Drug Class Description
Other antiepileptics
Generic Name
Lacosamide
Drug Description
Syrup. Clear solution, slightly yellow to yellow-brown in colour.
Presentation
Each ml of syrup contains 15 mg lacosamide. 1 bottle of 200 ml contains 3000 mg lacosamide. 1 bottle of 465 ml contains 6975 mg lacosamide. Excipients: Each ml of Vimpat syrup contains 280 mg sorbitol (E420), 0.2 mg sodium propylparahydroxybenzoate (E217), 2.0 mg sodium methylparahydroxybenzoate (E219), 0.05 mg aspartame (E951) and 1.89 mg sodium.
Indications
Vimpat is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older.
Adult Dosage
Vimpat syrup is provided with a measuring cup with graduation marks and instructions for use in the package leaflet. Vimpat must be taken twice a day. The recommended starting dose is 50 mg twice a day which should be increased to an initial therapeutic dose of 100 mg twice a day after one week. Depending on response and tolerability, the maintenance dose can be further increased by 50 mg twice a day every week, to a maximum recommended daily dose of 400 mg (200 mg twice a day).
Vimpat may be taken with or without food. In accordance with current clinical practice, if Vimpat has to be discontinued, it is recommended this be done gradually (e.g. taper the daily dose by 200 mg/week). Use in patients with renal impairment No dose adjustment is necessary in mildly and moderately renally impaired patients (CLCR >30 ml/min). A maximum dose of 250 mg/day is recommended for patients with severe renal impairment (CLCR =30 ml/min) and in patients with endstage renal disease. For patients requiring haemodialysis a supplement of up to 50% of the divided daily dose directly after the end of haemodialysis is recommended.
Treatment of patients with end-stage renal disease should be made with caution as there is little clinical experience and accumulation of a metabolite (with no known pharmacological activity). In all patients with renal impairment, the dose titration should be performed with caution. Use in patients with hepatic impairment No dose adjustment is needed for patients with mild to moderate hepatic impairment. The dose titration in these patients should be performed with caution considering co-existing renal impairment. The pharmacokinetics of lacosamide has not been eva luated in severely hepatic impaired patients.
Child Dosage
Paediatric patients Vimpat is not recommended for use in children and adolescents below the age of 16 as there is no data on safety and efficacy in these age groups.
Elderly Dosage
Use in elderly (over 65 years of age) No dose reduction is necessary in elderly patients. The experience with lacosamide in elderly patients with epilepsy is limited. Age associated decreased renal clearance with an increase in AUC levels should be considered in elderly patients.
Contra Indications
Hypersensitivity to the active substance or to any of the excipients. Known second- or third-degree atrioventricular (AV) block.
Special Precautions
