topiramate
Drug Details
- Generic Name
- topiramate
- Brand Names
- topiramate, TOPIRAMATE, Trokendi XR, Topamax
- Application Number
- ANDA078877
- Sponsor
- Zydus Lifesciences Limited
- NDC Codes
- 50
- Dosage Forms
- CAPSULE, COATED PELLETS, TABLET, FILM COATED, CAPSULE, EXTENDED RELEASE, TABLET, COATED, POWDER
- Routes
- ORAL
- Active Ingredients
- TOPIRAMATE
Indications and Usage
1 INDICATIONS AND USAGE Topiramate is indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1 ); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older ( 1.2 ) Preventive treatment of migraine in patients 12 years of age and older ( 1.3 ) 1.1 Monotherapy Epilepsy Topiramate tablets and topiramate capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. 1.2 Adjunctive Therapy Epilepsy Topiramate tablets and topiramate capsules are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older. 1.3 Migraine Topiramate tablets and topiramate capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older.