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Source – Druginfozone - Novartis Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has approved oxcarbazepine (Trileptal) tablets and oral suspension as adjunctive therapy in the treatment of partial seizures in children as young as two-years old with epilepsy.
The approval is based on data from a study which evaluated 128 paediatric patients who were still experiencing partial seizures while taking up to two concomitant AEDs. Patients received either
high-dose (60 mg/kg/day) or low-dose (10 mg/kg/day) oxcarbazepine oral suspension, and high-dose oxcarbazepine adjunctive therapy was significantly more effective in controlling partial seizures in young
children than treatment with low-dose (while both doses were generally well tolerated). Study results will be published in an upcoming issue of Neurology.
Oxcarbazepine is licensed for children over 6 years of age in the United Kingdom.
For more information go to: http://www.druginfozone.nhs.uk/record%20viewing/viewRecord.aspx?id=5573 62
Prepared by Susan Wileman Medicines Information Technician
Date of Preparation: 30th November 2005
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