Actavis Pharma Manufacturing Pvt Ltd. (sod)
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Actavis Pharma Manufacturing Pvt Ltd. (sod) Drugs
Gabapentin is given orally with or without food.
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).
In adults with postherpetic neuralgia, gabapentin therapy may be initiated as a single 300-mg dose on Day 1, 600 mg/day on Day 2 (divided BID), and 900 mg/day on Day 3 (divided TID). The dose can subsequently be titrated up as needed for pain relief to a daily dose of 1800 mg (divided TID). 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. Additional benefit of using doses greater than 1800 mg/day was not demonstrated.
Gabapentin is 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 is 900 to 1800 mg/day and given in divided doses (three times a day) using 300 or 400 mg capsules. The starting dose is 300 mg three times a day. If necessary, the dose may be increased using 300 or 400 mg capsules 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 to 12 years: The starting dose should range from 10 to15 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 in patients 5 years of age and older is 25 to 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 CLINICAL PHARMACOLOGY, Pediatrics). 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.
It is not necessary to monitor gabapentin plasma concentrations to optimize gabapentin therapy. Further, because there are no significant pharmacokinetic interactions among gabapentin and other commonly used antiepileptic drugs, the addition of gabapentin does not alter the plasma levels of these drugs appreciably.
If gabapentin is 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 (CCr) can be reasonably well estimated using the equation of Cockcroft and Gault:
for females CCr = (0.85)(140-age)(weight)/[(72)(SCr)]
for males CCr = (140-age)(weight)/[(72)(SCr)]
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 Dosage Based on Renal Function Renal Function Creatinine Total Daily Dose Regimen Clearance Dose Range (mg) (mL/min) (mg/day) 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. ≥60 900 to 3600 300 TID 400 TID 600 TID 800 TID 1200 TID >30 to 59 400 to 1400 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
The use of gabapentin 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.
Gabapentin Capsules, USP are supplied as follows:
100 mg — Each white and light brown capsule printed with 665 on both cap and body in black ink contains 100 mg of gabapentin, USP. Capsules are supplied in bottles of 100 with a child-resistant closure (NDC 14550-511-02) and bottles of 500 (NDC 14550-511-04) without a child-resistant closure.
300 mg — Each yellow and light brown capsule printed with 2666 on both cap and body in black ink contains 300 mg of gabapentin, USP. Capsules are supplied in bottles of 100 with a child-resistant closure (NDC 14550-512-02) and bottles of 500 (NDC 14550-512-04) without a child-resistant closure.
400 mg — Each orange and light brown capsule printed with 667 on both cap and body in black ink contains 400 mg of gabapentin, USP. Capsules are supplied in bottles of 100 with a child-resistant closure (NDC 14550-513-02) and bottles of 500 (NDC 14550-513-04) without a child-resistant closure.
Dispense in a tight, light-resistant container as defined in the USP.
Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].
Maalox® is a registered trademark of Novartis Consumer Health, Inc.
Actavis Pharma Manufacturing Pvt. Ltd.,
Plot No. 101, 102, 107 & 108,
SIDCO Pharmaceutical Complex,
Alathur, Kanchipuram Dist–603 110,
Actavis Elizabeth LLC
200 Elmora Avenue
Elizabeth, NJ 07207 USA
Revised — May 2013
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