tetracosactide acetate depot. Adrenocortical function normal if the post-inj rise in plasma cortisol concentration increases 2- fold in 1st hr, and continues to rise steadily. Expected

323 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber levels in 1st hr: 600-1,250 nmol/l, increasing slowly up to 1000-1800 nmol/l by 5th hr. Child: IV 250 mcg/1.73 m2 BSA. Intramuscular

For short-term and intermittent long-term Adult ≥16 years: Apply therapy in the treatment of 0.03% or 0.1% to the patients with moderate to affected skin twice daily and severe atopic dermatitis in rub in gently and completely. whom the use of Children ≥ 2 years: Apply alternative, conventional Tacrolimus 0.03% D11AH01000G500 0.03% ointment thinly to the 1517. A* therapies are deemed Ointment 2XX affected skin bd and rub in inadvisable because of gently and completely. potential risks, or in the Treatment should be treatment of patients who continued for 1 week after are not adequately clearing of signs & symptoms responsive to or are of atopic dermatitis. intolerant of alternative, conventional therapies For short-term and intermittent long-term Adult ≥16 years: Apply therapy in the treatment of 0.03% or 0.1% to the patients with moderate to affected skin twice daily and severe atopic dermatitis in rub in gently and completely. whom the use of Children ≥ 2 years: Apply alternative, conventional Tacrolimus 0.1% D11AH01000G500 0.03% ointment thinly to the 1518. A* therapies are deemed Ointment 1XX affected skin bd and rub in inadvisable because of gently and completely. potential risks, or in the Treatment should be treatment of patients who continued for 1 week after are not adequately clearing of signs & symptoms responsive to or are of atopic dermatitis. intolerant of alternative, conventional therapies

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Primary immunosuppression in liver and kidney allograft recipients. ii) Liver and kidney allograft rejection resistant to conventional 0.1-0.2 mg/kg/day for liver immunosuppressive agents. transplantation and at 0.15- Tacrolimus 0.5 mg L04AD02000C1003 1519. A* It is recommended to be 0.3 mg/kg/day for kidney Capsule XX used concomitantly with transplantation administered adrenal corticosteroids. as 2 divided doses. Because of the risk of anaphylaxis. Injection should be reserved for patients unable to take capsules only. i) Prophylaxis of kidney transplant rejection: Tacrolimus PR therapy should commence at dose of 0.20-0.30 mg/kg/day administered once daily in the morning. Administration should commence within 24 hours after completion of surgery. ii) Prophylaxis of liver transplant rejection: Tacrolimus PR therapy should commence at a dose of 0.10-0.20 mg/kg/day i) Prophylaxis of transplant administered once daily in rejection in adult kidney or the morning. Administration liver allograft recipients. Tacrolimus 0.5mg should commence within 12- L04AD02000C2203 ii) Treatment of kidney or 1520. Prolonged -Release Hard A* 18 hours after completion of XX liver allograft rejection Capsule surgery. iii) Treatment of resistant to treatment with allograft rejection: Increased other immunosuppressive doses of tacrolimus, medicinal products in adult. supplemental corticosteroid therapy, and introduction of short courses of mono- /polyclonal antibodies have all been used to manage rejection episodes. If signs of toxicity such as severe adverse reactions are noted, the dose of Tacrolimus PR might need to be reduced. iv) Treatment of allograft rejection after kidney or liver transplantation: For conversion from other immunosuppressants to

325 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber once daily Tacrolimus PR, treatment should begin with the initial oral dose recommended in kidney and liver transplantation respectively for prophylaxis of transplant rejection. v) Conversion of Tacrolimus to Tacrolimus PR: Allograft transplant patients maintained on twice daily PR capsules dosing requiring conversion to once daily PR should be converted on a 1:1 (mg:mg) total daily dose basis. Tacrolimus PR should be administered in the morning. (Please refer to the product leaflet for further information on dosage) i) Primary immunosuppression in liver and kidney allograft recipients. ii) Liver and kidney allograft rejection resistant to 0.1-0.2 mg/kg/day for liver conventional transplantation and at 0.15- L04AD02000C1001 immunosuppressive agents. 1521. Tacrolimus 1 mg Capsule A* 0.3 mg/kg/day for kidney XX It is recommended to be transplantation administered used concomitantly with as 2 divided doses. adrenal corticosteroids. Because of the risk of anaphylaxis. Injection should be reserved for patients unable to take capsules only. i) Prophylaxis of kidney transplant rejection: Tacrolimus PR therapy should commence at dose of i) Prophylaxis of transplant 0.20-0.30 mg/kg/day rejection in adult kidney or administered once daily in liver allograft recipients. ii) the morning. Administration Tacrolimus 1mg L04AD02000C2201 Treatment of kidney or liver should commence within 24 1522. Prolonged -Release Hard A* XX allograft rejection resistant hours after completion of Capsule to treatment with other surgery. immunosuppressive ii) Prophylaxis of liver medicinal products in adult. transplant rejection: Tacrolimus PR therapy should commence at a dose of 0.10-0.20 mg/kg/day administered once daily in

326 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber the morning. Administration should commence within 12- 18 hours after completion of surgery. iii) Treatment of allograft rejection: Increased doses of tacrolimus, supplemental corticosteroid therapy, and introduction of short courses of mono-/polyclonal antibodies have all been used to manage rejection episodes. If signs of toxicity such as severe adverse reactions are noted, the dose of Tacrolimus PR might need to be reduced. iv) Treatment of allograft rejection after kidney or liver transplantation: For conversion from other immunosuppressants to once daily Tacrolimus PR, treatment should begin with the initial oral dose recommended in kidney and liver transplantation respectively for prophylaxis of transplant rejection. v) Conversion of Tacrolimus to Tacrolimus PR: Allograft transplant patients maintained on twice daily PR capsules dosing requiring conversion to once daily PR should be converted on a 1:1 (mg:mg) total daily dose basis. Tacrolimus PR should be administered in the morning. (Please refer to the product leaflet for further information on dosage) i) Primary immunosuppression in liver and kidney allograft 0.1-0.2 mg/kg/day for liver recipients. ii) Liver and transplantation and at 0.15- L04AD02000C1002 kidney allograft rejection 1523. Tacrolimus 5 mg Capsule A* 0.3 mg/kg/day for kidney XX resistant to conventional transplantation administered immunosuppressive agents. as 2 divided doses. It is recommended to be used concomitantly with adrenal corticosteroids.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Because of the risk of anaphylaxis. Injection should be reserved for patients unable to take capsules only.

i) Prophylaxis of kidney transplant rejection: Tacrolimus PR therapy should commence at dose of 0.20-0.30 mg/kg/day administered once daily in the morning. Administration should commence within 24 hours after completion of surgery. ii) Prophylaxis of liver transplant rejection: Tacrolimus PR therapy should commence at a dose of 0.10-0.20 mg/kg/day administered once daily in the morning. Administration should commence within 12- i) Prophylaxis of transplant 18 hours after completion of rejection in adult kidney or surgery. iii) Treatment of liver allograft recipients. ii) allograft rejection: Increased Tacrolimus 5mg L04AD02000C2202 Treatment of kidney or liver doses of tacrolimus, 1524. Prolonged -Release Hard A* XX allograft rejection resistant supplemental corticosteroid Capsule to treatment with other therapy, and introduction of immunosuppressive short courses of mono- medicinal products in adult. /polyclonal antibodies have all been used to manage rejection episodes. If signs of toxicity such as severe adverse reactions are noted, the dose of Tacrolimus PR might need to be reduced. iv) Treatment of allograft rejection after kidney or liver transplantation: For conversion from other immunosuppressants to once daily Tacrolimus PR, treatment should begin with the initial oral dose recommended in kidney and liver transplantation respectively for prophylaxis

328 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber of transplant rejection. v) Conversion of Tacrolimus to Tacrolimus PR: Allograft transplant patients maintained on twice daily PR capsules dosing requiring conversion to once daily PR should be converted on a 1:1 (mg:mg) total daily dose basis. Tacrolimus PR should be administered in the morning. (Please refer to the product leaflet for further information on dosage) i) Primary immunosuppression in liver and kidney allograft recipients. ii) Liver and kidney allograft rejection resistant to conventional 0.01-0.05 mg/kg for liver immunosuppressive agents. transplant and 0.05-0.1 Tacrolimus 5mg/ml L04AD02000P3001 1525. A* It is recommended to be mg/kg for kidney transplant Injection XX used concomitantly with as 24-hours continuous adrenal corticosteroids. infusion. Because of the risk of anaphylaxis. Injection should be reserved for patients unable to take capsules only. Tamoxifen Citrate 20 mg L02BA01136T1001 20 mg in 1-2 divided doses. 1526. A Breast cancer Tablet XX Max: 40 mg/day Second line treatment of functional symptoms of benign prostatic hyperplasia Tamsulosin HCl 400 mcg G04CA02110T500 (BPH) in patients who do 1527. A* 400 mcg once daily Extended Release Tablet 1XX not tolerate first line drugs or when first line drugs are inappropriate or contraindicated Dandruff, seborrhoeic Massage into wet hair, rinse Tar, Coal Tar and Oleyl D05AA00952L5001 1528. A/KK dermatitis and atopic and repeat. Use once or Alcohol Liquid XX dermatitis twice weekly

