Trileptal: Advanced Seizure Control with Oxcarbazepine
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Synonyms | |||
Trileptal (oxcarbazepine) is a second-generation antiepileptic drug (AED) indicated for the treatment of partial seizures in adults and children as young as 2 years of age, both as monotherapy and adjunctive therapy. Its active metabolite, 10-hydroxycarbazepine (MHD), exerts a primary mechanism of action through voltage-sensitive sodium channel blockade, stabilizing hyperexcited neuronal membranes and inhibiting repetitive neuronal firing. This targeted action provides effective seizure reduction while offering a favorable pharmacokinetic profile with reduced potential for certain drug interactions compared to older agents like carbamazepine. It represents a cornerstone in modern epilepsy management protocols.
Features
- Active ingredient: Oxcarbazepine
- Available in 150 mg, 300 mg, and 600 mg film-coated tablets, and a 60 mg/mL oral suspension
- Primary mechanism: Blockade of voltage-gated sodium channels
- Active metabolite: 10-hydroxycarbazepine (MHD)
- Linear pharmacokinetics with dose-proportional increases in plasma concentrations
- Hepatic metabolism via cytosolic ketoreductase enzymes (non-CYP450)
- Renal excretion of metabolites; negligible unchanged drug in urine
- Half-life of parent compound: 2 hours; half-life of MHD: 9 hours
Benefits
- Provides significant reduction in seizure frequency and severity in patients with partial-onset seizures
- Demonstrated efficacy as both monotherapy and adjunctive treatment, allowing for flexible therapeutic strategies
- Lower risk of autoinduction and certain pharmacokinetic drug interactions compared to first-generation antiepileptics
- Generally well-tolerated profile with a lower incidence of severe idiosyncratic reactions
- Available in multiple formulations (tablets, suspension) to support dosing accuracy across pediatric and adult populations
- May improve quality of life by enabling better seizure control with a simplified dosing regimen
Common use
Trileptal is primarily used in the management of partial seizures, with or without secondary generalization, in epilepsy patients. It is approved for use in adults and pediatric patients aged 2 years and older. In clinical practice, it is often selected for patients who have experienced adverse effects or insufficient efficacy with older antiepileptic drugs such as carbamazepine or phenytoin. It may also be used off-label in certain cases of bipolar disorder, trigeminal neuralgia, or neuropathic pain, though these uses are not FDA-approved and require careful clinical judgment.
Dosage and direction
Dosage must be individualized based on clinical response and tolerability. For adults initiating monotherapy, begin with 600 mg/day (300 mg BID). Increase by 300 mg/day every third day to a recommended daily dose of 1200 mg/day. Doses up to 2400 mg/day have been studied. For adjunctive therapy in adults, start with 600 mg/day (300 mg BID). May increase by a maximum of 600 mg/day at weekly intervals; recommended adjunctive dose is 600–2400 mg/day.
For pediatric patients (aged 2–16 years), dosing is based on body weight. Initiate at 8–10 mg/kg/day, not to exceed 600 mg/day. Target maintenance dose should be achieved over two weeks, typically ranging from 20–45 mg/kg/day. Doses above 45 mg/kg/day have not been studied. Administer in two divided doses, with or without food. Tablets should be swallowed whole; oral suspension should be shaken well before use and may be administered directly or mixed with a small amount of water.
Precautions
Hyponatremia (sodium <125 mmol/L) may occur, particularly in the elderly and patients on other medications that lower sodium. Monitor serum sodium levels during initial treatment and during maintenance, especially in at-risk populations. Serious dermatological reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported. Discontinue at first sign of rash unless clearly not drug-related. May cause dizziness and somnolence; advise patients against operating machinery or driving until familiar with effects. Use with caution in patients with renal impairment (CrCl <30 mL/min); dose adjustment recommended. Withdraw gradually to minimize risk of increased seizure frequency.
Contraindications
Trileptal is contraindicated in patients with a known hypersensitivity to oxcarbazepine or any component of the formulation. Cross-hypersensitivity with carbamazepine occurs in approximately 25–30% of patients; use with extreme caution in patients with a history of hypersensitivity reaction to carbamazepine.
Possible side effect
Common adverse reactions (≥5% incidence) include dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, abdominal pain, tremor, dyspepsia, and abnormal gait. Less common but serious adverse effects may include hyponatremia, serious dermatological reactions, leukopenia, agranulocytosis, aplastic anemia, hepatitis, and suicidal behavior or ideation. Patients should be monitored for emergence or worsening of depression, unusual changes in mood or behavior, or thoughts of self-harm.
Drug interaction
Oxcarbazepine and MHD may reduce the efficacy of hormonal contraceptives; additional non-hormonal contraception is recommended. May decrease exposure to felodipine, verapamil, and simvastatin. Strong CYP3A4 inducers (e.g., carbamazepine, phenytoin) may decrease MHD concentrations. Coadministration with other CNS depressants may enhance sedative effects. Caution with other drugs that lower serum sodium (e.g., diuretics, desmopressin).
Missed dose
If a dose is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped and the regular dosing schedule resumed. Doubling of doses is not recommended.
Overdose
Symptoms of overdose may include drowsiness, dizziness, nausea, vomiting, hyperkinesia, hyponatremia, ataxia, nystagmus, blurred vision, diplopia, coma, and convulsions. There is no specific antidote. Management should include supportive measures and gastric lavage if indicated. Hemodialysis may be effective due to the drug’s relatively low protein binding.
Storage
Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). Keep tablets in original container, tightly closed. Protect from moisture. Oral suspension should be stored at room temperature; discard any unused portion after 7 weeks of first opening.
Disclaimer
This information is intended for healthcare professionals and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of a qualified healthcare provider with any questions regarding a medical condition or treatment. Never disregard professional medical advice or delay in seeking it because of something you have read in this document.
Reviews
Clinical trials and post-marketing surveillance have demonstrated Trileptal’s efficacy and tolerability. In pivotal studies, responder rates (≥50% reduction in seizure frequency) reached 60% in adjunctive therapy and non-inferiority was shown versus older AEDs in monotherapy. Many clinicians report improved seizure control and quality of life, particularly in patients who could not tolerate carbamazepine. Some note the need for sodium monitoring and caution in elderly patients. Overall, it is regarded as a valuable option in the antiepileptic armamentarium.