2021 EMPIRE PLAN FLEXIBLE FORMULARY DRUG LIST Administered by CVS Caremark®
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Expert Review 2
2021 Expert Committee on Selection and Use of Essential Medicines Application review I.1 Albendazole, mebendazole and praziquantel for the indication of treatment of (item number) taeniid cestode cysts Does the application adequately ☒ Yes address the issue of the public health ☐ need for the medicine? No ☐ Not applicable Comments: The larval stages of three taeniid cestode parasites, Echinococcus granulosus, Echinococcus multilocularis and Taenia solium, produce cysts in humans that are of medical relevance. The diseases caused by these parasitic cysts are called cystic echinococcosis (CE), alveolar echinococcosis (AE), and cysticercosis (being neurocysticercosis (NCC) the most common form) respectively, and they are recognised by WHO as neglected tropical diseases. NCC is mainly a disease of poverty that predominantly affects rural populations in Africa, Asia and Latin America. Access to diagnostic and treatment, to better manage epilepsy and other NCC is a challenge for the people affected in these communities due to the availability and costs of specialised diagnostic and care. Stigma and social discrimination also mean that many people try to “hide” the disease. Briefly summarize the role of the The only real options for treatment of CE are albendazole (ALB) and Mebendazole proposed medicine(s) relative to other (MEB). ALB is the drug of choice as it has better bioavailability. ALB is also preferred to therapeutic agents currently included in MEB, because MEB requires a higher dose and a higher pill burden, for example, an the Model List, or available in the adult patient would require 8 tablets/day of MEB compared with 2 tablets/day ALB. market. ALB and praziquantel ( PZQ) are the only drugs used for the antiparasitic treatment of NCC. -
ALBENDAZOLE (Extrapolation to All Ruminants)
European Medicines Agency Veterinary Medicines and Inspections EMEA/MRL/865/03-FINAL June 2004 COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE ALBENDAZOLE (Extrapolation to all ruminants) SUMMARY REPORT (3) 1. Albendazole is a benzimidazole carbamate, used for the treatment of gastrointestinal infestations with roundworms, lungworms and tapeworms and adult flukes of Fasciola hepatica. Albendazole is currently entered into Annex I of Council Regulation (EEC) No. 2377/90 in accordance with the following table: Pharmacologically Marker residue Animal MRLs Target Other active substance(s) species tissues provisions Albendazole Sum of albendazole Bovine, 100 µg/kg Muscle sulphoxide, ovine 100 µg/kg Fat albendazole sulphone 1000 µg/kg Liver and albendazole 2- 500 µg/kg Kidney amino sulphone 100 µg/kg Milk expressed as albendazole 2. In reviewing the availability of endo- and ectoparasiticides for sheep and goats, albendazole was considered for extrapolation from bovine and ovine species to all ruminants. The considerations and criteria leading to the identification of albendazole are described in the Position Paper Regarding Availability of Veterinary Medicines – Extrapolation of MRLs (EMEA/CVMP/457/03-FINAL). 3. The scientific justification for this extrapolation was assessed in accordance with the Notes for Guidance on Risk Analysis Approach for Residues of Veterinary Medicinal Products in Food of Animal Origin (EMEA/CVMP/187/00-FINAL) and on the Establishment of Maximum Residue Limits for Minor Animal Species (EMEA/CVMP/153a/97-FINAL). 4. In setting the ADI in the original assessment of albendazole, the data summarised on the paragraphs below were considered. 5. The mode of action of albendazole is by binding strongly with the tubulin in the cells of nematodes. -
Efficacy and Tolerability of Quinacrine Monotherapy and Albendazole Plus Chloroquine Combination Therapy in Nitroimidazole-Refractory Giardiasis: a Tropnet Study
