Product Dossier
TOPIRAMATE-WGR
Product Dossier for TOPIRAMATE-WGR (topiramate 200 mg, GM Pharma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: GM Pharma
- Active ingredient: topiramate 200 mg
- Therapeutic area: Neurology
- Same area: GILENYA
- Same area: RIVOTRIL
What it is
TOPIRAMATE-WGR is available as tablets containing 25 mg, 50 mg, 100 mg or 200 mg topiramate.
Approved indications
— Monotherapy in adults and children 2 years and over with newly diagnosed epilepsy. — Conversion to monotherapy in patients with epilepsy. — Add-on therapy in adults and children 2 years and over for partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with Lennox-Gastaut syndrome. — Prophylaxis of migraine headache in adults.
Dosing overview
Therapy should be initiated at a low dose followed by slow titration to an effective dose, with dose titration 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/day at weekly or longer intervals to a 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 children 2 years and over as 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 a recommended target dose of 3 to 6 mg/kg/day. For 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 a target dose of 200 to 400 mg/day. The maximum recommended dose should not exceed 1,000 mg/day.
Regulatory history
TOPIRAMATE-WGR tablets in strengths of 25 mg, 50 mg, 100 mg and 200 mg were first listed on the Australian Register of Therapeutic Goods on 20 July 2007.