Maximum Dose of Levetiracetam
The maximum recommended dose of levetiracetam for adults and children over 12 years is 3000 mg/day (given as 1500 mg twice daily), though higher doses up to 60 mg/kg/day in children have been studied and may be tolerated in refractory cases. 1
FDA-Approved Maximum Dosing
Adults and Adolescents ≥16 Years
- Maximum daily dose: 3000 mg/day (1500 mg BID) for partial onset seizures 1
- Treatment starts at 1000 mg/day and increases by 1000 mg/day increments every 2 weeks 1
- Doses greater than 3000 mg/day have been used in open-label studies for 6+ months, but there is no evidence that doses above 3000 mg/day confer additional benefit 1
Adolescents 12-15 Years
- Maximum daily dose: 60 mg/kg/day (30 mg/kg BID) for partial onset seizures 1
- For patients >40 kg, this translates to 3000 mg/day maximum (same as adults) 1
- For myoclonic seizures in patients ≥12 years: 3000 mg/day is the recommended dose 1
Pediatric Dosing (Ages 4-15 Years)
- Maximum recommended dose: 60 mg/kg/day (30 mg/kg BID) 1
- Start at 20 mg/kg/day and increase by 20 mg/kg increments every 2 weeks 1
- If 60 mg/kg/day is not tolerated, the dose may be reduced; mean daily dose in clinical trials was 52 mg/kg 1
Higher Doses in Refractory Cases
While not FDA-approved, research demonstrates that some children may benefit from and tolerate doses exceeding the standard maximum:
- Doses up to 275 mg/kg/day have been used in pediatric refractory epilepsy with a median of 146 mg/kg/day 2
- In this cohort, 44% achieved >50% seizure reduction and 16% became seizure-free at these higher doses 2
- Only 12% experienced adverse effects (all behavioral) at these elevated doses 2
- These higher doses should only be considered in children who partially respond to standard doses of 60 mg/kg/day 2
Special Situations
Loading Doses for Acute Seizure Management
- 20-60 mg/kg IV loading doses are safe and effective for status epilepticus 3
- Adult loading doses of 2500 mg IV showed 83% seizure termination within 24 hours 3
CAR T-Cell Therapy Prophylaxis
- 10 mg/kg (maximum 500 mg per dose) every 12 hours for 30 days following infusion 4
- This lower prophylactic dose is specifically for seizure prevention, not treatment 4
Important Caveats
- Renal adjustment required: Dose modifications are necessary in renal dysfunction 4
- No dose-response relationship: Within the 1000-3000 mg/day range in adults, higher doses do not consistently show greater efficacy 1, 5
- Tolerability profile: Most adverse events are CNS-related (somnolence, asthenia, headache, dizziness) and occur predominantly in the first 4 weeks 6
- Pediatric considerations: Children have 30-40% higher apparent body clearance than adults, requiring weight-adjusted doses that are 130-140% of adult doses on a mg/kg basis 7