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, POWDER, TABLET, COATED
- Routes
- ORAL
- Active Ingredients
- TOPIRAMATE
Indications and Usage
1 INDICATIONS AND USAGE Topiramate capsules are 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 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 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 capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older.