Topiramate

Product manufactured by Direct Rx

Application Nr Approved Date Route Status External Links
ANDA090278 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications & Usage Section Indications And Usagemonotherapy Epilepsy Topiramate Tablets Are Indicated As Initial Monotherapy In Patients 10 Years Of Age And Older With Partial Onset Or Primary Generalized Tonic-Clonic Seizures. Effectiveness Was Demonstrated In A Controlled Trial In Patients With Epilepsy Who Had No More Than 2 Seizures In The 3 Months Prior To Enrollment. 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. Adjunctive Therapy Epilepsy Topiramate Tablets 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.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Topiramate TOPIRAMATE ZINC95616603

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