TOPAMAX

What it is

TOPAMAX is a medicine containing topiramate, available as film-coated tablets in strengths of 25 mg, 50 mg, 100 mg and 200 mg . TOPAMAX Sprinkle capsules are also available in 15 mg, 25 mg and 50 mg strengths, consisting of sugar spheres enclosed in gelatin capsules .

Approved indications

— Monotherapy in adults and children aged 2 years and over with newly diagnosed epilepsy . — Conversion to monotherapy in adults and children aged 2 years and over with epilepsy . — Add-on therapy for partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with Lennox-Gastaut syndrome in adults and children aged 2 years and over . — Prophylaxis of migraine headache in adults .

Dosing overview

TOPAMAX therapy should be initiated at a low dose followed by slow titration to an effective dose, guided by clinical outcome .

For epilepsy monotherapy in adults, titration should begin at 25 mg as a single nightly dose for one week or longer, then increased by 25 to 50 mg per day at weekly or longer intervals to the recommended target dose of 100 mg per day . The maximum recommended dose is 500 mg per day . The daily dosage should be taken as two divided doses . For children aged 2 years and over with monotherapy, titration should begin at 0.5 to 1 mg/kg as a single nightly dose for the first week, then increased by 0.5 to 1 mg/kg per day at weekly or longer intervals to the recommended target dose of 3 to 6 mg/kg per day .

For epilepsy add-on therapy in adults, titration should begin at 25 to 50 mg as a single nightly or divided dose for one week or longer, then increased by 25 to 100 mg per day at weekly or longer intervals to a target dose of 200 to 400 mg per day . The maximum recommended dose should not exceed 1000 mg per day .

For children aged 2 years and over receiving add-on therapy, titration should begin at 1 to 3 mg/kg per day up to 25 mg per day as a single nightly dose for the first week, then increased by 1 to 3 mg/kg per day at weekly or longer intervals to a recommended total daily dose of 5 to 9 mg/kg per day .

PBS listing

TOPAMAX Sprinkle capsules are listed on the PBS with streamlined authority required restriction at 15 mg, 25 mg and 50 mg strengths. The ex-manufacturer prices are A$10.52 (15 mg), A$8.66 (25 mg) and A$14.44 (50 mg) .

Regulatory history

TOPAMAX tablets in 25 mg, 50 mg, 100 mg and 200 mg strengths were first registered on the ARTG on 30 January 1998 . TOPAMAX Sprinkle capsules in 15 mg, 25 mg and 50 mg strengths were first listed on the ARTG on 30 April 2010 .