Active Ingredient: Levetiracetam
Levetiracetam is indicated as adjunctive therapy:
• in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy.
• in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with
Juvenile Myoclonic Epilepsy.
• in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
In the case that 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. Refer to Paediatric population section for dosing adjustments based on weight.
If levetiracetam has to be discontinued it is recommended to withdraw it gradually (e.g. in adults weighing more than 50 kg: 500 mg decreases twice daily every two to four weeks).
For:
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.
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 weighing more than 50 kg: 500 mg decreases twice daily every two to four weeks).
For:
Regimen A, in the case that patient weight is ≥ 50 kg :
Oral, 500 milligrams levetiracetam, 2 times daily, over the duration of 2 weeks. Afterwards, oral, between 500 milligrams levetiracetam and 1,500 milligrams levetiracetam, 2 times daily.
Regimen B, in the case that patient weight is < 50 kg :
Oral, 10 milligrams levetiracetam per kilogram of body weight, 2 times daily, over the duration of 2 weeks. Afterwards, oral, between 10 milligrams levetiracetam per kilogram of body weight and 30 milligrams levetiracetam per kilogram of body weight, 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 initial therapeutic dose is 10 mg/kg twice daily.
Depending upon the clinical response and tolerability, the dose can be increased by 10 mg/kg twice daily every 2 weeks up to 30 mg/kg twice daily. Dose changes should not exceed increases or decreases of 10 mg/kg twice daily every two weeks. The lowest effective dose should be used for all indications.
Dose recommendations for adolescents:
| Weight | Starting dose: 10 mg/kg twice daily | Maximum dose: 30 mg/kg twice daily |
| 25 kg | 250 mg twice daily | 750 mg twice daily |
| From 50 kg1 | 500 mg twice daily | 1500 mg twice daily |
1 Dose in children and adolescents 50 kg or more is the same as in adults.
If levetiracetam has to be discontinued it is recommended to withdraw it gradually (e.g. in 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:
Regimen A, in the case that patient weight is ≥ 50 kg :
Intravenous, 500 milligrams levetiracetam, 2 times daily, over the duration of 2 weeks. Afterwards, intravenous, between 500 milligrams levetiracetam and 1,500 milligrams levetiracetam, 2 times daily.
Regimen B, in the case that patient weight is < 50 kg :
Intravenous, 10 milligrams levetiracetam per kilogram of body weight, 2 times daily, over the duration of 2 weeks. Afterwards, intravenous, between 10 milligrams levetiracetam per kilogram of body weight and 30 milligrams levetiracetam per kilogram of body weight, 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 initial therapeutic dose is 10 mg/kg twice daily.
Depending upon the clinical response and tolerability, the dose can be increased by 10 mg/kg twice daily every 2 weeks up to 30 mg/kg twice daily. Dose changes should not exceed increases or decreases of 10 mg/kg twice daily every two weeks. The lowest effective dose should be used for all indications.
Dose recommendations for adolescents:
| Weight | Starting dose: 10 mg/kg twice daily | Maximum dose: 30 mg/kg twice daily |
| 25 kg | 250 mg twice daily | 750 mg twice daily |
| From 50 kg1 | 500 mg twice daily | 1500 mg twice daily |
1 Dose in children and adolescents 50 kg or more is the same as in adults.
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).
For:
Oral, 10 milligrams levetiracetam per kilogram of body weight, 2 times daily, over the duration of 2 weeks. Afterwards, oral, between 10 milligrams levetiracetam per kilogram of body weight and 30 milligrams levetiracetam per kilogram of body weight, 2 times daily.
The initial therapeutic dose is 10 mg/kg twice daily.
Depending upon the clinical response and tolerability, the dose can be increased by 10 mg/kg twice daily every 2 weeks up to 30 mg/kg twice daily. Dose changes should not exceed increases or decreases of 10 mg/kg twice daily every two weeks. The lowest effective dose should be used for all indications.
Dose in children 50 kg or greater is the same as in adults for all indications.