329 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Technetium-99m as pertechnetate is obtained by elution with a sterile solution of Sodium Chloride 0.9%. The dosage depend on type of scan i) Thyroid scintigraphy: 18.5- 80 MBq (0.5-2.2 mCi) Scintigraphy performed 20 minutes after intravenous injection ii) Salivary gland scintigraphy: 40 MBq (1.1 mCi) Scintigraphy performed immediately after intravenous injection and at regular intervals up to 15 minutes iii) Meckel?s diverticulum scintigraphy: 400 MBq (10.8 mCi) Scintigraphy performed immediately after intravenous injection and at Sodium pertechnetate is regular interval up to 30 used for scintigraphy or minutes nuclear scan particularly of Technetium-99m Sterile V09CA01000P300 iv) Brain scintigraphy: 370- 1529. A* the brain and thyroid to Generator 1XX 800 MBq (10-22 mCi) Rapid prepare various technetium- sequential images are taken 99m labelled injections for immediately within the first selective organ imaging minute after intravenous administration, static images 1 to 4 hours later. Thyroid and coriod plexus should be blocked to avoid non-specific 99mTc uptake v) Cardiac and vascular scintigraphy: 740-925 MBq (20-25 mCi) Red cells are labeled in vivo or in vitro by pretreating with a reducing agent. Dynamic images are taken in the first minute after intravenous administration, followed by regular images over 30 minutes vi) Gastrointestinal bleeding: 740-925 MBq (20-25 mCi) Red cells are labeled in vivo or in vitro by pretreating with a reducing agent. Dynamic images are taken in the first minutes after intravenous

330 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber administration, followed by regular images at appropriate intervals for up to 24 hours vii) Lacrimal duct scintigraphy: 2-4 MBq each eye (50-100 mCi) Drops are instilled into eye and dynamic images are taken over 2 minutes, followed by static images at appropriate intervals over 20 minutes

Tegafur 100 mg & uracil L01BC53980C1001 300-600 mg daily in 2-3 1530. A* Non small cell lung cancer 224 mg Capsule XX divided doses ADULT and CHILD over 16 years: 600 mg once daily. Treatment of chronic Renal Dose Adjustment: hepatitis B in patients with Telbivudine 600 mg J05AF11000T1001 600mg every 48hours (30- 1531. A* evidence of viral replication Tablet XX 49ml/min), 600 mg every and active liver 72hours. (<30ml/min; not inflammation requiring dialysis); 600mg every 96 days (ESRD) Hypertension in patients C09CA07000T100 1532. Telmisartan 40 mg Tablet A/KK who cannot tolerate ACE 40mg - 80mg once daily 1XX inhibitors because of cough Telmisartan 80 mg & Hypertension in patients C09DA07000T100 1533. Hydrochlorothiazide 12.5 A/KK who cannot tolerate ACE 1 tablet daily 1XX mg Tablet inhibitors because of cough

331 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Treatment of essential hypertension in adults: i) Replacement therapy:Patients receiving telmisartan and amlodipine from separate tablets may instead receive one tablet Single-pill combination containing the same should be taken once daily. component doses Initiate with telmisartan Telmisartan 80 mg and C09DB04935T100 ii) Add on therapy: Patients 80mg/amlodipine 5mg one 1534. A/KK Amlodipine 10 mg Tablet 2XX who blood pressure is not tablet per day. The maximum adequately controlled on recommendation dose is telmisartan or amlodipine telmisartan 80mg/amlodipine monotherapy 10mg one tablet per day. iii) Initial therapy: May also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals Treatment of essential hypertension in adults: i) Replacement therapy:Patients receiving telmisartan and amlodipine from separate tablets may Single-pill combination instead receive one tablet should be taken once daily. containing the same Initiate with telmisartan component doses ii) Add on Telmisartan 80 mg and C10BX03935T1008 80mg/amlodipine 5mg one 1535. A/KK therapy: Patients who blood Amlodipine 5 mg Tablet XX tablet per day. The maximum pressure is not adequately recommendation dose is controlled on telmisartan or telmisartan 80mg/amlodipine amlodipine monotherapy iii) 10mg one tablet per day. Initial therapy: May also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals i) Hypertension in patients who cannot tolerate ACE inhibitors because of cough ii) Reduction of the risk of myocardial infarction, C09CA07000T100 stroke, or death from i) 40mg - 80mg once daily 1536. Telmisartan 80 mg Tablet A/KK 2XX cardiovascular causes in ii) 80mg once daily patients 55 years or older at high risk of developing major cardiovascular events who are unable to take ACE inhibitors

332 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Concomitant phase : 75mg/m2 daily with In patients with radiotherapy for 42 days, glioblastoma multiforme followed by 6 cycle of who fulfill all the following adjuvant treatment. Adjuvant Temozolomide 100 mg L01AX03000C1003 criteria : phase: Additional 6 cycles of 1537. A* Capsule XX i. Total /near total resection adjuvant phase. Cycle 1- ii. ECOG/WHO 150mg/m2 once daily for 5 performance status 0-2 days followed by 23 days iii. Age less than 60 years without treatment. Cycle 2-6 : 200mg/m2 once daily for 5 days per 28-day cycle Concomitant phase : 75mg/m2 daily with In patients with radiotherapy for 42 days, glioblastoma multiforme followed by 6 cycle of who fulfill all the following adjuvant treatment. Adjuvant Temozolomide 20 mg L01AX03000C1001 criteria : phase: Additional 6 cycles of 1538. A* Capsule XX i. total /near total resection adjuvant phase. Cycle 1- ii. ECOG/WHO 150mg/m2 once daily for 5 performance status 0-2 days followed by 23 days iii. Age less than 60 years without treatment. Cycle 2-6 : 200mg/m2 once daily for 5 days per 28-day cycle Acute myocardial reinfarction where Less than 60 kg: 30 mg, 60 - streptokinase is 69 kg: 35 mg, 70 - 79 kg: 40 contraindicated due to Tenecteplase 10,000 unit B01AD11000P400 mg; 80 -90 kg: 45 mg, 90 kg 1539. A* previous streptokinase (50 mg) Injection 1XX or above: 50 mg. Administer induced antibodies. single IV bolus over 5-10 [Indicated when antibodies seconds was given more than 5 days and less than 12 months] Treatment of HIV-1 infection in adults in Tenofovir Disoproxil combination with other Fumarate 300 mg & J05AR03964T1001 1540. A/KK antiretroviral agents (such 1 tablet once daily. Emtricitabine 200 mg XX as non-nucleoside reverse Tablet transcriptase inhibitors or protease inhibitors). i) Treatment of HIV-1 infected adults in combination with other 300mg once daily. Renal antiretroviral agents. Dose Adjustment: 300mg ii) Use as first line every 48hours (30- Tenofovir Disoproxil J05AF07138T1001 monotherapy for chronic 1541. A* 49ml/min); 300mg every Fumarate 300 mg Tablet XX hepatitis B or as a rescue 72hours (10-29ml/min); therapy for patients with 300mg every 7 days after drug resistance hepatitis B dialysis (Hemodialysis) virus (according to resistant profile or treatment guidelines).

333 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Only for treatment of Initially 1 mg at night, Benign Prostatic Terazosin HCl 1 mg G04CA03110T100 increased in a stepwise 1542. A/KK Hyperplasia. Not to be used Tablet 1XX fashion to 2 mg, 5 mg or 10 for treatment of mg once daily hypertension i) Initially 1 mg at night, increased in a stepwise fashion to 2 mg, 5 mg or 10 i) Treatment of Benign mg once daily. Terazosin HCl 2 mg G04CA03110T100 1543. A/KK Prostatic Hyperplasia. ii) Initial: 1mg once daily at Tablet 2XX ii) Hypertension bedtime, Maintenance: 1- 5mg once (morning or evening) or twice daily. Max: 20-40mg/day i) Initially 1 mg at night, increased in a stepwise fashion to 2 mg, 5 mg or 10 i) Treatment of Benign mg once daily. Terazosin HCl 5 mg G04CA03110T100 1544. A/KK Prostatic Hyperplasia. ii) Initial: 1mg once daily at Tablet 3XX ii) Hypertension bedtime, Maintenance: 1- 5mg once (morning or evening) or twice daily. Max: 20-40mg/day Fungal infections especially 250 mg once daily for 6 Terbinafine HCl 250 mg D01BA02110T1001 1545. A/KK onchomycosis caused by weeks for fingernails: 12 Tablet XX dermatophytes weeks for toenails ADULT and CHILD more than 12 years : 1 inhalation 6 hourly. Severe cases : Single Bronchial asthma, chronic dose may be increased to 3 bronchitis, emphysema and inhalation. Maximum 12 Terbutaline 0.5mg/dose R03AC03183A200 1546. B other lung diseases where inhalation/24 hour. CHILD 3- Inhaler 1XX bronchospasm is a 12 year : 1 inhalation 6 complicating factor hourly. Severe cases : Single dose may be increased to 2 inhalation. Maximum 8 inhalation/24 hour SC, IM or slow IV : 250-500 mcg up to 4 times daily. CHILD 2 - 15 years Bronchial asthma, chronic 10mcg/kg to a maximum of bronchitis, emphysema and Terbutaline Sulphate 0.5 R03CC03183P300 300 mcg. Continuous IV 1547. B other lung diseases where mg/ml Injection 1XX infusion, as a solution broncoconstriction is a containing 3 - 5 mcg/ml, 1.5 - complicating factor 5 mcg/minute for 8 - 10 hours; reduce dose for children ADULT : 5 - 10 mg 2 -4 times Asthma and other daily, additional doses may Terbutaline Sulphate 10 R03AC03183A300 conditions associated with 1548. B be necessary in severe acute mg/ml Nebulizer Solution 1XX reversible airways asthma. CHILD up to 3 years obstruction : 2 mg, 3 - 6 years : 3 mg, 6 -

