DESCRIPTION Neurontin® (gabapentin) Capsules, Neurontin (gabapentin) Tablets, and Neurontin (gabapentin) Oral Solution are supplied as imprinted hard shell capsules containing 100 mg, 300 mg, and 400 mg of gabapentin, elliptical film-coated tablets containing 600 mg and 800 mg of gabapentin or an oral solution containing 250 mg/5 mL of gabapentin. Gabapentin 100mg Hard, Capsules - Summary of Product Characteristics (SmPC) by Strides Pharma UK Ltd Gabapentin Ipca 400 mg Hard Capsules - Summary of Product Characteristics (SmPC) by Ipca Laboratories UK Ltd In a study involving healthy volunteers (N=12), when a 60 mg controlled-release morphine capsule was administered 2 hours prior to a 600 mg gabapentin capsule, mean gabapentin AUC increased by 44% compared to gabapentin administered without morphine. Gabapentin 100 mg capsules - Summary of Product Characteristics (SmPC) by Rivopharm UK Ltd Gabapentin 100mg capsules - Summary of Product Characteristics (SmPC) by Aurobindo Pharma - Milpharm Ltd. Gabapentin 100 mg hard capsules - Summary of Product Characteristics (SmPC) by Morningside Healthcare Ltd DESCRIPTION Neurontin® (gabapentin) Capsules, Neurontin (gabapentin) Tablets, and Neurontin (gabapentin) Oral Solution are supplied as imprinted hard shell capsules containing 100 mg, 300 mg, and 400 mg of gabapentin, elliptical film-coated tablets containing 600 mg and 800 mg of gabapentin or an oral solution containing 250 mg/5 mL of gabapentin. Gabapentin Ipca 300 mg Hard Capsules - Summary of Product Characteristics (SmPC) by Ipca Laboratories UK Ltd Gabapentin Sandoz 400 mg Capsules - Summary of Product Characteristics (SmPC) by Sandoz Limited Clinical Particulars Therapeutic Indications Gabapentin Capsule is indicated for treatment of peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia in adults, as adjunctive therapy in treatment of partial onset seizures, with and without secondary generalization, in adults and pediatrics patients 6 years and older with epilepsy and as monotherapy in Renal impairment Dose adjustment is recommended in patients with compromised renal function as described in Table 2 and/or those undergoing haemodialysis. Gabapentin 100 mg capsules can be used to follow dosing recommendations for patients with renal insufficiency. Each NEURONTIN capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: lactose, cornstarch, talc, gelatin, titanium dioxide, FD&C Blue No. 2, yellow iron oxide (300 mg and 400 mg only), and red iron oxide (400 mg only). Gabapentin Capsules USP 300mg Technical Specification: Product Name: Gabapentin Capsules USP Brand Name: Generic Strength: 100mg, 300mg, 400mg Dosage Form: Capsules (Hard gelatin) Route of Administration: Via Oral Route Packing: 10s, 30s, 100s, 500s Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summ Description of update: To update section 4.6 of the SmPC in line with the reference product, Neurontin 100mg hard capsules, MAH Upjohn UK Limited. Consequently, the PIL is updated and additional editorial changes have been made. Neurontin 100mg Hard Capsules - Summary of Product Characteristics (SmPC) by Upjohn UK Limited Gabapentin Ipca 100 mg Hard Capsules - Summary of Product Characteristics (SmPC) by Ipca Laboratories UK Ltd Pharmacokinetic properties of the active substance Gabapentin has an oral bioavailability of 60 % (from a 300 mg capsule). Following an oral dose of gabapentin maximal plasma concentrations occur within 2-3 hours. The pharmacokinetics of gabapentin is not affected by food, and therefore there are no restrictions with respect to food in the SmPC of the originator. The pharmacokinetics is non Gabapentin Glenmark 300 mg capsules - Summary of Product Characteristics (SmPC) by Glenmark Pharmaceuticals Europe Ltd The active ingredient in gabapentin capsules, USP is gabapentin, which has the chemical name 1- (aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the
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