DOCSLIB.ORG

Medicines Formulary

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Medicines Formulary MEDICINES FORMULARY Medicines formulary between MCHFT and Primary Care as agreed by the Joint Medicines Management committee Introduction Welcome to the MCHFT Medicines Formulary. The formulary includes medicines that have been approved by the Joint Medicines Management Committee (JMMC) for prescribing within the trust. The purpose of the formulary is to ensure prescribing is evidence based and cost effective. All prescribing within the trust (i.e. inpatient, outpatient and FP10HNC prescribing) must comply with the formulary. This will be monitored on a regular basis. Some drugs may appear in more than one section. The formulary is arranged in sections corresponding to those in the British National Formulary (BNF) as below; GASTRO-INTESTINAL SYSTEM ................................................................................................................ 4 CARDIOVASCULAR SYSTEM .................................................................................................................... 8 RESPIRATORY SYSTEM .......................................................................................................................... 13 CENTRAL NERVOUS SYSTEM ................................................................................................................ 16 INFECTIONS ............................................................................................................................................. 22 ENDOCRINE SYSTEM .............................................................................................................................. 25 OBSTETRICS, GYNAECOLOGY AND URINARY-TRACT DISORDERS .................................................. 30 MALIGNANT DISEASE AND IMMUNOSUPPRESSION ............................................................................ 33 NUTRITION AND BLOOD ......................................................................................................................... 38 MUSCULOSKELETAL AND JOINT DISORDERS ..................................................................................... 42 EYE ............................................................................................................................................................ 44 EAR, NOSE AND OROPHARYNX ............................................................................................................. 48 SKIN ........................................................................................................................................................... 49 IMMUNOLOGICAL PRODUCTS AND VACCINES .................................................................................... 54 ANAESTHESIA .......................................................................................................................................... 55 Page 1 of 56 Operation of the Formulary Items available for general prescribing and restricted items are identified according to the following colour coding; Item Colour Code Items available for general prescribing Second line/use on specialist advice Consultant prescribing only Where a drug is the subject of a NICE Technology Appraisal (TA) the reference number of the guidance is given below the drug entry. Where a drug has been approved by the Joint Medicines Management Committee (JMMC) the month and year of the relevant meeting is also listed below the drug entry. NICE guidance can be found at; Technology Appraisals (TA) http://www.nice.org.uk/guidance/published?type=ta Clinical Guidelines (CG) http://www.nice.org.uk/guidance/published?type=cg MHRA Alerts and recalls on drugs and medical devices https://www.gov.uk/drug-device-alerts Patients taking a non-formulary drug on admission Treatment with a non-formulary drug may be continued