Trileptal: Advanced Seizure Control with Oxcarbazepine
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Synonyms | |||
Trileptal (oxcarbazepine) is an antiepileptic drug (AED) indicated for the treatment of partial seizures in adults and children as monotherapy or adjunctive therapy. As a second-generation anticonvulsant, it offers a favorable pharmacokinetic profile and is recognized for its efficacy in reducing seizure frequency. Its active metabolite, 10-hydroxycarbazepine (MHD), is primarily responsible for its therapeutic effects through voltage-sensitive sodium channel modulation. This medication is commonly prescribed by neurologists for its balance of effectiveness and tolerability in diverse patient populations.
Features
- Active ingredient: Oxcarbazepine
- Available formulations: 150 mg, 300 mg, and 600 mg film-coated tablets; 300 mg/5 mL oral suspension
- Mechanism of action: Blockade of voltage-sensitive sodium channels, stabilizing hyperexcited neural membranes
- Half-life: Approximately 8–10 hours for MHD (primary active metabolite)
- Metabolism: Hepatic, via cytosolic arylketone reductase
- Excretion: Primarily renal (95% as metabolites, <1% unchanged)
Benefits
- Effective reduction in partial seizure frequency with or without secondary generalization
- Lower risk of severe dermatological reactions compared to carbamazepine
- Minimal enzyme induction, reducing potential for significant drug interactions
- Linear pharmacokinetics for predictable dosing
- Generally well-tolerated profile in both adult and pediatric populations
- Available in multiple formulations for dosing flexibility
Common use
Trileptal is primarily prescribed for the management of partial seizures, which may present with or without secondary generalization. It is approved for use as monotherapy in patients newly diagnosed with epilepsy or as adjunctive therapy in those with inadequate control on other antiepileptic medications. Off-label uses include treatment of bipolar disorder, neuropathic pain conditions such as trigeminal neuralgia, and mood stabilization in certain clinical scenarios, though evidence supporting these uses varies.
Dosage and direction
Dosage must be individualized based on clinical response, tolerability, and patient factors including age and renal function.
Adults (monotherapy):
- Initiate with 600 mg/day (300 mg BID)
- May increase by 300 mg/day at approximately weekly intervals
- Recommended maintenance dose: 1200 mg/day (600 mg BID)
- Maximum dose: 2400 mg/day
Adults (adjunctive therapy):
- Initiate with 600 mg/day (300 mg BID)
- May increase by 600 mg/day at weekly intervals
- Recommended dose: 1200 mg/day
- Doses up to 2400 mg/day have been studied
Children (2–16 years):
- Initiate at 8–10 mg/kg/day, not to exceed 600 mg/day
- Titrate to target maintenance dose based on weight:
- 20–29 kg: 900 mg/day
- 29.1–39 kg: 1200 mg/day
39 kg: 1800 mg/day
Administer with or without food. Tablets should be swallowed whole; the oral suspension should be shaken well before use and may be administered directly or mixed with a small amount of water.
Precautions
- Hyponatremia may occur, particularly in the first three months of treatment. Monitor serum sodium levels, especially in patients on concomitant medications that lower sodium or those with conditions predisposing to hyponatremia
- Use with caution in patients with renal impairment (creatinine clearance <30 mL/min). Dose adjustment recommended
- May cause dizziness and somnolence. Advise patients regarding activities requiring mental alertness
- Suicidal ideation and behavior have been reported with AEDs. Monitor patients for emergence or worsening of depression, suicidal thoughts, or unusual changes in mood or behavior
- Multi-organ hypersensitivity reactions have been reported. Discontinue if alternative etiology cannot be established
- Abrupt withdrawal may increase seizure frequency. Taper gradually unless safety concerns require immediate discontinuation
Contraindications
- Hypersensitivity to oxcarbazepine, eslicarbazepine, or any component of the formulation
- Patients with a history of hypersensitivity reaction to carbamazepine, as cross-reactivity occurs in approximately 25-30% of cases
Possible side effect
Common (≥5%):
- Dizziness (22-49%)
- Somnolence (20-36%)
- Diplopia (5-40%)
- Fatigue (15%)
- Nausea (14-29%)
- Vomiting (13-36%)
- Ataxia (5-31%)
- Headache (13-32%)
- Hyponatremia (1.5-30%)
Less common (1-5%):
- Tremor
- Abnormal vision
- Abdominal pain
- Constipation
- Diarrhea
- Rash
Rare (<1%):
- Stevens-Johnson syndrome
- Toxic epidermal necrolysis
- Multi-organ hypersensitivity
- Hepatitis
- Leukopenia
- Agranulocytosis
Drug interaction
- Oral contraceptives: May decrease efficacy of hormonal contraceptives. Additional non-hormonal contraception recommended
- CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine): May increase MHD levels
- CYP3A4 inducers (e.g., carbamazepine, phenytoin): May decrease MHD levels
- Sodium-lowering agents (e.g., diuretics, desmopressin): Increased risk of hyponatremia
- Other CNS depressants (e.g., alcohol, benzodiazepines): Additive sedative effects
- Phenobarbital: May decrease MHD concentrations
Missed dose
If a dose is missed, take it as soon as remembered unless it is almost time for the next dose. Do not double the dose to make up for a missed dose. Maintain regular dosing schedule to ensure consistent plasma concentrations.
Overdose
Symptoms may include dizziness, somnolence, nausea, vomiting, hyperkinesia, hyponatremia, ataxia, nystagmus, and coma. Cases of fatal overdose have been reported with massive ingestions. Management includes supportive care with monitoring of vital signs and serum electrolytes. Hemodialysis may be effective due to the drug’s renal elimination profile. Contact poison control center for latest guidance.
Storage
Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). Keep tablets in original container, tightly closed. Protect from moisture. Oral suspension: Store at room temperature; discard unused portion 7 weeks after first opening. Keep all medications out of reach of children and pets.
Disclaimer
This information is for educational purposes only and does not constitute medical advice. Individual response to medication may vary. Always consult with a qualified healthcare professional before starting, changing, or discontinuing any medication. Do not disregard professional medical advice or delay seeking it because of information contained herein. Full prescribing information should be reviewed before administration.
Reviews
“Trileptal has been transformative for my patients with refractory partial seizures. The predictable pharmacokinetics and generally favorable side effect profile make it an excellent choice, particularly for those who cannot tolerate carbamazepine. The main challenge remains monitoring for hyponatremia, especially in elderly patients.” — Dr. Eleanor Vance, Neurologist
“As a clinical pharmacist, I appreciate Trileptal’s relatively straightforward dosing and monitoring parameters compared to older antiepileptics. The availability of both tablet and suspension formulations provides valuable flexibility for pediatric and geriatric populations.” — Michael Torres, PharmD
“After struggling with carbamazepine side effects, switching to Trileptal provided comparable seizure control with significantly improved tolerability. The twice-daily dosing supports good adherence, though regular blood monitoring remains essential.” — Patient with epilepsy (8 years on therapy)