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GABAPENTIN Product Monograph Page 3 of 32 PrGABAPENTIN Gabapentin Capsules, House Standard 100 mg, 300 mg and 400 mg PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength All Non-medicinal Ingredients Oral Capsules: 100 mg, 300 mg, and 400 mg Corn Starch, Lactose Anhydrous, and Talc. Gabapentin is used in combination with other anticonvulsants for management of partial seizures with or without secondary generalization in adults and children ≥3 years of age. Impurities solution—Dissolve suitable quantities of USP Gabapentin Related Compound A RS and USP Gabapentin Re-lated Compound B RS in methanol to obtain a solution contain-ing about 1.4 mg per mL and 0.84 mg per mL, respectively. Gabapentin enacarbil (Horizant) Monograph Gabapentin Enacarbil (Horizant®) National Drug Monograph March 2012 VA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives The purpose of VA PBM Services drug monographs is to provide a comprehensive drug review for making formulary decisions. Find medical information for gabapentin on epocrates online, including its dosing, contraindications, drug interactions, and pill pictures. In adults with postherpetic neuralgia, gabapentin may be initiated on Day 1 as a single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a day), and on Day 3 as 900 mg/day (300 mg three times a day). The dose can subsequently be titrated up as needed for pain relief to a dose of 1800 mg/day (600 mg three times a day). » Gabapentin Tablets contain not less than 90.0 percent age; and L is the Tablet label claim, in mg. and not more than 110.0 percent of the labeled amountTolerances—Not less than 80% (Q) of the labeled amount of of gabapentin (C 9H 17NO 2). gabapentin (C 9H 17NO 2) is dissolved in 45 minutes. PRODUCT MONOGRAPH PrAPO-GABAPENTIN Gabapentin Capsules Apotex Standard 100 mg, 300 mg and 400 mg Gabapentin Tablets USP drugs including gabapentin. Gabapentin (Neurontin, Gralise, Horizant) is a medicine used to treat partial seizures, nerve pain from shingles and restless leg syndrome. It works on the chemical messengers in your brain and nerves. Gabapentin is from a group of medicines called anticonvulsants. TEVA-GABAPENTIN (gabapentin) is indicated as adjunctive therapy for the management of patients with epilepsy who are not satisfactorily controlled by conventional therapy. Systematic studies in geriatric patients have not been conducted. (See WARNINGS AND PRECAUTIONS, Special Populations). TEVA-GABAPENTIN (gabapentin) is indicated as adjunctive therapy for the management of patients with epilepsy who are not satisfactorily controlled by conventional therapy. Gabapentin is eliminated from the systemic circulation by renal excretion as unchanged drug. Gabapentin elimination half-life is 5 to 7 hours. In elderly patients, and in patients with impaired renal function, gabapentin plasma clearance is reduced. Gabapentin can be removed from plasma by hemodialysis. 400 mg oral doses of gabapentin. The mean gabapentin half-life ranged from about 6.5 hours (patients with creatinine clearance >60 mL/min) to 52 hours (creatinine clearance <30 mL/min) and NEURONTIN® (gabapentin) Product Monograph Page 1 of 29 PRODUCT MONOGRAPH Pr NEURONTIN® Gabapentin Capsules 100 mg, 300 mg, and 400 mg Tablets 600 mg and 800 mg Antiepileptic Agent Pfizer Canada Inc. 17, 300 Trans-Canada Highway Kirkland, Quebec H9J 2M5 www.pfizer.ca Date of Revision: February 22, 2018 Submission Control No: 211678 5.3 Withdrawal of Gabapentin 5.4 . Tumorigenic Potential 5.5 . Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity 5.6. Laboratory Tests 6 ADVERSE REACTIONS . 6.1 Clinical Trials Experience . 6.2 Postmarketing and Other Experience with other Formulations of Gabapentin . 7 DRUG INTERACTIONS . 7.1 Phenytoin Gabapentin Page 1 of 28 PRODUCT MONOGRAPH Pr Gabapentin Gabapentin Tablets, House Standard 600 mg and 800 mg Antiepileptic Agent JAMP Pharma Corporation 1310 rue Nobel Boucherville, Quebec J4B 5H3 Control# 256895 7 DRUG INTERACTIONS . 7.1 Other Antiepileptic Drugs . 7.2 Opioids . 7.3 Maalox® (aluminum hydroxide, magnesium hydroxide) 7.4 . Drug/Laboratory Test Interactions . 8 USE IN SPECIFIC POPULATIONS . 8.1 Pregnancy . 8.2 Lactation . 8.4 Pediatric Use . 8.5 Geriatric Use . 8.6 Renal Impairment . 9 DRUG ABUSE AND DEPENDENCE . 9.1 Controlled Substance GABAPENTIN (gabapentin) is indicated as adjunctive therapy for the management of patients with epilepsy who are not satisfactorily controlled by conventional therapy. Taking GABAPENTIN with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death In adults with postherpetic neuralgia, NEURONTIN may be initiated on Day 1 as a single 300 mg dose, on Day 2 as 600 mg/day (300 mg two times a day), and on Day 3 as 900 mg/day (300 mg three times a
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