in this instance; however it must be borne in mind that there may be a delay in obtaining a non-formulary drug. Additions to the formulary The addition of a new drug or preparation will only be made after approval by the Joint Medicines Management Committee. To request an addition to the formulary a New Product Request (NPR) form must be submitted to the JMMC. This form can be found under Frequently Used Forms- Medicines Management on the trust intranet. New non-formulary drugs required for an individual patient in exceptional circumstances Such an application for a “one-off” use may be made to the chairperson of the JMMC, if the drug is required before the next JMMC meeting. Page 2 of 56 Updates Date BNF Update Details Section February 11.8.2 Nepafanac eye drops 2015 8.1.5 Imatinib 2.8.2 Apixaban 1.6.7 Linaclotide 4.10.1 Nalmefene 8.1.1 Bendamustine/Thalidomide/Dexamethasone March 5.3.1 Dolutegravir and dolutegravir in combination with Abacavir and lamivudine. 2015 8.1 Folfirinox regime 11.3.1 Cefuroxime Intracameral injection April 2015 2.8.2 Dabigatran 9.1.3 Eculizumab 4.8.1 Retigabine May 2015 5.3.3 Simeprevir 5.3.3 Sofosbuvir 8.1.1 Cyclophosphamide 1.5.3 Infliximab/adalimumab/golimumab June 2015 5.1.7 Rifaximin for hepatic encephalopathy 6.1.2 Empagliflozin 2.8.2 Rivaroxaban ASC with raised cardiac biomarkers July 2015 5.1.7 Rifaximin pathway approved 8.1.3 Cytarabine subcutaneous route approved August 3 APC newly approved products added 2015 13.5.3 Secukinumab 11.8.2 Aflibercept 11.4.1 Dexamethasone ocular implant 10.1.3 Etanercept and tocilizumab 2.8.2 Apixaban 1.5.3 Vedolizumab 13.5.3 Ustekinumab 5.1.7 Rifaximin September 3.4.2 Omalizumab 2015 8.2.3 Obinutuzumab 8.2.3 Ofatumumab 9.4.1 Locasol 8.1.5 Nintedanib October 1.5.3 Vedolizumab 2015 2.8.2 Edoxaban 1.6.7 Naloxagol 10.1.3 Infliximab biosimilar November 6.1.6 Freestyle Optium beta-ketone testing strip 2015 5.1.7 Fosfomycin injection 5.1.1.2 Temocillin Injection 5.2.3 Amphotericin suspension December 6.1.2 Dulaglutide 2015 2.5.5 Entresto Page 3 of 56 1 Gastro-Intestinal System 1.1 Dyspepsia and gastro-oesophogeal reflux-disease 1.1.1 Antacids and simeticone MAGNESIUM TRISILICATE MIXTURE SIMETICONE LIQUID SODIUM CITRATE ORAL SOLUTION - OXETACAINE ANTACID SUSPENSION - On Christies recommendation 1.1.2 Compound alginates and proprietary indigestion preparations GAVISCON® ADVANCE SF SUSPENSION and TABLETS GAVISCON® INFANT DUAL-SACHETS GAVISON® SF LIQUID (Aniseed) 1.2 Antispasmodics and other drugs altering gut motility Antimuscarinics DICYCLOVERINE LIQUID and TABLETS HYOSCINE BUTYLBROMIDE INJECTION and TABLETS KOLANTICON® GEL Other antispasmodics ALVERINE CITRATE CAPSULES MEBERINE 135mg TABLETS PEPPERMIINT OIL E/C CAPSULES (Mintec®) MEBEVERINE 50mg/5ml LIQUID 1.3 Antisecretory drugs and mucosal protectants 1.3.1 H2 receptor antagonists RANITIDINE INJECTION LIQUID and TABLETS RANITIDINE 150mg EFFERVESCENT TABLETS 1.3.2 Selective antimuscarinics – No products on formulary 1.3.3 Chelates and complexes – No products on formulary 1.3.4 Prostaglandin analogues MISOPROSTOL 200microgram TABLETS 1.3.5 Proton pump inhibitors LANSOPRAZOLE CAPSULES OMEPRAZOLE CAPSULES AND INJECTION PANTOPRAZOLE TABLETS ESOMEPRAZOLE CAPSULES - Restricted for use in severe GORD LANSOPRAZOLE ORODISPERSIBLE TABLETS - For use in patients with swallowing difficulties only OMEPRAZOLE DISPERSIBLE TABLETS - For use in patients with swallowing difficulties only RABEPRAZOLE TABLETS 1.4 Acute Diarrhoea 1.4.1 Adsorbents and bulk-forming drugs – No products on formulary 1.4.2 Antimotility drugs LOPERAMIDE CAPSULES and LIQUID 1.4.3 Enkephalinase inhibitors RACECADOTRIL - JMMC Approved Dec 2012 for treatment of acute diarrhoea in paediatrics 1.5 Chronic bowel disorder Page 4 of 56 1.5.1 Aminosalicylates BALSALAZIDE 750mg CAPSULES MESALAZINE 1g FOAM ENEMA ( Asacol® or Salofalk®) MESALAZINE 500mg SACHETS (Salofalk®) MESALAZINE 