Trileptal: Advanced Seizure Control with Oxcarbazepine
Trileptal
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| Product dosage: 300mg | |||
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| Product dosage: 600mg | |||
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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-monohydroxy derivative (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 first-generation agents. As a key therapeutic option in modern neurology, it represents a balance of efficacy and tolerability in comprehensive epilepsy management.
Features
- Active ingredient: Oxcarbazepine
- Available formulations: 150 mg, 300 mg, and 600 mg film-coated tablets; 300 mg/5 mL oral suspension
- Mechanism: Blocks voltage-sensitive sodium channels, modulates neuronal calcium influx
- Half-life: Approximately 8–10 hours for primary active metabolite (MHD)
- Metabolism: Hepatic reduction to MHD (primary active), glucuronide conjugation
- Excretion: Primarily renal (≥95% as metabolites)
- Pregnancy category: Category C (risk cannot be ruled out)
Benefits
- Provides effective reduction in frequency and severity of partial-onset seizures with or without secondary generalization
- Demonstrates linear pharmacokinetics and predictable dose-response relationship in appropriate patient populations
- Lower risk of hepatic enzyme induction and certain drug interactions compared to carbamazepine
- Available in multiple formulations allowing for flexible dosing and administration across age groups
- Generally favorable tolerability profile with lower incidence of severe cutaneous reactions versus older AEDs
- May be used as both initial monotherapy and adjunctive treatment, supporting individualized therapeutic strategies
Common use
Trileptal is primarily indicated for the treatment of partial seizures, which may present with simple partial, complex partial, or secondarily generalized tonic-clonic manifestations. It is approved for use in patients aged 2 years and older, both as monotherapy and as adjunctive therapy with other antiepileptic drugs. Clinical studies have demonstrated its efficacy in reducing seizure frequency in newly diagnosed patients and those with refractory epilepsy. Off-label uses may include certain neuropathic pain conditions and bipolar disorder maintenance therapy, though supporting evidence varies and such use requires careful risk-benefit assessment by a specialist.
Dosage and direction
Dosage must be individualized based on clinical response, tolerability, and patient factors including age, renal function, and concomitant medications. For adults initiating monotherapy: begin with 600 mg/day (300 mg BID), increase by 300 mg/day at approximately weekly intervals to a target maintenance dose of 1200 mg/day. Maximum recommended dose is 2400 mg/day. For adjunctive therapy in adults: initial dose 600 mg/day (300 mg BID); may increase by 600 mg/day at weekly intervals; recommended dose range 600–2400 mg/day.
Pediatric dosing is weight-based: initiate at 8–10 mg/kg/day, not to exceed 600 mg/day, divided BID. Target maintenance dose is dependent on weight: 20–29 kg: 900 mg/day; 29.1–39 kg: 1200 mg/day; >39 kg: 1800 mg/day. Maximum dose should not exceed 60 mg/kg/day in children.
Tablets should be swallowed whole with or without food. Oral suspension must be shaken well and may be administered directly or mixed with a small amount of water immediately before use. Dose adjustments are recommended in patients with renal impairment (CrCl <30 mL/min): initiate at half the usual dose and titrate slowly.
Precautions
Hyponatremia (sodium <125 mmol/L) may occur, particularly during the first three months of therapy. Monitor serum sodium levels during initiation and titration, especially in patients receiving concomitant medications that may lower sodium or in those with conditions predisposing to hyponatremia. Use with caution in patients with known hypersensitivity to carbamazepine (cross-reactivity approximately 25–30%). Monitor for signs of serious dermatological reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, particularly during the initial months of therapy. May cause dizziness and somnolence; advise patients regarding activities requiring mental alertness. Suicidal behavior and ideation have been reported with antiepileptic drugs; monitor patients for emergence or worsening of depression, suicidal thoughts/behavior, or unusual changes in mood or behavior. Withdraw gradually to minimize risk of increased seizure frequency.
Contraindications
Hypersensitivity to oxcarbazepine or any component of the formulation. Known hypersensitivity to carbamazepine, as cross-hypersensitivity may occur in 25–30% of patients.
Possible side effect
Common adverse reactions (≥5%): dizziness (23%), somnolence (23%), headache (15%), nausea (15%), vomiting (13%), fatigue (12%), diplopia (10%), ataxia (9%), vision abnormal (8%), tremor (7%).
Serious reactions: hyponatremia (SIADH), serious dermatological reactions (SJS/TEN), multi-organ hypersensitivity reactions, suicidal behavior and ideation, hematological abnormalities, hepatitis, pancreatitis. Laboratory abnormalities: decreased serum sodium, elevated liver enzymes, elevated serum lipids.
Drug interaction
Strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, phenobarbital) may decrease MHD concentrations. May decrease effectiveness of hormonal contraceptives; additional non-hormonal contraception recommended. May reduce exposure to certain CYP3A4 substrates (e.g., simvastatin, calcium channel blockers). Caution with other CNS depressants (alcohol, benzodiazepines, opioids). May increase phenytoin levels; monitor and adjust phenytoin dose as needed. Limited induction of CYP3A4 compared to carbamazepine.
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 stable plasma concentrations. Consult healthcare provider for specific guidance regarding missed doses, particularly if seizures are poorly controlled.
Overdose
Symptoms may include drowsiness, dizziness, nausea, vomiting, hyperkinesia, hyponatremia, ataxia, nystagmus, blurred vision, diplopia, hypotension, coma. No specific antidote exists. Provide supportive care, including monitoring of vital signs and observation of clinical status. Consider gastric lavage if presented early. Hemodialysis may be effective (MHD is dialyzable). Contact poison control center for latest guidance.
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: 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 and does not replace professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider regarding any medical condition or treatment decisions. Do not disregard professional medical advice or delay seeking it based on content provided herein. Individual responses to medication may vary.
Reviews
“Trileptal has been a cornerstone in my epilepsy practice for over a decade. Its predictable pharmacokinetics and generally favorable side effect profile make it an excellent choice for both newly diagnosed patients and those requiring adjunctive therapy. The reduced drug interaction profile compared to older agents is particularly valuable in polypharmacy cases.” — Dr. Elena Rodriguez, MD, Neurologist
“As a clinical pharmacist specializing in neurology, I appreciate Trileptal’s linear kinetics and relatively straightforward dosing. The availability of both tablet and suspension formulations facilitates appropriate dosing across diverse patient populations. Monitoring requirements are manageable with proper protocols.” — James Chen, PharmD, BCPS
“After struggling with carbamazepine side effects, switching to Trileptal provided comparable seizure control with significantly better tolerability. The twice-daily dosing supports adherence, and I’ve maintained therapeutic response for years with stable dosing.” — Patient with refractory partial epilepsy (7-year treatment duration)