Nerve Pain

Gabapentin

100 mg / 400 mg 90 Tablets ct.

Management of postherpetic neuralgia in adults

NDC:
100 mg: 74157-0013-90 | 400 mg: 74157-0111-90
Manufacturer:
Ina Pharmaceutics Inc.
BG

INDICATIONS & USAGE

GABARONE 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

DOSAGE AND ADMINISTRATION

Dosage for Postherpetic Neuralgia

In adults with postherpetic neuralgia, GABARONE 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.

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 GABARONE is 300 mg to 600 mg three times a day. Dosages up to 2400 mg/day have been well administered 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. Administer GABARONE three times a day using 300 mg or 400 mg, 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 GABARONE in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses. The recommended maintenance dose of GABARONE in patients 5 to 11 years of age is 25 mg/kg/day to 35 mg/kg/day, given in three divided doses. GABARONE 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 administered in a long-term clinical study. The maximum time interval between doses should not exceed 12 hours.

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.

Administration Information

Administer GABARONE orally with or without food.

Inform patients that, should they divide the scored 600 mg or 800 mg GABARONE 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 GABARONE 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).

Full Prescribing Information: DailyMed

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