Vimpat Dosage/Direction for Use

Monotherapy: Initial monotherapy: Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with lacosamide.
The recommended starting dose is 100 mg twice a day (200 mg/day) which should be increased to a therapeutic dose of 150 mg twice a day (300 mg/day) after one week.
Depending on response and tolerability, the dose can be further increased at weekly interval by 50 mg twice a day (100 mg/day), to a maximum recommended maintenance daily dose of 200 mg twice a day (400 mg/day).
Conversion to monotherapy: For patients who will convert to lacosamide monotherapy, the recommended starting dose is 100 mg twice a day (200 mg/day) which should be increased to a therapeutic dose of 150 mg twice a day (300 mg/day) after one week.
Depending on response and tolerability, the dose can be further increased at weekly interval by 50 mg twice a day (100 mg/day), to a maximum recommended maintenance daily dose of 200 mg twice a day (400 mg/day).
The recommended maintenance daily dose should be maintained for at least 3 days before initiating conversion to lacosamide monotherapy. A gradual withdrawal of the concomitant antiepileptic drug over at least 6-weeks is recommended. If the patient is on more than one antiepileptic drug, the antiepileptic drugs should be withdrawn sequentially.
Safety and efficacy of lacosamide have not been established for simultaneous conversion to monotherapy from two or more concomitant antiepileptic drugs.
Adjunctive therapy: 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).
Initiation of lacosamide treatment with a loading dose: Lacosamide treatment (initial monotherapy, conversion to monotherapy and adjunctive therapy) may also be initiated with a single loading dose of 200 mg, followed approximately 12 hours later by a 100 mg twice daily (200 mg/day) maintenance dose regimen. A loading dose may be initiated in patients in situations when the physician determines that rapid attainment of lacosamide steady state plasma concentration and therapeutic effect is warranted. It should be administered under medical supervision with consideration of the potential for increased incidence of central nervous system adverse reactions (see Adverse Reactions). Administration of a loading dose has not been studied in acute conditions such as status epilepticus.
Discontinuation: 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).
Method of administration: FC tab: For oral use.
VIMPAT must be taken twice a day (usually once in the morning and once in the evening).
VIMPAT may be taken with or without food.
Soln for infusion: Vimpat must be administered twice a day.
Vimpat therapy can be initiated with either oral or i.v. administration.
Vimpat solution for infusion is also an alternative for patients when oral administration is temporarily not feasible.
The solution for infusion is infused over a period of 15 to 60 minutes twice daily. Vimpat solution for infusion can be administered i.v. without further dilution.
Conversion to or from oral and i.v. administration can be done directly without titration. The total daily dose and twice daily administration should be maintained.
There is experience with twice daily infusions of Vimpat up to 5 days.
Special populations: Renal impairment: No dose adjustment is necessary in mildly and moderately renally impaired patients (CL_CR >30 ml/min). In patients with mild or moderate renal impairment, a loading dose of 200 mg may be considered, but further dose titration (>200 mg daily) should be performed with caution. In patients with severe renal impairment (CL_CR ≤30 ml/min) and in patients with endstage renal disease, a maximum maintenance dose of 250 mg/day is recommended. In these patients, the dose titration should be performed with caution. If a loading dose is indicated, an initial dose of 100 mg followed by a 50 mg twice daily regimen for the first week should be used. 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 endstage renal disease should be made with caution as there is little clinical experience and accumulation of a metabolite (with no known pharmacological activity).
Hepatic impairment: FC tab: A maximum dose of 300 mg/day is recommended for patients with mild to moderate hepatic impairment.
Soln for infusion: No dose adjustment is needed for patients with mild to moderate hepatic impairment.
FC tab and Soln for infusion: The dose titration in these patients should be performed with caution considering co-existing renal impairment. A loading dose of 200 mg may be considered, but further dose titration (>200 mg daily) should be performed with caution.
The pharmacokinetics of lacosamide has not been evaluated in severely hepatic impaired patients (see Pharmacology: Pharmacokinetics under Actions).
FC tab: Lacosamide should be administered to patients with severe hepatic impairment only when the expected therapeutic benefits are anticipated to outweigh the possible risks. The dose may need to be adjusted while carefully observing disease activity and potential side effects in the patient.
Elderly population (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 (see Renal impairment in the previous text and Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of lacosamide in children aged below 16 years have not yet been established. No data are available.