What is the appropriate maintenance dose of Focale (levetiracetam) for a 12-year-old patient weighing 75kg?

Levetiracetam Maintenance Dosing for a 12-Year-Old, 75kg Patient

For a 12-year-old weighing 75kg, the appropriate maintenance dose of Focale (levetiracetam) is 1500 mg twice daily (3000 mg/day total), which can be administered as three 500mg tablets twice daily.

Weight-Based Dosing Algorithm

Since this patient weighs >40 kg, they fall into the adult dosing category per FDA guidelines 1:

• Initial dose: 500 mg twice daily (1000 mg/day total) 1
• Titration: Increase by 1000 mg/day every 2 weeks 1
• Target maintenance dose: 1500 mg twice daily (3000 mg/day total) 1

The FDA label specifically states that for pediatric patients >40 kg, the recommended daily dose is 3000 mg/day (administered as 2 × 750 mg tablets BID, or equivalently 3 × 500 mg tablets BID) 1.

Clinical Context for Seizure Type

For Partial Onset Seizures

• Patients >40 kg should receive 3000 mg/day divided twice daily as the target maintenance dose 1
• This represents 40 mg/kg/day for this 75kg patient, which is within the recommended range 1

For Primary Generalized Tonic-Clonic Seizures

• The same dosing applies: 3000 mg/day (1500 mg BID) for patients >40 kg 1
• Doses lower than 3000 mg/day have not been adequately studied for efficacy 1

For Myoclonic Seizures (if applicable at age 12+)

• Target dose remains 3000 mg/day (1500 mg BID) 1
• Effectiveness of lower doses has not been established 1

Practical Administration

Using 500mg tablets (Focale 500mg):

• Morning dose: 3 tablets (1500 mg)
• Evening dose: 3 tablets (1500 mg)
• Can be taken with or without food 1

Important Caveats

Renal Function Considerations

• Critical: Levetiracetam is primarily renally cleared, and dose adjustments are necessary in renal dysfunction 2, 3
• If this patient has any renal impairment, doses must be reduced based on creatinine clearance 1
• In patients with CrCl 10-30 mL/min, maintenance dosing should be reduced to 500-1000 mg every 12 hours 1

Titration Timeline

• Do not start at the full 3000 mg/day dose 1
• Begin with 1000 mg/day (500 mg BID) and increase by 1000 mg/day increments every 2 weeks 1
• This gradual titration minimizes CNS-related adverse effects (somnolence, asthenia, dizziness) that occur predominantly in the first 4 weeks 4

Maximum Dosing

• While 3000 mg/day is the recommended dose, doses up to 4500 mg have been used in open-label studies 1
• However, there is no evidence that doses >3000 mg/day confer additional benefit 1
• Recent evidence suggests that for status epilepticus, loading doses of 40 mg/kg (3000 mg for this patient) provide adequate therapeutic levels 5

Common Pitfalls to Avoid

• Underdosing: The American Academy of Neurology warns against using prophylactic doses when therapeutic doses are needed 2
• Inadequate measuring: Only whole tablets should be administered; do not split tablets 1
• Premature discontinuation: Most adverse effects are mild-to-moderate and occur in the first 4 weeks of treatment 4