Product Dossier

APO-TOPIRAMATE

Product Dossier for APO-TOPIRAMATE (topiramate, Arrotex Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

APO-TOPIRAMATE contains topiramate as the active ingredient, available as tablets in strengths of 25 mg, 50 mg, 100 mg or 200 mg.

Approved indications —

Epilepsy in adults and children 2 years and over, as monotherapy in patients with newly diagnosed epilepsy — Epilepsy in adults and children 2 years and over, for conversion to monotherapy in patients with epilepsy — Epilepsy in adults and children 2 years and over, as add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with Lennox-Gastaut syndrome — <cite index="1-9">Prophylaxis of migraine headache in adults

Dosing overview

For optimum seizure control in both adults and children, therapy should be initiated at a low dose followed by slow titration to an effective dose, guided by clinical outcome. APO-TOPIRAMATE tablets should be swallowed whole and can be taken without regard to meals. 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/day at weekly or longer intervals to the recommended target dose of 100 mg/day. The maximum recommended dose is 500 mg/day. The daily dosage should be taken as two divided doses. 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/day at weekly or longer intervals to the target dose of 200 to 400 mg/day. The maximum recommended dose should not exceed 1,000 mg/day. In children aged 2 years and over for 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/day at weekly or longer intervals to the recommended target dose of 3 to 6 mg/kg/day.

PBS listing

APO-TOPIRAMATE is listed on the PBS in all four tablet strengths with streamlined restrictions. The 25 mg tablets are listed at an ex-manufacturer price of A$4.00, the 50 mg tablets at A$5.26, the 100 mg tablets at A$8.27, and the 200 mg tablets at A$13.91. Each strength has 2 PBS items.

Regulatory history

APO-TOPIRAMATE was first registered on the ARTG on 20 July 2007, with eight separate entries covering 25 mg, 50 mg, 100 mg and 200 mg tablet strengths in both blister pack and bottle packaging formats.