ARTG Entry
LACOMED
ARTG entry for LACOMED (lacosamide), ARTG 461328 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Medsurge Pharma
- Active ingredient: lacosamide
- Therapeutic area: Neurology
What it is
LACOMED contains lacosamide and is available as film-coated tablets in strengths of 50 mg, 100 mg, 150 mg or 200 mg. LACOMED oral solution contains 10 mg/mL of lacosamide.
Approved indications —
Monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. — Add-on therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older. — Add-on therapy in the treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older.
Dosing overview
LACOMED film-coated tablets and oral solution may be taken with or without food. The film-coated tablets must not be divided. The oral solution may be diluted in a glass of water. A nasogastric tube or gastrostomy tube may be used when administering the oral solution, and the tube should be flushed (twice the volume of dead space) after product delivery to ensure the correct dose of lacosamide is administered. Conversion to or from oral and IV administration can be done directly without titration, maintaining the total daily dose and twice daily administration. If LACOMED has to be discontinued, it is recommended this be done gradually, such as by tapering the daily dose by 200 mg/week.
Regulatory history
LACOMED lacosamide tablets and oral solution were first listed on the ARTG on 13 November 2025, comprising five registered products: 50 mg tablets (ARTG 461331), 100 mg tablets (ARTG 461328), 150 mg tablets (ARTG 461329), 200 mg tablets (ARTG 461330), and 10 mg/mL oral solution (ARTG 461327).