Product Dossier

LAMOTRIGINE-WGR

Product Dossier for LAMOTRIGINE-WGR (lamotrigine, GM Pharma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

LAMOTRIGINE-WGR is an antiepileptic drug for the treatment of partial and generalised seizures in adults and children. LAMOTRIGINE-WGR dispersible/chewable tablets come in four strengths and contain 25 mg, 50 mg, 100 mg and 200 mg of lamotrigine.

Approved indications

— Partial and generalised seizures in adults and children.

Dosing overview

In monotherapy for 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; thereafter the dose should be increased by a maximum of 50 to 100 mg every one to two weeks until optimal response is achieved, with usual maintenance of 100 to 200 mg daily given once daily or as two divided doses. For add-on therapy in adults and children over 12 years taking sodium valproate, the initial dose is 25 mg every alternate day for two weeks, followed by 25 mg once daily for two weeks; thereafter the dose should be increased by a maximum of 25–50 mg every 1–2 weeks until optimal response is achieved, with usual maintenance 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; thereafter the dose should be increased by a maximum of 100 mg every 1–2 weeks until optimal response is achieved, with usual maintenance of 200 to 400 mg daily as a divided dose.

Key safety warnings

Severe, potentially life-threatening rashes have been reported in association with the use of lamotrigine, particularly in children, and lamotrigine 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

LAMOTRIGINE-WGR was first registered on the ARTG on 27 August 2020 across four strengths: 25 mg, 50 mg, 100 mg and 200 mg dispersible/chewable tablets (licence category RE).