Oxcarbazepine

What it is and how it works

Mechanism of Action The pharmacological activity of oxcarbazepine is primarily exerted through the 10-monohydroxy metabolite (MHD) of oxcarbazepine . The precise mechanism by which oxcarbazepine and MHD exert their anti-seizure effect is unknown; however, in vitro electrophysiological studies indicate that they produce blockade of voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses. These actions are thought to be important in the prevention of seizure spread in the intact brain.

Indications

Oxcarbazepine oral suspension is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. Oxcarbazepine oral suspension is indicated for: • Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures • Pediatrics: -Monotherapy in the treatment of partial-onset seizures in children 4 to 16 years -Adjunctive therapy in the treatment of partial-onset seizures in children 2 to 16 years

Dosage and administration (summary)

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 1,200 mg/day • Conversion to Monotherapy: Withdrawal concomitant over 3 to 6 weeks; reach maximum dose of oxcarbazepine oral suspension in 2 to 4 weeks with increments of 600 mg/day at weekly intervals to a recommended daily dose of 2,400 mg/day • Initiation of Monotherapy: Increments of 300 mg/day every third day to a dose of 1,200 mg/day • Initiate at one-half the usual starting dose and increase slowly in patients with a creatinine clearance < 30 mL/min Pediatrics : Initiation with 8 to 10 mg/kg/day, given twi…

Contraindications

Oxcarbazepine oral suspension is contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate . Known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate ( 4, 5.2 )

Warnings and precautions

• Hyponatremia: Monitor serum sodium levels • Cross Hypersensitivity Reaction to Carbamazepine: Discontinue immediately if hypersensitivity occurs • Serious Dermatological Reactions: If occurs, consider discontinuation • Suicidal Behavior and Ideation: Monitor for suicidal thoughts/behavior • Withdrawal of AEDs: Withdraw oxcarbazepine gradually • Cognitive/Neuropsychiatric Adverse Reactions: May cause cognitive dysfunction, somnolence, and coordination abnormalities.

Pregnancy

Pregnancy Risk Summary Although oxcarbazepine is closely related structurally to carbamazepine, which is considered to be teratogenic in humans, available human data from published literature and ongoing pregnancy registry studies on use of oxcarbazepine during pregnancy have not demonstrated an increased prevalence of major congenital malformation…

Storage and supply

Suspension Oxcarbazepine oral suspension USP, 300 mg/5 mL (60 mg/mL) is supplied as off-white to yellowish orange colored, cherry flavored suspension with cherry odor. Available in amber glass bottles containing 250 mL of oral suspension. Supplied with a 10 mL dosing syringe and press-in bottle adapter.

Source: Oxcarbazepine (Oxcarbazepine) — US FDA prescribing information, 2024-11-18, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.