What is the recommended per kilogram (kg) dose of Oxcarbamazepine (Trileptal)?

Oxcarbazepine Per Kilogram Dosing

For pediatric patients, initiate oxcarbazepine at 8-10 mg/kg/day divided into two doses, with the ability to titrate upward by 10 mg/kg/day at weekly intervals to a maximum maintenance dose of 60 mg/kg/day for children aged 2-4 years, or weight-based targets of 30-46 mg/kg/day for older children. 1

Pediatric Dosing by Age Group

Children Aged 4-16 Years (Adjunctive Therapy)

• Initial dose: 8-10 mg/kg/day (generally not exceeding 600 mg/day), given in twice-daily dosing 1
• Titration schedule: Increase dose over 2 weeks to reach weight-based maintenance targets 1
• Weight-based maintenance targets: 1
  • 20-29 kg: 900 mg/day
  • 29.1-39 kg: 1200 mg/day

  • 39 kg: 1800 mg/day

• Clinical trial data showed median daily doses of 31 mg/kg (range 6-51 mg/kg) 1

Children Aged 2 to <4 Years (Adjunctive Therapy)

• Initial dose: 8-10 mg/kg/day (generally not exceeding 600 mg/day) in twice-daily dosing 1
• For patients <20 kg: Consider starting dose of 16-20 mg/kg/day 1
• Maximum maintenance dose: 60 mg/kg/day divided twice daily, achieved over 2-4 weeks 1
• In clinical trials, 50% of patients in this age group reached a final dose of at least 55 mg/kg/day 1

Age-Related Pharmacokinetic Considerations

Younger children require substantially higher weight-based doses due to faster drug clearance: 1

• Children aged 2 to <4 years may require up to twice the dose per body weight compared to adults 1
• Children aged 4 to ≤12 years may require 50% higher dose per body weight compared to adults 1

Monotherapy Dosing Strategies

Conversion to Monotherapy (Ages 4-16 Years)

• Initial oxcarbazepine dose: 8-10 mg/kg/day in twice-daily dosing while simultaneously reducing concomitant antiepileptic drugs 1
• Titration: Increase by maximum increments of 10 mg/kg/day at weekly intervals 1
• Concomitant drug withdrawal: Complete over 3-6 weeks 1

Initiation of Monotherapy (Ages 4-16 Years)

• Starting dose: 8-10 mg/kg/day in twice-daily dosing 1
• Titration: Increase by 5 mg/kg/day every third day to reach recommended maintenance dose 1

Adult Dosing (For Context)

• Initial dose: 600 mg/day in twice-daily dosing 1
• Titration: May increase by maximum of 600 mg/day at weekly intervals 1
• Recommended daily dose: 1200 mg/day, though doses up to 2400 mg/day show greater effectiveness but with reduced tolerability 1

Alternative Titration Approach from Clinical Experience

Research evidence supports a more gradual titration option: 2

• Starting dose: 150 mg/day at night (or 8-10 mg/kg/day in children) 2, 3
• Slow titration: Increase by 150 mg every 2-3 days until target of 900-1200 mg/day is reached 2
• Rapid titration option: Start with up to 600 mg/day and increase by weekly increments up to 600 mg/day if necessary 2, 3

Special Population Adjustments

Renal Impairment

• For creatinine clearance <30 mL/min: Initiate at one-half the usual starting dose (300 mg/day in adults) and titrate slowly 1
• Dose adjustment may be necessary based on renal clearance 2

Hepatic Impairment

• No dose adjustment required for mild-to-moderate hepatic impairment 1, 2

Very Young Children (<4 Years)

• Clinical experience in children aged 6-45 months (mean 22.8 months) showed effective doses ranging from 14-71 mg/kg/day with a mean of 36.5 mg/kg/day 4
• 70% experienced significant seizure reduction and 50% became seizure-free 4

Critical Monitoring Considerations

• No routine safety monitoring required except for uncommon hyponatremia 2
• Consider baseline serum sodium only if patient has renal disease, takes medications that lower sodium (diuretics, oral contraceptives, NSAIDs), or has symptoms of hyponatremia 3
• Monitor serum sodium during maintenance if sodium-lowering medications are added or symptoms develop 3

Common Pitfalls to Avoid

• Underdosing young children: Failure to account for age-related differences in clearance can lead to subtherapeutic dosing in children under 12 years 1
• Contraceptive counseling: Oxcarbazepine decreases oral contraceptive effectiveness through enzyme induction; alternative contraception should be used 5
• Drug interactions: Monitor phenytoin levels as oxcarbazepine can increase phenytoin concentrations through CYP2C19 inhibition 5