Product Dossier
NOUMED
Product Dossier for NOUMED (terbinafine, Avallon Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Avallon Pharmaceuticals
- Active ingredient: terbinafine
- Therapeutic area: Dermatology
- Related brand: TINASIL
- Related brand: APO-TERBINAFINE
- Related brand: TAMSIL
- Same area: DERMATANE
- Same area: NEOTIGASON
What it is
NOUMED TOPIRAMATE is a film-coated tablet containing topiramate in strengths of 25 mg, 50 mg, 100 mg or 200 mg.
Approved indications —
Monotherapy in adults and children 2 years and over with newly diagnosed epilepsy — Conversion to monotherapy in adults and children 2 years and over 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, guided by clinical outcome. For adults with epilepsy monotherapy, titration begins at 25 mg as a single nightly dose for one week or longer, then increases by 25 to 50 mg per day at weekly or longer intervals to a target dose of 100 mg per day, with a maximum recommended dose of 500 mg per day. The daily dosage should be taken as two divided doses. Some patients with refractory forms of epilepsy have tolerated doses of 1,000 mg per day. For adults with epilepsy add-on therapy, titration begins at 25 to 50 mg as a single nightly or divided dose for one week or longer, then increases by 25 to 100 mg per day at weekly or longer intervals to a target dose of 200 to 400 mg per day, not exceeding 1,000 mg per day, taken as two divided doses. For children aged 2 years and over with epilepsy monotherapy, titration begins at 0.5 to 1 mg per kg as a single nightly dose for the first week, then increases by 0.5 to 1 mg per kg per day at weekly or longer intervals to a target dose of 3 to 6 mg per kg per day. The daily dosage should be given as two divided doses. For children aged 2 years and over with epilepsy add-on therapy, titration begins 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 increases by 1 to 3 mg per kg per day at weekly or longer intervals to a recommended total daily dose of 5 to 9 mg per kg per day.
Regulatory history
NOUMED TOPIRAMATE in four strengths (25 mg, 50 mg, 100 mg and 200 mg) was first registered on the ARTG on 2017-06-07.