Gabapentin

GABAPENTIN — gabapentin tablet, film coated
Zydus Pharmaceuticals (USA) Inc.

1 INDICATIONS AND USAGE

Gabapentin tablets 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 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 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 600 mg or 800 mg tablets. 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.

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

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.

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
15a 100 to 300 100 QD 125 QD 150 QD 200 QD 300 QD
Post-Hemodialysis Supplemental Dose (mg)b
Hemodialysis 125b 150b 200b 250b 350b

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:

Gabapentin tablets
(click image for full-size original)

The use of gabapentin 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 tablets orally with or without food.

Inform patients that, should they divide the scored 600 mg or 800 mg gabapentin tablets in order to administer a half-tablet, they should take the unused half-tablet as the next dose. Half-tablets not used within 28 days of dividing the scored tablet should be discarded.

If 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).

3 DOSAGE FORMS AND STRENGTHS

Gabapentin Tablets USP, 600 mg are white to off-white having mottled spots, oval-shaped, biconvex, film-coated tablets debossed with ‘ZE72’ with bisect on one side and plain with bisect on other side.

Gabapentin Tablets USP, 800 mg are white to off-white having mottled spots, oval-shaped, bevelled-edge, biconvex, film-coated tablets debossed with ‘ZE71’ with bisect on one side and plain with bisect on other side.

4 CONTRAINDICATIONS

Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.

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