Gabapentin: Package Insert and Label Information

GABAPENTIN — gabapentin capsule
Alivio Medical Products, LLC

Each capsule contains:

300 mg of gabapentin, USP.

Dosage and Use:

See package insert

for full prescribing information

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.

Pharmacist: Please dispense

with medication guide

provided separately

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

FULL PRESCRIBING INFORMATION: CONTENTS

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:

  • 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

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.

DRUG ABUSE AND DEPENDENCE

Controlled Substance — Gabapentin is not a scheduled drug.

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.

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/STORAGE AND HANDLING

Gabapentin capsules, USP

PATIENT COUNSELING INFORMATION

copy of label
(click image for full-size original)

GABAPENTIN gabapentin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69512-102
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GABAPENTIN (GABAPENTIN) GABAPENTIN 300 mg in 300 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
Product Characteristics
Color yellow (Yellow (buff buff)) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code IP102
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69512-102-10 100 CAPSULE in 1 BOTTLE contains a CAPSULE
1 300 mg in 1 CAPSULE This package is contained within the BOTTLE (69512-102-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078428 10/01/2015
Labeler — Alivio Medical Products, LLC (079670828)

Revised: 10/2015 Alivio Medical Products, LLC

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.