Active Ingredient: Oxcarbazepine
Oxcarbazepine is indicated for the treatment of partial seizures with or without secondarily generalised tonicclonic seizures.
Oxcarbazepine is indicated for use as monotherapy or adjunctive therapy in adults and in children of 6 years of age and above.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
8 - 46 mg per kg of body weight
From 4 To 23 mg per kg of body weight 2 time(s) per day every day
8 mg per kg of body weight
Recommended initial dose: In mono- and adjunctive therapy, Oxcarbazepine Mylan should be initiated with a dose of 8-10 mg/kg/day given in 2 divided doses.
Maintenance dose: In adjunctive therapy trials, a maintenance dose of 30-46 mg/kg/day, achieved over two weeks, is shown to be effective and well tolerated in children. Therapeutic effects were seen at a median maintenance dose of approximately 30
mg/kg/day.
Maximum recommended dose: If clinically indicated, the dose may be increased by a maximum of 10 mg/kg/day at approximately weekly intervals from the starting dose, to a maximum dose of 46 mg/kg/day, to achieve the desired clinical response.
Oxcarbazepine is recommended for use in children of 6 years of age and above. Safety and efficacy have been evaluated in controlled clinical trials involving approximately 230 children aged less than 6 years (down to 1 month).
Oxcarbazepine is not recommended in children aged less than 6 years since safety and efficacy have not been adequately demonstrated.
All the above dosing recommendations are based on the doses studied in clinical trials. However, lower initiation doses may be considered where appropriate.
Oxcarbazepine can be taken with or without food.
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