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber 8 years : 4 mg, over 8 years : 5 mg 2 - 4 times daily 2 mg IV bolus over 1 minute. Maintenance: 1 - 2 mg IV bolus 4 - 6 hourly until Terlipressin 1mg/5mg H01BA04000P400 Acute oesophageal variceal 1549. A* bleeding is controlled, up to Injection 1XX bleeding 24 - 36 hours. The maximum daily dosage is 120-150 mcg/kg body weight. By IM only. Hypogonadism 250 mg every 2-3 weeks. To Only for treatment of male maintain an adequate infertility, protein deficiency androgenic effect 250 mg during convalescence after every 3-6 weeks. Potency Testosterone 250 mg/ml G03BA03000P300 surgery and wasting 1550. A* disorders 250 mg every 4 Injection 1XX disorder. In women, weeks. Male climateric supplementary therapy of disorders: 250 mg every 3-4 progressive mammary weeks. Repeated 6-8 weeks carcinoma courses at 2-3 months interval 2 doses of 0.5 mL IM at an interval of 4-8 wk, followed J07AM01000P3001 Immunization against 1551. Teta nus Toxoid Injection C+ by the 3rd dose 6-12 mth XX tetanus infection later. Booster: 0.5 mL IM every 10 yr. Adult: 250-500 mg 6 hrly. Tetracycline HCl 250 mg J01AA07110C1001 Infections caused by 1552. B Max: 4 g/day. Child: ≥12 yr Capsule XX susceptible pathogens Max: 2 g daily Adult: 250-500 mg 6 hrly. Tetracycline HCl 250 mg J01AA07110T1001 Infections caused by 1553. B Max: 4 g/day. Child: ≥12 yr Tablet XX susceptible pathogens Max: 2 g daily First line induction therapy in newly diagnosed multiple myeloma, salvage therapy in relapsed multiple myeloma and maintenance Thalidomide 50 mg L04AX02000C1001 therapy in multiple myeloma 1554. A* 50 mg to 200 mg daily Capsule XX (contraindicated for pregnant women; pregnancy test for females in reproductive age group before starting treatment should be done). Used in myocardial perfusion scintigraphy, acute myocardial infarction Thallous Chloride V09GX01100P300 and post-surgical 1555. A* As IV infusion (Thallium-201) Injection 1XX assessment of coronary artery bypass graft patency, muscle perfusion scintigraphy, visualisation of

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber brain and thyroid tumours and metastases

ADULT: 125 mg 3 - 4 times daily after food, increased to Reversible airways Theophylline 125 mg R03DA04000T100 250 mg if required. CHILD: 1 1556. B obstruction, acute severe Tablet 1XX - 15 years : 5 mg/kg/dose (up asthma to 600 mg/ day) every 3 - 4 times daily ADULT: 250 mg 2 times Reversible airways Theophylline 250 mg R03DA04000T500 daily. CHILD under 12 years 1557. B obstruction and acute Long Acting Tablet 1XX : Up to 10 mg/kg body weight severe asthma 2 times daily ADULT : 125 mg 3 - 4 times daily after food, increased to Reversible airways Theophylline 80 mg/15 ml R03DA04000L9001 250 mg if required. CHILD 1 1558. B obstruction and acute Syrup XX - 15 years : 5 mg/kg/dose (up severe asthma to 600 mg/day) every 3 - 4 times per day i) For the prevention or i) Mild to chronic deficiency: treatment of Vitamin B1 10-25 mg daily. Severe deficiency syndromes deficiency: 200- 300 mg daily Thiamine HCl 100 mg/ml A11DA01110P300 including beri-beri and 1559. B ii) 500 mg every 8 hours for 2 Injection 1XX peripheral neuritis days, followed by 100 mg 2 associated with pellagra times daily until patient can ii) Wernicke-Korsakoff take oral dose Syndrome i) For the prevention or i) Mild to chronic deficiency: treatment of Vitamin B1 10-25 mg daily. Severe deficiency syndromes deficiency: 200- 300 mg daily Thiamine Mononitrate 10 A11DA01221T1002 including beri-beri and 1560. C ii) 500 mg every 8 hours for 2 mg Tablet XX peripheral neuritis days, followed by 100 mg 2 associated with pellagra times daily until patient can ii) Wernicke-Korsakoff take oral dose Syndrome i) For the prevention or i) Mild to chronic deficiency: treatment of Vitamin B1 10-25 mg daily. Severe deficiency syndromes deficiency: 200 - 300 mg Thiamine Mononitrate 3 A11DA01221T1001 including beri-beri and daily 1561. C mg Tablet XX peripheral neuritis ii) 500 mg every 8 hours for 2 associated with pellagra days, followed by 100 mg 2 ii) Wernicke-Korsakoff times daily until patient can Syndrome take oral dose

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Refer to specific protocols. Usually 100 mg/m2 for 5 - 7 days (acute myeloid For acute leukaemia and leukaemia) or up to 2 weeks L01BB03000T1001 1562. Thioguanine 40 mg Tablet A chronic granulocytic (chronic myeloid leukaemia XX leukaemia for accelerated/ advanced disease). CHILD: 40 - 60 g/m2 daily according to protocol i) ADULT : For induction 200 - 400 mg. For repeat injection 3 - 5 mg/kg over 10 i) General anaesthesia, - 15 seconds until desired induction depth of anaesthesia is Thiopental Sodium 500 N05CA19520P300 1563. B ii) Anticonvulsant for cases obtained. Not FDA approved mg Injection 1XX resistant to conventional for use in pediatric patients anticonvulsants in the ICU ii) 75 - 125 mg IV single dose; for local-anaesthetic induced convulsion: 125 - 250 mg IV over 10 minutes Thymol Compound A01AD11985M200 For sore throat and minor 1564. C To be gargled 3-4 times daily Gargle 1XX mouth inflammation A two-injection regimen is recommended for thyrotropin administration.The two- injection regimen is thyrotropin 0.9 mg intramuscularly (IM), followed by a second 0.9 mg IM injection 24 hours later. After Thyrogen (thyrotropin alfa) reconstitution with 1.2 mL is indicated for use as an Sterile Water for Injection, adjunctive treatment for 1.0 mL solution (0.9 mg radioiodine ablation of thyrotropin alfa) is thyroid tissue remnants in administered by Thyrotropin alfa 0.9mg/ml H01AB01000P300 patients who have intramuscular injection to the 1565. A* Injection 2XX undergone a near-total or buttock. For radioiodine total thyroidectomy for well- imaging or treatment, differentiated thyroid cancer radioiodine administration and who do not have should be given 24 hours evidence of distant following the final Thyrogen metastatic thyroid cancer. injection. Diagnostic scanning should be performed 48 hours after radioiodine administration, whereas post-therapy scanning may be delayed additional days to allow background activity to decline.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Treatment of complaints resulting from the natural or surgical menopause & in G03CX01000T100 1566. Tibolone 2.5 mg Tablet A* cases at high risk for breast 2.5mg daily 1XX carcinomas where general hormone replacement therapy is contraindicated a) Patient who failed clopidogrel readmitted to hospital with recurrent atherothrombotic event while patients are on clopidogrel. b) ACS patients with: Initially, 180mg as single i) STEMI - going for B01AC24000T1001 dose followed by 90mg bd 1567. Ticagrelor 90 mg Tablet A* invasive (PCI), XX with maintenance dose of ii) NSTEMI/UA - ASA 75-150 mg daily. intermediate to high risk (based on TIMI score). iii) Other complicated ACS cases treated either medically or invasively via PCI or CABG (risk of Stent thrombosis, 3VD etc.) i) Prevention of thrombotic stroke for patients who are sensitive /intolerant to Acetysalicylic Acid Ticlopidine HCl 250 mg B01AC05110T1001 ii) Maintenance of coronary 250 mg twice daily taken with 1568. A/KK Tablet XX bypass surgery or food angioplasty iii) Maintenance of patency of access in patients on chronic haemodialysis Initially, 1 drop of 0.25% 2 Elevated intraocular Timolol Maleate 0.5% Eye S01ED01253D200 times daily, if clinical 1569. A pressure, chronic open Drops 2XX response is not adequate, 1 angle glaucoma drop of 0.5% 2 times daily i) ADULT : 2 g as a single dose for 2 - 3 days. CHILD 3 years and older : 50 mg/kg daily for 3 days i) Amoebiasis ii) ADULT : 2 g as a single P01AB02000T1001 1570. Tinidazole 500 mg Tablet B ii) Urogenital trichomoniasis dose (repeated once if XX and giardiasis necessary). Sexual partners should be treated concomitantly with the same dose. CHILD 6 years and older : single dose of 1 gram

338 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Treatment of DVT and PE, in conjunction with warfarin: 175 anti-Factor Xa IU/kg SC once daily for at least 6 days. ii) Thromboprophylaxis in i) Treatment of deep vein patients with:Moderate risk of thrombosis (DVT) and thrombosis (general pulmonary embolism (PE), surgery):3,500 anti-Factor Xa Tinzaparin sodium 10,000 not amounting to IU SC 2 hrs before surgery anti-Factor Xa IU/ml B01AB10520P5001 1571. A* hemodynamic instability. and postoperatively, 3,500 Injection in Prefilled XX ii) Prevention of post- anti-Factor Xa IU once daily syringe/cartridge operative DVT in patients for 7-10 days. High risk of undergoing general and thrombosis (eg. total hip orthopaedic surgery. replacement):4,500 anti- Factor Xa IU SC or 50 anti- Factor Xa IU/kg body weight SC 2 hrs before surgery and then once daily until the patients has been mobilized. i) Treatment of DVT and PE, in conjunction with warfarin: 175 anti-Factor Xa IU/kg SC once daily for at least 6 days. ii) Thromboprophylaxis in i) Treatment of deep vein patients with:Moderate risk of thrombosis (DVT) and thrombosis (general pulmonary embolism (PE), surgery):3,500 anti-Factor Xa Tinzaparin sodium 20,000 not amounting to IU SC 2 hrs before surgery anti-Factor Xa IU/ml B01AB10520P5002 1572. A* hemodynamic instability. and postoperatively, 3,500 Injection in Prefilled XX ii) Prevention of post- anti-Factor Xa IU once daily syringe/cartridge operative DVT in patients for 7-10 days. High risk of undergoing general and thrombosis (eg. total hip orthopaedic surgery. replacement):4,500 anti- Factor Xa IU SC or 50 anti- Factor Xa IU/kg body weight SC 2 hrs before surgery and then once daily until the patients has been mobilized. Skin fungal infections Gently massage into the D01AC07000G100 resistant to antifungal drugs 1573. Tioconazole 1% Cream A affected and surrounding 1XX such as miconazole and area 1-2 times daily clotrimazole Adult & Child > 12yr: Insert Tioconazole 100 mg G01AF08000S100 1574. A Vulvovaginal candidiasis nightly on retiring for 3-6 or Vaginal Tablet 1XX 14 days Apply 4.6 g intravaginally Tioconazole 6.5% Vaginal G01AF08000G500 prior to bedtime as a single 1575. A Vulvaginal candidiasis Ointment 1XX dose therapy, therapy may extend to 7 days

