FDA Label for Gabapentin
View Indications, Usage & Precautions
- DESCRIPTION
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- PRECAUTIONS
- SUMMARY OF SAFETY AND EFFECTIVENESS
- OTHER
- INDICATIONS & USAGE
- DOSAGE FORMS & STRENGTHS
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
- ADVERSE REACTIONS
- DRUG INTERACTIONS
- USE IN SPECIFIC POPULATIONS
- DRUG ABUSE AND DEPENDENCE
- OVERDOSAGE
- CLINICAL PHARMACOLOGY
- NONCLINICAL TOXICOLOGY
- CLINICAL STUDIES
- HOW SUPPLIED
- PATIENT MEDICATION INFORMATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Gabapentin Product Label
The following document was submitted to the FDA by the labeler of this product Alivio Medical Products, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
Each capsule contains:
300 mg of gabapentin, USP.
DESCRIPTION
The active ingredient in gabapentin capsules, USP is gabapentin which has the chemical name
1-(aminoethyl) cyclohexaneacetic acid.
Dosage & Administration
Dosage and Use:
See package insert
for full prescribing information
DOSAGE AND ADMINISTRATION
Gabapentin capsules, USP are given orally with or without food. Gabapentin capsules, USP should be
swallowed whole with plenty of water.
Storage And Handling
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.
Precautions
Pharmacist: Please dispense
with medication guide
provided separately
Summary Of Safety And Effectiveness
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
Other
FULL PRESCRIBING INFORMATION: CONTENTS
Indications & Usage
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 Forms & Strengths
DOSAGE FORMS AND STRENGTHS
Capsules:
- 100 mg; white-white, opague hard gelatin capsules printed with "IP 101 " on both cap and body.
- 300 mg: buff-buff, opague hard gelatin capsules printed with "IP 102" on both cap and body.
- 400 mg: light caramel-light caramel, opague hard gelatin capsules printed with "IP 103" on both cap and body
Contraindications
CONTRAINDICATIONS
Gabapentin capsules, USP are contraindicated in patients who have demonstrated hypersensitivity to
the drug or its ingredients.
Warnings And Precautions
WARNINGS AND PRECAUTIONS
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Multiorgan Hypersensitivity
Drug Reaction with with Eosinophilia and Systemic Symptoms
Adverse Reactions
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
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
USE IN SPECIFIC POPULATIONS
Pregnanacy - Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women.
Drug Abuse And Dependence
DRUG ABUSE AND DEPENDENCE
Controlled Substance - Gabapentin is not a scheduled drug.
Overdosage
OVERDOSAGE
A lethal dose of gabapentin was not identified in mice and rats receiving single oral doses as high
as 8000 mg / kg.
Clinical Pharmacology
CLINICAL PHARMACOLOGY
Mechanism of Action - The precise mechanisms by which gabapentin produces its analgesic
and antiepileptic actions are unknown.
Nonclinical Toxicology
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility - Gabapentin was adminstered orally to
mice and rats in 2-year carcinogenicity studies.
Clinical Studies
CLINICAL STUDIES
Postherpetic Neuralgia Gabapentin was evaluated for the management of postherpetic neuralgia
(PHN) in two randomized, double-blind, placebo-controlled multicenter studies.
How Supplied
HOW SUPPLIED/STORAGE AND HANDLING
Gabapentin capsules, USP
Patient Medication Information
PATIENT COUNSELING INFORMATION
Package Label.Principal Display Panel
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