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The recommended posology for adults, adolescents and children from 4 years of age is summarised in Tables 2 and 3. (See Tables 2 and 3.)
Lacosamide must be taken twice a day, approximately 12 hours apart.
If an oral dose is missed, the patient should be instructed to take the missed oral dose immediately, and then to take the next oral dose of lacosamide at the regularly scheduled time. If the patient notices the missed oral dose within 6 hours of the next one, he/she should be instructed to wait to take the next oral dose of lacosamide at the regularly scheduled time. Patients should not take a double oral dose.
Lacosamide therapy can be initiated with either oral administration (either tablets or syrup) or intravenous administration (solution for infusion). Solution for infusion is an alternative for patients when oral administration is temporarily not feasible. The overall duration of treatment with intravenous lacosamide is at the physician's discretion; there is experience from clinical studies with twice daily infusions of lacosamide for up to 5 days in adjunctive therapy.
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. 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 (see Method of administration as follows and Precautions).
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Click on icon to see table/diagram/imageAdolescents and children weighing 50 kg or more, and adults: Monotherapy (in the treatment of partial-onset seizures): The recommended starting dose is 50 mg twice a day (100 mg/day) which should be increased to an initial therapeutic dose of 100 mg twice a day (200 mg/day) after one week.
Lacosamide can also be initiated at the dose of 100 mg twice a day (200 mg/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 200 mg twice a day (400 mg/day) and who need an additional antiepileptic medicinal product, the posology that is recommended for adjunctive therapy 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 (100 mg/day) which should be increased to an initial therapeutic dose of 100 mg twice a day (200 mg/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 200 mg twice a day (400 mg/day).
Children from 4 years of age and adolescents weighing less than 50 kg: The dose is determined based on body weight. It is therefore recommended to initiate treatment with the syrup and switch to tablets, if desired. When prescribing the syrup, the dose should be expressed in volume (ml) rather than weight (mg).
Monotherapy (in the treatment of partial-onset seizures): The recommended starting dose is 1 mg/kg twice a day (2 mg/kg/day) which should be increased to an initial therapeutic dose of 2 mg/kg twice a day (4 mg/kg/day) after one week.
Depending on response and tolerability, the maintenance dose can be further increased by 1 mg/kg twice a day (2 mg/kg/day) every week. The dose should be gradually increased until the optimum response is obtained. The lowest effective dose should be used. In children weighing from 10 kg to less than 40 kg, a maximum dose of up to 6 mg/kg twice a day (12 mg/kg/day) is recommended. In children weighing from 40 to under 50 kg, a maximum dose of 5 mg/kg twice a day (10 mg/kg/day) is recommended.
Tables 4 and 5 provide examples of volumes of syrup per intake or volumes of solution for infusion per administration depending on prescribed dose and body weight. The precise volume of syrup or solution for infusion is to be calculated according to the exact body weight of the child. The calculated volume of syrup should be rounded to the nearest measuring device graduated increment. If the calculated volume of syrup is equidistant between two graduated increments, the larger graduated increment should be used (see Method of administration as follows). (See Tables 4 and 5.)
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Click on icon to see table/diagram/imageAdjunctive therapy (in the treatment of partial-onset seizures or in the treatment of primary generalised tonic-clonic seizures): The recommended starting dose is 1 mg/kg twice a day (2 mg/kg/day) which should be increased to an initial therapeutic dose of 2 mg/kg twice a day (4 mg/kg/day) after one week.
Depending on response and tolerability, the maintenance dose can be further increased by 1 mg/kg twice a day (2 mg/kg/day) every week. The dose should be gradually adjusted until the optimum response is obtained. The lowest effective dose should be used. Due to an increased clearance compared to adults, in children weighing from 10 kg to less than 20 kg, a maximum dose of up to 6 mg/kg twice a day (12 mg/kg/day) is recommended. In children weighing from 20 to under 30 kg, a maximum dose of 5 mg/kg twice a day (10 mg/kg/day) is recommended and in children weighing from 30 to under 50 kg, a maximum dose of 4 mg/kg twice a day (8 mg/kg/day) is recommended, although in open-label studies (see Adverse Reactions and Pharmacology: Pharmacokinetics under Actions), a dose up to 6 mg/kg twice a day (12 mg/kg/day) has been used by a small number of children from this latter group.