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD) in which the diagnosis of COPD is confirmed by spirometry. ii) As add-on maintenance bronchodilator treatment in Tiotropium 2.5mcg/puff R03BB04320A300 5 mcg (2 puff) once daily, at 1576. A/KK adult patients with asthma solution for inhalation 1XX the same time of the day who are currently treated with the maintenance combination of inhaled corticosteroids (≥800µg budesonide/day or equivalent) and long-acting β2-agonist and who experienced one or more severe exacerbations in the previous year. Long term maintenance treatment of bronchospasm and dypsnoea associated Contents of one capsule is with COPD. Tiotropium has Tiotropium Bromide 18 R03BB04320C990 inhaled once daily with the 1577. A/KK usually been added to mcg Inhalation Capsules 1XX Handihaler inhalation device standard therapy (e.g. at the same time of the day. inhaled steroids, theophylline, albuterol rescue) Unstable angina or non-ST segment elevation myocardial infarction with By IV infusion, 0.4 the following: elevated mcg/kg/min for 30 minutes, Tirofiban HCl 0.25 mg/ml B01AC17110P990 1578. A* cardiac markers, refractory then 0.1 mcg/kg/min for at Injection 1XX chest pain, ST-segment least 48 hours, maximum changes and thrombolysis 108 hours in myocardial infarction (TIMI) risk score 4

340 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Indicated for the treatment of moderate to severe active rheumatoid arthritis Recommended dose for (RA) in adult patients: rheumatoid arthritis of i) with inadequate respond tocilizumab for adult patients or intolerance to is 8mg/kg given once every 4 conventional disease- weeks as a single-drip IV modifying antirheumatic infusion over 1 hour. It drugs (DMARDS) should be diluted to 100 ml Tocilizumab 20 mg/ml L04AC07000P3001 ii) who has failed antitumour 1579. A* by a healthcare professional Injection XX necrosis factors (antiTNFs) with sterile 0.9% w/v sodium iii) where TNF is chloride solution over 1 hour. contraindicated (patients For patients whose body with history of pulmonary weight is more than 100kg, tuberculosis [PTB]) It also doses exceeding 800mg per can be used as infusion are not monotherapy or with recommended combination with methotrexate (MTX) and/ or other DMARDS. Treatment of overactive 4 mg once daily. May Tolterodine Tartrate ER 4 G04BD07123C200 bladder with symptoms of decrease to 2 mg once daily 1580. A* mg Capsule 2XX urinary, frequency or urge depending on response and incontinence tolerability ADULT: Initially 25-50mg nightly for 1 week. Subsequently at wkly or bi- wkly intervals, increase dose by 25-50 to 100mg/day in 2 divided doses. CHILD aged 2 and above: Approx 5-9 Topiramate 100 mg N03AX11000T1003 Add-on therapy for 1581. A* mg/kg/day in 2 divided Tablet XX intractable partial epilepsy doses. Titrate at 25mg (or less, based on a range of 1- 3mg/kg/day) nightly for the 1st week. Subsequently at 1 or 2 wkly intervals, with increments of 1-3 mg/kg/day in 2 divided dose. ADULT: Initially 25-50mg nightly for 1 week. Subsequently at wkly or bi- wkly intervals, increase dose by 25-50 to 100mg/day in 2 divided doses. CHILD aged 2 Topiramate 15 mg N03AX11000C100 Add-on therapy for 1582. A* and above: Approx 5-9 Capsule Sprinkle 1XX intractable partial epilepsy mg/kg/day in 2 divided doses. Titrate at 25mg (or less, based on a range of 1- 3mg/kg/day) nightly for the 1st week. Subsequently at 1 or 2 wkly intervals, with

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber increments of 1-3 mg/kg/day in 2 divided dose. ADULT: Initially 25-50mg nightly for 1 week. Subsequently at wkly or bi- wkly intervals, increase dose by 25-50 to 100mg/day in 2 divided doses. CHILD aged 2 and above: Approx 5-9 Topiramate 25 mg N03AX11000C100 Add-on therapy for 1583. A* mg/kg/day in 2 divided Capsule Sprinkle 2XX intractable partial epilepsy doses. Titrate at 25mg (or less, based on a range of 1- 3mg/kg/day) nightly for the 1st week. Subsequently at 1 or 2 wkly intervals, with increments of 1-3 mg/kg/day in 2 divided dose. ADULT: Initially 25-50mg nightly for 1 week. Subsequently at wkly or bi- wkly intervals, increase dose by 25-50 to 100mg/day in 2 divided doses. CHILD aged 2 and above: Approx 5-9 N03AX11000T1001 Add-on therapy for 1584. Topiramate 25 mg Tablet A* mg/kg/day in 2 divided XX intractable partial epilepsy doses. Titrate at 25mg (or less, based on a range of 1- 3mg/kg/day) nightly for the 1st week. Subsequently at 1 or 2 wkly intervals, with increments of 1-3 mg/kg/day in 2 divided dose. ADULT: Initially 25-50mg nightly for 1 week. Subsequently at wkly or bi- wkly intervals, increase dose by 25-50 to 100mg/day in 2 divided doses. CHILD aged 2 and above: Approx 5-9 N03AX11000T1002 Add-on therapy for 1585. Topiramate 50 mg Tablet A* mg/kg/day in 2 divided XX intractable partial epilepsy doses. Titrate at 25mg (or less, based on a range of 1- 3mg/kg/day) nightly for the 1st week. Subsequently at 1 or 2 wkly intervals, with increments of 1-3 mg/kg/day in 2 divided dose. Only to be used to cover Trace Elements and B05XA30905P3001 daily loss of electrolyte and 10 ml added to 500-1000 ml 1586. Electrolytes (Adult) A* XX trace elements for patient solution, given by IV infusion Solution on parenteral nutrition

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber According to the needs of the patient. INFANT and CHILD weighing 15 kg or less: Basal requirements of the included trace elements are covered by 1 ml/kg/day to a maximum Only to be used to cover Trace Elements and dose of 15 ml. CHILD B05XA30905P3002 daily loss of electrolyte and 1587. Electrolytes (Paediatric) A* weighing 15 kg or more, a XX trace elements for patient Solution daily dose of 15 ml, should on parenteral nutrition meet basic trace element requirements. However, for patients weighing more than 40 kg the adult preparation trace element should be used Post-operative pain, chronic Tramadol HCl 100 mg N02AX02110S200 cancer pain, analgesia/pain 1588. A 100mg rectally up to qds Suppository 1XX relief for patients with impaired renal function Post-operative pain, chronic 50 - 100 mg every 4 hours. Tramadol HCl 100 mg/ml N02AX02110D500 cancer pain, analgesia/pain 1589. A Max : 400 mg daily. Not Drops 1XX relief for patients with recommended in children impaired renal function. Moderate to severe acute ADULT: 50mg initially, can or chronic pain (eg. Post- take another 50mg after 30 - operative pain, chronic 60 min if pain not relieved. Tramadol HCl 50 mg N02AX02110C100 1590. A/KK cancer pain and Max 400 mg daily. CHILD: Capsule 1XX analgesia/pain relief for 1mg/kg/dose repeated every patients with impaired renal 6 hours (Max: 2mg/kg/dose function) and 100mg/dose) Moderate to severe acute ADULT: IV/IM/SC 50 - or chronic pain (eg. Post- 100mg. (IV inj over 2-3 min operative pain, chronic or IV infusion). Initially 100 Tramadol HCl 50 mg/ml N02AX02110P300 1591. A cancer pain and mg then 50 - 100 mg every 4 Injection 1XX analgesia/pain relief for - 6 hours. . Max: 400 mg patients with impaired renal daily. CHILD (1 year and function) above): 1 - 2mg/kg/dose ADULT: Slow IV 0.5-1 g (10 - 15 mg/kg) 3 times daily. Tranexamic Acid 100 B02AA02000P3001 Haemorrhage associated Continuous infusion at a rate 1592. B mg/ml Injection XX with excessive fibrinolysis of 25 - 50 mg/kg daily. CHILD: slow IV 10 mg/kg/day 2-3 times daily ADULT: 1-1.5 g (15-25 mg/kg) 2-4 times daily. CHILD: 25 mg/kg/day 2-3 Tranexamic Acid 250 mg B02AA02000C100 Haemorrhage associated times daily. Menorrhagia 1593. B Capsule 1XX with excessive fibrinolysis (initiated when menstruation has started), 1 g 3 times daily for up to 4 days; maximum 4 g daily

