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Drug Catalog - Product Detail

GABAPENTIN CP 400MG 100

NDC Mfr Size Str Form
65162-0103-10 AMNEAL PHARMACEUTICALS 100 400MG CAPSULE
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Description
DESCRIPTION The active ingredient in gabapentin capsules, USP is gabapentin, USP which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is: Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin, USP capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: magnesium stearate, pregelatinized starch (corn), starch (corn) and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate and titanium dioxide. The 300 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, and iron oxide yellow. The 400 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, FD&C Yellow No.6 and FD&C Blue No.1.
How Supplied
HOW SUPPLIED/STORAGE AND HANDLING Gabapentin capsules, USP are supplied as follows: 100 mg capsules: White-White, opaque hard gelatin capsules printed with “IP 101” on both cap and body. They are available as follows: Bottles of 30: NDC 65162-101-03 Bottles of 100: NDC 65162-101-10 Bottles of 500: NDC 65162-101-50 Bottles of 1000: NDC 65162-101-11 300 mg capsules: Buff-Buff, opaque hard gelatin capsules printed with “IP 102” on both cap and body. They are available as follows: Bottles of 30: NDC 65162-102-03 Bottles of 100: NDC 65162-102-10 Bottles of 500: NDC 65162-102-50 Bottles of 1000: NDC 65162-102-11 400 mg capsules: Light caramel-Light caramel, opaque hard gelatin capsules printed with “IP 103” on both cap and body. They are available as follows: Bottles of 30: NDC 65162-103-03 Bottles of 100: NDC 65162-103-10 Bottles of 500: NDC 65162-103-50 Bottles of 1000: NDC 65162-103-11 Store gabapentin capsules at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in tight (USP), child-resistant containers.
Indications & Usage
INDICATIONS AND USAGE Gabapentin capsules are indicated for: Postherapetic 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 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
Dosage and Administration
DOSAGE AND ADMINISTRATION Postherpetic Neuralgia Dose can be titrated up as needed to a dose of 1800 mg/day Day 1: Single 300 mg dose Day 2: 600 mg/day (i.e., 300 mg two times a day) Day 3: 900 mg/day (i.e., 300 mg three times a day) Epilepsy with Partial Onset Seizures Patients 12 years of age and older: starting dose is 300 mg three times daily; may be titrated up to 600 mg three times daily Patients 3 to 11 years of age: starting dose range is 10 to 15 mg/kg/day, given in three divided doses; recommended dose in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses; the recommended dose in patients 5 to 11 years of age is 25 to 35 mg/kg/day, given in three divided doses. The recommended dose is reached by upward titration over a period of approximately 3 days Dose should be adjusted in patients with reduced renal function Dosage for Postherpetic Neuralgia In adults with postherpetic neuralgia, gabapentin capsules, USP 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). In clinical studies, efficacy was demonstrated over a range of doses from 1800 mg/day to 3600 mg/day with comparable effects across the dose range; however, in these clinical studies, the additional benefit of using doses greater than 1800 mg/day was not demonstrated. Dosage for Epilepsy with Partial Onset Seizures Patients 12 years of age and above The starting dose is 300 mg three times a day. The recommended maintenance dose of gabapentin capsules, USP is 300 mg to 600 mg three times a day. Dosages up to 2400 mg/day have been well tolerated in long-term clinical studies. Doses of 3600 mg/day have also been administered to a small number of patients for a relatively short duration, and have been well tolerated. Administer gabapentin capsules, USP three times a day using 300 mg or 400 mg capsules. The maximum time between doses should not exceed 12 hours. Pediatric Patients Age 3 to 11 years The starting dose range is 10 mg/kg/day to 15 mg/kg/day, given in three divided doses, and the recommended maintenance dose reached by upward titration over a period of approximately 3 days. The recommended maintenance dose of gabapentin capsules, USP in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. The recommended maintenance dose of gabapentin capsules, USP in patients 5 to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses. Gabapentin capsules, USP may be administered as the oral solution, capsule, or tablet, or using combinations of these formulations. Dosages up to 50 mg/kg/day have been well tolerated in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours. Dosage Adjustment in Patients with Renal Impairment Dosage adjustment in patients 12 years of age and older with renal impairment or undergoing hemodialysis is recommended, as follows (see dosing recommendations above for effective doses in each indication): TID = Three times a day; BID = Two times a day; QD = Single daily dose a For patients with creatinine clearance <15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive). b Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table. Creatinine clearance (CLCr) is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance can be reasonably well estimated using the equation of Cockcroft and Gault. The use of gabapentin capsules, USP in patients less than 12 years of age with compromised renal function has not been studied. Dosage in Elderly Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients. Administration Information Administer gabapentin capsules, USP orally with or without food. Gabapentin capsules, USP should be swallowed whole with water. If the If the gabapentin capsules, USP dose is reduced, discontinued, or substituted with an alternative medication, this should be done gradually over a minimum of 1 week (a longer period may be needed at the discretion of the prescriber).