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Basic Drug Info
Drug Name:Gabapentin
Manufacturer:MUTUAL PHARMACEUTICAL COMPANY, INC.
Other Info:Maalox® is a registered trademark of Novartis Consumer Health, Inc.Manufactured By:MUTUAL PHARMACEUTICAL COMPANY, INC.Philadelphia, PA 19124 USARev: May 2006S



Clinical Trials:


Indications and Usage
Gabapentin is indicated for the management of postherpetic neuralgia in adults.
Postherpetic neuralgia -- Pain in nerves, frequently involving facial SKIN, resulting from the activation the latent varicella-zoster virus (HERPESVIRUS 3, HUMAN). The two forms of the condition preceding the pain are HERPES ZOSTER OPTICUS; and HERPES ZOSTER OPHTHALMICUS. Following the healing of the rashes and blisters, the pain sometimes persists.

Contraindications
Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Gabapentin use in pediatric patients with epilepsy 3-12 years of age is associated with the occurrence of central nervous system related adverse events.

The most significant of these can be classified into the following categories: 1) emotional lability (primarily behavioral problems), 2) hostility, including aggressive behaviors, 3) thought disorder, including concentration problems and change in school performance, and 4) hyperkinesia (primarily restlessness and hyperactivity).

Among the gabapentin-treated patients, most of the events were mild to moderate in intensity.In controlled trials in pediatric patients 3-12 years of age, the incidence of these adverse events was: emotional lability 6% (gabapentin-treated patients) vs 1.3% (placebo-treated patients); hostility 5.2% vs 1.3%; hyperkinesia 4.7% vs 2.9%; and thought disorder 1.7% vs 0%.

One of these events, a report of hostility, was considered serious.

Discontinuation of gabapentin treatment occurred in 1.3% of patients reporting emotional lability and hyperkinesia and 0.9% of gabapentin-treated patients reporting hostility and thought disorder.

One placebo-treated patient (0.4%) withdrew due to emotional lability.
Branded Drugs
The following US Branded drugs contain Gabapentin


NEURONTIN -- PFIZER PHARMACEUTICALS LTD

NEURONTIN -- PARKE DAVIS DIV WARNER LAMBERT CO


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