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Trileptal (oxcarbazepine) Tablets and Oral Solution

Apr 19, 2005 | www.fda.gov

Novartis Pharmaceuticals and the FDA notified healthcare professionals about revisions to the warnings and precautions sections of the prescribing information for Trileptal(oxcarbazepine) tablets and oral suspension, indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and children ages 4-16 years with epilepsy.

The updated warnings section describes serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) that have been reported in both children and adults in association with Trileptal use. The PRECAUTIONS section has been updated to include language regarding multi-organ hypersensitivity reactions that have been reported in association with Trileptal use.


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