Oxcarbazepine

TRILEPTAL is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. TRILEPTAL is indicated for: Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures Pediatrics: - Monotherapy in the treatment of partial-onset seizures in children 4-16 years - Adjunctive therapy in the treatment of partial-onset seizures in children 2-16 years

The pharmacological activity of TRILEPTAL is primarily exerted through the 10-monohydroxy metabolite (MHD) of oxcarbazepine. The precise mechanism by which oxcarbazepine and MHD exert their anti-seizure effect is unknown, however, in vitro electrophysiological studies indicate that they produce blockade of voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses. These actions are thought to be important in the prevention of seizure spread in the intact brain. In addition, increased potassium conductance and modulation of high-voltage activated calcium channels may contribute to the anticonvulsant effects of the drug. No significant interactions of oxcarbazepine or MHD with brain neurotransmitter or modulator receptor sites have been demonstrated.

Adults: Initiate with a dose of 600 mg/day, given twice a day Adjunctive Therapy: Maximum increment of 600 mg/day at approximately weekly intervals. The recommended daily dose is 1200 mg/day. Conversion to Monotherapy: Withdrawal concomitant over 3 to 6 weeks, reach maximum dose of TRILEPTAL in 2 to 4 weeks with increments of 600 mg/day at weekly intervals to a recommended daily dose of 2400 mg/day. Initiation of Monotherapy: Increments of 300 mg/day every third day to a dose of 1200 mg/day. Initiate at one-half the usual starting dose and increase slowly in patients with a creatinine clearance < 30 mL/min. Pediatrics: Initiation with 8 to 10 mg/kg/day, given twice a day. For patients aged 2 to < 4 years and under 20 kg, a starting dose of 16 to 20 mg/kg/day may be considered. Recommended daily dose is dependent upon patient weight.

TRILEPTAL is contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate. Known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate

Hyponatremia: Monitor serum sodium levels. Cross Hypersensitivity Reaction to Carbamazepine: Discontinue immediately if hypersensitivity occurs. Serious Dermatological Reactions: If occurs, consider discontinuation. Suicidal Behavior and Ideation: Monitor for suicidal thoughts/behavior. Withdrawal of AEDs: Withdraw TRILEPTAL gradually. Cognitive/Neuropsychiatric Adverse Reactions: May cause cognitive dysfunction, somnolence, and coordination abnormalities. Use caution when operating machinery. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity: Monitor and discontinue if another cause cannot be established. Hematologic Events: Consider discontinuing. Seizure Control During Pregnancy: Active metabolite may decrease. Risk of Seizure Aggravation: Discontinue if occurs

The following serious adverse reactions are described below and elsewhere in the labeling: Hyponatremia Anaphylactic Reactions and Angioedema Cross Hypersensitivity Reaction to Carbamazepine Serious Dermatological Reactions Suicidal Behavior and Ideation Cognitive/Neuropsychiatric Adverse Reactions Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity Hematologic Events The most common (≥ 10% more than placebo for adjunctive or low dose for monotherapy) adverse reactions in adults and pediatrics were: dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, headache, nystagmus, tremor, and abnormal gait

Phenytoin: Increased phenytoin levels. Reduced dose of phenytoin may be required. Carbamazepine, Phenytoin, and Phenobarbital: Decreased plasma levels of MHD (the active metabolite). Dose adjustments may be necessary. Oral Contraceptive: TRILEPTAL may decrease the effectiveness of hormonal contraceptives

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Bottle containing 250 mL of oral suspension……………………………………………………………NDC 0078-0357-52 Store TRILEPTAL oral suspension in the original container.