1g M/R SACHETS (Pentasa®) MESALAZINE SUPPOSITORIES MESALAZINE E/C; M/R TABLETS (Octasa®) MESALAZINE 500mg M/R TABLETS (Pentasa®) MESALAZINE 250mg E/C TABLETS (Salofalk®) SULFASALAZINE LIQUID, SUPPOSITORIES and TABLETS MESALAZINE 1200mg M/R TABLETS (Mezavant®) 1.5.2 Corticosteroids PREDNISOLONE 20mg FOAM AEROSOL PREDNISOLONE 20mg in 100ml ENEMA PREDNISOLONE 5mg SUPPOSITORIES BUDESONIDE 3mg E/C CAPSULES (Budenofalk®) BUDESONIDE 3mg M/R CAPSULES (Entocort®) 1.5.3 Drugs affecting the immune response AZATHIOPRINE MERCAPTOPURINE METHOTREXATE Cytokine modulators ADALIMUMAB INJECTION - NICE guidance TA187 – Crohn’s disease JMMC Approved Jun 2008 NICE guidance TA329 (includes review of TA140 and TA262) – treatment of moderate to severe ulcerative colitis after failure of conventional therapy JMMC Approved May 2015 INFLIXIMAB - NICE guidance TA163 – Ulcerative colitis (acute exacerbations) NICE guidance TA187 – Crohn’s disease NICE guidance TA329 (includes review of TA140 and TA262) – treatment of moderate to severe ulcerative colitis after failure of conventional therapy JMMC Approved May 2015 GOLIMUMAB- NICE guidance TA329 (includes review of TA140 and TA262) – treatment of moderate to severe ulcerative colitis after failure of conventional therapy JMMC Approved May 2015 VEDOLIZUMAB- NICE guidance TA342 – Moderate to severe active ulcerative colitis JMMC Approved Aug 2015 NICE guidance TA352 – Moderate to severe active Crohn’s disease after prior therapy JMMC Approved Oct 2015 1.5.4 Food allergy - No products on formulary 1.6 Laxatives 1.6.1 Bulk-forming laxatives ISPAGHULA HUSK SACHETS (Fybogel® orange) METHYLCELLULOSE 500mg TABLETS NOMACOL® PLUS SACHETS NORMACOL® SACHETS 1.6.2 Stimulant laxatives BISACODYL SUPPOSITORIES and TABLETS DOCUSATE SODIUM CAPSULES and LIQUID GLYCEROL SUPPOSITORIES SENNA LIQUID and TABLETS CO-DANTHRAMER CAPSULES and LIQUID - Only for constipation
Load more

Recommended publications
  • Chlorpromazine-Induced Cataract and Corneal Pigmentation
    Case Report Chlorpromazine-induced cataract and corneal pigmentation Chlorpromazine (CPZ) is a low-potency neuroleptic used bution was symmetrical in both eyes. Two independent clini- in the treatment of various psychiatric disorders.1 Chlorpro- cians documented the condition. The pupils were dilated with mazine-induced cataract and corneal pigmentation was first 1% tropicamide for retinoscopy. A dilatation of only 4 mm could described by Greiner & Berry in 1964.2 The prevalence in pa- be achieved. Fundus examination by indirect ophthalmoscopy tients treated over time with large doses of CPZ therapy, ranges was normal. Systemic examination was normal; apart from a from 15% to 74%. Though other low-potency neuroleptics like few extrapyramidal symptoms there were no other side-ef- thioridazine and fluphenazine have been reported to cause fects of CPZ, including skin discoloration. Investigations in- pigmentary changes, characteristic corneal and lenticular pig- cluding liver function tests and peripheral smear were nor- mentation is predominantly if not exclusively a side-effect of mal. With subjective correction, the patient’s vision improved CPZ. We report a case of a 45-year-old female with ocular to 6/9. With the psychiatrist’s consultation, CPZ was substi- effects due to long-term CPZ therapy for bipolar disease. tuted with trifluoperazine. Case report Discussion A 45-year-old female had been taking treatment for manic- Chlorpromazine is an aliphatic phenothiazine used in all depressive psychosis with chlorpromazine 300 mg per day for types of psychosis, especially schizophrenia. The adverse ef- 25 years. In addition, she was found to have received lithium fects include drowsiness, lethargy, postural hypotension, an- 300 mg and haloperidol 5 mg, both twice daily for florid psy- ticholinergic side-effects, infertility and extrapyramidal symp- chotic symptoms.
