Active Ingredient: Eslicarbazepine
Eslicarbazepine is indicated as:
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 400 milligrams eslicarbazepine, once daily, over the duration of 1 to 2 weeks. Afterwards, oral, 800 milligrams eslicarbazepine, once daily. The maximum allowed total dose is 1,200 milligrams eslicarbazepine daily.
Eslicarbazepine may be taken as monotherapy or added to existing anticonvulsant therapy. The recommended starting dose is 400 mg once daily which should be increased to 800 mg once daily after one or two weeks. Based on individual response, the dose may be increased to 1,200 mg once daily. Some patients on monotherapy regimen may benefit from a dose of 1,600 mg once daily.
No dose adjustment is needed in the elderly population provided that the renal function is not disturbed. Due to very limited data on the 1,600 mg monotherapy regimen in the elderly, this dose is not recommended for this population.
It may be taken with or without food.
For patients who are unable to swallow whole tablets, the tablets may be crushed and mixed with water or soft foods, such as apple sauce, immediately prior to use and administered orally.
For:
Regimen A: Oral, 10 milligrams eslicarbazepine per kilogram of body weight, once daily, over the duration of 1 to 2 weeks. Afterwards, oral, between 20 milligrams eslicarbazepine per kilogram of body weight and 40 milligrams eslicarbazepine per kilogram of body weight, once daily, over the duration of 1 to 2 weeks.
Regimen B: In case that patient weight is ≥ 60 kg, oral, 400 milligrams eslicarbazepine, once daily, over the duration of 1 to 2 weeks. Afterwards, in case that patient weight is ≥ 60 kg, oral, 800 milligrams eslicarbazepine, once daily, over the duration of 2 weeks. The maximum allowed total dose is 1,200 milligrams eslicarbazepine daily.
Children above 6 years of age: The recommended starting dose is 10 mg/kg/day once daily. Dosage should be increased in weekly or bi-weekly increments of 10 mg/kg/day up to 30 mg/kg/day, based on individual response. The maximum dose is 1,200 mg once daily.
Children with a body weight of ≥60 kg: Children with a body weight of 60 kg or more should be given the same dose as for adults. Eslicarbazepine may be taken as monotherapy or added to existing anticonvulsant therapy. The recommended starting dose is 400 mg once daily which should be increased to 800 mg once daily after one or two weeks. Based on individual response, the dose may be increased to 1,200 mg once daily. Some patients on monotherapy regimen may benefit from a dose of 1,600 mg once daily.
The safety and efficacy of eslicarbazepine acetate in children aged 6 years and below has not yet been established.
It may be taken with or without food.
For patients who are unable to swallow whole tablets, the tablets may be crushed and mixed with water or soft foods, such as apple sauce, immediately prior to use and administered orally.
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