Klinik für Infektiologie & Spitalhygiene Efficacy and tolerability of quinacrine monotherapy and albendazole plus chloroquine combination therapy in nitroimidazole-refractory giardiasis: a TropNet study Andreas Neumayr, Mirjam Schunk, Caroline Theunissen, Marjan Van Esbroeck, Matthieu Mechain, Manuel Jesús Soriano Pérez, Kristine Mørch, Peter Sothmann, Esther Künzli, Camilla Rothe, Emmanuel Bottieau Journal Club 01.03.21 Andreas Neumayr Background on giardia treatment: • 1st-line treatment: 5-nitroimidazoles: metronidazole (1957), tinidazole, ornidazole, secnidazole • cure rate of 5NIs in 1st-line treatment: ~90% • in the last decade, an increase of 5NI-refractory giardia cases has been observed in travel medicine clinics across Europe: Hospital for Tropical Diseases, London: 2008: 15% --> 2013: 40% 70% of 5NI-refractory cases imported from India • 2nd-line treatment: effectiveness of a 2nd round with a 5NI: ~17% alternative drugs: albendazole, mebendazole, nitazoxanide, quinacrine, furazolidone, chloroquine, paromomycin 2012 TropNet member survey: 53 centres use 39 different treatment regimens, consisting of 7 different drugs in mono- or combination-therapy in various dosages and durations JC 01.03.21 Nabarro LE et al. Clin Microbiol Infect. 2015;21:791-6. • by 2013, there were only 13 reports of 2nd-line therapy for giardiasis (8 case series, 5 individual case reports): n=110 Cure rates Albendazole 6/32 18.7% Paromomycin 5/17 29.4% Nitazoxanide 2/5 40.0% Albendazole + 5-NI 42/53 79.2% Quinacrine 19/21 90.5% Quinacrine + 5-NI 14/14 100% Quinacrine + Paromomycin 2/2 100% • 2013: TropNet "GiardiaREF" study kick-off: Study on efficacy and tolerability of two 2nd-line regimens in nitroimidazole-refractory giardiasis: Quinacrine JC 01.03.21 Meltzer E et al. -
Folic Acid, Pyridoxine, and Cyanocobalamin Combination
ORIGINAL INVESTIGATION Folic Acid, Pyridoxine, and Cyanocobalamin Combination Treatment and Age-Related Macular Degeneration in Women The Women’s Antioxidant and Folic Acid Cardiovascular Study William G. Christen, ScD; Robert J. Glynn, ScD; Emily Y. Chew, MD; Christine M. Albert, MD; JoAnn E. Manson, MD Background: Observational epidemiologic studies indi- and visually significant AMD, defined as confirmed in- cate a direct association between homocysteine concentra- cident AMD with visual acuity of 20/30 or worse attrib- tion in the blood and the risk of age-related macular degen- utable to this condition. eration (AMD), but randomized trial data to examine the effect of therapy to lower homocysteine levels in AMD are Results:Afteranaverageof7.3yearsoftreatmentandfollow- lacking. Our objective was to examine the incidence of AMD up, there were 55 cases of AMD in the combination treat- in a trial of combined folic acid, pyridoxine hydrochloride ment group and 82 in the placebo group (relative risk, 0.66; (vitamin B6), and cyanocobalamin (vitamin B12) therapy. 95% confidence interval, 0.47-0.93 [P=.02]). For visually significant AMD, there were 26 cases in the combination Methods: We conducted a randomized, double-blind, treatment group and 44 in the placebo group (relative risk, placebo-controlled trial including 5442 female health care 0.59; 95% confidence interval, 0.36-0.95 [P=.03]). professionals 40 years or older with preexisting cardio- vascular disease or 3 or more cardiovascular disease risk Conclusions: These randomized trial data from a large factors. A total of 5205 of these women did not have a cohort of women at high risk of cardiovascular disease diagnosis of AMD at baseline and were included in this indicate that daily supplementation with folic acid, pyri- analysis. -
R Graphics Output
Dexamethasone sodium phosphate ( 0.339 ) Melengestrol acetate ( 0.282 ) 17beta−Trenbolone ( 0.252 ) 17alpha−Estradiol ( 0.24 ) 17alpha−Hydroxyprogesterone ( 0.238 ) Triamcinolone ( 0.233 ) Zearalenone ( 0.216 ) CP−634384 ( 0.21 ) 17alpha−Ethinylestradiol ( 0.203 ) Raloxifene hydrochloride ( 0.203 ) Volinanserin ( 0.2 ) Tiratricol ( 0.197 ) trans−Retinoic acid ( 0.192 ) Chlorpromazine hydrochloride ( 0.191 ) PharmaGSID_47315 ( 0.185 ) Apigenin ( 0.183 ) Diethylstilbestrol ( 0.178 ) 4−Dodecylphenol ( 0.161 ) 2,2',6,6'−Tetrachlorobisphenol A ( 0.156 ) o,p'−DDD ( 0.155 ) Progesterone ( 0.152 ) 4−Hydroxytamoxifen ( 0.151 ) SSR150106 ( 0.149 ) Equilin ( 0.3 ) 3,5,3'−Triiodothyronine ( 0.256 ) 17−Methyltestosterone ( 0.242 ) 17beta−Estradiol ( 0.24 ) 5alpha−Dihydrotestosterone ( 0.235 ) Mifepristone ( 0.218 ) Norethindrone ( 0.214 ) Spironolactone ( 0.204 ) Farglitazar ( 0.203 ) Testosterone propionate ( 0.202 ) meso−Hexestrol ( 0.199 ) Mestranol ( 0.196 ) Estriol ( 0.191 ) 2,2',4,4'−Tetrahydroxybenzophenone ( 0.185 ) 3,3,5,5−Tetraiodothyroacetic acid ( 0.183 ) Norgestrel ( 0.181 ) Cyproterone acetate ( 0.164 ) GSK232420A ( 0.161 ) N−Dodecanoyl−N−methylglycine ( 0.155 ) Pentachloroanisole ( 0.154 ) HPTE ( 0.151 ) Biochanin A ( 0.15 ) Dehydroepiandrosterone ( 0.149 ) PharmaCode_333941 ( 0.148 ) Prednisone ( 0.146 ) Nordihydroguaiaretic acid ( 0.145 ) p,p'−DDD ( 0.144 ) Diphenhydramine hydrochloride ( 0.142 ) Forskolin ( 0.141 ) Perfluorooctanoic acid ( 0.14 ) Oleyl sarcosine ( 0.139 ) Cyclohexylphenylketone ( 0.138 ) Pirinixic acid ( 0.137 ) -
