Trileptal

Trileptal

oxcarbazepine

Manufacturer:

Novartis Healthcare

Distributor:

Zuellig
Concise Prescribing Info
Contents
Oxcarbazepine
Indications/Uses
Partial seizures (including simple, complex & partial seizures evolving to secondarily generalized seizures) & generalized tonic-clonic seizures in adults & childn ≥1 mth. As 1st-line monotherapy or adjunctive therapy. Replacement for other antiepileptic drugs when current therapy provides insufficient seizure control.
Dosage/Direction for Use
Monotherapy & adjunctive therapy Adult Initially 600 mg/day in 2 divided doses. Maintenance: 600-2,400 mg/day. If clinically indicated, may increase by a max of 600 mg/day at approx wkly intervals from the starting dose. Max: 2,400 mg/day. Childn Initially 8-10 mg/kg/day in 2 divided doses. Maintenance: 30-46 mg/kg/day for adjunctive therapy. If clinically indicated, may increase by a max of 10 mg/kg/day at approx wkly intervals from the starting dose. Max: 60 mg/kg/day. Renal impairment CrCl <30 mL/min Initially 300 mg/day.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to oxcarbazepine or eslicarbazepine.
Special Precautions
Hypersensitivity reactions including multi-organ hypersensitivity, & to carbamazepine. Avoid in patients who are +ve for HLA-B*1502. Risk of seizure aggravation. Hyponatremia. Discontinue if any evidence of significant bone marrow depression develops; hepatitis is suspected. Monitor patients for signs of suicidal ideation & behavior. W/draw gradually to minimize potential for increased seizure frequency. Concomitant use w/ hormonal contraceptives & alcohol. Perform thyroid function test before starting therapy especially in childn ≤ 2 yr. May impair ability to drive or operate machinery. Renal impairment (CrCl <30 mL/min). Severe hepatic impairment. Pregnancy. Not to be used during lactation. Childn <1 mth.
Adverse Reactions
Somnolence, headache, dizziness; diplopia, vomiting, nausea, fatigue. Increased wt; hyponatremia; agitation, affect lability, confusional state, depression, apathy; ataxia, tremor, nystagmus, disturbance in attention, amnesia; blurred vision, visual disturbance; vertigo; diarrhea, abdominal pain, constipation; rash, alopecia, acne; asthenia. Childn 1 mth to <4 yr: Ataxia, irritability, vomiting, lethargy, fatigue, nystagmus, tremor, decreased appetite & increased blood uric acid.
Drug Interactions
Decreased plasma conc of dihydropyridine Ca antagonists, OCs, antiepileptic drugs (eg, carbamazepine), immunosuppressants (eg, ciclosporin). Increased plasma levels of phenytoin & phenobarb. Decreased mean AUC values of ethinylestradiol & levonorgestrel. Lowered AUC values of felodipine (after repeated co-administration).
MIMS Class
ATC Classification
N03AF02 - oxcarbazepine ; Belongs to the class of carboxamide derivatives antiepileptic.
Presentation/Packing
Form
Trileptal oral susp 60 mg/mL
Packing/Price
100 mL x 1's;250 mL x 1's
Form
Trileptal FC tab 300 mg
Packing/Price
50's
Form
Trileptal FC tab 600 mg
Packing/Price
50's
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