Monograph Details

Central Nervous System > Seizure disorders
TRILEPTAL SUSPENSION
Manufacturer
Novartis Pharmaceuticals Corp
Legal Classification
Rx
Pharmacological Class
Dibenzazepine.
Generic Name
Oxcarbazepine 300mg/5mL; lemon flavor; contains alcohol.
Also
TRILEPTAL
Indications
Monotherapy or adjunct in partial seizures in adults and children 4–16 years of age.
Children
Give in two equally divided doses. <2 years: not recommended. 4–16 years: Monotherapy: initially 8–10mg/kg per day; increase by 5mg/kg per day every 3rd day to max dose (varies with weight; see literature); Adjunctive therapy: initially 8–10mg/kg per day; usual max 600mg/day; target maintenance doses (attain over 2 weeks): 20–29 kg: 900mg/day; 29.1–39 kg: 1.2 g/day; >39 kg: 1.8g/day; Converting to monotherapy: initially 8–10mg/kg per day; increase by 10mg/kg per day at weekly intervals to max dose (see literature) while withdrawing other AED over 3–6 weeks (reduce dose of other AED when starting oxcarbazepine). Renal impairment (CrCl <30mL/min): reduce initial dose by ½ and titrate more slowly.
Adults
Give in two equally divided doses. Monotherapy: initially 600mg/day; increase by 300mg/day every 3rd day to 1.2g/day. Adjunctive therapy: initially 600mg/day; may increase by up to 600mg/day at weekly intervals to 1.2g/day. Converting to monotherapy: initially 600mg/day; increase by 600mg/day at weekly intervals to usual max of 2.4g/day; attempt to reach oxcarbazepine max dose in 2–4 weeks while withdrawing other AED over 3–6 weeks (reduce dose of other AED when starting oxcarbazepine). Renal impairment (CrCl <30mL/min): reduce initial dose by ½ and titrate more slowly.
Precautions
Carbamazepine allergy. Renal or severe hepatic impairment. Suicidal tendencies (monitor). Monitor for hyponatremia. Avoid abrupt cessation. Elderly. Pregnancy (Cat.C), nursing mothers: not recommended.
Interactions
Monitor plasma levels of other AEDs (esp. during titration) and adjust if needed; withdraw gradually. Potentiates CNS depression with alcohol, other CNS depressants. Potentiates phenobarbital, phenytoin. Antagonized by carbamazepine, phenobarbital, phenytoin, valproic acid, verapamil. May affect, or be affected by, other drugs metabolized by CYP2C19, CYP3A4/5 (eg, dihydropyridine calcium channel blockers). Increases clearance of felodipine, hormonal contraceptives (use non-hormonal method). May affect thyroid (T4) tests. Caution with other drugs that cause hyponatremia.
Adverse Reactions
Dizziness, somnolence, fatigue, GI upset, ataxia, tremor, abnormal vision or gait, abdominal pain, nystagmus, rash, (may be serious, eg, Stevens-Johnson syndrome, toxic epidermal necrolysis), headache, cognitive effects, hyponatremia.
How Supplied
Tabs—100, 1000
Susp—250mL (w. dosing syringe)
Additional Resources
Related Prescribing Note