Oxcarbazepine Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Seizures

For use as adjunctive treatment or monotherapy in the treatment of partial seizures:

Adjunctive Therapy:
Initial Dose: 600 mg/day, (given as 300 mg twice a day). If clinically indicated, the dose may be increased by a maximum of 600 mg/day at approximately weekly intervals. The recommended daily dose is 1200 mg/day. Daily doses above 1200 mg/day have shown somewhat greater effectiveness in controlled trials, but most patients were not able to tolerate the 2400 mg/day dose, primarily because of CNS effects. It is recommended that the patient be observed closely and plasma levels of the concomitant antiepileptic drugs be monitored during the period of oxcarbazepine titration, as these plasma levels may be altered, especially at oxcarbazepine doses greater than 1200 mg/day.

Conversion to Monotherapy
Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine at 600 mg/day (given as 300 mg twice a day) while simultaneously reducing the dose of the concomitant antiepileptic drugs. The concomitant antiepileptic drugs should be completely withdrawn over 3 to 6 weeks, while the maximum dose of oxcarbazepine should be reached in about 2 to 4 weeks. Oxcarbazepine may be increased as clinically indicated by a maximum increment of 600 mg/day at approximately weekly intervals to achieve the recommended daily dose of 2400 mg/day. Patients should be observed closely during this transition phase.

Initiation of Monotherapy
Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine should be initiated at a dose of 600 mg/day (given as 300 mg twice a day); the dose should be increased by 300 mg/day every third day to a dose of 1200 mg/day. A daily dose of 1200 mg/day has been shown in one study to be effective in patients in whom monotherapy has been initiated with oxcarbazepine.

Usual Pediatric Dose for Seizures

For use as adjunctive treatment for partial seizures in children ages 2 to 16:

Initial Dose: 8-10 mg/kg generally not to exceed 600 mg/day, (given as 300 mg twice a day). The target maintenance dose of oxcarbazepine should be achieved over 2 weeks, and is dependent upon patient weight, according to the following:

20-29 kg: 900 mg/day

29.1-39 kg: 1200 mg/day

>39 kg: 1800 mg/day

2 to<4 years: Treatment should also be initiated at a daily dose of 8 to 10 mg/kg generally not to exceed 600 mg/day, given in a twice daily regimen.

For patients under 20 kg: A starting dose of 16 to 20 mg/kg may be considered. The
maximum maintenance dose of oxcarbazepine should be achieved over 2 to 4 weeks and should not exceed 60 mg/kg/day in a twice daily regimen.

In the clinical trial in pediatric patients (2 to 4 years of age) in which the intention was to
reach the target dose of 60 mg/kg/day, 50% of patients reached a final dose of at least 55 mg/kg/day.

When normalized by body weight, apparent clearance (L/hr/kg) decreased when age increased such that children 2 to <4 years of age may require up to twice the oxcarbazepine dose per body weight compared to adults; and children 4 to 12 years of age may require a 50% higher oxcarbazepine dose per body weight compared to adults.


For use as monotherapy for partial seizures in patients ages 4 to 16:

Conversion to Monotherapy
Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with oxcarbazepine at approximately 8 to 10 mg/kg/day given in a twice daily regimen, while simultaneously initiating the reduction of the dose of the concomitant antiepileptic drugs. The concomitant antiepileptic drugs can be completely withdrawn over 3 to 6 weeks
while oxcarbazepine may be increased as clinically indicated by a maximum increment of 10 mg/kg/day at approximately weekly intervals to achieve the recommended daily dose. Patients should be observed closely during this transition phase. The recommended total daily dose of oxcarbazepine is shown below.

Initiation of Monotherapy
Patients not currently being treated with antiepileptic drugs may have monotherapy initiated with oxcarbazepine. In these patients, oxcarbazepine should be initiated at a dose of 8 to 10 mg/kg/day given in a twice daily regimen. The dose should be increased by 5 mg/kg/day every third day to the recommended daily dose shown below.

Range of Maintenance Doses of oxcarbazepine for Children by Weight During Monotherapy:
If the patient's weight is 20 kg, then dose from 600 to 900 mg/day.
If the patient's weight is 25 kg, then dose from 900 to 1200 mg/day.
If the patient's weight is 30 kg, then dose from 900 to 1200 mg/day.
If the patient's weight is 35 kg, then dose from 900 to 1500 mg/day.
If the patient's weight is 40 kg, then dose from 900 to 1500 mg/day.
If the patient's weight is 45 kg, then dose from 1200 to 1500 mg/day.
If the patient's weight is 50 kg, then dose from 1200 to 1800 mg/day.
If the patient's weight is 55 kg, then dose from 1200 to 1800 mg/day.
If the patient's weight is 60 kg, then dose from 1200 to 2100 mg/day.
If the patient's weight is 65 kg, then dose from 1200 to 2100 mg/day.
If the patient's weight is 70 kg, then dose from 1500 to 2100 mg/day.

Renal Dose Adjustments

In patients with impaired renal function (creatinine clearance <30 mL/min) oxcarbazepine therapy should be initiated at one-half the usual starting dose (300 mg/day) and increased slowly to achieve the desired clinical response.

Liver Dose Adjustments

Dose adjustments are not required in patients with mild to moderate hepatic
impairment.

Dialysis

In patients with impaired renal function (creatinine clearance <30 mL/min) oxcarbazepine therapy should be initiated at one-half the usual starting dose (300 mg/day) and increased slowly to achieve the desired clinical response.

Other Comments

All dosing should be given in a twice a day regimen.

Oxcarbazepine oral suspension and oxcarbazepine film-coated tablets may be interchanged at equal doses.

Oxcarbazepine can be taken with or without food.

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