Section 01 · Monograph

Oxcarbazepine

Reviewed Nov 2026FDA label
TrileptalNa+ channel blocker
Forms
Tab: 150, 300, 600mg | Susp: 300mg/5mL
Dose
600-2400mg/day
MOA
Blocks voltage-gated Na+ channels

Indications

  • Monotherapy or adjunctive therapy for partial-onset seizures in adultsFDA-labeled
  • Monotherapy for partial-onset seizures in children ages 4–16FDA-labeled
  • Adjunctive therapy for partial-onset seizures in children ages 2–16FDA-labeled

Mechanism of Action

  • Blocks voltage-gated Na+ channels, stabilizing hyperexcited neuronal membranes
  • Pharmacologic activity is largely mediated by its active metabolite, the 10-monohydroxy derivative (MHD/licarbazepine)
  • Structurally related to carbamazepine but metabolized via a different pathway (reduction rather than epoxidation), which reduces but does not eliminate cross-reactivity

Full Dosing

Adult / usual

  • Adjunctive therapy, adults: initiate 600mg/day in 2 divided doses, increase by up to 600mg/day at weekly intervals as needed, usual target dose 1200mg/day
  • Monotherapy conversion in adults: may titrate to doses up to 2400mg/day

Renal

  • Renal impairment (CrCl <30mL/min): initiate at half the usual starting dose and titrate more slowly

Pediatric

  • Pediatric dosing is weight-based, typically initiated around 8–10mg/kg/day in 2 divided doses and titrated over about 2 weeks

Contraindications

  • Known hypersensitivity to oxcarbazepine or any component of the formulation

Drug Interactions

  • Approximately 25–30% cross-reactivity for hypersensitivity reactions in patients with a history of carbamazepine hypersensitivity — ask about prior carbamazepine reactions before starting
  • Moderate induction of CYP3A4/5 reduces efficacy of hormonal contraceptives — alternative or additional contraception recommended
  • Inhibits CYP2C19, which can increase phenytoin levels at higher oxcarbazepine doses
  • Additive risk of hyponatremia with other sodium-lowering drugs (e.g., diuretics, SSRIs)

Adverse Effects

  • Common: dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, headache, nystagmus, tremor, abnormal gait
  • Clinically significant hyponatremia (sodium <125mmol/L) occurred in about 2.5% of patients in controlled trials, versus no cases on placebo — most common in the first 3 months but can occur later
  • Anaphylaxis and angioedema
  • Serious dermatologic reactions and multiorgan hypersensitivity reactions

Monitoring Parameters

  • Serum sodium, particularly during the first several months of treatment, in patients on concurrent sodium-lowering drugs, or if symptoms such as nausea, malaise, headache, confusion, or worsening seizures occur
  • Signs of hypersensitivity reaction, especially in patients with a history of carbamazepine sensitivity

Pregnancy & Lactation

  • Limited human pregnancy data; animal studies show developmental toxicity at clinically relevant exposures
  • Consider enrollment in the North American Antiepileptic Drug (NAAED) Pregnancy Registry
  • Present in breast milk; weigh benefits of breastfeeding against potential infant exposure

References

  1. General clinical pharmacology reference — DailyMed (NIH) drug label search

Same class

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