343 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Used only in adjuvant setting for patients with Initial loading dose is 4 HER2 over-expressed mg/kg administered as a 90 breast cancer, that is HER2 minutes IV infusion. Trastuzumab 440 mg L01XC03000P4001 3+ by 1594. A* Subsequent doses is 2 Injection XX immunohistochemistry and mg/kg administered as 30 over-expressed by FISH minutes IV infusion weekly (Fluorescence in situ for 51 weeks hybridization) and high risk group Used only in adjuvant setting for patients with The recommended fixed HER2 over-expressed dose of trastuzumab 600mg breast cancer, that is HER2 is 600mg irrespective of the Trastuzumab 600mg/5ml L01XC03000P3001 3+ by patient?s body weight. No 1595. Solution for Injection (for A* XX immunohistochemistry and loading dose is required. This subcutaneous) over-expressed by FISH dose should be administered (Fluorescence in situ over 2-5 minutes every three hybridization) and high risk weeks. group. To decrease intraocular pressure (IOP) in patients with open-angle glaucoma Travoprost 0.004% & S01ED51990D200 1 drop in the affected eye(s) 1596. A* or ocular hypertension who Timolol 0.5% Eye Drops 3XX once daily are insufficiently responsive to other topical anti glaucomas Apply thinly to the affected area once daily or twice Acne vulgaris, recalcitrant daily. Avoid exposure to D10AD01000G300 1597. Tretinoin 0.01% Gel A/KK cases of acne (comedonal sunlight. Duration of 1XX type) treatment: 8-12 weeks is required before any noticeable response Apply thinly to the affected area once daily or twice Acne vulgaris and daily. Avoid exposure to D10AD01000G100 1598. Tretinoin 0.05% Cream A/KK recalcitrant cases of acne sunlight. Duration of 1XX (comedonal type) treatment: 8 - 12 weeks is required before any noticeable response Apply thinly to the affected area once daily or twice Acne vulgaris and daily. Avoid exposure to D10AD01000G100 1599. Tretinoin 0.1% Cream A recalcitrant cases of acne sunlight. Duration of 2XX (comedonal type) treatment: 8 - 12 weeks is required before any noticeable response Triamcinolone Acetonide A01AC01351G310 Apply a thin layer to affected 1600. B Oral and perioral lesions 0.1% Oral Paste 1XX area 2-4 times daily

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Smaller joints: 2.5 - 5 mg and larger joints: 5 - 15 mg. Triamcinolone Acetonide H02AB08351P300 Inflammation of joints, 1601. A Treatment should be limited 10 mg/ml Injection 1XX bursae and tendon sheaths to 1 mg/injection site to prevent cutaneous atrophy Allergies, dermatoses, Triamcinolone Acetonide H02AB08351P300 rheumatoid arthritis and 40-80 mg deep into the 1602. A/KK 40 mg/ml Injection 2XX inflammatory opthalmic gluteal muscle diseases ADULT: Initially 5 mg twice daily, increase by 5 mg after 1 week, then at 3-day intervals. Maximum 40 Trifluoperazine HCI 5 mg N05AB06110T1001 1603. B Psychotic disorder mg/day. CHILD up to 12 Tablet XX years: Initially up to 5 mg daily in divided doses adjusted to response, age and body weight Trimetazidine 20 mg C01EB15110T1001 Prophylactic treatment of 1604. B 20 mg 3 times daily Tablet XX episodes of angina pectoris 35 mg twice daily in the Trimetazidine 35 mg MR C01EB15110T5001 Prophylactic treatment of 1605. B morning and evening with Tablet XX episodes of angina pectoris meals ADULT: 200 mg daily in 1 or 2 divided doses or 300 mg daily as a single dose. Acute infection: 200 mg twice daily. Treatment of urinary tract Trimethoprim 100 mg J01EA01000T1001 CHILD: 6-8 mg/kg/day in 2 1606. B infections due to Tablet XX divided doses. 6 - 12 years: susceptible pathogens 100 mg twice daily; 6 months - 5 years: 50 mg twice daily. 6 weeks - 5 months: 25mg twice daily ADULT: 200 mg daily in 1 or 2 divided doses or 300 mg daily as a single dose. Acute Treatment of urinary tract infection: 200 mg twice daily. Trimethoprim 300 mg J01EA01000T1002 1607. B infections due to CHILD: 6 - 12 years: 100 mg Tablet XX susceptible pathogens twice daily; 6 months - 5 years: 50 mg twice daily. 6 weeks - 5 months: 25mg twice daily 5 - 10 mg daily, 2 - 4 hours before exposure to sunlight. D05BA01000T1001 1608. Trioxsalen 5 mg Tablet A Vitiligo To increase pigmentation: 10 XX mg daily, 2 hours prior to UV irradiation

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Decongestion of the upper respiratory tract in common ADULT and CHILD more Triprolidine HCl 1.25 mg cold, hay fever, allergic and R01BA52110L9001 than 12 year : 10 ml. CHILD 1609. and Pseudoephedrine B vasomotor rhinitis and XX 6 - 12 years : 5 ml 2 - 5 years HCl 30 mg per 5 ml Syrup sinusitis. Doses to be taken : 2.5 ml twice daily or three times daily ADULT 2.5 mg every 4 - 6 hours; maximum dose 10 mg/day. CHILD (syrup) 6 - Decongestion of the upper 12 years : 1.25 mg every 4 - Triprolidine HCl 2.5 mg respiratory tract in common 6 hours; maximum dose 5 R01BA52988T1002 1610. and Pseudoephedrine B cold, hay fever, allergic and mg/day 4 - 6 years : 0.938 XX HCl 60 mg Tablet vasomotor rhinitis and mg every 4 - 6 hours; aerotitis maximum dose 3.744 mg/day 2 - 4 years : 0.625 mg every 4 - 6 hours; maximum dose 2.5 mg/day 1 intramuscular injection every 4 weeks. The i) Treatment of confirmed treatment must be started in central precocious puberty the first 5 days of the (preterm sexual menstrual cycle. The development) in girls under duration of treatment 9 years, boys under 10 depends on the initial years of age severity of the endometriosis ii) Genital and extragenital Triptorelin 3.75 mg L02AE04000P2001 and the changes observed in 1611. A endometriosis (stage I to Injection XX the clinical features. In stage IV). Treatment should principle, the treatment not be administered for should be administered for at more than 6 months. It is least 4 months and for at not recommended to start a most 6 months. It is not second treatment course recommended to start a with triptorelin or another second treatment course GnRH analogue. with triptorelin or another GnRH analogue. Topical use to produce Tropicamide 1% Eye S01FA06000D2002 1 - 2 drops several times a 1612. A/KK cycloplegic refraction for Drops XX day diagnostic purposes Symptomatic treatment for urge incontinence and/or increased urinary frequency 1 tablet twice daily. Tablet and urgency as may occur should be swallowed whole in patients with overactive with a glass of water before bladder (eg. Idiopathic or Trospium Chloride 20mg G04BD09100C100 meals on empty stomach. 1613. A* neurologic detrusor coated tablet 1XX Severe renal impairment overactivity) Place in (CrCl between 10 & 30 therapy: As first line mL/min/1.73 m2): 1 tab daily treatment for overactive or every 2nd day bladder in patients with Parkinsonism, Alzheimer's or other cognitive disease

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber V04CF01000P3001 For routine Mantoux 10 units is injected 1614. Tuberculine PPD Injection B XX (tuberculin sensitivity) test intradermally Active immunization against ADULT and CHILD 6 years J07AP01000C1001 1615. Typhoid Vaccine Capsule B typhoid fever in adult and of age or older, 1 capsule on XX child 6 years of age or older days 1, 3 and 5 0.5 ml single IM injection into Active immunization against Typhoid Vaccine Injection J07AP02000P3001 the deltoid or vastus lateralis, 1616. B typhoid fever in adult and (20 doses) XX may reimmunize with 0.5 ml child more than 2 years IM every 3 years if needed. Dosage is one tablet to be Emergency contraception taken orally as soon as within 4-5 days of possible, but no later than Ulipristal Acetate 30mg G03AD02122T100 1617. A unprotected sexual 120 hours (5 days) after Tablet 1XX intercourse for sexual unprotected sexual assault victim. intercourse or contraceptive failure. To be individualized. 75 IU- 150 IU daily and maybe Urofollitropin (FSH) 150 G03GA04000P300 Stimulation of follicular 1618. A* increased or decreased by IU Injection 2XX growth in infertile women up to 75 IU/day at 7 or 14 day intervals if necessary To be individualized. 75 IU- 150 IU daily and maybe Urofollitropin (FSH) 75 IU G03GA04000P300 Stimulation of follicular 1619. A* increased or decreased by Injection 1XX growth in infertile women up to 75 IU/day at 7 or 14 day intervals if necessary ADULT: Acute pulmonary embolism: IV loading dose 4400 iu/kg over 10 mins, maintenance 4400 iu/kg/hour for 12 hours. Peripheral Treatment of vascular occlusion: infuse thromboembolic disease 2500 iu/ml into clot at a rate such as mycocardial of 4000 iu/min for 2 hours. Urokinase 6000 IU B01AD04000P400 infarction, peripheral artery 1620. A This may be repeated up to 4 Injection 1XX occlusion, pulmonary times. Hyphaema: 5000 IU in embolism, retinal artery 2 ml saline solution is thrombosis and other injected and withdrawn ophthalmologic use repeatedly over the iris. If residual clot remains, leave 0.3ml in the anterior chambers for 24-48 hours to facilitate futher dissolution 10-15 mg/kg daily in 2 to 4 divided doses usually for 3 Cholestatic liver diseases months to 2 years. If there is Ursodeoxycholic Acid 250 A05AA02000C100 (eg. primary biliary 1621. A no decrease in stone size mg Capsule 1XX cirrhosis, primary after 18 months, further cholangitis etc) treatment seems not to be useful

