TAMATE

What it is

TAMATE is a topiramate tablet available in strengths of 25 mg, 50 mg, 100 mg, or 200 mg.

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 in adults and children aged 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. TAMATE tablets should be swallowed whole and can be taken without regard to meals.

Key safety warnings

Antiepileptic drugs including topiramate increase the risk of suicidal thoughts or behaviour in patients taking these drugs for any indication. Patients treated with any antiepileptic drug should be monitored for the emergence or worsening of depression, suicidal thoughts or behaviour, and any unusual changes in mood or behaviour. Serious skin reactions including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis have been reported in patients receiving topiramate, with the majority of cases occurring in patients concurrently taking other medications known to be associated with these conditions, although several cases have occurred in patients receiving monotherapy. Patients, especially those with a predisposition to nephrolithiasis, may be at increased risk for renal stone formation. Maintaining adequate hydration whilst using topiramate is very important, as hydration can reduce the risk of nephrolithiasis. Proper hydration prior to and during activities such as exercise or exposure to warm temperatures may reduce the risk of heat-related adverse events. Oligohydrosis (decreased sweating) and anhidrosis have been reported in association with topiramate use, with decreased sweating and an elevation in body temperature characterising these cases. The majority of reports have been in children, and paediatric patients treated with topiramate should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather. A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving topiramate, with symptoms including acute onset of decreased visual acuity or ocular pain, typically occurring within 1 month of initiating topiramate therapy.

Contraindications

Hypersensitivity to any component of TAMATE. For migraine prophylaxis: pregnancy and women of childbearing potential if not using a highly effective method of contraception.

Regulatory history

TAMATE topiramate tablets in strengths of 25 mg, 50 mg, 100 mg, and 200 mg were first listed on the ARTG on 1 June 2009.