Active Ingredient: Levetiracetam
Levetiracetam is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
In the case that patient age in years is ≥ 16 and patient weight is ≥ 50 kg :
Oral, 500 milligrams levetiracetam, 2 times daily, over the duration of 2 weeks. Afterwards, oral, between 250 milligrams levetiracetam and 1,500 milligrams levetiracetam, 2 times daily.
The initial therapeutic dose is 500 mg twice daily. This dose can be started on the first day of treatment. However, a lower initial dose of 250 mg twice daily may be given based on physician assessment of seizure reduction versus potential side effects. This can be increased to 500 mg twice daily after two weeks.
Depending upon the clinical response and tolerability, the daily dose can be increased up to 1500 mg twice daily. Dose changes can be made in 250 mg or 500 mg twice daily increases or decreases every two to four weeks.
The physician should prescribe the most appropriate pharmaceutical form, presentation and strength according to weight, age and dose.
If levetiracetam has to be discontinued it is recommended to withdraw it gradually (e.g. in adults and adolescents weighing more than 50 kg: 500 mg decreases twice daily every two to four weeks; in adolescents weighing less than 50 kg: dose decrease should not exceed 10 mg/kg twice daily every two weeks).
For:
In the case that patient age in years is ≥ 16 and patient weight is ≥ 50 kg :
Intravenous, 500 milligrams levetiracetam, 2 times daily, over the duration of 2 weeks. Afterwards, intravenous, between 250 milligrams levetiracetam and 1,500 milligrams levetiracetam, 2 times daily.
The initial therapeutic dose is 500 mg twice daily. This dose can be started on the first day of treatment. However, a lower initial dose of 250 mg twice daily may be given based on physician assessment of seizure reduction versus potential side effects. This can be increased to 500 mg twice daily after two weeks.
Depending upon the clinical response and tolerability, the daily dose can be increased up to 1500 mg twice daily. Dose changes can be made in 250 mg or 500 mg twice daily increases or decreases every two to four weeks.
The physician should prescribe the most appropriate pharmaceutical form, presentation and strength according to weight, age and dose. Refer to Paediatric population section for dosing adjustments based on weight.
There is no experience with administration of intravenous levetiracetam for longer period than 4 days.
If levetiracetam has to be discontinued it is recommended to withdraw it gradually (e.g. in adults and adolescents weighing more than 50 kg: 500 mg decreases twice daily every two to four weeks; in adolescents weighing less than 50 kg: dose decrease should not exceed 10 mg/kg twice daily every two weeks).
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