Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
GABAPENTIN (UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)
REMEDYREPACK INC.
GABAPENTIN
GABAPENTIN 300 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
GABAPENTIN- GABAPENTIN CAPSULE REMEDYREPACK INC. ---------- 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 FOR ORAL USE INITIAL U.S. APPROVAL: 1993 RECENT MAJOR CHANGES Warnings and Precautions: Anaphylaxis and Angioedema: discontinue Gabapentin and evaluate patient immediately (5.2) 9/2015 INDICATIONS AND USAGE Gabapentin is indicated for: · Postherpetic neuralgia in adults (1)· 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 (1) DOSAGE AND ADMINISTRATION · Postherpetic Neuralgia ( 2.1) o Dose can be titrated up as needed to a dose of 1800 mg/day o Day 1: Single 300 mg dose o Day 2: 600 mg/day (i.e., 300 mg two times a day) o Day 3: 900 mg/day (i.e., 300 mg three times a day) · Epilepsy with Partial Onset Seizures (2.2) o Patients 12 years of age and older: starting dose is 300 mg three times daily; may be titrated up to 600 mg three times daily o Patients 3 to 11 years of age: starting dose range is 10 to 15 mg/kg/day, given in three divided doses; recommended dose in patients 3 to 4 years of age is 40 mg/kg/day, given in three divided doses; the recommended dose in patients 5 to 11 years of age is 25 to 35 mg/kg/day, given in three divided doses. The recommended dose is reached by upward titration over a period of approximately 3 days · Dose should be adjusted in patients with reduced renal function ( 2.3, 2.4) DOSAGE FORMS AND STRENGTHS · Capsules: 100 mg, 300 mg, and 400 mg (3) CONTRAINDICATIONS Known hypersensitivity to gabapentin or its ingredients (4) WARNINGS AND PRECAUTIONS · Drug Reaction with Eosinophilia and Systemic Symptoms (Multiorgan hypersensitivity): discontinue gabapentin if an alternative etiology cannot be established (5.1) · Anaphylaxis and Angioedema: discontinue gabapentin and evaluat Прочитайте повний документ