Topiramate
Product manufactured by Proficient Rx Lp
Indications and Purposes
| 1 Indications And Usage Topiramate Tablets Usp Are An Antiepileptic (Aed) Agent Indicated For: • Monotherapy Epilepsy: Initial Monotherapy In Patients ≥10 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) 1.1 Monotherapy Epilepsy Topiramate Tablets Usp Are Indicated As Initial Monotherapy In Patients 10 Years Of Age And Older With Partial Onset Or Primary Generalized Tonic-Clonic Seizures. Safety And Effectiveness In Patients Who Were Converted To Monotherapy From A Previous Regimen Of Other Anticonvulsant Drugs Have Not Been Established In Controlled Trials [See Clinical Studies (14.1)]. 1.2 Adjunctive Therapy Epilepsy Topiramate Tablets Usp Are Indicated As Adjunctive Therapy For Adults And Pediatric Patients Ages 2 To 16 Years With Partial Onset Seizures Or Primary Generalized Tonic-Clonic Seizures, And In Patients 2 Years Of Age And Older With Seizures Associated With Lennox-Gastaut Syndrome [See Clinical Studies (14.2)]. |
All Formulated Excipients (0 Total)
None
Active Ingredients ( 1 Total)
| Name | Structure | ZINC ID(s) |
|---|---|---|
| 1. Topiramate |
|
ZINC95616603 |