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Treatment of moderate to Body weight less than 100kg: severe plaque psoriasis in Initial dose of 45 mg SC, adults who failed to, or who followed by 45 mg 4 weeks have contraindication to, or later, then every 12 weeks Ustekinumab 90 mg/ml L04AC05000P3002 are intolerant to 1622. A* thereafter. Body weight more Injection XX conventional systemic than 100 kg: initial dose 90 therapies including mg SC, followed by 90 mg 4 ciclosporin, methotrexate weeks later, & then every 12 and photochemotherapy weeks thereafter. (PUVA). For adult patients who have received other than kidney transplant, the recommended dose is 900 mg (two 450 mg tablets) once a day starting For the prevention of within 10 days of cytomegalovirus (CMV) transplantation until 100 days Valganciclovir 450 mg J05AB14110T1001 disease in CMV-negative post-transplantation. For 1623. A* Tablet XX patients who have received adult patients who have a solid organ transplant received a kidney transplant, from a CMV-positive donor the recommended dose is 900 mg (two 450 mg tablets) once a day starting within 10 days of transplantation until 200 days post- transplantation. i) Adults: Dosage should start at 500mg daily increasing by 200mg at i) In the treatment of three-day intervals until generalized or partial control is achieved. This is epilepsy, particularly with generally within the dosage the following patterns of range 1000mg to 2000mg seizures:absence, per day. Children: >20KG: myoclonic, tonic-clonic, 500mg/day (irrespective of atonic-mixed as well as, for Valproic Acid and Sodium weight) with spaced N03AG01520T500 partial epilepsy:simple or 1624. Valproate (ER) 500mg B increases until control is 1XX complex seizures, Tablet achieved. secondary generalized ii) Initial dose of 1000mg/day, seizures, specific syndrome to be increase rapidly as (West, Lennox-Gastatut). possible to achieve lowest ii) Treatment and therapeutic dose, which prevention of mania produce desired clinical associated with bipolar effects. Recommend initial disorders. dose is 1000mg & 2000mg daily. Max dose 3000mg daily. Valsartan 160 mg and C09DA03935T100 Treatment of essential 1625. Hydrochlorothiazide 12.5 A/KK 1 tablet once daily 5XX hypertension mg Tablet

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) 80 or 160 mg once daily. May be increased to 320 mg Patients who cannot once daily. tolerate ACE inhibitors ii) 40 mg twice daily. because of cough, in C09CA03000T100 Uptitration to 80 mg and 160 1626. Valsartan 160 mg Tablet A/KK i) Hypertension 2XX mg twice daily. Max: 320 mg ii) Heart failure in divided doses. iii) Post myocardial iii) 20 mg twice daily. infarction Uptitration to max of 160 mg twice daily. Valsartan 80 mg and Hypertension in patients C09DA03935T100 1627. H ydrochlorothiazide 12.5 A/KK who cannot tolerate ACE 1 tablet once daily 1XX mg Tablet inhibitors because of cough i) 80 or 160 mg once daily. May be increased to 320 mg Patients who cannot once daily. tolerate ACE inhibitors ii) 40 mg twice daily. because of cough, in Uptitration to 80 mg and C09CA03000T100 1628. Valsartan 80 mg Tablet A/KK i) Hypertension 160mg twice daily. Max: 320 1XX ii) Heart failure mg in divided doses. iii) Post myocardial iii) 20 mg twice daily infarction increased over several weeks to 160mg twice daily if tolerated. Slow IV infusion, ADULT: 500 mg over at least 60 minutes every 6 hours or 1 g over at least 100 minutes every 12 hours. NEONATE Vancomycin HCl 500 mg J01XA01110P4001 Only for the treatment of up to 1 week, 15 mg/kg 1629. A* Injection XX MRSA and CAPD peritonitis initially, then 10 mg/kg every 12 hours. INFANT 1 - 4 weeks, 15 mg/kg initially then 10 mg/kg every 8 hours. CHILD over 1 month, 10 mg/kg every 6 hours 0.5 mg once daily for Day 1- 3, then 0.5 mg twice daily for Varenicline Tartrate 0.5 N07BA03123T1001 Smoking cessation 1630. A/KK Day 4-7, then 1 mg twice mg and 1 mg Tablet XX treatment daily; duration of treatment is 12 weeks 0.5 mg once daily for Day 1- 3, then 0.5 mg twice daily for Varenicline Tartrate 1 mg N07BA03123T1002 Smoking cessation 1631. A/KK Day 4-7, then 1 mg twice Tablet XX treatment daily; duration of treatment is 12 weeks

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Health staff working with children, pregnant women, transplant, cancer and immunocompromised patients who are at high risk of contacting varicella and transmitting it to at risk patients ii) Transplant patients or candidates who are: a) Immunocompetent and not receiving immunosuppressant drugs, do not have graft versus host disease 2 years or more after transplant b) Susceptible to Varicella- Zoster virus at least 3 weeks before grafting iii) Children: a) with impaired humoral immunity b) HIV-infected children more than 12 months of ADULT and CHILD 13 years age, in CDC class N1 or more: 2 doses of 0.5 ml Varicella Virus Vaccine J07BK01000P4001 (asymptomatic) or A1 SC injection separated by 4 - 1632. A* Live Attenuated Injection XX (mildly symptomatic) with 8 weeks apart. CHILD 12 age specific CD4 more than months - 12 years: 0.5ml SC 25% c) with conditions that as a single dose require systemic steroid therapy less than 2 mg/kg body weight or a total of 20 mg/day of prednisolone or its equivalent. [Those receiving high doses of systemic steroids at 2 mg/kg body weight or more of prednisolone for more than 2 weeks may be vaccinated after steroid therapy has been discontinued for at least three months] iv) Acute lymphoblastic leukemia (ALL) patients with negative history of varicella who:- a) are 12 months to 17 years of age b) have leukemia in remission for at least 12 months

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber c) have a peripheral blood lymphocyte count 700 cells/ mm3 or more. [If platelet count of greater 100,000/mm3 within 24 hours of vaccination are not being submitted to radiotherapy. Chemotherapy should be withheld for seven days before and after immunisation] v) Susceptible subjects in clinical trials who will be submitted for chemotherapy vi) Children and susceptible patients on chronic dialysis

i) 5 - 20 units SC or IM every 4 hours i) Pituitary diabetes ii) 20 units in 100 - 200 ml Vasopressin 20 units/ml H01BA01000P300 insipidus 5% dextrose saline over 15 1633. A Injection 1XX ii) Oesophageal variceal minutes as infusion which bleeding may be repeated after at intervals of 1 - 2 hours. Maximum: 4 doses ADULT & NEONATES > 5 MONTHS Initial: 80-100 mcg/kg as inj. Maintenance: 20-30 mcg/kg, adjust according to response. As an adjunct in Alternatively, as continuous Vecuronium Bromide 10 M03AC03320P300 1634. A* anaesthesia to produce infusion at 0.8-1.4 mg/10 ml Injection 1XX skeletal muscle relaxation mcg/kg/min after initial IV dose of 40-100 mcg/kg. NEONATE and INFANT up to 4 months: Initially 10 - 20 mcg/kg, then incremental dose to achieve response ADULT & NEONATES > 5 MONTHS Initial: 80-100 mcg/kg as inj. Maintenance: 20-30 mcg/kg, adjust As an adjunct in according to response. Vecuronium Bromide 4 M03AC03320P300 1635. A* anaesthesia to produce Alternatively, as continuous mg/ml Injection 2XX skeletal muscle relaxation infusion at 0.8-1.4 mcg/kg/min after initial IV dose of 40-100 mcg/kg. NEONATE and INFANT up to 4 months: Initially 10 - 20

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber mcg/kg, then incremental dose to achieve response.

i), ii) & iii) ADULT: 75 mg once daily. May increase dose by 75 mg/day every 4 days to a maximum dose of i) Depression 225 mg/day, (severe ii) Generalized anxiety Venlafaxine HCl 150 mg depression: max: N06AX16110C200 disorder 1636. Extended Release A* 375mg/day) 2XX iii) Social anxiety disorder Capsule iv) 37.5 mg/day for the first 4- (social phobia) 7 days after which the dose iv) Panic disorder should be increased to 75 mg once daily. CHILD and ADOLESCENT under 18 years not recommended. i), ii) & iii) ADULT: 75 mg once daily. May increase dose by 75 mg/day every 4 days to a maximum dose of i) Depression 225 mg/day, (severe ii) Generalized anxiety Venlafaxine HCl 75 mg depression: max: N06AX16110C200 disorder 1637. Extended Release A* 375mg/day) 1XX iii) Social anxiety disorder Capsule iv) 37.5 mg/day for the first 4- (social phobia) 7 days after which the dose iv) Panic disorder should be increased to 75 mg once daily. CHILD and ADOLESCENT under 18 years not recommended Initially 5-10mg given by slow IV over at least 2 minutes. Verapamil HCl 2.5 mg/ml C08DA01110P300 Supraventricular The dose can be repeated 1638. A/KK Injection 1XX tachycardia 10mg 30 minutes after the first dose if the initial response is not adequate. i) Supraventricular ADULT: 40 - 80 mg 3-4 times Verapamil HCl 40 mg C08DA01110T100 1639. B tachyarrhythmias (SVT) daily. In oral long term Tablet 1XX prophylaxis ii) angina therapy, max: 480 mg daily

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber FUKKM restriction: As add- on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. - Treatment 50 mg/850 mg or 50 of type 2 diabetes mellitus Vildagliptin 50 mg and mg/1000 mg twice daily. A10BD08926T1002 patients who are unable to 1640. Metformin HCl 1000 mg A* Maximum daily dose is 100 XX achieve sufficient glycaemic Tablet mg vildagliptin plus 2000 mg control at their maximally metformin hydrochloride. tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets. FUKKM restriction: As add- on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. - Treatment 50/500mg or 50/850mg or of type 2 diabetes mellitus Vildagliptin 50 mg and 50/1000mg twice daily. A10BD08926T1003 patients who are unable to 1641. Metformin HCl 500 mg A* Maximum daily dose is XX achieve sufficient glycaemic Tablet 100mg vildagliptin and control at their maximally 2000mg metformin. tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets. FUKKM restriction: As add- on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. - Treatment 50 mg/850 mg or 50 of type 2 diabetes mellitus Vildagliptin 50 mg and mg/1000 mg twice daily. A10BD08926T1001 patients who are unable to 1642. Metformin HCl 850 mg A* Maximum daily dose is 100 XX achieve sufficient glycaemic Tablet mg vildagliptin plus 2000 mg control at their maximally metformin hydrochloride. tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.

