What is the use and dosage of Oxycarbazepine (Trileptal) for treating epilepsy and bipolar disorder?

Oxcarbazepine (Trileptal) for Epilepsy and Bipolar Disorder

Oxcarbazepine is FDA-approved for epilepsy treatment as monotherapy or adjunctive therapy for partial seizures in adults and children, but has limited evidence for bipolar disorder despite some clinical use. 1

Indications

Epilepsy

• FDA-approved for use as monotherapy in adults and children aged 4 years and above with partial seizures 1
• FDA-approved for adjunctive therapy in adults and children aged 2 years and above with epilepsy 1
• Effective for both newly diagnosed and refractory partial seizures 2

Bipolar Disorder

• Not FDA-approved for bipolar disorder treatment 1
• Limited evidence suggests potential efficacy for manic symptoms in bipolar and schizoaffective disorders 3
• WHO guidelines mention carbamazepine as an option for bipolar mania, but do not specifically recommend oxcarbazepine 4

Dosing for Epilepsy

Adults

• Adjunctive Therapy:

  • Initial dose: 600 mg/day in divided doses (BID) 1
  • May increase by maximum 600 mg/day at approximately weekly intervals 1
  • Recommended daily dose: 1200 mg/day 1
  • Maximum dose: 2400 mg/day (though many patients cannot tolerate this dose due to CNS effects) 1

• Conversion to Monotherapy:

  • Initial dose: 600 mg/day (BID) while simultaneously reducing concomitant AEDs 1
  • Concomitant AEDs should be withdrawn over 3-6 weeks 1
  • Increase oxcarbazepine by maximum 600 mg/day weekly to reach 2400 mg/day 1
  • A daily dose of 1200 mg/day has been shown effective in some patients 1

• Initiation of Monotherapy:

  • Initial dose: 600 mg/day (BID) 1
  • Increase by 300 mg/day every third day to 1200 mg/day 1
  • Maximum dose: 2400 mg/day 1

Pediatric Patients

• Adjunctive Therapy (Ages 2-16 years):

  • Ages 4-16 years: Initial dose 8-10 mg/kg/day (not exceeding 600 mg/day) in BID regimen 1
  • Target maintenance dose based on weight:
    • 20-29 kg: 900 mg/day
    • 29.1-39 kg: 1200 mg/day

    • 39 kg: 1800 mg/day 1

  • Ages 2-4 years: Initial dose 8-10 mg/kg/day (not exceeding 600 mg/day) in BID regimen 1
  • For patients under 20 kg, consider 16-20 mg/kg starting dose 1
  • Maximum maintenance dose: 60 mg/kg/day in BID regimen 1

• Conversion to Monotherapy (Ages 4-16 years):

  • Initial dose: 8-10 mg/kg/day in BID regimen while reducing concomitant AEDs 1
  • Increase by maximum 10 mg/kg/day weekly as clinically indicated 1

• Initiation of Monotherapy (Ages 4-16 years):

  • Initial dose: 8-10 mg/kg/day in BID regimen 1
  • Increase by 5 mg/kg/day every third day to recommended dose 1

Special Populations

Renal Impairment

• For creatinine clearance <30 mL/min: Start with half the usual dose (300 mg/day) and increase slowly 1

Hepatic Impairment

• No dose adjustments required for mild-to-moderate hepatic impairment 1

Dosing for Bipolar Disorder

• No FDA-approved dosing regimen for bipolar disorder 1
• Limited evidence suggests similar dosing to epilepsy treatment may be effective for manic symptoms 3
• WHO guidelines recommend lithium, valproate, or carbamazepine for bipolar mania, with haloperidol as an alternative 4

Administration

• Can be taken with or without food 1
• Oral suspension and film-coated tablets may be interchanged at equal doses 1
• For better tolerability, medication can be taken at bedtime to minimize dizziness 4

Monitoring and Safety

• Monitor serum sodium levels, especially in patients:
  • With renal disease
  • Taking medications that may lower sodium (diuretics, oral contraceptives, NSAIDs)
  • Showing symptoms of hyponatremia 5
• Hyponatremia occurs in approximately 3% of patients 5
• Consider HLA-B*15:02 screening before initiating treatment, especially in patients of Han Chinese descent, to reduce risk of Stevens-Johnson syndrome/toxic epidermal necrolysis 4
• Common adverse effects include somnolence, dizziness, headache, nausea, and vomiting 2
• Oxcarbazepine decreases plasma levels of oral contraceptives; alternative contraceptive methods should be used 6

Pregnancy Considerations

• Prenatal exposure to antiepileptic drugs may increase risk of adverse fetal outcomes 4
• For female patients with mild manifestations, consider discontinuing therapy prior to or during pregnancy 4
• Comprehensive risk-benefit evaluation should be conducted prior to conception 4