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Gabapentin (gabapentin 300 mg) Dailymed


Generic: gabapentin is used for the treatment of Bipolar Disorder Epilepsies, Partial Phobic Disorders Neuralgia, Postherpetic


IMPRINT: IP102     SHAPE: capsule
    COLOR: yellow

All Imprints

gabapentin 300 mg - ip102 capsule yellow

gabapentin 100 mg - ip101 capsule white

gabapentin 400 mg - ip103 capsule brown

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Description Section


Each capsule contains:

300 mg of gabapentin, USP.

Dosage & Administration Section


Dosage and Use:

See package insert

for full prescribing information

Storage And Handling Section


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 Section


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


FULL PRESCRIBING INFORMATION:  CONTENTS

Indications & Usage Section


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 Section


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 Section


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 Section


CONTRAINDICATIONS

Gabapentin capsules, USP are contraindicated in patients who have demonstrated hypersensitivity to

the drug or its ingredients.

Warnings And Precautions Section


WARNINGS AND PRECAUTIONS

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Multiorgan Hypersensitivity

Drug Reaction with with Eosinophilia and Systemic Symptoms

Adverse Reactions Section


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 Section


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 Section


USE IN SPECIFIC POPULATIONS

Pregnanacy - Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women.

Drug Abuse And Dependence Section


DRUG ABUSE AND DEPENDENCE

Controlled Substance - Gabapentin is not a scheduled drug.

Overdosage Section


OVERDOSAGE

A lethal dose of gabapentin was not identified in mice and rats receiving single oral doses as high

as 8000 mg / kg.

Description Section


DESCRIPTION

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

1-(aminoethyl) cyclohexaneacetic acid.

Clinical Pharmacology Section


CLINICAL PHARMACOLOGY

Mechanism of Action - The precise mechanisms by which gabapentin produces its analgesic

and antiepileptic actions are unknown.

Nonclinical Toxicology Section


NONCLINICAL TOXICOLOGY

Carcinogenesis, Mutagenesis, Impairment of Fertility - Gabapentin was adminstered orally to

mice and rats in 2-year carcinogenicity studies.



Clinical Studies Section


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 Section


HOW SUPPLIED/STORAGE AND HANDLING

Gabapentin capsules, USP

Patient Medication Information Section


PATIENT COUNSELING INFORMATION

Package Label.principal Display Panel




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"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

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"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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