API

Oxcarbazepine (450mg)

Drug classification

Antiepileptic drug; specific subclass: dibenzazepine carboxamide derivative.

Dosage form

Film-coated oral tablet containing 450 mg oxcarbazepine.

API strength per dosage

Dose

Oxcarbazepine dosing is individualized. Adults typically start at 600 mg/day in divided doses, titrated as needed. Children’s dosing is weight-based. In renal impairment (CrCl <30 mL/min), initiate at half the usual dose. Use caution in severe hepatic impairment. Always refer to local prescribing information for specific recommendations and adjustments.

Mechanism of action

Oxcarbazepine blocks voltage-gated sodium channels in neuronal membranes, stabilizing hyperexcited neural tissue, inhibiting repetitive neuronal firing, and reducing synaptic propagation of impulses. This action decreases seizure activity by limiting sustained high-frequency firing of action potentials, primarily in the brain’s epileptogenic foci.

Indications

Epilepsy/Seizures

Side effects

Headache Nausea Vomiting Fatigue Dizziness Nystagmus involuntary eye movement Tremors Vertigo Drowsiness Abnormality of voluntary movements Abnormal gait Visual disturbance Increased sodium level in blood

Pregnancy category

Oxcarbazepine may increase risk of fetal malformations; use only if benefits outweigh risks. Advise effective contraception and discuss potential risks with patients.

Precautions

Monitor for hyponatremia, CNS effects (drowsiness, dizziness), allergic reactions, worsening seizures, hepatic and renal function, blood counts, drug interactions, suicidal thoughts or behavior, caution in pregnancy and lactation, avoid abrupt discontinuation, adjust dose in renal impairment, monitor for skin reactions (SJS/TEN).

Contraindications

Hypersensitivity to oxcarbazepine or any component, hypersensitivity to eslicarbazepine acetate, known hypersensitivity to carbamazepine, history of angioedema with oxcarbazepine, severe hepatic impairment.