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Trileptal

(oxcarbazepine)

Full Prescribing Information DailyMed Drug Information

Forms/Strengths

  • Tablets: 150 mg, 300 mg, 600 mg
  • Liquid (plum-lemon flavor): 300 mg/5 mL (60 mg/mL)

Dosing

  • Age: ≥ 4 y/o
  • Considerations: Plum-lemon flavored; Monitor for hyponatremia. Watch for sedation, dizziness, and cognitive side effects.
  • Initial Dose: 8–10 mg/kg/day in two divided doses, not to exceed 600 mg/day
  • Titration: 5 mg/kg/day every 3–7 days
  • Typical dose:

    • 20-29 kg - 900 mg/day

    • 29.1-39 kg - 1200 mg/day

    • >39 kg - 1800 mg/day

  • Max Dose: 60 mg/kg/day, do not exceed 2,400 mg/day

Quick Facts

  • Blocks voltage-sensitive sodium channels; stabilizes hyperexcited neurons
  • Can reduce clinically significant hyponatremia; monitor serum sodium regularly
  • Common side effects: dizziness, headache, nausea, somnolence, diplopia, hyponatremia
  • Lower enzyme induction and fewer drug interactions compared to carbamazepine
  • May decrease the effectiveness of hormonal contraceptives (relevant for adolescents)
  • Use caution in severe hepatic impairment; minimal data available
  • Can cause sedation – caution when driving, operating machinery, or during school hours
  • Pediatric Behavioral Note: Increasing clinical experience supports its off-label use for impulse control disorders, aggression, and ADHD-related mood dysregulation, particularly when first-line treatments have proven insufficient.

Off-Label Uses

  • Intermittent Explosive Disorder (F63.81):

    • Used when the child has recurrent episodes of impulsive, aggressive outbursts that exceed normal developmental behavior.

  • Oppositional Defiant Disorder (F91.3):

    • Appropriate when the child demonstrates a consistent pattern of defiant, disobedient, and hostile behavior toward authority figures.

  • Conduct Disorder (F91.1):

    • Considered if the aggressive or antisocial behaviors are severe and meet criteria for conduct disorder. This is generally used when the behavior is more extreme.

  • Attention-Deficit/Hyperactivity Disorder (F90.0 – F90.2):

    • If the patient has ADHD (predominantly inattentive, predominantly hyperactive-impulsive, or combined type) with marked impulsivity and secondary aggression, this code may be used. Documentation should clarify that the behavioral dysregulation is significant and not fully controlled with standard ADHD treatments.

  • Bipolar Disorder (F31.0 or F31.9):

    • In cases where the clinical picture includes mood dysregulation (such as rapid cycling or manic features) that justifies the use of a mood stabilizer, these codes might be appropriate.

  • Disruptive Mood Dysregulation Disorder (DMDD):

    • Although ICD-10 does not have a specific DMDD code, some providers use codes for other specified or unspecified childhood emotional disorders (e.g., F92.8 or F98.8, depending on the system) to capture the chronic irritability and severe temper outbursts seen in DMDD.
    • F92.8: Other mixed disorders of conduct and emotions
    • F98.8: Other specified behavioral and emotional disorders with onset in childhood and adolescence

How to Take

  • Take twice daily, at the same times each day.
  • Can be taken with or without food; taking with food may help reduce nausea.
  • Swallow the tablet whole; do not crush or chew.
  • If using the oral suspension, shake well before each dose and measure with a provided dosing syringe—do not use household spoons.
  • If a dose is missed, take it as soon as possible unless it is close to the next dose—do not double up.
  • Do not abruptly stop taking; tapering is required to prevent withdrawal seizures.

Side Effects

  • CNS: Dizziness, drowsiness, fatigue, ataxia, tremor, confusion
  • GI: Nausea, vomiting, abdominal pain
  • Hyponatremia: Can be significant (headache, nausea, confusion, fatigue)
  • Dermatologic: Rash (including SJS/TEN), potential severe cutaneous reactions
  • Potential for suicidal thoughts/behaviors

Monitoring / Labs

  • Serum sodium (due to hyponatremia risk)
  • Signs of serious skin reactions (SJS/TEN)
  • Watch for hypersensitivity (especially with carbamazepine allergy)
  • Monitor for suicidality
  • In children, weight-based dose; watch for sedation or other CNS effects
  • Renal function (dose adjustment if CrCl <30 mL/min)

Education

  • When to Call the Doctor:

    • Severe mood changes, depression, or suicidal thoughts.
    • Signs of low sodium levels (confusion, severe fatigue, headache, nausea, seizures).
    • Unusual bruising, bleeding, or signs of infection (sore throat, fever).
    • Rash, swelling, or difficulty breathing (possible allergic reaction or Stevens-Johnson Syndrome).
    • Worsening seizure frequency or severity.

  • Safety Tips:

    • Monitor sodium levels periodically, especially in elderly patients or those taking diuretics.
    • Avoid alcohol, as it may increase drowsiness and dizziness.
    • Use caution when driving or operating heavy machinery due to potential sedation.
    • Taper gradually when discontinuing to prevent seizure rebound.
    • May decrease the effectiveness of hormonal contraceptives—consider alternative birth control methods.

  • Parent Tips for Pediatric Patients:

    • Monitor for changes in mood, irritability, or unusual drowsiness.
    • If using the liquid form, ensure accurate dosing with the provided syringe.
    • Encourage adequate hydration to help prevent low sodium levels.
    • Report any rash or allergic reactions immediately.

Additional Information

  • Contraindications:

    • Hypersensitivity to oxcarbazepine or carbamazepine.
    • Use with caution in patients with renal impairment or hyponatremia.

  • Pregnancy:

    • Category C; may increase the risk of birth defects.
    • Use only if benefits outweigh risks—consider folic acid supplementation.

  • Lactation:

    • Excreted in breast milk; use with caution as it may cause drowsiness in infants.

  • Drug Interactions:

    • May decrease the effectiveness of hormonal contraceptives—use alternative birth control.
    • CYP3A4 inducers (e.g., rifampin, phenytoin) may lower Trileptal levels.
    • CNS depressants (e.g., alcohol, benzodiazepines) may increase sedation.
    • Diuretics may increase the risk of low sodium levels.
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