GABAPENTIN- gabapentin capsule
Actavis Pharma, Inc.
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
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 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.
Patients 12 Years of Age and Above
The starting dose is 300 mg three times a day. The recommended maintenance dose of gabapentin 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 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 in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. The recommended maintenance dose of gabapentin 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.
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):
Renal Function Creatinine Clearance (mL/min)
Total Daily Dose Range (mg/day)
Dose Regimen (mg)
900 to 3,600
>30 to 59
400 to 1,400
>15 to 29
200 to 700
100 to 300
Post-Hemodialysis Supplemental Dose (mg)b
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 in patients less than 12 years of age with compromised renal function has not been studied.
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.
Administer gabapentin capsules orally with or without food.
Gabapentin capsules should be swallowed whole with water.
If the gabapentin 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).
• 100 mg: white and light brown capsule printed with 665 on both cap and body in black ink
• 300 mg: yellow and light brown capsule printed with 2666 on both cap and body in black ink
• 400 mg: orange and light brown capsule printed with 667 on both cap and body in black ink
Gabapentin capsules are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
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