FDA Approves Gabapentin Capsules (gabapentin) for Postherpetic Neuralgia and Partial Onset Seizures
The FDA has approved Gabapentin Capsules, USP, a generic formulation of gabapentin, for two established neurological indications. The approval covers management of postherpetic neuralgia in adults and adjunctive therapy for partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.
This approval provides clinicians with another generic treatment option for neuropathic pain and seizure disorders. For postherpetic neuralgia, dosing follows a titration schedule starting at 300 mg on day one, increasing to 600 mg/day on day two, and 900 mg/day on day three, with potential titration up to 1800 mg/day based on pain relief needs. For epilepsy, dosing varies by age, with adult patients starting at 300 mg three times daily and pediatric dosing based on weight.
The availability of this generic formulation may increase access to gabapentin therapy while maintaining the established dosing protocols and renal adjustment requirements outlined in the prescribing information.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Not reported in label.
Gabapentin Capsules, USP are indicated for: Management of postherpetic neuralgia in adults. Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.
For Postherpetic Neuralgia in adults: Initiate on Day 1 as a single 300 mg dose, Day 2 as 600 mg/day (300 mg two times a day), and Day 3 as 900 mg/day (300 mg three times a day). Titrate up as needed to 1800 mg/day (600 mg three times a day). In clinical studies, efficacy was demonstrated over 1800-3600 mg/day, but additional benefit above 1800 mg/day was not demonstrated.
For Epilepsy with Partial Onset Seizures: Patients ≥12 years: starting dose 300 mg three times daily; may titrate to 600 mg three times daily. Doses up to 2400 mg/day well tolerated long-term; 3600 mg/day tolerated short-term in small numbers. Patients 3-11 years: starting dose 10-15 mg/kg/day in three divided doses; recommended maintenance dose: 40 mg/kg/day (ages 3-4) or 25-35 mg/kg/day (ages 5-11) in three divided doses, titrated over ~3 days. Dosages up to 50 mg/kg/day well tolerated long-term.
Renal adjustment required for patients ≥12 years (see table in label). Use Cockcroft-Gault equation to estimate creatinine clearance. Not studied in patients <12 years with renal impairment. Elderly patients may need dose adjustment based on renal function. Administer orally with/without food. Swallow capsules whole with water. Reduce/discontinue/substitute gradually over ≥1 week.
For postherpetic neuralgia: Efficacy demonstrated over 1800-3600 mg/day range with comparable effects; additional benefit above 1800 mg/day not demonstrated. For epilepsy: Doses up to 2400 mg/day well tolerated in long-term studies; 3600 mg/day tolerated short-term in small numbers. Pediatric doses up to 50 mg/kg/day well tolerated in long-term study.
Not reported in label.
Not reported in label.
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