Tables 6, 7 and 8 provide examples of volumes of syrup per intake or volumes of solution for infusion per administration depending on prescribed dose and body weight. The precise volume of syrup or solution for infusion is to be calculated according to the exact body weight of the child. The calculated volume of syrup should be rounded to the nearest measuring device graduated increment. If the calculated volume of syrup is equidistant between two graduated increments, the larger graduated increment should be used. (See Tables 6, 7 and 8.)
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Click on icon to see table/diagram/imageInitiation 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): In adolescents and children weighing 50 kg or more, and adults, lacosamide 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: If lacosamide has to be discontinued, it is recommended that the dose is reduced gradually in weekly decrements of 4 mg/kg/day (for patients with a body weight less than 50 kg) or 200 mg/day (for patients with a body weight of 50 kg or more) for patients who have achieved a dose of lacosamide ≥6 mg/kg/day or ≥300 mg/day, respectively. A slower taper in weekly decrements of 2 mg/kg/day or 100 mg/day can be considered, if medically necessary.
In patients who develop serious cardiac arrhythmia, clinical benefit/risk assessment should be performed and if needed lacosamide should be discontinued.
Special populations: 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 Renal impairment as follows 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 and paediatric patients (CLCR >30 ml/min). In paediatric patients weighing 50 kg or more and in adult 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 paediatric patients weighing 50 kg or more and in adult patients with severe renal impairment (CLCR ≤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. In paediatric patients weighing less than 50 kg with severe renal impairment (CLCR ≤30 ml/min) and in those with end-stage renal disease, a reduction of 25% of the maximum dose is recommended. 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 paediatric patients weighing 50 kg or more and for adult patients with mild to moderate hepatic impairment.
The dose titration in these patients should be performed with caution considering co-existing renal impairment. In adolescents and adults weighing 50 kg or more, a loading dose of 200 mg may be considered, but further dose titration (>200 mg daily) should be performed with caution. Based on data in adults, in paediatric patients weighing less than 50 kg with mild to moderate hepatic impairment, a reduction of 25% of the maximum dose should be applied. The pharmacokinetics of lacosamide has not been evaluated in severely hepatic impaired patients (see Pharmacology: Pharmacokinetics under Actions). Lacosamide should be administered to adult and paediatric 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.
Paediatric population: Lacosamide is not recommended for use in children below the age of 4 years in the treatment of primary generalized tonic-clonic seizures and in the treatment of partial-onset seizures as there is limited data on safety and efficacy in these age groups.
Loading dose: Administration of a loading dose has not been studied in children. Use of a loading dose is not recommended in adolescents and children weighing less than 50 kg.
Children less than 4 years: The safety and efficacy of lacosamide in children aged below 4 years have not yet been established. No data are available.
Method of administration: Film-coated tablet: Lacosamide film-coated tablets are for oral use. Lacosamide may be taken with or without food.
Syrup: Lacosamide syrup must be taken orally.
The bottle containing Vimpat syrup should be shaken well before use. Lacosamide may be taken with or without food.
Lacosamide syrup is provided with a 30 ml measuring cup. One full measuring cup (30 ml) corresponds to 300 mg of lacosamide. The minimum volume is 5 ml which corresponds to 50 mg of lacosamide. As from the 5 ml graduation mark, each increment corresponds to 5 ml which is 50 mg of lacosamide.
Lacosamide syrup is provided with a 10 ml oral syringe (black graduation marks) with an adaptor. One full oral syringe (10 ml) corresponds to 100 mg of lacosamide. The minimum extractable volume is 1 ml which is 10 mg of lacosamide. As from the 1 ml graduation mark, each increment corresponds to 0.25 ml which is 2.5 mg of lacosamide.
The physician should instruct the patient on the appropriate measuring device to use.
Solution for infusion: The solution for 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.
Vimpat solution for 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.
