DOSAGE & ADMINISTRATION Oxcarbazepine is recommended as adjunctive treatment in the treatment of partial seizures in adults and children aged 2-16 years. Oxcarbazepine is also recommended as monotherapy in the treatment of partial seizures in adults and children aged 4-16 years. All dosing should be given in a twice-a-day (BID) regimen. Oxcarbazepine oral suspension and Oxcarbazepine filmcoated tablets may be interchanged at equal doses. Oxcarbazepine should be kept out of the reach and sight of children. Oxcarbazepine can be taken with or without food (see CLINICAL PHARMACOLOGY, Pharmacokinetics subsection). Adults Adjunctive Therapy PRECAUTIONS, Drug Interactions subsection). Conversion to Monotherapy Patients receiving concomitant AEDs may be converted to monotherapy by initiating treatment with Oxcarbazepine at 600 mg/day (given in a BID regimen) while simultaneously initiating the reduction of the dose of the concomitant AEDs. The concomitant AEDs should be completely withdrawn over 3-6 weeks, while the maximum dose of Oxcarbazepine should be reached in about 2-4 weeks.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. 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. Patients should be observed closely during this transition phase. Initiation of Monotherapy Pediatric Patients Adjunctive Therapy (Aged 2-16 years) In pediatric patients aged 4-16 years, treatment should be initiated at a daily dose of 8-10 mg/kg generally not to exceed 600 mg/day, given in a BID regimen. The target maintenance dose of Oxcarbazepine should be achieved over two weeks, and is dependent upon patient weight, according to the following chart: 20-29 kg - 900 mg/day 29.1-39 kg - 1200 mg/day >39 kg - 1800 mg/day In the clinical trial, in which the intention was to reach these target doses, the median daily dose was 31 mg/kg with a range of 6-51 mg/kg. In pediatric patients aged 2-<4 years, treatment should also be initiated at a daily dose of 8-10 mg/kg generally not to exceed 600 mg/day, given in a BID regimen. For patients under 20 kg, a starting dose of 16-20 mg/kg may be considered (see CLINICAL PHARMACOLOGY ). The maximum maintenance dose of Oxcarbazepine should be achieved over 2-4 weeks and should not exceed 60 mg/kg/day in a BID 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. Under adjunctive therapy (with and without enzyme-inducing AEDs), 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 to12 years of age may require a 50% higher oxcarbazepine dose per body weight compared to adults. Conversion to Monotherapy (Aged 4-16 years) Patients receiving concomitant antiepileptic drugs may be converted to monotherapy by initiating treatment with Oxcarbazepine at approximately 8-10 mg/kg/day given in a BID regimen, while simultaneously initiating the reduction of the dose of the concomitant antiepileptic drugs. The concomitant antiepileptic drugs can be completely withdrawn over 3-6 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 in the table below. Initiation of Monotherapy (Aged 4-16 years) 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 8-10 mg/kg/day given in a BID regimen. The dose should be increased by 5 mg/kg/day every third day to the recommended daily dose shown in the table below. Table 8: Range of Maintenance Doses of Oxcarbazepine for Children by Weight During Monotherapy FromToWeight in kgDose (mg/day)Dose (mg/day) 20600900259001200309001200359001500409001500451200150050120018005512001800601200210065120021007015002100 Patients with Hepatic Impairment In general, dose adjustments are not required in patients with mild-to-moderate hepatic impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations subsection). Patients with Renal Impairment 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 (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations subsection).