LOGEM

What it is

LOGEM is a chewable/dispersible tablet containing lamotrigine, available in strengths of 25 mg, 50 mg, 100 mg and 200 mg.

Approved indications

LOGEM is an anti-epileptic drug used for the treatment of partial and generalised seizures in adults and children. It has extensive experience as add-on therapy and has been found to be effective as monotherapy following withdrawal of concomitant anti-epileptic drugs. Initial monotherapy treatment in newly diagnosed paediatric patients is not recommended.

Dosing overview

For monotherapy in adults and children over 12 years of age, the initial dose is 25 mg once daily for two weeks, then 50 mg once daily for two weeks, followed by increments of maximum 50 to 100 mg every one to two weeks until optimal response is achieved, with usual maintenance dose of 100 to 200 mg/day given once daily or as two divided doses. For add-on therapy in adults and children over 12 years of age taking sodium valproate, the initial dose is 25 mg every alternate day for two weeks, then 25 mg once daily for two weeks, with increments of maximum 25 to 50 mg every one to two weeks until optimal response is achieved, and usual maintenance dose of 100 to 200 mg/day given once daily or as a divided dose. For patients not taking sodium valproate, the initial dose is 50 mg once daily for two weeks, then 100 mg/day in two divided doses for two weeks, with further increments of maximum 100 mg every one to two weeks until optimal response is achieved, and usual maintenance dose of 200 to 400 mg/day as a divided dose.

Key safety warnings

Severe, potentially life-threatening rashes have been reported with lamotrigine use, particularly in children. LOGEM should be discontinued at the first sign of rash unless the rash is clearly not drug related. Careful incremental titration of the dose may decrease the severity of skin rashes. The risk of serious rash is associated with high initial doses and exceeding the recommended dose escalation for lamotrigine. It is recommended that lamotrigine not be restarted in patients who have discontinued due to rash associated with prior treatment with lamotrigine unless the potential benefit clearly outweighs the risk.

Regulatory history

LOGEM was first listed on the ARTG on 17 March 2005 across four strengths (25 mg, 50 mg, 100 mg and 200 mg as chewable/dispersible tablets).