Topiramate

Product manufactured by Proficient Rx Lp

Application Nr Approved Date Route Status External Links
ANDA077627 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

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 TOPIRAMATE ZINC95616603

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