Dose recommendations for infants from 6 months of age, children and adolescents:
| Weight | Starting dose: 10 mg/kg twice daily | Maximum dose: 30 mg/kg twice daily |
| 6 kg1 | 60 mg twice daily | 180 mg twice daily |
| 10 kg1 | 100 mg twice daily | 300 mg twice daily |
| 15 kg1 | 150 mg twice daily | 450 mg twice daily |
| 20 kg1 | 200 mg twice daily | 600 mg twice daily |
| 25 kg | 250 mg twice daily | 750 mg twice daily |
| From 50 kg2 | 500 mg twice daily | 1500 mg twice daily |
1 Children 25 kg or less should preferably start the treatment with Keppra 100 mg/ml oral solution.
2 Dose in children and adolescents 50 kg or more is the same as in adults.
For:
In the case that patient age in years is ≥ 4 and patient age in years is ≤ 11 and patient weight is < 50 kg :
Intravenous, 10 milligrams levetiracetam per kilogram of body weight, 2 times daily, over the duration of 2 weeks. Afterwards, intravenous, between 10 milligrams levetiracetam per kilogram of body weight and 30 milligrams levetiracetam per kilogram of body weight, 2 times daily.
The initial therapeutic dose is 10 mg/kg twice daily.
Depending upon the clinical response and tolerability, the dose can be increased up to 30 mg/kg twice daily. Dose changes should not exceed increases or decreases of 10 mg/kg twice daily every two weeks. The lowest effective dose should be used for all indications.
Dose in children 50 kg or greater is the same as in adults for all indications.
Dose recommendations:
| Weight | Starting dose: 10 mg/kg twice daily | Maximum dose: 30 mg/kg twice daily |
| 15 kg1 | 150 mg twice daily | 450 mg twice daily |
| 20 kg1 | 200 mg twice daily | 600 mg twice daily |
| 25 kg | 250 mg twice daily | 750 mg twice daily |
| From 50 kg2 | 500 mg twice daily | 1500 mg twice daily |
1 Children 25 kg or less should preferably start the treatment with the oral solution.
2 Dose in children 50 kg or more is the same as in adults.
For:
Regimen A, in the case that patient age in months is ≥ 6 :
Oral, 10 milligrams levetiracetam per kilogram of body weight, 2 times daily, over the duration of 2 weeks. Afterwards, oral, between 10 milligrams levetiracetam per kilogram of body weight and 30 milligrams levetiracetam per kilogram of body weight, 2 times daily.
Regimen B, in the case that patient age in months is ≥ 1 and patient age in months is < 6 :
Oral, 7 milligrams levetiracetam per kilogram of body weight, 2 times daily, over the duration of 2 weeks. Afterwards, oral, between 7 milligrams levetiracetam per kilogram of body weight and 21 milligrams levetiracetam per kilogram of body weight, 2 times daily.
The initial therapeutic dose is 10 mg/kg twice daily.
Depending upon the clinical response and tolerability, the dose can be increased by 10 mg/kg twice daily every 2 weeks up to 30 mg/kg twice daily. Dose changes should not exceed increases or decreases of 10 mg/kg twice daily every two weeks. The lowest effective dose should be used for all indications.
Dose in children 50 kg or greater is the same as in adults for all indications.
Please refer to the above section on Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more for all indications.
Dose recommendations for infants from 6 months of age, children and adolescents:
| Weight | Starting dose: 10 mg/kg twice daily | Maximum dose: 30 mg/kg twice daily |
| 6 kg1 | 60 mg twice daily | 180 mg twice daily |
| 10 kg1 | 100 mg twice daily | 300 mg twice daily |
| 15 kg1 | 150 mg twice daily | 450 mg twice daily |
1 Children 25 kg or less should preferably start the treatment with levetiracetam oral solution.
The initial therapeutic dose is 7 mg/kg twice daily.
Depending upon the clinical response and tolerability, the dose can be increased by 7 mg/kg twice daily every 2 weeks up to recommended dose of 21 mg/kg twice daily. Dose changes should not exceed increases or decreases of 7 mg/kg twice daily every two weeks. The lowest effective dose should be used.
Infants should start the treatment with levetiracetam oral solution.
Dose recommendations for infants aged from 1 month to less than 6 months:
| Weight | Starting dose: 7 mg/kg twice daily | Maximum dose: 21 mg/kg twice daily |
| 4 kg | 28 mg twice daily | 84 mg twice daily |
| 5 kg | 35 mg twice daily | 105 mg twice daily |
| 7 kg | 49 mg twice daily | 147 mg twice daily |
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