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Generic Trileptal
Active ingredient: Oxcarbazepine
$21.60
In stock (100 available)
A prescription is required
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About this medicine
What it is used for
1 INDICATIONS AND USAGE Oxcarbazepine oral suspension 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. Oxcarbazepine oral suspension 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 to 16 years -Adjunctive therapy in the treatment of partial-onset seizures in children 2 to 16 years ( 1 )
How it is taken
2 DOSAGE AND ADMINISTRATION 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 1,200 mg/day ( 2.1 ) • Conversion to Monotherapy: Withdrawal concomitant over 3 to 6 weeks; reach maximum dose of oxcarbazepine oral suspension in 2 to 4 weeks with increments of 600 mg/day at weekly intervals to a recommended daily dose of 2,400 mg/day ( 2.2 ) • Initiation of Monotherapy: Increments of 300 mg/day every third day to a dose of 1,200 mg/day ( 2.3 ) • Initiate at one-half the usual starting dose and increase slowly in patients with a creatinine clearance < 30 mL/min ( 2.7 ) 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. • Adjunctive Patients (Aged 2 to 16 Years): For patients aged 4 to 16 years, target maintenance dose should be achieved over 2 weeks ( 2.4 ). For patients aged 2 to < 4 years, maximum maintenance dose should be achieved over 2 to 4 weeks and should not exceed 60mg/k
Warnings
5 WARNINGS AND PRECAUTIONS • Hyponatremia: Monitor serum sodium levels ( 5.1 ) • Cross Hypersensitivity Reaction to Carbamazepine: Discontinue immediately if hypersensitivity occurs ( 5.3 ) • Serious Dermatological Reactions: If occurs, consider discontinuation ( 5.4 ) • Suicidal Behavior and Ideation: Monitor for suicidal thoughts/behavior ( 5.5 ) • Withdrawal of AEDs: Withdraw oxcarbazepine gradually ( 5.6 ) • Cognitive/Neuropsychiatric Adverse Reactions: May cause cognitive dysfunction, somnolence, and coordination abnormalities. Use caution when operating machinery ( 5.7) • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity: Monitor and discontinue if another cause cannot be established ( 5.8 ) • Hematologic Events: Consider discontinuing ( 5.9 ) • Seizure Control During Pregnancy: Active metabolite may decrease ( 5.10 ) • Risk of Seizure Aggravation: Discontinue if occurs ( 5.11 ) 5.1 Hyponatremia Clinically significant hyponatremia (sodium < 125 mmol/L) can develop during oxcarbazepine use. In the 14 controlled epilepsy studies, 2.5% of oxcarbazepine-treated patients (38/1,524) had a sodium of less than 125 mmol/L at some point during t
Source: openFDA / DailyMed. Provided for information only — always follow the directions given by your own prescriber.