GABAPENTIN — gabapentin capsule
Graviti Pharmaceuticals Private Limited
1 INDICATIONS AND USAGE
Gabapentin Capsules 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
2 DOSAGE AND ADMINISTRATION
2.1 Dosage for Postherpetic Neuralgia
In adults with postherpetic neuralgia, gabapentin capsules 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 1,800 mg/day (600 mg three times a day). In clinical studies, efficacy was demonstrated over a range of doses from 1,800 mg/day to 3,600 mg/day with comparable effects across the dose range; however, in these clinical studies, the additional benefit of using doses greater than 1,800 mg/day was not demonstrated.
2.2 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 is 300 mg to 600 mg three times a day. Dosages up to 2,400 mg/day have been well tolerated in long-term clinical studies. Doses of 3,600 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 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 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 in patients 5 to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses. 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.
2.3 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):
TABLE 1. GABAPENTIN Dosage Based on Renal Function
|Renal Function Creatinine Clearance (mL/min)||Total Daily Dose Range (mg/day)||Dose Regimen (mg)|
|≥60||900 to 3,600||300 TID||400 TID||600 TID||800 TID||1,200 TID|
|>30 to 59||400 to 1,400||200 BID||300 BID||400 BID||500 BID||700 BID|
|>15 to 29||200 to 700||200 QD||300 QD||400 QD||500 QD||700 QD|
|15*||100 to 300||100 QD||125 QD||150 QD||200 QD||300 QD|
|Post-Hemodialysis Supplemental Dose (mg)†|
|TID = Three times a day; BID = Two times a day; QD = Single daily dose|
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:
|CLCr =||[140 – age (years)] x weight (kg)||(x 0.85 for female patients)|
|72 x serum creatinine (mg/dL)|
The use of Gabapentin capsules in patients less than 12 years of age with compromised renal function has not been studied.
2.4 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.
2.5 Administration Information
Administer gabapentin capsules orally with or without food.
Gabapentin capsules should be swallowed whole with water.
If the gabapentin capsules 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).
3 DOSAGE FORMS AND STRENGTHS
- Gabapentin Capsules, USP 100 mg are size ‘3’ Hard gelatin capsules with white opaque cap and white opaque body, imprinted “100 mg” in blue ink on cap and “236” in blue ink on body, filled with white to off-white powder.
- Gabapentin Capsules, USP 300 mg are size ‘1’ Hard gelatin capsules with yellow opaque cap and yellow opaque body, imprinted “300 mg” in blue ink on cap and “235” in blue ink on body, filled with white to off-white powder.
- Gabapentin Capsules, USP 400 mg are size ‘0’ Hard gelatin capsules with orange opaque cap and orange opaque body, imprinted “400 mg” in blue ink on cap and “234” in blue ink on body, filled with white to off-white powder.
Gabapentin capsules are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
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