Gabapentin (Page 9 of 11)

Epilepsy

Gabapentin tablets USP are recommended for add-on therapy in patients 3 years of age and older. Effectiveness in pediatric patients below the age of 3 years has not been established.

Patients >12 years of age:

The effective dose of gabapentin tablets USP is 900 to 1800 mg/day and given in divided doses (three times a day) using 600 or 800 mg tablets. The starting dose is 300 mg three times a day. If necessary, the dose may be increased using 600 or 800 mg tablets three times a day up to 1800 mg/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. The maximum time between doses in the TID schedule should not exceed 12 hours.

Pediatric Patients Age 3–12 years:

The starting dose should range from 10-15 mg/kg/day in 3 divided doses, and the effective dose reached by upward titration over a period of approximately 3 days. The effective dose of gabapentin tablets USP in patients 5 years of age and older is 25–35 mg/kg/day and given in divided doses (three times a day). The effective dose in pediatric patients ages 3 and 4 years is 40 mg/kg/day and given in divided doses (three times a day) (see ). 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. CLINICAL PHARMACOLOGY, Pediatric

It is not necessary to monitor gabapentin plasma concentrations to optimize gabapentin tablets USP therapy. Further, because there are no significant pharmacokinetic interactions among gabapentin tablets USP and other commonly used antiepileptic drugs, the addition of gabapentin tablets USP does not alter the plasma levels of these drugs appreciably.

If gabapentin tablets USP are discontinued and/or an alternate anticonvulsant medication is added to the therapy, this should be done gradually over a minimum of 1 week.

Dosage in Renal Impairment

Creatinine clearance is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance (C ) can be reasonably well estimated using the equation of Cockcroft and Gault: Cr

for females C =(0.85)(140-age)(weight)/[(72)(S )] Cr Cr

for males C =(140-age)(weight)/[(72)(S )] Cr Cr

in which age is in years, weight is in kilograms and SCr is serum creatinine in mg/dL.

Dosage adjustment in patients ≥12 years of age with compromised renal function or undergoing hemodialysis is recommended as follows (see dosing recommendations above for effective doses in each indication).

TABLE 6. Gabapentin Tablets USP Dosage Based on Renal Function

Renal Function Creatinine Clearance

(mL/min)

Total Daily Dose Range

(mg/day)

Dose Regimen

(mg)

≥60

900-3600

300 TID

400 TID

600 TID

800 TID

1200 TID

>30-59

400-1400

200 BID

300 BID

400 BID

500 BID

700 BID

>15-29

200-700

200 QD

300 QD

400 QD

500 QD

700 QD

15 a

100-300

100 QD

125 QD

150 QD

200 QD

300 QD

Post-Hemodialysis Supplemental Dose (mg) b

Hemodialysis

125 b

150 b

200 b

250 b

350 b

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). a

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. b

The use of gabapentin tablets USP in patients <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.

HOW SUPPLIED

NDC:64725-0126-1 in a BOTTLE of 100 TABLETS

Storage (Tablets)

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Manufactured by:

Colvale-Bardez, Goa 403 513, India Glenmark Generics Ltd.

Manufactured for:
Glenmark logo

Mahwah, NJ 07430 Glenmark Generics Inc., USA

Questions? 1 (888)721-7115

www.glenmarkgenerics.com

June 2013

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