Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)
REMEDYREPACK INC.
TOPIRAMATE
TOPIRAMATE 100 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
TOPIRAMATE- TOPIRAMATE TABLET REMEDYREPACK INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TOPIRAMATE TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TOPIRAMATE TABLETS, USPTOPIRAMATE TABLETS, USP FOR ORAL USE INITIAL U.S. APPROVAL: 1996 RECENT MAJOR CHANGES Warnings and Precautions, Visual Field Defects ( 5.2) 01/2014 INDICATIONS AND USAGE Topiramate is indicated for: Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic- clonic seizures ( 1.1). Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) ( 1.2) DOSAGE AND ADMINISTRATION See DOSAGE AND ADMINISTRATION, Epilepsy: Monotherapy and Adjunctive Therapy Use for additional details ( 2.1). Initial Dose Titration Recommended Dose Epilepsy monotherapy: children 2 to <10 years ( 2.1) 25 mg/day administered nightly for the first week The dosage should be titrated over 5 to 7 weeks Daily doses in two divided doses based on weight (Table 2) Epilepsy monotherapy: adults and pediatric patients ≥10 years ( 2.1) 50 mg/day in two divided doses. The dosage should be increased weekly by increment of 50 mg for the first 4 weeks then 100 mg for weeks 5 to 6. 400 mg/day in two divided doses Epilepsy adjunctive therapy: adults with partial onset seizures or LGS ( 2.1) 25 to 50 mg/day The dosage should be incrased weekly to an effective dose by increments of 25 to 50 mg. 200 to 400 mg/day in two divided doses Epilepsy adjunctive therapy: adults with primary generalized tonic-clonic seizures ( 2.1) 25 to 50 mg/day The dosage should be increased weekly to an effective dose by increments of 25 to 50 mg. 400 mg/day in two divided doses Epilepsy adjunctive therapy: pediatric patients with partial onset sei Lugege kogu dokumenti