    [Show full text]
  • Non-Steroidal Drug-Induced Glaucoma MR Razeghinejad Et Al 972
    Eye (2011) 25, 971–980 & 2011 Macmillan Publishers Limited All rights reserved 0950-222X/11 www.nature.com/eye 1,2 1 1 Non-steroidal drug- MR Razeghinejad , MJ Pro and LJ Katz REVIEW induced glaucoma Abstract vision. The majority of drugs listed as contraindicated in glaucoma are concerned with Numerous systemically used drugs are CAG. These medications may incite an attack in involved in drug-induced glaucoma. Most those individuals with narrow iridocorneal reported cases of non-steroidal drug-induced angle.3 At least one-third of acute closed-angle glaucoma are closed-angle glaucoma (CAG). glaucoma (ACAG) cases are related to an Indeed, many routinely used drugs that have over-the-counter or prescription drug.1 Prevalence sympathomimetic or parasympatholytic of narrow angles in whites from the Framingham properties can cause pupillary block CAG in study was 3.8%. Narrow angles are more individuals with narrow iridocorneal angle. The resulting acute glaucoma occurs much common in the Asian population. A study of a more commonly unilaterally and only rarely Vietnamese population estimated a prevalence 4 bilaterally. CAG secondary to sulfa drugs is a of occludable angles at 8.5%. The reported bilateral non-pupillary block type and is due prevalence of elevated IOP months to years to forward movement of iris–lens diaphragm, after controlling ACAG with laser iridotomy 5,6 which occurs in individuals with narrow or ranges from 24 to 72%. Additionally, a open iridocorneal angle. A few agents, significant decrease in retinal nerve fiber layer including antineoplastics, may induce thickness and an increase in the cup/disc ratio open-angle glaucoma.
    [Show full text]
  • )&F1y3x PHARMACEUTICAL APPENDIX to THE
    )&f1y3X PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE )&f1y3X PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 3 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. Product CAS No. Product CAS No. ABAMECTIN 65195-55-3 ACTODIGIN 36983-69-4 ABANOQUIL 90402-40-7 ADAFENOXATE 82168-26-1 ABCIXIMAB 143653-53-6 ADAMEXINE 54785-02-3 ABECARNIL 111841-85-1 ADAPALENE 106685-40-9 ABITESARTAN 137882-98-5 ADAPROLOL 101479-70-3 ABLUKAST 96566-25-5 ADATANSERIN 127266-56-2 ABUNIDAZOLE 91017-58-2 ADEFOVIR 106941-25-7 ACADESINE 2627-69-2 ADELMIDROL 1675-66-7 ACAMPROSATE 77337-76-9 ADEMETIONINE 17176-17-9 ACAPRAZINE 55485-20-6 ADENOSINE PHOSPHATE 61-19-8 ACARBOSE 56180-94-0 ADIBENDAN 100510-33-6 ACEBROCHOL 514-50-1 ADICILLIN 525-94-0 ACEBURIC ACID 26976-72-7 ADIMOLOL 78459-19-5 ACEBUTOLOL 37517-30-9 ADINAZOLAM 37115-32-5 ACECAINIDE 32795-44-1 ADIPHENINE 64-95-9 ACECARBROMAL 77-66-7 ADIPIODONE 606-17-7 ACECLIDINE 827-61-2 ADITEREN 56066-19-4 ACECLOFENAC 89796-99-6 ADITOPRIM 56066-63-8 ACEDAPSONE 77-46-3 ADOSOPINE 88124-26-9 ACEDIASULFONE SODIUM 127-60-6 ADOZELESIN 110314-48-2 ACEDOBEN 556-08-1 ADRAFINIL 63547-13-7 ACEFLURANOL 80595-73-9 ADRENALONE
    [Show full text]
  • 49 Medical Vs. Surgical Methods for Second Trimester Abortion
    49 Medical vs. surgical methods for second trimester abortion Lohr et al. (2008) compared dilatation and evacuation (D&E) to medical methods of abortion in the second trimester (≥ 13 weeks), specifically intra-amniotic installation of prostaglandin F2α and mifepristone and misoprostol. The outcomes considered were complications, side-effects, completion of abortion and patient satisfaction. Although this review is from 2008, it is considered up-to-date as a recent litera- ture review revealed no additional studies which would meet inclusion criteria. Only two trials were included, one addressing each comparison. Gestational age ranged from 13 to 20 weeks among included trials. The trial quality is rated as low, given only one trial is included in each comparison and for the D&E versus mifepristone and misoprostol comparison the trial was very small (n=18) and had a primary outcome (feasibility of randomising US women to one of two methods of abor- tion) differing from the outcomes assessed in the review. The review found that the incidence of combined minor and major complications was lower with D&E compared with installation of prostaglandin F2α (Table 33). Fewer women experienced adverse events with D&E compared with mifepristone combined with misoprostol, although there were no differences in efficacy between the two groups. These results should be interpreted with caution given they are based on one small trial (n=18). The authors conclude that D&E is superior to installation of prostaglandin F2α and that the limited available evidence also favours D&E over mifepristone and misoprostol for decreased rates of adverse events.
