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TRILEPTAL
Seizure disorders
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Drug Name:

TRILEPTAL Rx

Generic Name and Formulations:
Oxcarbazepine 150mg, 300mg, 600mg; tabs.

Company:
Novartis Pharmaceuticals Corp

Therapeutic Use:

Indications for TRILEPTAL:

Monotherapy in partial seizures in adults and children ≥4yrs of age. Adjunctive therapy in partial seizures in adults and children ≥2yrs of age.

Adult:

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.

Children:

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.

Contraindications:

Hypersensitivity to eslicarbazepine.

Warnings/Precautions:

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.

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. 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.

See Also:

TRILEPTAL SUSPENSION

Pharmacological Class:

Dibenzazepine.

Adverse Reactions:

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.

Note:

To enroll in the North American Antiepileptic Drug Pregnancy Registry call (888) 233-2334.

How Supplied:

Tabs—100; Susp—250mL (w. dosing syringe)

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