Vimpat/Vimpat Injection Dosage/Direction for Use

Monotherapy (in the treatment of partial-onset seizures): The recommended starting dose is 50 mg twice a day which should be increased to a therapeutic dose of 100 mg twice a day after one week.
Lacosamide (Vimpat) can also be initiated at the dose of 100 mg twice a day based on the physician's assessment of required seizure reduction versus potential side effects.
Depending on response and tolerability, the maintenance dose can be further increased at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 300 mg twice a day (600 mg/day).
In patients having reached a dose greater than 400 mg/day and who need an additional antiepileptic medicinal product, the posology that is recommended for adjunctive therapy as follows should be followed.
Adjunctive therapy (in the treatment of partial-onset seizures or in the treatment of primary generalised tonic-clonic seizures): 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 at weekly intervals by 50 mg twice a day (100 mg/day), up to a maximum recommended daily dose of 400 mg (200 mg twice a day).
Initiation of lacosamide treatment with a loading dose (initial monotherapy or conversion to monotherapy in the treatment of partial-onset seizures or adjunctive therapy in the treatment of partial-onset seizures or adjunctive therapy in the treatment of primary generalised tonic-clonic seizures): Lacosamide (Vimpat) treatment may also be initiated with a single loading dose of 200 mg, followed approximately 12 hours later by a 100 mg twice a day (200 mg/day) maintenance dose regimen. Subsequent dose adjustments should be performed according to individual response and tolerability as described previously. 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 serious cardiac arrhythmia and 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 lacosamide (Vimpat) has to be discontinued, it is recommended this be done gradually (e.g. taper the daily dose by 200 mg/week).
In patients who develop serious cardiac arrhythmia, clinical benefit/risk assessment should be performed and if needed lacosamide (Vimpat) should be discontinued.
Posology: The following table summarises the recommended posology for patients from 16 years of age and for adults. More details are provided in the table as follows.
Vimpat: Lacosamide (Vimpat) must be taken twice a day (approximately 12 hours apart).
If a dose is missed, the patient should be instructed to take the missed dose immediately, and then to take the next dose of lacosamide at the regularly scheduled time. If the patient notices the missed dose within 6 hours of the next one, he/she should be instructed to wait to take the next dose of lacosamide at the regularly scheduled time. Patients should not take a double dose. (See Table 2.)

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Method of administration: Vimpat: Lacosamide (Vimpat) film-coated tablets are for oral use. Lacosamide (Vimpat) may be taken with or without food.
Vimpat Injection: Lacosamide (Vimpat) must be taken twice a day.
Lacosamide (Vimpat) therapy can be initiated with either oral or i.v. administration.
Lacosamide (Vimpat) solution IV infusion is also an alternative for patients when oral administration is temporarily not feasible.
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.
The solution for IV infusion is infused over a period of 15 to 60 minutes twice a day. An infusion duration of at least 30 minutes for administration >200 mg per infusion (i.e. >400 mg/day) is preferred.
Monitor closely patients with known cardiac conduction problems, on concomitant medications that prolong PR interval, or with severe cardiac disease (e.g. myocardial ischemia, heart failure) when lacosamide dose is higher than 400 mg/day.
Lacosamide (Vimpat) solution for IV infusion can be administered intravenously without further dilution or can be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection, glucose 50 mg/ml (5%) solution for injection or lactated Ringer's solution for injection.
Special population: Elderly (over 65 years of age): No dose reduction is necessary in elderly patients.
Age associated decreased renal clearance with an increase in AUC levels should be considered in elderly patients (see following paragraph 'Renal Impairment' and Pharmacology: Pharmacokinetics under Actions). There is limited clinical data in the elderly patients with epilepsy, particularly at doses greater than 400 mg/day (see Precautions, Adverse Reactions, and Pharmacology: Pharmacodynamics under Actions).
Renal impairment: No dose adjustment is necessary in mildly and moderately renally impaired adult 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) or with end-stage renal disease, a maximum dose of 250 mg/day is recommended and 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 all 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).
Hepatic impairment: A maximum dose of 300 mg/day is recommended for patients with mild to moderate hepatic impairment.
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). 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.