Neurontin

NEURONTIN- gabapentin capsule
REMEDYREPACK INC.

1 INDICATIONS AND USAGE

NEURONTIN ® is 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, NEURONTIN 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 1800 mg/day (600 mg three times a day). 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; however, in these clinical studies, the additional benefit of using doses greater than 1800 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 NEURONTIN is 300 mg to 600 mg three times a 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. Administer NEURONTIN three times a day using 300 mg or 400 mg capsules, or 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 NEURONTIN in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. The recommended maintenance dose of NEURONTIN in patients 5 to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses. NEURONTIN may be administered as the oral solution, capsule, or tablet, or using combinations of these formulations. 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. NEURONTIN Dosage Based on Renal Function
TID = Three times a day; BID = Two times a day; QD = Single daily dose
*
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).
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)
≥ 60900 to 3600300 TID400 TID600 TID800 TID1200 TID
>30 to 59400 to 1400200 BID300 BID400 BID500 BID700 BID
>15 to 29200 to 700200 QD300 QD400 QD500 QD700 QD
15 *100 to 300100 QD125 QD150 QD200 QD300 QD
Post-Hemodialysis Supplemental Dose (mg)
Hemodialysis125 150 200 250 350

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:

Equation
(click image for full-size original)

The use of NEURONTIN 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 NEURONTIN orally with or without food.

NEURONTIN capsules should be swallowed whole with water.

Inform patients that, should they divide the scored 600 mg or 800 mg NEURONTIN tablet 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 the NEURONTIN 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

Capsules

  • 100 mg: white hard gelatin capsules printed with “PD” on the body and “Neurontin/100 mg” on the cap
  • 300 mg: yellow hard gelatin capsules printed with “PD” on the body and “Neurontin/300 mg” on the cap
  • 400 mg: orange hard gelatin capsules printed with “PD” on the body and “Neurontin/400 mg” on the cap

Tablets

  • 600 mg: white elliptical film-coated scored tablets debossed with “NT” and “16″ on one side
  • 800 mg: white elliptical film-coated scored tablets debossed with “NT” and “26″ on one side

Oral solution: 250 mg per 5 mL (50 mg per mL), clear colorless to slightly yellow solution

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