Active Ingredient: Lacosamide
Lacosamide is indicated as adjunctive therapy in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 50 milligrams lacosamide, 2 times daily, over the duration of 1 week. Afterwards, oral, between 100 milligrams lacosamide and 200 milligrams lacosamide, 2 times daily. The maximum allowed total dose is 400 milligrams lacosamide daily.
Lacosamide 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.
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).
If lacosamide has to be discontinued, it is recommended that the dose is reduced gradually in weekly decrements of 200 mg/day for patients who have achieved a dose of lacosamide ≥300 mg/day. A slower taper in weekly decrements of 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.
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. There is limited clinical data in the elderly patients with epilepsy, particularly at doses greater than 400 mg/day.
Lacosamide may be taken with or without food.
For:
Regimen A: In case that patient weight is ≥ 50 kg, oral, 50 milligrams lacosamide, 2 times daily, over the duration of 1 week. Afterwards, in case that patient weight is ≥ 50 kg, oral, between 100 milligrams lacosamide and 200 milligrams lacosamide, 2 times daily.
Regimen B: In case that patient weight is ≥ 10 kg and patient weight is ≤ 20 kg, oral, 1 milligrams lacosamide per kilogram of body weight, 2 times daily, over the duration of 1 week. Afterwards, in case that patient weight is ≥ 10 kg and patient weight is ≤ 20 kg, oral, between 2 milligrams lacosamide per kilogram of body weight and 6 milligrams lacosamide per kilogram of body weight, 2 times daily. The maximum allowed total dose is 12 milligrams lacosamide per kilogram of body weight daily.
Regimen C: In case that patient weight is ≥ 20 kg and patient weight is ≤ 30 kg, oral, 1 milligrams lacosamide per kilogram of body weight, 2 times daily, over the duration of 1 week. Afterwards, in case that patient weight is ≥ 20 kg and patient weight is ≤ 30 kg, oral, between 2 milligrams lacosamide per kilogram of body weight and 5 milligrams lacosamide per kilogram of body weight, 2 times daily. The maximum allowed total dose is 10 milligrams lacosamide per kilogram of body weight daily.
Regimen D: In case that patient weight is ≥ 30 kg and patient weight is ≤ 50 kg, oral, 1 milligrams lacosamide per kilogram of body weight, 2 times daily, over the duration of 1 week. Afterwards, in case that patient weight is ≥ 30 kg and patient weight is ≤ 50 kg, oral, between 2 milligrams lacosamide per kilogram of body weight and 4 milligrams lacosamide per kilogram of body weight, 2 times daily.
Lacosamide 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.
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).
The dose is determined based on body weight. It is therefore recommended to initiate treatment with the syrup and switch to tablets, if desired.
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, 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.
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 who have achieved a dose of lacosamide ≥6 mg/kg/day. A slower taper in weekly decrements of 2 mg/kg/day, if medically necessary.
In patients who develop serious cardiac arrhythmia, clinical benefit/risk assessment should be performed and if needed lacosamide should be discontinued.
Lacosamide may be taken with or without food.
For:
Intravenous, 50 milligrams lacosamide, 2 times daily, over the duration of 1 week. Afterwards, intravenous, between 100 milligrams lacosamide and 200 milligrams lacosamide, 2 times daily. The maximum allowed total dose is 400 milligrams lacosamide daily.
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.
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).
If lacosamide has to be discontinued, it is recommended that the dose is reduced gradually in weekly decrements of 200 mg/day for patients who have achieved a dose of lacosamide ≥300 mg/day. A slower taper in weekly decrements of 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.
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. There is limited clinical data in the elderly patients with epilepsy, particularly at doses greater than 400 mg/day.
Lacosamide may be taken with or without food.
For:
Regimen A: In case that patient weight is ≥ 50 kg, intravenous, 50 milligrams lacosamide, 2 times daily, over the duration of 1 week. Afterwards, in case that patient weight is ≥ 50 kg, intravenous, between 100 milligrams lacosamide and 200 milligrams lacosamide, 2 times daily. The maximum allowed total dose is 400 milligrams lacosamide daily.
Regimen B: In case that patient weight is ≥ 10 kg and patient weight is ≤ 20 kg, intravenous, 1 milligrams lacosamide per kilogram of body weight, 2 times daily, over the duration of 1 week. Afterwards, in case that patient weight is ≥ 10 kg and patient weight is ≤ 20 kg, intravenous, between 2 milligrams lacosamide per kilogram of body weight and 6 milligrams lacosamide per kilogram of body weight, 2 times daily. The maximum allowed total dose is 12 milligrams lacosamide per kilogram of body weight daily.
Regimen C: In case that patient weight is ≥ 20 kg and patient weight is ≤ 30 kg, intravenous, 1 milligrams lacosamide per kilogram of body weight, 2 times daily, over the duration of 1 week. Afterwards, in case that patient weight is ≥ 20 kg and patient weight is ≤ 30 kg, intravenous, between 2 milligrams lacosamide per kilogram of body weight and 5 milligrams lacosamide per kilogram of body weight, 2 times daily. The maximum allowed total dose is 10 milligrams lacosamide per kilogram of body weight daily.
Regimen D: In case that patient weight is ≥ 30 kg and patient weight is ≤ 50 kg, intravenous, 1 milligrams lacosamide per kilogram of body weight, 2 times daily, over the duration of 1 week. Afterwards, in case that patient weight is ≥ 30 kg and patient weight is ≤ 50 kg, intravenous, between 2 milligrams lacosamide per kilogram of body weight and 4 milligrams lacosamide per kilogram of body weight, 2 times daily. The maximum allowed total dose is 8 milligrams lacosamide per kilogram of body weight daily.
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.
Lacosamide must be taken twice a day (approximately 12 hours apart).
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).
The dose is determined based on body weight. It is therefore recommended to initiate treatment with the syrup and switch to tablets, if desired.
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, 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.
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 who have achieved a dose of lacosamide ≥6 mg/kg/day. A slower taper in weekly decrements of 2 mg/kg/day, if medically necessary.
In patients who develop serious cardiac arrhythmia, clinical benefit/risk assessment should be performed and if needed lacosamide should be discontinued.
Lacosamide may be taken with or without food.
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