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Topamax

[Topiramate]

Titrating in increments of 25 mg/ week may delay the time to reach an effective dose. Daily doses above 1,600 mg have not been studied. In the study of primary generalized tonic-clonic seizures the initial titration rate was slower than in previous studies; the assigned dose was reached at the end of 8 weeks (see CLINICAL STUDIES, Controlled Trials in Patients With Primary Generalized Tonic-Clonic Seizures).

Pediatric Patients (Ages 2-16 Years)

-Partial Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome

Text Continues Below



The recommended total daily dose of TOPAMAX ® (topiramate) as adjunctive therapy for patients with partial seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome is approximately 5 to 9 mg/ kg/ day in two divided doses. Titration should begin at 25 mg (or less, based on a range of 1 to 3 mg/ kg/ day) nightly for the first week. The dosage should then be increased at 1-or 2-week intervals by increments of 1 to 3 mg/ kg/ day (administered in two divided doses), to achieve optimal clinical response. Dose titration should be guided by clinical outcome.

In the study of primary generalized tonic-clonic seizures the initial titration rate was slower than in previous studies; the assigned dose of 6 mg/ kg/ day was reached at the end of 8 weeks (see CLINICAL STUDIES, Controlled Trials in Patients With Primary Generalized Tonic-Clonic Seizures).

Administration of TOPAMAX ® Sprinkle Capsules TOPAMAX ® (topiramate capsules) Sprinkle Capsules may be swallowed whole or may be administered by carefully opening the capsule and sprinkling the entire contents on a small amount (teaspoon) of soft food. This drug/ food mixture should be swallowed immediately and not chewed. It should not be stored for future use.

Patients with Renal Impairment

In renally impaired subjects (creatinine clearance less than 70 mL/ min/ 1.73m 2 ), one half of the usual adult dose is recommended. Such patients will require a longer time to reach steady-state at each dose.

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