Oxcarbazepine is indicated for:

Adults: As monotherapy or adjunctive therapy in the treatment of partial seizures.

Pediatrics: Monotherapy for partial seizures in children aged 4–16 years, Adjunctive therapy for partial seizures in children aged 2–16 years

The main pharmacological effect of Oxcarbazepine is mediated through its active metabolite, 10-monohydroxy derivative (MHD).

Although the exact mechanism of its antiseizure action is not fully understood, studies show that both Oxcarbazepine and MHD block voltage-sensitive sodium channels. This stabilizes overexcited neuronal membranes, reduces repetitive firing of neurons, and decreases the spread of synaptic impulses. These effects help prevent seizure propagation in the brain. Additionally, increased potassium conductance and modulation of high-voltage calcium channels may contribute to its anticonvulsant activity. No significant interaction with major neurotransmitter receptor systems has been identified.

Adults: initiate with a dose of 600 mg/day, given twice-a-day.

• Adjunctive Therapy: Maximum increment of 600 mg/day at approximately weekly intervals. The recommended daily dose is 1200 mg/day.
• Conversion to Monotherapy: withdrawal concomitant over 3 to 6 weeks; reach maximum dose of Oxcarbazepine in 2 to 4 weeks with increments of 600 mg/day at weekly intervals to a recommended daily dose of 2400 mg/day.
• Initiation of Monotherapy: Increments of 300 mg/day every third day to a dose of 1200 mg/day.
• Creatinine Clearance <30 mL/min: Initiate at one half the usual starting dose and increase slowly.

Pediatrics: initiation with 8 to 10 mg/kg/day, given twice-a-day. For patients aged 2 to <4 years and under 20 kg, a starting dose of 16 to 20 mg/kg/day may be considered. Recommended daily dose is dependent upon patient weight.

• Adjunctive Patients (Aged 2-16 Years): For patients aged 4 to 16 years, target maintenance dose should be achieved over 2 weeks. For patients aged 2 to <4 years, maximum maintenance dose should be achieved over 2 to 4 weeks and should not to exceed 60 mg/kg/day.
• Conversion to Monotherapy for Patients (Aged 4-16 Years): Maximum increment of 10 mg/kg/day at weekly intervals, concomitant antiepileptic drugs can be completely withdrawn over 3 to 6 weeks.
• Initiation of Monotherapy for Patients (Aged 4-16 Years): Increments of 5 mg/kg/day every third day.

In vitro and in vivo studies indicate that Oxcarbazepine has little or no interaction with cytochrome P450 enzymes. When used as adjunct therapy, studies with other antiepileptic drugs show minimal interaction effects. No clinically significant drug interactions have been reported with cimetidine, dextropropoxyphene, erythromycin, or warfarin.

Oxcarbazepine is contraindicated in patients with known hypersensitivity to Oxcarbazepine, its components, or to eslicarbazepine acetate.

Clinical studies show that Oxcarbazepine is generally better tolerated than carbamazepine. Most common side effects include: CNS: dizziness, headache, diplopia, nystagmus, abnormal gait, Gastrointestinal: nausea, vomiting, abdominal pain, Dermatologic: skin rash ,Electrolytes: hyponatremia. Bone marrow suppression and hepatotoxicity, commonly associated with carbamazepine, are rarely seen with Oxcarbazepine.

Pregnancy Category C: There are no adequate controlled studies in pregnant women. Oxcarbazepine should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. The drug is excreted in human breast milk, with a milk-to-plasma ratio of approximately 0.5. Therefore, Oxcarbazepine is not recommended during breastfeeding.

Cognitive and neuropsychiatric effects such as drowsiness, fatigue, difficulty concentrating, speech problems, ataxia, and gait disturbances may occur. Asymptomatic hyponatremia has been reported; serum sodium should be monitored in at-risk patients or when symptoms such as nausea, confusion, headache, or malaise appear. Patients with a history of hypersensitivity to carbamazepine should only use Oxcarbazepine under strict medical supervision.

Adjunct anti-epileptic drugs.

Store at a temperature not exceeding 30°C in a dry place. Protect from light and moisture.