    [Show full text]
  • PPH 2Nd Edn #23.Vp
    43 Standard Medical Therapy for Postpartum Hemorrhage J. Unterscheider, F. Breathnach and M. Geary INTRODUCTION firm contraction of the organ. If severe haemorrhage has already set in, it is highly recommended that the drug should Failure of the uterus to contract and retract following be given by the intravenous route. For this purpose one-third childbirth has for centuries been recognized as the of the standard size ampoule may be injected or, for those most striking cause of postpartum hemorrhage (PPH) who wish accurate dosage, a special ampoule containing and complicates up to 10% of pregnancies globally. In 0.125 mg is manufactured. An effect may be looked for in less the developing world, PPH is responsible for one than one minute.’ maternal death every 7 minutes1. Another uterotonic agent, oxytocin, the hypothalamic In the 19th century, uterine atony was treated by polypeptide hormone released by the posterior pitu- intrauterine placement of various agents with the aim itary, was discovered in 1909 by Sir Henry Dale8 and of achieving a tamponade effect. ‘A lemon imperfectly synthesized in 1954 by du Vigneaud9. The develop- quartered’ or ‘a large bull’s bladder distended with ment of oxytocin constituted the first synthesis of water’ were employed for this purpose, with apparent a polypeptide hormone and gained du Vigneaud a success. Douching with vinegar or iron perchloride Nobel Prize for his work. was also reported2,3. Historically, the first uterotonic The third group of uterotonics comprises the ever- drugs were ergot alkaloids,
    [Show full text]
  • Acepromazine and Chlorpromazine As Pharmaceutical-Grade Alternatives to Chlorprothixene for Pupillary Light Reflex Imaging in Mice
    Journal of the American Association for Laboratory Animal Science Vol 59, No 2 Copyright 2020 March 2020 by the American Association for Laboratory Animal Science Pages 197–203 Acepromazine and Chlorpromazine as Pharmaceutical-grade Alternatives to Chlorprothixene for Pupillary Light Reflex Imaging in Mice Samantha S Eckley,1 Jason S Villano,1 Nora S Kuo,1 and Kwoon Y Wong2,* Studies of visual responses in isoflurane-anesthetized mice often use the sedative chlorprothixene to decrease the amount of isoflurane used because excessive isoflurane could adversely affect light-evoked responses. However, data are not available to justify the use of this nonpharmaceutical-grade chemical. The current study tested whether pharmaceutical-grade sedatives would be appropriate alternatives for imaging pupillary light reflexes. Male 15-wk-old mice were injected intraperitoneally with 1 mg/kg chlorprothixene, 5 mg/kg acepromazine, 10 mg/kg chlorpromazine, or saline. After anesthetic induction, anes- thesia maintenance used 0.5% and 1% isoflurane for sedative- and saline-injected mice, respectively. A photostimulus (16.0 log photons cm−2 s−1; 470 nm) was presented to the right eye for 20 min, during which the left eye was imaged for consensual pupillary constriction and involuntary pupil drift. Time to immobilization, loss of righting reflex, physiologic parameters, gain of righting reflex, and degree of recovery were assessed also. The sedative groups were statistically indistinguishable for all measures. By contrast, pupillary drift occurred far more often in saline-treated mice than in the sedative groups. Fur- thermore, saline-treated mice took longer to reach maximal pupil constriction than all sedative groups and had lower heart rates compared with chlorpromazine- and chlorprothixene-sedated mice.
    [Show full text]
  • Tropicamide Tropicamide Eye Drops
    Minims® Tropicamide Tropicamide Eye Drops Consumer Medicine Information Tell your doctor if you have or What is in this leaflet Before you use Minims have had any of the following Tropicamide This leaflet answers some common medical conditions: questions about Minims * glaucoma (high pressure in the Tropicamide, including how to use When you must not use it eye) the eye drops. * fast heartbeat or any heart Do not use Minims Tropicamide if It does not contain all the available condition or had heart surgery. you have an allergy to: information. It does not take the Tell your doctor if you are place of talking to your doctor or * any medicine containing pregnant or are breast-feeding. pharmacist. tropicamide Your doctor will discuss with you * any of the ingredients listed at the All medicines have benefits and the risks and benefits involved. risks. Your doctor has weighed the end of this leaflet. Tell your doctor if you wear risks of you using Minims Some of the symptoms of an allergic contact lenses. Tropicamide against the benefits they reaction may include: You should not wear contact lenses expect it will have for you. * shortness of breath while using this medicine. If you have any concerns about * wheezing or difficulty breathing using this medicine, ask your * swelling of the face, lips, tongue If you have not told your doctor doctor or pharmacist. about any of the above, tell or other parts of the body him/her before you start using Keep this leaflet with the medicine. * rash, itching or hives on the skin.
