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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 )] . Additional Pediatric Use Information For Patients Ages 12 To 17 Years Is Approved For Janssen Pharmaceuticals, Inc.’s Topamax (Topiramate) Tablets And Sprinkle Capsules. However, Due To Janssen Pharmaceuticals, Inc.’s Marketing Exclusivity Rights, This Drug Product Is Not Labeled With That Pediatric Information.
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