Indications And Usage

Postherpetic Neuralgia:

Gabapentin capsules, USP are indicated for the management of postherpetic neuralgia in adults.

Epilepsy:

Gabapentin capsules, USP are indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. Gabapentin capsules, USP are also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years.

Administration

Gabapentin capsules are 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 capsules 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).

Epilepsy:

Gabapentin capsules 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 capsules 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 to 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 capsules 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, Pediatric.). 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.

Contraindications

Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.

Precautions

Patients should be advised that gabapentin may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm.

Patients should be advised that gabapentin may cause dizziness, somnolence, and other symptoms and signs of CNS depression. Accordingly, they should be advised neither to drive a car nor to operate other complex machinery until they have gained sufficient experience on gabapentin to gauge whether or not it affects their mental and/or motor performance adversely.

Patients who require concomitant treatment with morphine may experience increases in gabapentin concentrations. Patients should be carefully observed for signs of CNS depression, such as somnolence, and the dose of gabapentin or morphine should be reduced appropriately

Adverse Reactions

Drug Reaction with Eosinophilia and Systemic Symptom (DRESS)/Multiorgan Hypersensitivity, Anaphylaxis and Angioedema, Somnolence/Sedation and Dizziness, Withdrawal Precipitated Seizure, Status Epilepticus, Suicidal Behavior and Ideation, Respiratory Depression, Neuropsychiatric Adverse Reactions (Pediatric Patients 3 to 12 Years of Age), Sudden and Unexplained Death in Patients with Epilepsy

Pregnancy and lactation

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Renal and liver Impairment

Because gabapentin is not metabolized, no study was performed in patients with hepatic impairment.

Laboratory Tests