    [Show full text]
  • Inquiry Into Therapeutic Goods Amendment (Repeal of Ministerial
    1 THERAPEUTIC GOODS AMENDMENT (REPEAL OF MINISTERIAL RESPONSIBILITY FOR APPROVAL OF RU486) BILL 2005 INTRODUCTION 1.1 The Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005 (the Bill) is a private Senators' bill that was introduced into the Senate on 8 December 2005 by Senator Nash and also on behalf of Senators Troeth, Allison and Moore. On the same day, 8 December 2005, the Bill was referred on the motion of Senator Troeth to the Committee for inquiry and report by the second sitting day in 2006 (effectively 8 February 2006). 1.2 A majority of the Committee (Senators Adams and Moore dissenting) agreed that a short extension to the reporting date should be sought. Following the receipt of advice relating to Senate business programming, the Committee subsequently agreed (Senator Fielding dissenting) that it would not formally seek an extension from the Senate. THE BILL 1.3 The Bill expresses as its purpose 'to remove the responsibility for approval of RU486 from the Minister and to provide responsibility for approval of RU486 to the Therapeutic Goods Administration'.1 1.4 The Bill achieves this purpose through the amendment of the Therapeutic Goods Act 1989 by repealing subsection 3(1) (definition of restricted goods), section 6AA (importation of restricted goods), section 6AB (exempt goods), section 23AA (ministerial approval of evaluation, registration or listing of exempt goods) and subsection 57(9) (delegation). 1.5 Although the title and stated purpose of the Bill refer only to RU486, the provisions to be repealed by the Bill deal with abortifacient drugs, not specifically RU486.
    [Show full text]
  • 208151Orig1s000
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208151Orig1s000 SUMMARY REVIEW NDA 208151, ISOPTO Atropine (atropine sulfate ophthalmic solution) 1% Cycloplegia, Mydriasis, Penalization of the healthy eye in the treatment of amblyopia Division Director Summary Review Material Reviewed/Consulted OND Action Package, including: Names of discipline reviewers Medical Officer Review Wiley Chambers, William Boyd 9/13/2016 CDTL Review William Boyd, Wiley Chambers 11/29/2016 Statistical Review Abel Eshete, Yan Wang 11/8/2016 Pharmacology Toxicology Review Aaron Ruhland, Lori Kotch 11/7/2016 CMC Review Haripada Sanker, Milton Sloan, Maotang Zhou, Denise Miller, Vidya Pai, Om Anand, Erin Andrews, Chunchun Zhang, Paul Perdue 10/12/2016, 11/10/2016 Clinical Pharmacology Review Abhay Joshi, Philip Colangelo 11/9/2016 OPDP/DPDP Carrie Newcomer 11/7/2016 OSI/DGCPC N/A Proprietary Name Michelle Rutledge, Yelena Maslov, Lubna Merchant 6/1/2016 Conditionally acceptable letter Todd Bridges 6/2/2016 OSE/DMEPA Michelle Rutledge, Yelena Maslov 6/8/2016 OSE/DDRE N/A OSE/DRISK N/A Project Manager Michael Puglisi OND=Office of New Drugs CDTL=Cross-Discipline Team Leader OSI/DGCPC=Office of Scientific Investigations/Division of Good Clinical Practice Compliance OPDP/DPDP=Office of Prescription Drug Promotion/Division of Prescription Drug Promotion OSE= Office of Surveillance and Epidemiology DMEPA=Division of Medication Error Prevention and Analysis DDRE= Division of Drug Risk Evaluation DRISK=Division of Risk Management Page 2 of 24 Reference ID: 4021108 NDA 208151, ISOPTO Atropine (atropine sulfate ophthalmic solution) 1% Cycloplegia, Mydriasis, Penalization of the healthy eye in the treatment of amblyopia Division Director Summary Review Signatory Authority Review Template 1.
