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Although this study failed to demonstrate an effect of oxcarbazepine as monotherapy in pediatric patientsseveral design elementsincluding the short treatment and assessment periodthe absence of a true placeboand the likely persistence of plasma levels of previously administered AEDs during the treatment periodmake the results uninterpretableFor this reasonthe results do not undermine the conclusionbased on pharmacokinetic/pharmacodynamic considerationsthat oxcarbazepine is effective as monotherapy in pediatric patients 4 years old and older.

Body as a Wholemulti-organ hypersensitivity disorders characterized by features such as rashfeverlymphadenopathyabnormal liver function testseosinophilia and arthralgiasee WARNINGS AND PRECAUTIONS

Oxcarbazepine increased mutation frequencies in the in vitro Ames test in the absence of metabolic activationBoth oxcarbazepine and MHD produced increases in chromosomal aberrations and polyploidy in the Chinese hamster ovary assay in vitro in the absence of metabolic activationMHD was negative in the Ames testand no mutagenic or clastogenic activity was found with either oxcarbazepine or MHD in V79 Chinese hamster cells in vitroOxcarbazepine and MHD were both negative for clastogenic or aneugenic effectsmicronucleus formationin an in vivo rat bone marrow assay.

Have or have had suicidal thoughts or actionsdepression or mood problems have liver problems have kidney problems are allergic to carbamazepineMany people who are allergic to carbamazepine are also allergic to TRILEPTALuse birth control medicineTRILEPTAL may cause your birth control medicine to be less effectiveTalk to your healthcare provider about the best birth control method to useare pregnant or plan to become pregnantTRILEPTAL may harm your unborn babyTell your healthcare provider right away if you become pregnant while taking TRILEPTALYou and your healthcare provider will decide if you should take TRILEPTAL while you are pregnant.

Oxcarbazepine and its active metaboliteMHDexhibit anticonvulsant properties in animal seizure modelsThey protected rodents against electrically induced tonic extension seizures andto a lesser degreechemically induced clonic seizuresand abolished or reduced the frequency of chronically recurring focal seizures in Rhesus monkeys with aluminum implantsNo development of tolerancei.eattenuation of anticonvulsive activitywas observed in the maximal electroshock test when mice and rats were treated daily for 5 days and 4 weeksrespectivelywith oxcarbazepine or MHD.

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