Drug Class Description
Other antiepileptics
Generic Name
Lacosamide
Drug Description
Film-coated tablet - 50 mg: Pinkish, oval film-coated tablet debossed with ‘SP’ on one side and ‘50’ on the other side. 100 mg: Dark yellow, oval film-coated tablet debossed with ‘SP’ on one side and ‘100’ on the other side. 150 mg: Salmon, oval film-coated tablet debossed with ‘SP’ on one side and ‘150’ on the other side. 200 mg: Blue, oval film-coated tablet debossed with ‘SP’ on one side and ‘200’ on the other side.
Presentation
Vimpat 50 mg: Each film-coated tablet contains 50 mg lacosamide - Excipients: Each film-coated tablet contains 0.17 mg soya-lecithin.Vimpat 100 mg: Each film-coated tablet contains 100 mg lacosamide - Excipients: Each film-coated tablet contains 0.34 mg soya-lecithin.Vimpat 150 mg: Each film-coated tablet contains 150 mg lacosamide - Excipients: Each film-coated tablet contains 0.50 mg soya-lecithin.Vimpat 200 mg: Each film-coated tablet contains 200 mg lacosamide - Excipients: Each film-coated tablet contains 0.67 mg soya-lecithin.
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 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). Vimpat treatment initiation pack contains 4 different packages (one for each tablet strength) with 14 tablets each, for the first 2 to 4 weeks of therapy depending on the patient´s response and tolerability. The packages are marked with ‘week 1 (2, 3 or 4)’. On the first day of treatment the patient starts with Vimpat 50 mg tablets twice a day.
During the second week, the patient takes Vimpat 100 mg tablets twice a day. Depending on response and tolerability, Vimpat 150 mg tablets may be taken twice a day during the third week and Vimpat 200 mg tablets twice a day during the fourth 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 peanuts or soya or to any of the excipients. Known second- or third-degree atrioventricular (AV) block.
Special Precautions
Dizziness
