ARTG Entry
EPIRAMAX
ARTG entry for EPIRAMAX (topiramate), ARTG 135596 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Arrotex Pharmaceuticals
- Active ingredient: topiramate
- Therapeutic area: Neurology
What it is
Epiramax is topiramate, available in tablet strengths of 25 mg, 50 mg, 100 mg or 200 mg.
Approved indications
— Monotherapy in patients with newly diagnosed epilepsy (adults and children 2 years and over). — Conversion to monotherapy in patients with epilepsy (adults and children 2 years and over). — Add-on therapy in partial onset seizures with or without secondary generalised seizures (adults and children 2 years and over). — Add-on therapy in primary generalised tonic-clonic seizures (adults and children 2 years and over). — Add-on therapy in drop attacks associated with Lennox-Gastaut syndrome (adults and children 2 years and over). — 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. For epilepsy monotherapy, titration in adults 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. For epilepsy add-on therapy, titration in adults 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 the target dose of 200 to 400 mg per day. The maximum recommended dose should not exceed 1,000 mg per day. In children aged 2 years and over for monotherapy, titration should begin at 0.5 to 1 mg per kg as a single nightly dose for the first week, then increased by 0.5 to 1 mg per kg per day at weekly or longer intervals to the recommended target dose of 3 to 6 mg per kg per day. For add-on therapy in children aged 2 years and over, titration should begin at 1 to 3 mg per 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 per kg per day at weekly or longer intervals to the recommended total daily dose of 5 to 9 mg per kg per day. Epiramax tablets should be swallowed whole and can be taken without regard to meals.
Regulatory history
Epiramax was first registered on the ARTG on 14 January 2008, with multiple strengths in tablet form (25 mg, 50 mg, 100 mg and 200 mg in both blister pack and bottle presentations), followed by capsule formulations (15 mg, 25 mg and 50 mg) registered on 11 February 2008.