topiramate spinkle
Drug Details
- Generic Name
- topiramate spinkle
- Brand Names
- TOPIRAMATE
- Application Number
- ANDA078418
- Sponsor
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- NDC Codes
- 1
- Dosage Forms
- CAPSULE
- 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 is 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 is 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 is indicated for the preventive treatment of migraine in patients 12 years of age and older.