Original GlobalRPh source
- Product / population
- Preserved GlobalRPh source, not a freshly verified product label
- Renal measure
- Use the method specified in the original source
Historical source: not automatically current. Review current official labeling and separately attributed additions before use.
Historical GlobalRPh table transcription. Verify the exact current product label and whether its creatinine-clearance table is indexed to body surface area before applying it.
Indications and formulation
The source describes KEPPRA adjunctive treatment for partial-onset seizures from age 4 years, myoclonic seizures in juvenile myoclonic epilepsy from age 12 years, and primary generalized tonic-clonic seizures from age 6 years. These recommendations describe immediate-release tablets/oral solution, not extended-release products. Tablets are swallowed whole; treatment may be taken with or without food.
Partial-onset seizures
Adults and adolescents age 16 years or older: start 500 mg twice daily. Increase the total daily dose by 1,000 mg every 2 weeks to 3,000 mg/day. Trials demonstrated efficacy at 1,000, 2,000 and 3,000 mg/day, divided twice daily, without a consistent incremental benefit at higher doses. Doses above 3,000 mg/day were used in open-label treatment for 6 months or longer, but the source reports no evidence of additional benefit.
Children age 4 to under 16 years: start 10 mg/kg twice daily (20 mg/kg/day); increase by 20 mg/kg/day every 2 weeks to 30 mg/kg twice daily (60 mg/kg/day). Reduce if not tolerated. The mean daily dose in the referenced trial was 52 mg/kg/day.
Children weighing 20 kg or less should receive oral solution; those above 20 kg may receive tablets or solution. The source's tablet dosing table gives these twice-daily doses for total daily targets of 20, 40 and 60 mg/kg/day respectively:
- Weight 20.1-40 kg: 250, 500 and 750 mg twice daily (500, 1,000 and 1,500 mg/day).
- Weight over 40 kg: 500, 1,000 and 1,500 mg twice daily (1,000, 2,000 and 3,000 mg/day).
Oral solution volume per day (mL) = prescribed daily dose (mg/kg/day) x body weight (kg) / 100 mg/mL. Use a calibrated measuring device, not a household spoon.
Myoclonic and primary generalized tonic-clonic seizures
Myoclonic seizures, age 12 years or older: start 500 mg twice daily; increase by 1,000 mg/day every 2 weeks to 3,000 mg/day. Lower doses were not studied for effectiveness in this indication.
Primary generalized tonic-clonic seizures, age 16 years or older: the same 500 mg twice-daily start and 1,000 mg/day increases every 2 weeks to 3,000 mg/day; effectiveness at lower doses has not been adequately studied.
Primary generalized tonic-clonic seizures, age 6 to under 16: start 20 mg/kg/day divided twice daily; increase by 20 mg/kg/day every 2 weeks to 60 mg/kg/day. Effectiveness below 60 mg/kg/day was not adequately studied. Use solution for patients at or below 20 kg; swallow tablets whole.
Renal Dosing
The source lists adult creatinine-clearance bands in mL/min:
- Above 80: 500-1,500 mg every 12 hours.
- 50-80: 500-1,000 mg every 12 hours.
- 30-50: 250-750 mg every 12 hours.
- Below 30: 250-500 mg every 12 hours.
Hemodialysis
500-1,000 mg every 24 hours with a supplemental 250-500 mg dose after dialysis.