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Topiramate Update

In May, topiramate was approved for use in Canada to control partial seizures in paediatric cases. At that time, Topamax® Sprinkle Capsules were also made available in Canada.

In October, the US Food and Drug Administration (FDA) approved another indication for topiramate (Topamax®) as an add-on treatment for primary generalized tonic-clonic seizures in adults and paediatric patients 2-16. This follows its announcement in July clearing topiramate as add-on therapy for partial seizures in children 2-16.

According to Janssen-Ortho Inc., the Canadian manufacturer of Topamax®, topiramate is indicated in Canada as an adjunctive therapy for the management of seizures (in adults and children 2 years and older with epilepsy) which are not satisfactorily controlled with conventional therapy. The company's most recent monograph states that some data demonstrating efficacy of topiramate as adjunctive therapy in adults and a small number of paediatric patients for primary generalized tonic-clonic seizures and seizures associated with Lennox-Gastaut syndrome are available from randomized, double-blind, placebo-controlled trials, and that there is limited information on the use of topiramate in monotherapy at this time.

In Canada, Janssen-Ortho Inc. offers a toll-free Medical Information line: 800-576-3331.

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Last Modified: 06/22/2006 09:28:36 AM