Product Dossier

RBX

Product Dossier for RBX (topiramate, Sun Pharma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

RBX contains topiramate as the active ingredient, available in tablet 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 — 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 be increased by 25 to 50 mg per day at weekly or longer intervals to a recommended target dose of 100 mg per day. The maximum recommended dose is 500 mg per 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 be increased by 25 to 100 mg per day at weekly or longer intervals to a target dose of 200 to 400 mg per day. The maximum recommended dose should not exceed 1,000 mg per day.

Key safety warnings

When patients are being converted to topiramate monotherapy, consideration should be given to the effects of seizure control when withdrawing concomitant antiepileptic agents, with gradual discontinuation at the rate of approximately one-third of the concomitant dose every 2 weeks recommended unless safety concerns require an abrupt withdrawal. When enzyme-inducing drugs are withdrawn, topiramate levels will increase, and a decrease in topiramate dosage may be required if clinically indicated.

Regulatory history

RBX topiramate was first registered on the ARTG on 10 May 2010, with eight entries approved covering 25 mg, 50 mg, 100 mg and 200 mg tablets in both bottle and blister pack presentations.