Study Assessing Prices, Availability and Affordability of Children's
Study assessing prices, availability and affordability of children’s medicine in Chhattisgarh, India Part of the Better Medicine for Children project Authors Dr Antony KR Virendra Jain Puni Kokho Dr Kamlesh Jain The salient findings and views expressed in this report are solely those of the authors. Please direct correspondence to the authors: ([email protected], [email protected] [email protected], [email protected]). This publication does not necessarily represent the decisions or policies of the World Health Organization. ii Contents Acknowledgements ........................................................................................... v Abbreviations ................................................................................................... vi Executive summary ......................................................................................... vii Medicine availability .............................................................................................vii Medicine costs ................................................................................................... viii Affordability of standard treatment regimens ........................................................... ix Price components survey ...................................................................................... ix Conclusion .......................................................................................................... x 1. Introduction ................................................................................................. -
Guidelines on Food Fortification with Micronutrients
GUIDELINES ON FOOD FORTIFICATION FORTIFICATION FOOD ON GUIDELINES Interest in micronutrient malnutrition has increased greatly over the last few MICRONUTRIENTS WITH years. One of the main reasons is the realization that micronutrient malnutrition contributes substantially to the global burden of disease. Furthermore, although micronutrient malnutrition is more frequent and severe in the developing world and among disadvantaged populations, it also represents a public health problem in some industrialized countries. Measures to correct micronutrient deficiencies aim at ensuring consumption of a balanced diet that is adequate in every nutrient. Unfortunately, this is far from being achieved everywhere since it requires universal access to adequate food and appropriate dietary habits. Food fortification has the dual advantage of being able to deliver nutrients to large segments of the population without requiring radical changes in food consumption patterns. Drawing on several recent high quality publications and programme experience on the subject, information on food fortification has been critically analysed and then translated into scientifically sound guidelines for application in the field. The main purpose of these guidelines is to assist countries in the design and implementation of appropriate food fortification programmes. They are intended to be a resource for governments and agencies that are currently implementing or considering food fortification, and a source of information for scientists, technologists and the food industry. The guidelines are written from a nutrition and public health perspective, to provide practical guidance on how food fortification should be implemented, monitored and evaluated. They are primarily intended for nutrition-related public health programme managers, but should also be useful to all those working to control micronutrient malnutrition, including the food industry. -
Valbazen ® (Albendazole)
