TRILEPTAL 600/MG FC TAB 50/FC TAB

Indications

Approved Uses

Treatment of partial-onset seizures in adults (monotherapy or adjunctive therapy), Treatment of partial-onset seizures in children aged 4-16 years (monotherapy), Treatment of partial-onset seizures in children aged 2 years and above (adjunctive therapy)

Dosage & Administration

Dosing by Condition

Partial (focal) seizures-Adults: Adjunctive therapy start 300 mg twice daily, increase by up to 600 mg/day at ~weekly intervals; usual maintenance 600-1200 mg/day; max 2400 mg/day. Monotherapy conversion start 300 mg twice daily and increase by 300 mg/day every ~3 days to ~1200 mg/day (max 2400 mg/day). Pediatrics (adjunctive, 2-16 years): start ~8-10 mg/kg/day (max 600 mg/day) in 2 doses; titrate to weight‑based maintenance (typically ~30-46 mg/kg/day).

Initial Dose

600mg per day (300mg twice daily) in adults

Maintenance Dose

1200mg per day in two divided doses (adjunctive); up to 2400mg/day in monotherapy

Maximum Dose

2400mg per day

Children's Dosage

Children 2-16 years (adjunctive): 4-5mg/kg/day in 2 divided doses initially; titrate over 2 weeks to target dose based on weight (20kg: 600-900mg/day; 25-30kg: 900-1200mg/day; 35-40kg: 900-1500mg/day; 45kg: 1200-1500mg/day; 50-55kg: 1200-1800mg/day; 60-65kg: 1200-1800mg/day; 70kg: 1500-2100mg/day). Children under 2 years: not recommended.

How to Take

Swallow the film‑coated tablet whole with water; may be taken with or without food; take in 2 divided doses at consistent times each day.

Side Effects

Common Side Effects

Dizziness, Drowsiness (somnolence), Headache, Nausea, Vomiting, Double vision (diplopia), Fatigue, Ataxia, Abnormal gait, Confusion, Tremor, Abdominal pain.

Side Effect Frequency

Very common (>10%): dizziness, somnolence, headache, diplopia, nausea, vomiting, fatigue. Common (1-10%): ataxia, tremor, nystagmus/abnormal vision, abdominal pain, rash, hyponatremia, confusion.

Safety & Warnings

Contraindications

Hypersensitivity to oxcarbazepine or to eslicarbazepine acetate (and/or any component of the formulation).

Warnings & Precautions

Monitor for hyponatremia (check sodium especially in at-risk patients), serious rash/SJS/TEN (higher risk with HLA-B*1502 in certain Asian ancestries), hypersensitivity/cross-reactivity with carbamazepine, suicidal ideation/behavior, CNS effects (dizziness/somnolence), and taper gradually to avoid seizure worsening.

Age Restriction

Approved for adjunctive therapy in children ≥2 years and for monotherapy in children ≥4 years (safety/efficacy not established <2 years).

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Key interactions: reduces efficacy of hormonal contraceptives (CYP3A induction); enzyme-inducing ASMs (e.g., carbamazepine, phenytoin, phenobarbital) can lower MHD exposure; oxcarbazepine can increase phenytoin levels; additive CNS depression with alcohol/other sedatives.

Interaction Severity

MAJOR: Hormonal contraceptives (reduced efficacy via enzyme induction-use non‑hormonal/additional contraception). MODERATE: Strong enzyme inducers (carbamazepine, phenytoin, phenobarbital) can lower MHD; oxcarbazepine can increase phenytoin levels at higher doses; additive CNS depression with alcohol/other sedatives. NOTE: Routine avoidance with MAOIs is not a standard labeled contraindication for oxcarbazepine.

Food Interaction

No clinically significant food restriction; may be taken with or without food.

Special Populations

Pregnancy

Not Assigned (Risk Summary)

Breastfeeding

Caution

Children

Children 2-16 years (adjunctive): 4-5mg/kg/day in 2 divided doses initially; titrate over 2 weeks to target dose based on weight (20kg: 600-900mg/day; 25-30kg: 900-1200mg/day; 35-40kg: 900-1500mg/day; 45kg: 1200-1500mg/day; 50-55kg: 1200-1800mg/day; 60-65kg: 1200-1800mg/day; 70kg: 1500-2100mg/day). Children under 2 years: not recommended.

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly; taper/withdraw gradually to reduce risk of increased seizure frequency/status epilepticus.

Overdose

Symptoms may include somnolence/dizziness, nausea/vomiting, ataxia, hyponatremia and other CNS effects; management is supportive (consider activated charcoal if recent), monitor vitals/ECG and electrolytes; no specific antidote-seek emergency care.

Patient Counseling

Take exactly as prescribed and do not stop abruptly; take consistently (BID) with or without food; may cause dizziness/somnolence-avoid driving until effects known and avoid alcohol/other sedatives; report rash or hypersensitivity symptoms urgently; counsel on hyponatremia symptoms (nausea, headache, confusion, seizures); hormonal contraceptives may be less effective-use additional/non‑hormonal contraception; report mood changes/suicidal thoughts; discuss pregnancy planning.

Monitoring Requirements

Monitor serum sodium (baseline and periodically, especially during the first 3 months and in high‑risk patients); monitor for suicidal ideation/behavior and mood changes; assess for rash/hypersensitivity; consider renal function monitoring (especially if impaired/elderly) and clinical response/adverse effects.

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 (MHD).

Duration of Effect

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

Bioavailability

Oxcarbazepine is well absorbed orally (≥90%); it is rapidly converted to MHD, with MHD systemic availability ~90% (food has no clinically meaningful effect).

Metabolism

Rapid, extensive hepatic reduction of oxcarbazepine to the active 10-monohydroxy derivative (MHD/licarbazepine) via cytosolic enzymes (aryl-ketone reductases); MHD is then mainly glucuronidated, with minimal CYP450 involvement in the primary metabolic step.

Product Information

Available Dosage Forms

Immediate‑release film‑coated tablet and oral suspension (immediate‑release); not an extended‑release tablet for Trileptal brand.

Composition per Dose

Each film-coated tablet: 600mg oxcarbazepine

Generic Availability

Yes

OTC Alternatives

No OTC alternative - prescription required for all anticonvulsant therapy

Also Used For

Partial seizures

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