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

Leptal® 300 mg: Each tablet contains Oxcarbazepine USP 300 mg.
Leptal® 600 mg: Each tablet contains Oxcarbazepine USP 600 mg.

The pharmacological action of Oxcarbazepine is primarily mediated through its 10-monohydroxy metabolite (MHD). While the exact mechanism by which Oxcarbazepine and MHD exert their antiseizure effects remains unclear, in vitro electrophysiological studies suggest they block voltage-sensitive sodium channels. This leads to stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and reduction of synaptic impulse propagation, all contributing to preventing the spread of seizures in the brain. Additionally, the drug may increase potassium conductance and modulate high-voltage activated calcium channels, further supporting its anticonvulsant effects. No significant interactions with brain neurotransmitter or modulator receptor sites have been identified.

Leptal is indicated for: Adults: Monotherapy or adjunctive therapy for the treatment of partial seizures.

Pediatrics: Monotherapy in the treatment of partial seizures in children aged 4–16 years.

Adjunctive therapy for partial seizures in children aged 2–16 years.

Adults:
Initial Dose: Start with 600 mg/day, administered twice daily.
Adjunctive Therapy: Increase by 600 mg/day at approximately weekly intervals. The recommended dose is 1200 mg/day.
Conversion to Monotherapy: Gradually withdraw concomitant medication over 3 to 6 weeks. Increase Oxcarbazepine by 600 mg/day at weekly intervals to a maximum of 2400 mg/day.
Initiation of Monotherapy: Increase the dose by 300 mg/day every third day until reaching 1200 mg/day.
Renal Impairment: In patients with creatinine clearance <30 mL/min, initiate at half the usual starting dose and increase slowly.

Pediatrics:
Initial Dose: Start with 8–10 mg/kg/day, given twice daily. For patients aged 2–<4 years weighing under 20 kg, a dose of 16–20 mg/kg/day may be considered.
Adjunctive Therapy: In children aged 4–16 years, the target maintenance dose should be achieved in 2 weeks. For children aged 2–<4 years, the maximum maintenance dose should be reached in 2–4 weeks, not exceeding 60 mg/kg/day.
Conversion to Monotherapy: Increase by 10 mg/kg/day at weekly intervals. Concomitant antiepileptic drugs should be withdrawn over 3 to 6 weeks.
Initiation of Monotherapy: Increase the dose by 5 mg/kg/day every third day.

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

Cognitive and neuropsychiatric events, such as psychomotor slowing, difficulty concentrating, language problems, somnolence, fatigue, ataxia, and gait disturbances, have been commonly associated with Oxcarbazepine. Cases of asymptomatic hyponatremia have been reported, so monitoring serum sodium levels is recommended, especially in patients on medications known to decrease sodium levels or if hyponatremia symptoms (nausea, malaise, headache, confusion) occur. Oxcarbazepine should be used with caution in patients with a hypersensitivity reaction to carbamazepine.

Oxcarbazepine is generally better tolerated than carbamazepine. Common side effects include:

Central Nervous System: Dizziness, diplopia, headache, nystagmus, abnormal gait.

Gastrointestinal: Nausea, vomiting, abdominal pain.

Dermatologic: Rash.

Serum Electrolytes: Hyponatremia.

Other: Bone marrow suppression and hepatotoxicity are rare compared to carbamazepine.

Oxcarbazepine exhibits minimal interaction with cytochrome P450 enzymes. Studies suggest no significant drug interactions with cimetidine, dextropropoxyphene, erythromycin, or warfarin. As Oxcarbazepine is often used adjunctively, its effects on other antiepileptics have been studied, showing minimal interactions.

Pregnancy: Category C. No well-controlled studies exist for pregnant women. Oxcarbazepine should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

Lactation: Oxcarbazepine is excreted in human milk with a milk-to-plasma concentration ratio of 0.5. Therefore, it is not recommended for use during breastfeeding.