Product Dossier
LACOSAMIDE LUPIN
Product Dossier for LACOSAMIDE LUPIN (lacosamide, Generic Health). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Generic Health
- Active ingredient: lacosamide
- Therapeutic area: Neurology
- Related brand: VIMCOSA
- Related brand: VIMPAT
- Related brand: LACOSAM
- Same area: GILENYA
- Same area: RIVOTRIL
What it is
LACOSAMIDE Lupin is available as film-coated tablets in strengths of 50 mg, 100 mg, 150 mg and 200 mg 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
The film-coated tablets may be taken with or without food. The film-coated tablets must not be divided. Conversion to or from oral and intravenous administration can be done directly without titration. The total daily dose and twice daily administration should be maintained.
Regulatory history
LACOSAMIDE Lupin was first listed on the ARTG on 29 May 2019 across all four strengths (50 mg, 100 mg, 150 mg and 200 mg film-coated tablets).