Topamax

[Topiramate]

Indications & Dosage
INDICATIONS AND USAGE

TOPAMAX ® (topiramate) Tablets and TOPAMAX ® (topiramate capsules) Sprinkle Capsules are indicated as adjunctive therapy for adults and pediatric patients ages 2-16 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.

DOSAGE AND ADMINISTRATION

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TOPAMAX ® has been shown to be effective in adults and pediatric patients ages 2-16 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. In the controlled add-on trials, no correlation has been demonstrated between trough plasma concentrations of topiramate and clinical efficacy. No evidence of tolerance has been demonstrated in humans. Doses above 400 mg/ day (600, 800, or 1,000 mg/ day) have not been shown to improve responses in dose-response studies in adults with partial onset seizures.

It is not necessary to monitor topiramate plasma concentrations to optimize TOPAMAX ® therapy. On occasion, the addition of TOPAMAX ® to phenytoin may require an adjustment of the dose of phenytoin to achieve optimal clinical outcome. Addition or withdrawal of phenytoin and/ or carbamazepine during adjunctive therapy with TOPAMAX ® may require adjustment of the dose of TOPAMAX ® . Because of the bitter taste, tablets should not be broken.

TOPAMAX ® can be taken without regard to meals.
Adults (17 Years of Age and Over) The recommended total daily dose of TOPAMAX ® as adjunctive therapy in adults with partial seizures is 200-400 mg/ day in two divided doses, and 400 mg/ day in two divided doses as adjunctive treatment in adults with primary generalized tonic-clonic seizures. It is recommended that therapy be initiated at 25 -50 mg/ day followed by titration to an effective dose in increments of 25 -50 mg/ week.

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