® (albendazole oral suspension) Broad-Spectrum Dewormer Oral Suspension for Use in Cattle, Sheep, and Goats for removal and control of liver flukes, tapeworms, stomach worms (including 4th stage inhibited larvae of Ostertagia ostertagi), intestinal worms, and lungworms in cattle and sheep and for the treatment of adult liver flukes in nonlactating goats Active Ingredient Albendazole ............................. 11.36% (equivalent to 113.6 mg/mL) 1 L/33.8 fl oz (1 qt 1.8 fl oz) Approved by FDA under NADA # 110-048 40029175 ® (albendazole oral suspension) Broad-Spectrum Dewormer Oral Suspension for Use in Cattle, Sheep, and Goats for removal and control of liver Indications: flukes, tapeworms, stomach worms (including 4th stage inhibited larvae of Ostertagia Cattle and sheep: Valbazen is a broad-spectrum anthelmintic effective in the removal ostertagi), intestinal worms, and lungworms in cattle and sheep and for the treatment and control of liver flukes, tapeworms, stomach worms (including 4th stage inhibited of adult liver flukes in nonlactating goats larvae of Ostertagia ostertagi ), intestinal worms, and lungworms as indicated below. Active Ingredient: Goats: For the treatment of adult liver flukes in nonlactating goats. Albendazole .......................................................... 11.36% (Equivalent to 113.6 mg/mL) Parasite Cattle Sheep Goats Adult Liver Flukes Fasciola hepatica Fasciola hepatica, Fascioloides magna Fasciola hepatica Heads and Segments Moniezia benedeni, M. expansa Common Tapeworm (Moniezia expansa), Fringed Tapeworm of Tapeworms (Thysanosoma actinioides) Adult and 4th Stage Brown Stomach Worm, including 4th stage Brown Stomach Worm (Ostertagia circumcincta, Marshallagia Larvae of Stomach inhibited larvae (Ostertagia ostertagi), marshalli), Barber Pole Worm (Haemonchus contortus), Small Worms Barber Pole Worm (Haemonchus Stomach Worm (Trichostrongylus axei) contortus, H. -
These Highlights Do Not Include All the Information Needed to Use M.V.I. Pediatric® Safely and Effectively
M.V.I. PEDIATRIC- ascorbic acid, retinol, ergocalciferol, thiamine hydrochloride, riboflavin 5- phosphate sodium, pyridoxine hydrochloride, niacinamide, dexpanthenol, .alpha.-tocopherol acetate, dl-, biotin, folic acid, cyanocobalamin, and phytonadione injection, powder, lyophilized, for solution Hospira, Inc. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use M.V.I. Pediatric® safely and effectively. See full prescribing information for M.V.I. Pediatric. M.V.I. Pediatric (multiple vitamins for injection), for intravenous use Initial U.S. Approval: 1983 RECENT MAJOR CHANGES Dosage And Administration, Dosage Information (2.2) 2/2019 INDICATIONS AND USAGE M.V.I. Pediatric is a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition (1) DOSAGE AND ADMINISTRATION M.V.I. Pediatric is a combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K, folic acid, biotin, and vitamin B12 (2.1) Supplied as a single-dose vial of lyophilized powder for reconstitution intended for administration by intravenous infusion after dilution. (2.1) Recommended daily dosage is based on patient's actual weight (2.2) Less than 1 kg: The daily dose is 1.5 mL 1 kg to 3 kg: The daily dose is 3.25 mL 3 kg or more: The daily dose is 5 mL One daily dose of the reconstituted solution (1.5 mL, 3.25 mL or 5 mL) is then added directly to the intravenous fluid (2.2,2.3) See Full Prescribing Information for reconstitution instructions (2.3) Monitor blood vitamin concentrations (2.4) See Full Prescribing Information for drug incompatibilities (2.5) DOSAGE FORMS AND STRENGTHS M.V.I. -
Becosules Junior
For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only Multivitamin with Vitamin A and Vitamin D3 Liquid BECOSULES JUNIOR 1. NAME OF THE MEDICINAL PRODUCT BECOSULES JUNIOR 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml (1 teaspoonful) contains: Vitamin A Concentrate Oil I.P. (as Palmitate) 2500 IU Cholecalciferol I.P. 200 IU Thiamine Hydrochloride I.P. 2 mg Riboflavin Sodium Phosphate I.P. 2.54 mg Pyridoxine Hydrochloride I.P. 1 mg Niacinamide I.P. 20 mg D-Panthenol I.P. 5 mg Ascorbic Acid I.P. 50 mg For Pediatric Use For a full list of excipients, see section 6.1. 