TRILEPTAL SUSPENSION Rx
Generic Name and Formulations:
Oxcarbazepine 300mg/5mL; lemon flavor; contains alcohol.
Novartis Pharmaceuticals Corp
Indications for TRILEPTAL SUSPENSION:
Monotherapy in partial seizures in adults and children ≥4yrs of age. Adjunctive therapy in partial seizures in adults and children ≥2yrs of age.
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.
Give in two equally divided doses. <2yrs: not recommended. Monotherapy (4–16yrs): initially 8–10mg/kg per day; increase by 5mg/kg per day every 3rd day to max dose (varies with weight; see full labeling). Adjunctive therapy (2–16yrs): initially 8–10mg/kg per day; usual max 600mg/day; target maintenance doses (attain over 2 weeks): <20kg: initially 16–20mg/kg per day; max 60mg/kg per day; 20–29kg: 900mg/day; 29.1–39kg: 1.2g/day; >39kg: 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 full labeling) 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.
Hypersensitivity to eslicarbazepine.
Risk of hyponatremia; monitor if signs/symptoms occur. Carbamazepine allergy. Discontinue if anaphylaxis or angioedema occurs; do not rechallenge. Evaluate for presence of HLA-B*1502 (esp. in Asians); if present, avoid oxcarbazepine use; increased risk of severe dermatological reactions. Suicidal behavior and ideation (monitor). Discontinue if DRESS/multi-organ hypersensitivity or seizure aggravation occurs. Monitor for seizures during pregnancy and through the postpartum period. Renal or severe hepatic impairment. Avoid abrupt cessation. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
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. Potentiates CYP2C19 substrates. Increases clearance of CYP3A4/5 (eg, dihydropyridine calcium channel blockers, oral contraceptives [use non-hormonal method], cyclosporine), felodipine. May affect thyroid (T4) tests. Caution with other drugs that cause hyponatremia.
Dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, tremor, abnormal vision or gait, abdominal pain, dyspepsia, nystagmus, rash (may be serious, eg, Stevens-Johnson syndrome, toxic epidermal necrolysis), headache, cognitive/neuropsychiatric reactions, hyponatremia; rare: pancytopenia, agranulocytosis, leukopenia (discontinue if occurs), DRESS, multi-organ hypersensitivity; also: patients <4yrs: infections and infestations.
To enroll in the North American Antiepileptic Drug Pregnancy Registry call (888) 233-2334.
Tabs—100; Susp—250mL (w. dosing syringe)
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