TRILEPTAL 300/MG FC TAB 50/FC TAB

Indications

Approved Uses

Partial-onset seizures (monotherapy and adjunctive therapy in adults), partial-onset seizures (adjunctive therapy in children aged 2 years and older), partial-onset seizures (monotherapy in children aged 4 years and older)

Dosage & Administration

Dosing by Condition

Partial-onset seizures (adults, monotherapy): start 300 mg twice daily (600 mg/day) and increase by 300 mg/day every 3 days as clinically indicated; usual maintenance 1200 mg/day; maximum 2400 mg/day. (Adjunctive and pediatric dosing exist but are not required to state if focusing on adult monotherapy.)

Initial Dose

600mg per day, administered in two divided doses (300mg twice daily).

Maintenance Dose

600-1200 mg/day in two divided doses for adjunctive therapy; up to 1200 mg/day for monotherapy

Maximum Dose

2400 mg/day in adults

Children's Dosage

Children 2-16 years (adjunctive): 8-10 mg/kg/day in two divided doses; target maintenance: 20-29 kg: 900 mg/day; 29.1-39 kg: 1200 mg/day; >39 kg: 1800 mg/day; max 60 mg/kg/day. Children 4-16 years (monotherapy): 8-10 mg/kg/day in two divided doses; max 60 mg/kg/day.

Dose Adjustment Notes

Renal impairment: if CrCl <30 mL/min, start at 50% of the usual initial dose and titrate slowly; Hepatic impairment: no adjustment for mild-moderate impairment, and use is not recommended/insufficiently studied in severe hepatic impairment; Conversion from carbamazepine: no fixed 1.5× rule-convert using clinical response/tolerability with careful titration.

How to Take

Swallow the film‑coated tablet whole with water; may be taken with or without food; administer in 2 divided doses (usually twice daily) as prescribed.

Side Effects

Common Side Effects

Dizziness, somnolence, headache, ataxia, nausea, vomiting, diplopia, fatigue, abnormal vision, abdominal pain, tremor, dyspepsia, abnormal gait

Side Effect Frequency

Very common (≥10%): dizziness, somnolence, headache, diplopia, fatigue, nausea, vomiting, ataxia/abnormal gait, abnormal vision. Common (1-10%): tremor, confusion, rash, hyponatremia (including clinically significant cases), among others; rare but serious: SJS/TEN, angioedema/anaphylaxis, blood dyscrasias, suicidal ideation.

Safety & Warnings

Contraindications

Hypersensitivity to oxcarbazepine or any component of the formulation; do not use in patients with known hypersensitivity to carbamazepine due to clinically significant cross-hypersensitivity risk.

Warnings & Precautions

Monitor serum sodium (hyponatremia risk, higher in elderly/with diuretics); risk of serious dermatologic reactions (SJS/TEN)-consider HLA-B*1502 screening in at-risk Asian ancestry and avoid if positive when alternatives exist; cross-hypersensitivity with carbamazepine; monitor for suicidal ideation/behavior; taper on discontinuation; caution in renal impairment; reduced efficacy of hormonal contraceptives; additive CNS depression with alcohol/CNS depressants.

Age Restriction

Approved for use in children 4 years and older for monotherapy, and 2 years and older for adjunctive therapy.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Hormonal contraceptives (reduced efficacy via CYP3A induction); enzyme-inducing antiepileptics (carbamazepine, phenytoin, phenobarbital) and rifampin (can lower active MHD exposure); phenytoin (oxcarbazepine can increase phenytoin levels at higher doses); alcohol/CNS depressants (additive CNS effects); diuretics or other hyponatremia-promoting drugs (additive hyponatremia risk).

Interaction Severity

MAJOR: Hormonal contraceptives (reduced efficacy via enzyme induction-use additional/alternative contraception). MODERATE: Phenytoin (oxcarbazepine can increase phenytoin levels at higher doses; bidirectional level changes possible), other enzyme inducers (e.g., carbamazepine/phenobarbital/phenytoin, rifampin) can reduce MHD exposure, CNS depressants/alcohol (additive sedation), and drugs that increase hyponatremia risk (e.g., diuretics/SSRIs) (additive hyponatremia risk).

Food Interaction

Immediate‑release Trileptal film‑coated tablets: may be taken with or without food (no food restriction).

Special Populations

Pregnancy

Category C

Breastfeeding

Caution

Children

Children 2-16 years (adjunctive): 8-10 mg/kg/day in two divided doses; target maintenance: 20-29 kg: 900 mg/day; 29.1-39 kg: 1200 mg/day; >39 kg: 1800 mg/day; max 60 mg/kg/day. Children 4-16 years (monotherapy): 8-10 mg/kg/day in two divided doses; max 60 mg/kg/day.

Elderly

Start at a lower dose (e.g., 300-450 mg/day) and titrate more slowly due to potential for reduced renal clearance.

Kidney Impairment

CrCl <30 mL/min: start at 50% of the usual initial dose (i.e., 300 mg/day total, typically 150 mg twice daily) and titrate more slowly; CrCl ≥30 mL/min: no adjustment.

Liver Impairment

Mild-to-moderate hepatic impairment: no dose adjustment needed; severe hepatic impairment: use with caution (insufficient data).

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly; taper gradually over several weeks (individualize, typically at least 2-4 weeks) to reduce risk of increased seizure frequency/status epilepticus.

Overdose

Symptoms may include somnolence, dizziness, ataxia, nystagmus, nausea/vomiting, agitation, hypotension/bradycardia, hyponatremia, and coma; management is immediate emergency evaluation with supportive/symptomatic care (airway/breathing/circulation), consider activated charcoal if early, and monitor ECG/vitals and electrolytes; no specific antidote.

Patient Counseling

Take exactly as prescribed (usually twice daily) with or without food; do not stop abruptly; may cause dizziness/drowsiness-avoid driving until effects known and avoid alcohol; report rash immediately; report symptoms of low sodium (nausea, headache, confusion, worsening seizures); use additional/alternative contraception if using hormonal birth control; report mood changes/suicidal thoughts; inform provider if pregnant/planning pregnancy or breastfeeding.

Monitoring Requirements

Monitor serum sodium (baseline and periodically-especially during the first 3 months and in high‑risk patients), and monitor for CNS adverse effects and suicidal ideation; assess renal function (especially if impairment/elderly) and consider LFTs/CBC if clinically indicated.

Pharmacology

Mechanism of Action

Blocks voltage‑sensitive sodium channels to stabilize hyperexcited neuronal membranes and inhibit repetitive firing; activity is primarily via the active metabolite (10‑monohydroxy derivative, MHD); may have additional effects on calcium currents and potassium conductance.

Duration of Effect

Approximately 12 hours per dose (supports twice‑daily dosing for immediate‑release tablets).

Half-Life

Oxcarbazepine: approximately 2 hours; active metabolite MHD: 9-11 hours

Bioavailability

Oral absorption is high (≥95% absorbed) with extensive conversion to MHD; MHD systemic availability is high (often described as ~100% relative exposure after formation).

Metabolism

Rapidly and extensively reduced to the active 10-monohydroxy derivative (MHD) via cytosolic reductases (non-CYP); MHD is then primarily glucuronidated, and oxcarbazepine/MHD can induce CYP3A4/3A5 (and inhibit CYP2C19).

Product Information

Available Dosage Forms

Film-coated tablet, Oral suspension.

Composition per Dose

Each film-coated tablet: 300 mg oxcarbazepine

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Also Used For

Partial seizures.

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 10-07-2026