Gabapentin by Alivio Medical Products, LLC GABAPENTIN capsule

Gabapentin by

Drug Labeling and Warnings

Gabapentin by is a Prescription medication manufactured, distributed, or labeled by Alivio Medical Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Each capsule contains:

300 mg of gabapentin, USP.

DOSAGE & ADMINISTRATION

Dosage and Use:

See package insert

for full prescribing information

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

SPL UNCLASSIFIED SECTION

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 & ADMINISTRATION

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 & 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.

DESCRIPTION

DESCRIPTION

The active ingredient in gabapentin capsules, USP is gabapentin which has the chemical name

1-(aminoethyl) cyclohexaneacetic acid.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GABAPENTIN 
gabapentin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69512-102
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)	GABAPENTIN	300 mg  in 300 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	yellow (Yellow (buff buff))	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	IP102
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69512-102-10	100 in 1 BOTTLE
1		300 mg in 1 CAPSULE; Type 0: Not a Combination Product

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)