Topiramate

Product manufactured by Unit Dose Services

Application Nr Approved Date Route Status External Links
ANDA079162 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1. 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 ) 1.1 Monotherapy Epilepsy Topiramate Tablets, Usp Are Indicated As Initial Monotherapy In Patients 2 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 TOPIRAMATE ZINC95616603

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