GABAPENTIN- gabapentin capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)

Disponible desde:

Pharmaceutica North America, Inc.

Designación común internacional (DCI):

GABAPENTIN

Composición:

GABAPENTIN 300 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Gabapentin is indicated for the management of postherpetic neuralgia in adults. Gabapentin is 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 is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years. Gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. The abuse and dependence potential of gabapentin has not been evaluated in human studies.

Resumen del producto:

Gabapentin capsules, USP are supplied as follows: 100 mg capsules; White hard gelatin capsules printed with “137” on cap and body; available in: Bottles of 100:      Child Resistant Cap NDC 62756-137-02                                Non Child Resistant Cap NDC 62756-137-03 Bottles of 500:      Non Child Resistant Cap NDC 62756-137-05 Bottles of 1000:    Non Child Resistant Cap NDC 62756-137-04 Unit dose 50's:     NDC 62756-137-01 300 mg capsules; Yellow hard gelatin capsules printed with “138” on cap and body; available in: Bottles of 100:      Child Resistant Cap NDC 62756-138-02                                Non Child Resistant Cap NDC 62756-138-03 Bottles of 500:      Non Child Resistant Cap NDC 62756-138-05 Bottles of 1000:    Non Child Resistant Cap NDC 62756-138-04 Unit dose 50's:     NDC 62756-138-01 400 mg capsules; Orange hard gelatin capsules printed with “139” on cap and body; available in: Bottles of 100:      Child Resistant Cap NDC 62756-139-02                                Non Child Resistant Cap NDC 62756-139-03 Bottles of 500:      Non Child Resistant Cap NDC 62756-139-05 Bottles of 1000:    Non Child Resistant Cap NDC 62756-139-04 Unit dose 50's:     NDC 62756-139-01 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

GABAPENTIN - GABAPENTIN CAPSULE
PHARMACEUTICA NORTH AMERICA, INC.
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GABAPENTIN CAPSULES, USP
DESCRIPTION
Gabapentin capsules, USP are supplied as imprinted hard shell capsules
containing 100 mg, 300 mg, and
400 mg of gabapentin USP.
The inactive ingredients for the capsules are calcium carbonate,
calcium sulfate dihydrate, glyceryl
behenate, and pregelatinized starch. The capsule shell contains
gelatin, titanium dioxide, sodium lauryl
sulfate, yellow iron oxide (300 mg and 400 mg) and red iron oxide (400
mg). The imprinting ink
contains shellac, dehydrated alcohol, isopropyl alcohol, butyl
alcohol, propylene glycol, strong
ammonia solution, black iron oxide, potassium hydroxide, and purified
water.
Gabapentin is described as 1-(aminomethyl)cyclohexaneacetic acid with
a molecular formula of
C H NO and a molecular weight of 171.24. The structural formula of
gabapentin is:
Gabapentin is a white to off-white crystalline solid with a pK of 3.7
and a pK of 10.7. It is freely
soluble in water and both basic and acidic aqueous solutions. The log
of the partition coefficient (n-
octanol/0.05M phosphate buffer) at pH 7.4 is -1.25.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The mechanism by which gabapentin exerts its analgesic action is
unknown, but in animal models of
analgesia, gabapentin prevents allodynia (pain-related behavior in
response to a normally innocuous
stimulus) and hyperalgesia (exaggerated response to painful stimuli).
In particular, gabapentin prevents
pain-related responses in several models of neuropathic pain in rats
or mice (e.g. spinal nerve ligation
models, streptozocin-induced diabetes model, spinal cord injury model,
acute herpes zoster infection
model). Gabapentin also decreases pain-related responses after
peripheral inflammation (carrageenan
footpad test, late phase of formalin test). Gabapentin did not alter
immediate pain-related behaviors (rat
9
17
2
a1
a2
tail flick test, formalin footpad acute phase, acetic acid abdominal
constriction test, footpad heat
irradiation test). The relev