Label: GABAPENTIN - gabapentin capsule

  • NDC Code(s): 69512-102-10
  • Packager: Alivio Medical Products, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 14, 2015

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    Each capsule contains:

    300 mg of gabapentin, USP.

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  • DOSAGE & ADMINISTRATION

    Dosage and Use:

    See package insert

    for full prescribing information

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  • 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.

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  • PRECAUTIONS

    Pharmacist: Please dispense

    with medication guide

    provided separately

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  • 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

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  • SPL UNCLASSIFIED SECTION

    FULL PRESCRIBING INFORMATION:  CONTENTS

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  • 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

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  • 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.

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  • 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
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  • CONTRAINDICATIONS

    CONTRAINDICATIONS

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

    the drug or its ingredients.

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  • WARNINGS AND PRECAUTIONS

    WARNINGS AND PRECAUTIONS

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

    Drug Reaction with with Eosinophilia and Systemic Symptoms

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  • 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

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  • 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

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  • USE IN SPECIFIC POPULATIONS

    USE IN SPECIFIC POPULATIONS

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

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  • DRUG ABUSE AND DEPENDENCE

    DRUG ABUSE AND DEPENDENCE

    Controlled Substance - Gabapentin is not a scheduled drug.

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  • OVERDOSAGE

    OVERDOSAGE

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

    as 8000 mg / kg.

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  • DESCRIPTION

    DESCRIPTION

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

    1-(aminoethyl) cyclohexaneacetic acid.

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  • CLINICAL PHARMACOLOGY

    CLINICAL PHARMACOLOGY

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

    and antiepileptic actions are unknown.

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  • NONCLINICAL TOXICOLOGY

    NONCLINICAL TOXICOLOGY

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

    mice and rats in 2-year carcinogenicity studies.


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  • 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.

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  • HOW SUPPLIED

    HOW SUPPLIED/STORAGE AND HANDLING

    Gabapentin capsules, USP

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  • PATIENT MEDICATION INFORMATION

    PATIENT COUNSELING INFORMATION

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  • 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)
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