GABAPENTIN - gabapentin capsule
Alivio Medical Products, LLC
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Store at 20 to 25 C (68 to 77 F); excursions
permitted to 15 to 30 C (59 to 86 F)) [See
USP Controlled Room Temperature].
Dispense in tight (USP), child-resistant containers.
Highlights of Prescribing Information
These highlights do not include all the information needed to use gabapentin capsules safely and
effectively. See full prescribing information for gabapentin capsules.
GABAPENTIN capsules, USP for oral use
Initial U.S. Approval: 1993
INDICATIONS AND USAGE
Gabapentin capsules, USP, are indicated for:
-management of postherpeticneuralgia 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
Gabapentin capsules, USP are given orally with or without food. Gabapentin capsules, USP should be
swallowed whole with plenty of water.
DOSAGE FORMS AND STRENGTHS
Capsules:
CONTRAINDICATIONS
Gabapentin capsules, USP are contraindicated in patients who have demonstrated hypersensitivity to
the drug or its ingredients.
WARNINGS AND PRECAUTIONS
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Multiorgan Hypersensitivity
Drug Reaction with with Eosinophilia and Systemic Symptoms
ADVERSE REACTIONS
The following severe adverse reactions are discussed in greater detail in other sections: Drug Reaction
with Eosiniphilia and Systemic Syndrome (DRESS) Multiorgan
DRUG INTERACTIONS
Other Antiepileptic Drugs Gabapentin is not appreciably metabolized nor does it interfere
with the metabolism of commonly co-administered antiepileptic drugs
USE IN SPECIFIC POPULATIONS
Pregnanacy - Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women.
OVERDOSAGE
A lethal dose of gabapentin was not identified in mice and rats receiving single oral doses as high
as 8000 mg / kg.
DESCRIPTION
The active ingredient in gabapentin capsules, USP is gabapentin which has the chemical name
1-(aminoethyl) cyclohexaneacetic acid.
CLINICAL PHARMACOLOGY
Mechanism of Action - The precise mechanisms by which gabapentin produces its analgesic
and antiepileptic actions are unknown.
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility - Gabapentin was adminstered orally to
mice and rats in 2-year carcinogenicity studies.
GABAPENTIN
gabapentin capsule |
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Labeler - Alivio Medical Products, LLC (079670828) |