    [Show full text]
  • World Health Organization Model List of Essential Medicines, 21St List, 2019
    World Health Organizatio n Model List of Essential Medicines 21st List 2019 World Health Organizatio n Model List of Essential Medicines 21st List 2019 WHO/MVP/EMP/IAU/2019.06 © World Health Organization 2019 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. World Health Organization Model List of Essential Medicines, 21st List, 2019. Geneva: World Health Organization; 2019. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris.
    [Show full text]
  • Tropicamide 2018 Newborn Use Only
    Tropicamide 2018 Newborn Use Only Alert Watch for apnoeas and abdominal distension following administration. Lower concentration solutions and regimens minimising number of additional drops are recommended. Indication Induction of mydriasis and cycloplegia for diagnostic and therapeutic ophthalmic procedures. Action Anticholinergic drug that produces pupillary dilatation by inhibiting the sphincter pupillae muscle and paralysis of accommodation. Drug Type Antimuscarinic. Trade Name Minims Tropicamide Eye Drops Mydriacyl Eye drops Presentation Minims Tropicamide Eye Drops 0.5%, 1.0% solution. Mydriacyl Eye drops 0.5%, 1.0% 15 mL (multidose—excipients benzalkonium chloride 0.01%, sodium chloride, disodium edetate, hydrochloric acid and/or sodium hydroxide, purified water). Dosage/Interval Use in combination with phenylephrine 2.5% with or without cyclopentolate 0.5%. REGIMEN 1: Phenylephrine 2.5% + cyclopentolate 0.5% + tropicamide 0.5% eye drops [1-4]. Instil one drop of each agent (5 minutes apart) into each eye 60 minutes prior to examination. Repeat if pupillary dilatation inadequate. Perform examination 60 to 120 minutes after instillation. REGIMEN 2: Phenylephrine 2.5% + tropicamide 0.5% eye drops [5-7]. Instil one drop of each agent (5 minutes apart) into each eye 60 minutes prior to examination. Repeat if pupillary dilatation inadequate. Perform examination 60 to 120 minutes after instillation. Dark irides may require additional drops. Maximum daily dose REGIMEN 1: 3 drops of each agent. REGIMEN 2: 4 drops of each agent. Route Topical instillation into the eyes from the container or use a microdrop (5–7 microL) cannula. Preparation/Dilution Administration Apply pressure to the lacrimal sac during and for 60 seconds after instillation of eye drop to minimise systemic absorption.
    [Show full text]
  • Maintenance Drug List Below Is Not Comprehensive and Is Subject to Change Without Prior Notification
    Maintenance Drugs Maintenance drugs are used on a continuing basis for the treatment of chronic conditions. Select health plans require that pharmacy benefit maintenance drugs are filled at Kaiser Permanente Washington Mail Order or Kaiser Permanente Clinic Pharmacies for ongoing health plan coverage. Please consult your Evidence of Coverage or call Member Services at 1-888-901-4636 if you have questions about your drug coverage. Non-maintenance drugs are generally used for episodic treatment, are considered narrow therapeutic index by Kaiser Permanente Washington, or are schedule 2 controlled substances. Non-maintenance products include: opioids, opioid reversal agents, opioid dependence agents, benzodiazepines, skeletal muscle relaxants, schedule 2 stimulants, vaccines, oral antibiotics, antiemetics, cough/cold/allergy products, emergency contraception, epinephrine pens, bowel preparations, smoking cessation, prednisone, enoxaparin, cyclosporine, digoxin, dofetilide, everolimus, lithium, mycophenolate, sirolimus, sotalol, tacrolimus, theophylline, and warfarin. The maintenance drug list below is not comprehensive and is subject to change without prior notification. Coverage is provided by Kaiser Permanente Health Plan of Washington and Kaiser Permanente Health Plan of Washington Options, Inc. MAINTENANCE DRUG LIST: ADHD/ANTI-NARCOLEPSY AGENTS DICLOFENAC NALFON ARMODAFINIL DICLOFENAC POTASSIUM NAPRELAN ATOMOXETINE DICLOFENAC SODIUM DR NAPROSYN CLONIDINE HCL ER DICLOFENAC SODIUM ER NAPROXEN GUANFACINE ER DICLOFENAC SODIUM/MISOPROSTOL NAPROXEN
    [Show full text]