ARTG Entry

LAMITAN

ARTG entry for LAMITAN (lamotrigine), ARTG 147633 — Product Information, dosage form, registration history. Compiled by arcimedes.

What it is

LAMITAN contains lamotrigine and is available as dispersible/chewable tablets in strengths of 25 mg, 50 mg, 100 mg and 200 mg.

Approved indications

— Treatment of partial and generalised seizures in adults and children.

Dosing overview

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

Key safety warnings

The risk of serious rash is associated with high initial doses and exceeding the recommended dose escalation for LAMITAN. Therapy should be initiated at the recommended doses, and careful incremental titration may decrease the severity of skin rashes. When restarting LAMITAN in patients who have discontinued it for any reason, prescribers should assess the need for escalation to maintenance dose; the greater the interval of time since the previous dose, the more consideration should be given to escalation, and when the interval exceeds five half-lives, LAMITAN should generally be escalated to the maintenance dose according to the appropriate schedule. LAMITAN should 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

LAMITAN lamotrigine dispersible/chewable tablets were first listed on the ARTG on 6 February 2008, with registrations for 25 mg, 50 mg, 100 mg and 200 mg strengths.

TGA Public Summary — ARTG 147633