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. Concomitant strong CYP3A4 or UGT inducers: may need oxcarbazepine dose adjustment; monitor.
Give in two equally divided doses. Monotherapy: <4yrs: not established. 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: <2yrs: not established. 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 (4–16yrs): 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. Concomitant strong CYP3A4 or UGT inducers: may need oxcarbazepine dose adjustment; monitor.
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 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. Doses >1200mg/day may potentiate concomitant phenytoin; monitor levels and may need to decrease phenytoin dose. Antagonized by strong CYP3A4 or UGT inducers (eg, rifampin, carbamazepine, phenytoin, phenobarbital); see Adults. May decrease effectiveness of hormonal contraceptives; use additional non-hormonal methods. Caution with other drugs that cause hyponatremia. CNS depression potentiated with alcohol, other CNS depressants. May affect thyroid (T4) tests.
Dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision or gait, headache, nystagmus, tremor; rash (may be serious, eg, Stevens-Johnson syndrome, toxic epidermal necrolysis), cognitive/neuropsychiatric reactions (monitor), hyponatremia; rare: pancytopenia, agranulocytosis, leukopenia (discontinue if occurs), DRESS; 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)