353 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber FUKKM restriction: As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. i) As second line therapy in type 2 diabetes patients inadequately controlled on maximal tolerated dose of metformin monotherapy and high risk of hypoglycaemia. ii) As second line therapy in type 2 diabetes patients inadequately controlled on maximal tolerated dose of sulphonylurea and intolerant/contraindicated for metformin therapy. iii) As third line therapy in type 2 diabetes patients ADULT over 18 years: 50mg inadequately controlled with A10BH02000T1001 bd when combine with 1643. Vildagliptin 50 mg Tablet A* dual OAD combination XX metformin, 50 mg od when therapy with sulphonylurea combine with sulphonylurea and metformin iv) As a monotherapy in type 2 diabetes mellitus patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. v) An adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus: As a dual therapy in combination with insulin in patients with insufficient glycaemic control. Insulin dose and regimen should be optimized before addition of vildagliptin.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Adult: Initially, 3.7 mg/m2, increase dose weekly based on WBC counts in increments of about 1.8 mg/m2 until leukocyte count decreases to about 3000/mm3, or maximum weekly dose of 18.5 mg/m2 reached. Usual dose: 5.5-7.4 mg/m2 per week. Do not administer next dose, even though 7 days have lapsed unless the leukocyte count has returned to at least Hodgkin's disease, 4000/mm3. Child: Initial 2.5 choriocarcinoma resistant mg/m2 of BSA, increased Vinblastine Sulphate 10 L01CA01183P3002 to other chemotherapeutic dose at weekly intervals in 1644. A mg Injection XX agents, non-small cell lung increments of about 1.25 cancer, Langerhans cell mg/m2 until leukocyte count histiocytosis decreases to about 3000/ mm3, or maximum weekly dose of 12.5 mg/m2 reached. Do not increase dose once leukocyte count reaches approximately 3000 cells/mm3, instead, a dose of 1 increment smaller to be admin at wkly intervals for maintenance. Do not administer next dose, even though 7 days have lapsed unless the leukocyte count has returned to at least 4000/mm3. i) ADULT: 1.4 mg/m2 weekly (maximum 2 mg weekly) i) Solid tumours ii) Refer to protocol ii) Gestational trophoblastic iii) 1.4 mg/m2 weekly disease (maximum 2 mg weekly) Vincristine Sulphate 1 mg L01CA02183P3001 iii) Non-Hodgkin's iv) 0.4 mg/m2 IV continuous 1645. A Injection XX lymphoma infusion on days 1 - 4 iv) Multiple myeloma v) Refer to protocol. CHILD: v) Acute lymphoblastic 1 mg/m2 to 2 mg/m2 weekly leukemia according to protocol (0.05 mg/kg for infants less than 10kg)

355 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Single agent: Adult 30mg/m2 IV administered over 6-10 minutes once weekly Combination with cisplatin : 30mg/m2 IV administered over 6- 10mintes once weekly combination with cisplatin IV on days and 29 and then i) First line treatment in non- every 6 weeks or Vinolrebine small cell lung cancer in administered at a dose of Vinorelbine 10 mg L01CA04000P4001 1646. A* combination with 25mg/m2 IV weekly in Injection XX cisplatin/ifosfomide combination with cisplatin ii) Metastatic breast cancer given every 4 weeks at a dose of 100mg/m2 ii) 25 - 30 mg/m2 diluted in saline solution, infused over 6 - 10 minutes, administered weekly or vinolrebine maybe given as an 8mg/m2 IV BOLUS followed by 8mg/m2 as a 96-hour intravenous infusion i) Single agent: Adult 30mg/m2 IV administered over 6-10 minutes once weekly Combination with cisplatin : 30mg/m2 IV administered over 6- 10mintes once weekly combination with cisplatin IV on days and 29 and then i) First line treatment in non- every 6 weeks or Vinolrebine small cell lung cancer in administered at a dose of Vinorelbine 50 mg L01CA04000P4002 1647. A* combination with 25mg/m2 IV weekly in Injection XX cisplatin/ifosfomide combination with cisplatin ii) Metastatic breast cancer given every 4 weeks at a dose of 100mg/m2 ii) 25 - 30 mg/m2 diluted in saline solution, infused over 6 - 10 minutes, administered weekly or vinolrebine maybe given as an 8mg/m2 IV BOLUS followed by 8mg/m2 as a 96-hour intravenous infusion. Not more than 10 ml daily, Vitamin A & D (Cod Liver A11CB00901L5001 allowance being made for 1648. C Prevention of ricketts Oil) XX Vitamin D obtained from other sources

356 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber 0.06 - 0.6ml (2,500-25,000 IU of Vitamin A and 250- Vitamin A & D A11CB00901L5002 2,500 IU of D) daily, 1649. Concentrate 25,000 B Prevention of ricketts XX allowance being made for A units/0.6ml Liquid and D obtained from other sources Children with measles i) 0-5 months, 50,000 IU malnutrition and serious Vitamin A 50,000 IU A11CA01000C100 ii) 6-11 months, 100,000 IU 1650. C infections. Category C can Capsule 1XX iii) 1-5 years, 200,000 IU. use this drug for Orang Asli Frequency twice daily and in Sabah Vitamin B Complex 10 ml A11EX00901P3001 Prophylaxis and treatment 1651. B 1-2 ml daily by IM Injection XX of vitamin B deficiency A11EA00901T1001 Prophylaxis and treatment 1652. Vitamin B Complex Tablet C+ 1-2 tablets daily XX of vitamin B deficiency Mild cases: 1 ampoule given For deficiency or raised Vitamin B1, B6, B12 A11DB00901P300 by IM 2-3 times weekly. 1653. B requirement of Vitamin B1, Injection 1XX Severe cases: 1 ampoule B6, B12 daily For deficiency or raised Vitamin B1, B6, B12 A11DB00901T1001 1 - 3 tablets 3 times daily 1654. B requirement of Vitamin B1, Tablet XX swallowed unchewed. B6, B12 To improve appetite and growth. Neurasthenia, nausea and vomiting in Vitamin E, B12, B6, A11E000901T1001 1655. A pregnancy, radiation 1 - 2 tablet daily Nicotinamide Tablet XX sickness and neuritis due to isoniazid therapy and alcoholism Prophylaxis of vitamin K deficiency bleeding in neonates Child: Neonate: 0.5-1 mg, given as a single dose via IM inj. Alternatively, 2 mg may be given orally, Vitamin K1 1 mg/ml B02BA01000P3001 Vitamin K deficiency in 1656. C+ followed by a 2nd dose of 2 Injection XX neonates mg after 4-7 days. Intravenous Vitamin K deficiency bleeding in neonates Child: Infant: 1 mg by IV/IM/SC inj, further doses may be given if necessary Haemorrhage associated 0.5 - 20 mg by very slow IV Vitamin K1 10 mg/ml B02BA01000P3002 with hypoprothrombinaemia 1657. B at a rate not exceeding 1 mg Injection XX caused by overdose of per minute anticoagulants

357 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Healthy neonate 2 mg orally at birth or soon after followed by 2 mg at 4 - 7 days. Exclusively breastfed baby, in addition, 2 mg orally at monthly intervals until end of Vitamin K1 Mixed Micelle B02BA01000P3004 Prevention of bleeding in breastfeeding period. 1658. B 2 mg/0.2 ml Injection XX neonates Neonate at special risk, 1 mg IM/IV at birth or soon after if oral route is not suitable. Treatment: 1 mg IV initially. Further doses depend on clinical picture and coagulation status i) Treatment of immunocompromised Adult and Children 12 years patients with progressive, and greater: Loading dose: 6 possibly life-threatening mg/kg 12 hourly for first 24 infections such as invasive hours. Maintenance: i) 4 aspergillosis, fluconazole- mg/kg 12 hourly ii) 3 mg/kg resistant serious invasive 12 hourly. Dose may be Voriconazole 200 mg J02AC03000P3001 1659. A* candidiasis, serious fungal increased to 4 mg/kg 12 Injection XX infections caused by hourly if response is Scedosporium species and inadequate. Children aged Fusarium species 2years to <12years with ii)Prevention of normal hepatic and renal breakthrough fungal function: No loading dose infections in febrile high-risk needed; 7mg/kg 12hourly neutropenic patients i) Treatment of Adult and Children 12 years immunocompromised and greater and over 40 kg: patients with progressive, Loading dose: 400 mg 12 possibly life-threatening hourly for first 24 hours. infections such as invasive Maintenance: 200 - 300 mg aspergillosis, fluconazole- 12 hourly. Less than 40 kg: resistant serious invasive Loading dose: 200 mg 12 Voriconazole 200 mg J02AC03000T1002 candidiasis, candidiasis of 1660. A* hourly for first 24 hours. Tablet XX the oesophagus, serious Maintenance: 100 - 150 mg fungal infections caused by 12 hourly. Children aged Scedosporium species and 2years to <12years with Fusarium species normal hepatic and renal ii) Prevention of function: No loading dose breakthrough fungal needed; 200mg infections in febrile high-risk 12hourly+F1655 neutropenic patients

358 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Treatment of immunocompromised patients with progressive, possibly life-threatening ADULT and CHILDREN 12 infections such as invasive years and greater and over aspergillosis, fluconazole- 40 kg: Loading dose: 400 mg resistant serious invasive 12 hourly for first 24 hours. Voriconazole 50 mg J02AC03000T1001 candidiasis, candidiasis of Maintenance: 200 - 300 mg 1661. A* Tablet XX the oesophagus, serious 12 hourly. Less than 40 kg: fungal infections caused by Loading dose: 200 mg 12 Scedosporium species and hourly for first 24 hours. Fusarium species Maintenance: 100 - 150 mg ii) Prevention of 12 hourly breakthrough fungal infections in febrile high-risk neutropenic patients Initially 10 mg daily for 2 Treatment and prophylaxis days. Maintenance dose, 3-9 Warfarin Sodium 1 mg B01AA03520T1001 1662. B of thromboembolic mg daily according to the Tablet XX disorders INR (taken at the same time each day) Initially 10 mg daily for 2 Treatment and prophylaxis days. Maintenance dose, 3-9 Warfarin Sodium 2 mg B01AA03520T1002 1663. B of thromboembolic mg daily according to the Tablet XX disorders INR (taken at the same time each day) Initially 10 mg daily for 2 Treatment and prophylaxis days. Maintenance dose, 3- Warfarin Sodium 3 mg B01AA03520T1003 1664. B of thromboembolic 10 mg daily according to the Tablet XX disorders INR (taken at the same time each day) Initially 10 mg daily for 2 Treatment and prophylaxis days. Maintenance dose, 3- Warfarin Sodium 5 mg B01AA03520T1004 1665. B of thromboembolic 10 mg daily according to the Tablet XX disorders INR (taken at the same time each day) As a diluent and vehicle for V07AB00000P3001 According to the needs of the 1666. Water for Injection C+ the administration of XX patient medications White Petroleum Keeping the eye lubricated S01XA20900G510 Apply a small amount into 1667. Anhydrous Liquid Landin, A and comfortable during the 1XX the eye Mineral Oil Eye Ointment night

