Active Ingredient: Lacosamide
Lacosamide is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Oral, 50 milligrams lacosamide, 2 times daily, over the duration of 1 week. Afterwards, oral, between 100 milligrams lacosamide and 300 milligrams lacosamide, 2 times daily. The maximum allowed total dose is 600 milligrams lacosamide daily.
Regimen B: Oral, 100 milligrams lacosamide, 2 times daily, over the duration of 1 week. Afterwards, oral, between 100 milligrams lacosamide and 300 milligrams lacosamide, 2 times daily. The maximum allowed total dose is 600 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.
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 below should be followed.
In 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 above. 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. Administration of a loading dose has not been studied in acute conditions such as status epilepticus.
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, respectively. 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. The maximum allowed total dose is 600 milligrams lacosamide daily. Afterwards, in case that patient weight is ≥ 50 kg, oral, between 100 milligrams lacosamide and 300 milligrams lacosamide, 2 times daily. The maximum allowed total dose is 600 milligrams lacosamide daily.
Regimen B: In case that patient weight is ≥ 50 kg, oral, 100 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 300 milligrams lacosamide, 2 times daily. The maximum allowed total dose is 600 milligrams lacosamide daily.
Regimen C: In case that patient weight is ≥ 10 kg and patient weight is ≤ 40 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 ≤ 40 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 D: In case that patient weight is ≥ 40 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 ≥ 40 kg and patient weight is ≤ 50 kg, oral, between 1 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.
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.
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 below should be followed.
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).
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.
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 above. 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. Administration of a loading dose has not been studied in acute conditions such as status epilepticus.
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 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.
Lacosamide may be taken with or without food.
For:
Regimen A: Intravenous, 50 milligrams lacosamide, 2 times daily, over the duration of 1 week. Afterwards, intravenous, between 100 milligrams lacosamide and 300 milligrams lacosamide, 2 times daily. The maximum allowed total dose is 600 milligrams lacosamide daily.
Regimen B: Intravenous, 100 milligrams lacosamide, 2 times daily, over the duration of 1 week. Afterwards, intravenous, between 100 milligrams lacosamide and 300 milligrams lacosamide, 2 times daily.
Lacosamide therapy can be initiated with either oral administration or intravenous administration. 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.
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 below should be followed.
In 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 above. 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. Administration of a loading dose has not been studied in acute conditions such as status epilepticus.
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 300 milligrams lacosamide, 2 times daily. The maximum allowed total dose is 600 milligrams lacosamide daily.
Regimen B: In case that patient weight is ≥ 50 kg, intravenous, 100 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 300 milligrams lacosamide, 2 times daily. The maximum allowed total dose is 600 milligrams lacosamide daily.
Regimen C: In case that patient weight is ≥ 10 kg and patient weight is ≤ 40 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 ≤ 40 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 D: In case that patient weight is ≥ 40 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 ≥ 40 kg and patient weight is ≤ 50 kg, intravenous, between 1 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.
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).
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.
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 below should be followed.
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).
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.
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 above. 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. Administration of a loading dose has not been studied in acute conditions such as status epilepticus.
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 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.
Lacosamide may be taken with or without food.
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