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Uses

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Partial Seizures

Management of partial seizures (alone or in combination with other anticonvulsants) in adults and children ≥4 years of age.

Bipolar Disorder

Treatment and prevention of acute manic or mixed episodes in patients with bipolar disorder†; used alone or in combination with other drugs (e.g., antipsychotic agents).

American Psychiatric Association recommends that oxcarbazepine be reserved for patients who cannot tolerate or have had an inadequate response to first-line agents (e.g., lithium, valproate).

Dosage and Administration

Administration

Oral Administration

Administer orally twice daily without regard to meals.

Tablets and suspension can be used interchangeably on a mg-for-mg basis.

Suspension

Shake suspension well prior to administration of each dose.

Measure and administer appropriate dose using an oral dosing syringe; dose may be added to a small glass of water or swallowed directly from the syringe. After each use, rinse the oral syringe with warm water and allowed to dry thoroughly.

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.

Pediatric Patients

Partial Seizures

Monotherapy

Oral

Children 4–16 years of age: Initially, 8–10 mg/kg daily in 2 divided doses. Increase by 5 mg/kg every third day to recommended maintenance dosage.

Combination Therapy

Oral

Children 4–16 years of age: Initially, 8–10 mg/kg daily (≤600 mg daily) in 2 divided doses. Increase to the target maintenance dosage over 2 weeks.

Conversion to Monotherapy

Oral

Children 4–16 years of age: Initially, 8–10 mg/kg daily in 2 divided doses. Increase dosage, based on patient response, by ≤10 mg/kg daily at weekly intervals to the recommended maintenance dosage for monotherapy. (See table under Monotherapy.) Observe patients closely during this transition phase.

As oxcarbazepine replaces the existing anticonvulsant regimen, dosage of the other anticonvulsant(s) is simultaneously reduced and discontinued over 3–6 weeks. Observe patient closely during transition phase.

Adults

Partial Seizures

Monotherapy

Oral

Initially, 600 mg daily administered in 2 equally divided doses. Increase dosage by 300-mg daily increments every third day up to a dosage of 1200 mg daily.

Combination Therapy

Oral

Initially, 600 mg daily in 2 equally divided doses. Increase dosage by 600-mg daily increments at approximately weekly intervals to recommended daily dosage of 1200 mg. Efficacy may be somewhat higher in patients receiving dosages >1200 mg daily, but most patients cannot tolerate daily dosages of 2400 mg, mainly because of adverse CNS effects.

Observe patients closely and monitor plasma concentrations of concomitantly administered anticonvulsants during dosage titration of oxcarbazepine; plasma concentrations of these drugs may be altered when dosage of oxcarbazepine exceeds 1200 mg daily.

Conversion to Monotherapy

Oral

Initially, 600 mg daily in 2 equally divided doses. Increase dosage by 600-mg daily increments at approximately weekly intervals to recommended daily dosage of 2400 mg, usually within 2–4 weeks.

As oxcarbazepine replaces the existing anticonvulsant regimen, dosage of the other anticonvulsant(s) is simultaneously reduced and discontinued over 3–6 weeks. Observe patient closely during transition phase.

Special Populations

Dosage in Hepatic Impairment

No dosage adjustment required in patients with mild to moderate hepatic impairment.

Dosage in Renal Impairment

Initially, 300 mg daily in patients with CL_cr <30 mL/minute; increase dosage slowly based on patient response.

Geriatric Patients

Manufacturer makes no specific dosage recommendations.