3. PHARMACOLOGICAL FORM Liquid Trademark Owner: Pfizer Products Inc. USA; Licensed User: Pfizer Limited, India BECOSULES JUNIOR Page 1 of 9 LPDBECJR122017 4. CLINICAL PARTICULARS 4.1 Indications Becosules Junior is indicated in the treatment of patients with deficiencies of, or increased requirement for vitamins A, B complex, C and D. Such patients and conditions include: • Decreased intake because of restricted or unbalanced diet as in anorexia, diabetes mellitus and obesity, and insufficient sunlight exposure.1 • Reduced availability during treatment with antimicrobials which alter normal intestinal flora, and anticonvulsants and glucocorticoids which alter vitamin D metabolism1, in prolonged diarrhea and in chronic gastrointestinal disorders. • Increased requirements due to increased metabolic rate as in fever and tissue wasting, e.g. febrile illness, acute or chronic infections, surgery, burns and fractures. • Stomatitis, glossitis, cheilosis, paraesthesias, neuralgia and dermatitis. 4.2 Posology and Method of Administration For children from 1-3 years - 1.25 ml, 4-9 years - 2.5 ml; and 10-13 years - 5 ml or as directed by physician. -
B-COMPLEX FORTE with VITAMIN C CAPSULES BECOSULES Capsules
For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory. B-COMPLEX FORTE WITH VITAMIN C CAPSULES BECOSULES Capsules 1. NAME OF THE MEDICINAL PRODUCT BECOSULES 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains: Thiamine Mononitrate I.P. 10 mg Riboflavin I.P. 10 mg Pyridoxine Hydrochloride I.P. 3 mg Vitamin B12 I.P. ( as STABLETS 1:100) 15 mcg Niacinamide I.P. 100 mg Calcium Pantothenate I.P. 50 mg Folic Acid I.P. 1.5 mg Biotin U.S.P. 100 mcg Ascorbic Acid I.P. (as coated) 150 mg Appropriate overages added For Therapeutic Use For a full list of excipients, see section 6.1. All strengths/presentations mentioned in this document might not be available in the market. 3. PHARMACOLOGICAL FORM Capsules 4. CLINICAL PARTICULARS 4.1 Therapeutic Indications Trademark Proprietor: Pfizer Products Inc. USA Licensed User: Pfizer Limited, India BECOSULES Capsules Page 1 of 7 LPDBCC092017 PfLEET Number: 2017-0033507 Becosules capsules are indicated in the treatment of patients with deficiencies of, or increased requirement for, vitamin B-complex, and vitamin C. Such patients and conditions include: Decreased intake because of restricted or unbalanced diet as in anorexia, diabetes mellitus, obesity and alcoholism. Reduced availability during treatment with antimicrobials which alter normal intestinal flora, in prolonged diarrhea and in chronic gastro-intestinal disorders. Increased requirements due to increased metabolic rate as in fever and tissue wasting, e.g. febrile illness, acute or chronic infections, surgery, burns and fractures. Stomatitis, glossitis, cheilosis, paraesthesias, neuralgia and dermatitis. Micronutrient deficiencies during pregnancy or lactation. -
Albendazole: a Review of Anthelmintic Efficacy and Safety in Humans
S113 Albendazole: a review of anthelmintic efficacy and safety in humans J.HORTON* Therapeutics (Tropical Medicine), SmithKline Beecham International, Brentford, Middlesex, United Kingdom TW8 9BD This comprehensive review briefly describes the history and pharmacology of albendazole as an anthelminthic drug and presents detailed summaries of the efficacy and safety of albendazole’s use as an anthelminthic in humans. Cure rates and % egg reduction rates are presented from studies published through March 1998 both for the recommended single dose of 400 mg for hookworm (separately for Necator americanus and Ancylostoma duodenale when possible), Ascaris lumbricoides, Trichuris trichiura, and Enterobius vermicularis and, in separate tables, for doses other than a single dose of 400 mg. Overall cure rates are also presented separately for studies involving only children 2–15 years. Similar tables are also provided for the recommended dose of 400 mg per day for 3 days in Strongyloides stercoralis, Taenia spp. and Hymenolepis nana infections and separately for other dose regimens. The remarkable safety record involving more than several hundred million patient exposures over a 20 year period is also documented, both with data on adverse experiences occurring in clinical trials and with those in the published literature and\or spontaneously reported to the company. The incidence of side effects reported in the published literature is very low, with only gastrointestinal side effects occurring with an overall frequency of just "1%. Albendazole’s unique broad-spectrum activity is exemplified in the overall cure rates calculated from studies employing the recommended doses for hookworm (78% in 68 studies: 92% for A. duodenale in 23 studies and 75% for N.