{"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"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Mechanism of Action - The precise mechanisms by which gabapentin produces its analgesic and antiepileptic actions are unknown."],"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."],"contraindications":["CONTRAINDICATIONS Gabapentin capsules, USP are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients."],"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_and_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."],"dosage_forms_and_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"],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE Controlled Substance - Gabapentin is not a scheduled drug."],"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"],"effective_time":"20151014","how_supplied":["HOW SUPPLIED/STORAGE AND HANDLING Gabapentin capsules, USP"],"id":"4820bdaf-5f5f-45c9-acd3-2d2199d2a678","indications_and_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"],"nonclinical_toxicology":["NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility - Gabapentin was adminstered orally to mice and rats in 2-year carcinogenicity studies."],"openfda":{},"overdosage":["OVERDOSAGE A lethal dose of gabapentin was not identified in mice and rats receiving single oral doses as high as 8000 mg / kg."],"package_label_principal_display_panel":["copy of label"],"patient_medication_information":["PATIENT COUNSELING INFORMATION"],"precautions":["Pharmacist: Please dispense with medication guide provided separately"],"set_id":"de44bde0-970c-4a26-a706-9d912d29c93c","spl_product_data_elements":["Gabapentin GABAPENTIN GABAPENTIN GABAPENTIN STARCH, CORN IP102 Yellow (buff buff)"],"spl_unclassified_section":["FULL PRESCRIBING INFORMATION: CONTENTS"],"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."],"summary_of_safety_and_effectiveness":["Highlights of Prescribing Information T hese 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"],"use_in_specific_populations":["USE IN SPECIFIC POPULATIONS Pregnanacy - Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women."],"version":"1","warnings_and_cautions":["WARNINGS AND PRECAUTIONS Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Multiorgan Hypersensitivity Drug Reaction with with Eosinophilia and Systemic Symptoms"]}