359 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber i) Prophylaxis of maternal- foetal HIV transmission during labour and delivery Adult: Loading dose: 2 mg/kg, followed by continuous infusion of 1 mg/kg/hr until umbilical cord is clamped. If caesarean section is planned, start the IV infusion 4 hr before the operation. Renal and Hepatic impairment: Dose reduction may be needed. HIV infection (to be discuss: not To reduce the rate of in indication) Adult: 1-2 maternal-foetal mg/kg every 4 hr, given as 2- transmission of HIV in: 4 mg/ml infusion over 1 hr. J05AF01000P3001 1668. Zidovudine 1% Injection A i) HIV-positive pregnant Child: As continuous XX women over 14 weeks of infusion: 20 mg/m2/hr. gestation Alternatively, as intermittent ii) Their newborn infants infusion: 120 mg/m2 every 6 hr. Renal impairment: Haemodialysis or peritoneal dialysis: 1 mg/kg every 6-8 hr. ii) Prophylaxis of HIV infection in neonates Child: Neonates: 1.5 mg/kg every 6 hr. Start treatment within 12 hr after birth and continue for 1st 6 wk of life. Dose to be given via IV infusion over 30 minutes. Renal impairment: Dose adjustment may be needed. i) HIV infection Adult: 600 mg daily in divided doses, in combination with other antiretroviral agents. Child: 6 wk - 12 yr: 160 mg/m2 every i) Management of patients 8 hr. Max: 200 mg every 8 with asymptomatic and hr. May be used in symptomatic (early or combination with other anti- Zidovudine 10 mg/ml J05AF01000L9001 1669. A* advanced) HIV infections retrovirals. Renal and Syrup XX with CD4 cell counts less Hepatic impairment: Dose than 500 cu. mm. reduction may be needed. ii) Neonatal prophylaxis ii) Prophylaxis of HIV infection in neonates Child: Neonates: 2 mg/kg every 6 hr for 1st 6 wk of life, starting within 12 hr after birth. Renal and hepatic impairment:

360 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Dose adjustment may be needed. i) HIV infection Adult: 600 mg daily in divided doses, in combination with other antiretroviral agents. Child: 6 wk - 12 yr: 160 mg/m2 every 8 hr. Max: 200 mg every 8 i) Management of patients hr. May be used in with asymptomatic and combination with other anti- symptomatic (early or retrovirals. Renal and Zidovudine 100 mg J05AF01000C1001 1670. A/KK advanced) HIV infections Hepatic impairment: Dose Capsule XX with CD4 cell counts less reduction may be needed. than 500 cu. mm ii) Prophylaxis of HIV ii) Neonatal prophylaxis infection in neonates Child: Neonates: 2 mg/kg every 6 hr for 1st 6 wk of life, starting within 12 hr after birth. Renal and hepatic impairment: Dose adjustment may be needed.

Zidovudine 300 mg & HIV infection in combination J05AR01964T1001 ADULT and CHILD over 12 1671. Lamivudine 150 mg A/KK with at least one other XX years: 1 tablet twice daily Tablet antiretroviral drug

361 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber HIV infection Adult: 600 mg daily in divided doses, in combination with other antiretroviral agents. Child: 6 wk - 12 yr: 160 mg/m2 every i) Management of patients 8 hr. Max: 200 mg every 8 with asymptomatic and hr. May be used in symptomatic (early or combination with other anti- J05AF01000T1001 advanced) HIV infections retrovirals. 1672. Zidovudine 300 mg Tablet A* XX with CD4 cell counts < 500 ii) Prophylaxis of maternal- cu. mm foetal HIV transmission ii) HIV positive pregnant Adult: 100 mg 5 times daily mothers or 200 mg tid or 300 mg bid. Start treatment after 14th wk of gestation until the start of labour. Haemodialysis or peritoneal dialysis (CrCl <10 ml/min: 100 mg every 6-8 hr. Skin protective in various D02AB00000G100 skin conditions such as Apply 3 times daily or as 1673. Zinc Oxide Cream C+ 1XX nappy rash, eczema and required problem skin Skin protective in various D02AB00240G500 Apply 3 times daily or as 1674. Zinc Oxide Ointment C skin conditions such as 1XX required nappy rash and eczema Insert 1 suppository night For relief of pruritus, and morning after bowel Zinc oxide, benzyl C05AX04931S100 burning and soreness in movements; do not use for 1675. benzoate and balsam C 1XX patients with haemorrhoids longer than 7 days OR peru suppository and perianal conditions please refer to the product insert. ADULT: Initially 10 mg (every 2 hour) or 20 mg (every 4 Ziprasidone 20 mg/ml N05AE04110P300 Acute agitation in 1676. A* hour). Maximum: 40 mg/day. Injection 1XX schizophrenia IM administration more than 3 days has not been studied i) Treatment of hypercalcaemia of malignancy 4 mg reconstituted and Zoledronic Acid 4 mg M05BA08000P300 ii) Prevention of skeletal should be given as a 15 1677. A* Injection 1XX related events in patients minutes IV infusion every 3-4 with multiple myeloma weeks involving multiple bone lesions 10-mg tablet daily. Stilnox should always be taken just before going to bed. In Zolpidem Tartrate 10 mg N05CF02123T1001 elderly patients or patients 1678. A For treatment of insomnia Tablet XX with hepatic insufficiency: Dosage should be halved ie, 5 mg. Dosage must never exceed 10 mg/day.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber For adults, usually 100 to As adjunctive therapy in the 200mg of zonisomide is to be treatment of partial seizures administered orally 1 to 3 in adults with epilepsy. times a day initially. The N03AX15000T1001 Restrictions: As adjunctive dose is gradually increased 1679. Zonisamide 100mg tablet A* XX therapy in the treatment of at every one to two weeks up partial seizures in adults to 200-400mg daily, in 1 to 3 with epilepsy when 1st line divided dose. The maximum and 2nd line therapy failed. daily dose should not exceed 600mg per day.

Acute Schizophrenia and Other Acute Psychoses; Severe Acute States of Agitation; Mania: Oral treatment: Usually 10-50 Zuclopenthixol 20 mg/ml N05AF05000D500 Only for psychoses with 1680. A* mg/day. In moderate to Drops 1XX insight or compliance severe cases initially 20 mg/day increased, if necessary, by 10-20 mg/day every 2-3 days to ≥75 mg daily.

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MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber Clopixol-Acuphase: Clopixol- Acuphase is administered by IM injection. The dosage range should normally be 50- 150 mg (1-3 mL) IM repeated if necessary, preferably with a time interval of 2-3 days. In a few patients, an additional injection may be needed 24- 48 hrs following the 1st injection. In the maintenance Only for treatment of therapy, treatment should be agitated and violent patients continued with oral Clopixol Zuclopenthixol Acetate N05AF05122P3002 suffering from or Clopixol Depot IM after the 1681. A* 100 mg/2 ml Injection XX schizophrenia who are not following guidelines: Change responding to the available to Oral Clopixol: 2-3 days standard drugs after the last injection of Clopixol-Acuphase, a patient who has been treated with 100 mg Clopixol-Acuphase, oral treatment should be started at a dosage of about 40 mg daily, possibly in divided dosages. If necessary, the dose can be further increased by 10-20 mg every 2-3 days up to 75 mg or more. Clopixol-Acuphase: Clopixol- Acuphase is administered by IM injection. The dosage range should normally be 50- 150 mg (1-3 mL) IM repeated if necessary, preferably with a time interval of 2-3 days. In a few patients, an additional injection may be needed 24- Only for treatment of 48 hrs following the 1st agitated and violent patients injection. In the maintenance Zuclopenthixol Acetate 50 N05AF05122P3001 suffering from therapy, treatment should be 1682. A* mg/ml Injection XX schizophrenia who are not continued with oral Clopixol responding to the available or Clopixol Depot IM after the standard drugs following guidelines: Change to Oral Clopixol: 2-3 days after the last injection of Clopixol-Acuphase, a patient who has been treated with 100 mg Clopixol-Acuphase, oral treatment should be started at a dosage of about 40 mg daily, possibly in divided dosages. If

364 / 365 Updated until MOH Medicines Formulary Review Panel Meeting 2/2016 (August 2016)

MINISTRY OF HEALTH MEDICINES FORMULARY (AUGUST 2016) Category Malaysia Drug No. Generic Name of Indications Dosage Code (MDC) Prescriber necessary, the dose can be further increased by 10-20 mg every 2-3 days up to 75 mg or more. By deep IM injection test dose 100 mg followed after 7 Only for treatment of - 28 days by 100 - 200 mg or agitated and violent patients more followed by 200 - 400 Zuclopenthixol Decanoate N05AF05135P2001 suffering from 1683. B mg at intervals of 2 - 4 weeks 200 mg/ml Injection XX schizophrenia who are not adjusted according to responding to the available response. Maximum 600 mg standard drugs weekly. Child not recommended

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