Partial seizure

In adjunctive therapy, treatment with oxcarbazepine is initiated with a clinically effective dose given in two divided doses. The dose may be increased depending on the clinical response of the patient. When other antiepileptic medicinal products are replaced by oxcarbazepine, the dose of the concomitant antiepileptic medicinal product(s) should be reduced gradually on initiation of oxcarbazepine therapy. In adjunctive therapy, as the total antiepileptic medicinal product load of the patient is increased, the dose of concomitant antiepileptic medicinal product(s) may need to be reduced and/or the oxcarbazepine dose increased more slowly.

Therapeutic drug monitoring

The therapeutic effect of oxcarbazepine is primarily exerted through the active metabolite 10-monohydroxy derivative (MHD) of oxcarbazepine.

Plasma level monitoring of oxcarbazepine or MHD is not routinely warranted. However, may be useful in situations where an alteration in MHD clearance is to be expected. In such situations, the dose of oxcarbazepine may be adjusted (based on plasma levels measured 2-4 hours post dose) to maintain peak MHD plasma levels <35 mg/L.

Recommended initial dose

Oxcarbazepine should be initiated with a dose of 600 mg/day (8-10 mg/kg/day) given in 2 divided doses.

Maintenance dose

If clinically indicated, the dose may be increased by a maximum of 600 mg/day at approximately weekly intervals from the starting dose to achieve the desired clinical response.

Therapeutic responses are seen at doses between 600 mg/day and 2,400 mg/day.

Maximum recommended dose

Daily doses from 600 to 2,400 mg/day have been shown to be effective in a controlled adjunctive therapy trial, although most patients were not able to tolerate the 2,400 mg/day dose without reduction of concomitant antiepileptic medicinal products, mainly because of CNS-related adverse events. Daily doses above 2,400 mg/day have not been studied systematically in clinical trials.

All the above dosing recommendations are based on the doses studied in clinical trials for all age groups. However, lower initiation doses may be considered where appropriate.

Recommended initial dose:

In adjunctive therapy, oxcarbazepine should be initiated with a dose of 8-10 mg/kg/day given in 2 divided doses.

Maintenance dose:

In adjunctive therapy trials, a maintenance dose of 30-46 mg/kg/day, achieved over two weeks, is shown to be effective and well tolerated in children. Therapeutic effects were seen at a median maintenance dose of approximately 30 mg/kg/day.

Maximum recommended dose:

If clinically indicated, the dose may be increased by a maximum of 10 mg/kg/day at approximately weekly intervals from the starting dose, to a maximum dose of 46 mg/kg/day, to achieve the desired clinical response.

Oxcarbazepine is recommended for use in children of 6 years of age and above. Safety and efficacy have been evaluated in controlled clinical trials involving approximately 230 children aged less than 6 years (down to 1 month). Oxcarbazepine is not recommended in children aged less than 6 years since safety and efficacy have not been adequately demonstrated.

All the above dosing recommendations are based on the doses studied in clinical trials for all age groups. However, lower initiation doses may be considered where appropriate.