Actavis Pharma Manufacturing Pvt Ltd. (sod)

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• Gabapentin
  

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  Gabapentin

  

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  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).

  Postherpetic Neuralgia

  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.

  Epilepsy

  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.

  HOW SUPPLIED

  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.

  Manufactured by:

  Actavis Pharma Manufacturing Pvt. Ltd.,

  Plot No. 101, 102, 107 & 108,

  SIDCO Pharmaceutical Complex,

  Alathur, Kanchipuram Dist–603 110,

  Tamilnadu, India.

  Distributed by:

  Actavis Elizabeth LLC

  200 Elmora Avenue

  Elizabeth, NJ 07207 USA

  40-9165

  Revised — May 2013

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