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Because of the potential for serious adverse reactions to trileptal in nursing infants, a decision should be made about whether to discontinue nursing or to discontinue the drug in nursing women, taking into account the importance of the drug to the mother.

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The safety and effectiveness for use as adjunctive therapy for partial seizures in pediatric patients below the age of 2 have not been established.

Hyponatremiasee WARNINGS AND PRECAUTIONSAnaphylactic Reactions and Angioedemasee WARNINGS AND PRECAUTIONSCross Hypersensitivity Reaction to Carbamazepinesee WARNINGS AND PRECAUTIONSSerious Dermatological Reactionssee WARNINGS AND PRECAUTIONSSuicidal Behavior and Ideationsee WARNINGS AND PRECAUTIONSCognitive/Neuropsychiatric Adverse Reactionssee WARNINGS AND PRECAUTIONSDrug Reaction with Eosinophilia and Systemic SymptomsDRESSMulti-Organ Hypersensitivitysee WARNINGS AND PRECAUTIONSHematologic Eventssee WARNINGS AND PRECAUTIONS

Drug Reaction with Eosinophilia and Systemic SymptomsDRESSalso known as multi-organ hypersensitivityhas occurred with TRILEPTALSome of these events have been fatal or life-threateningDRESS typicallyalthough not exclusivelypresents with feverrashlymphadenopathy and/or facial swellingin association with other organ system involvementsuch as hepatitisnephritishematologic abnormalitiesmyocarditisor myositis sometimes resembling an acute viral infectionEosinophilia is often presentThis disorder is variable in its expressionand other organ systems not noted here may be involvedIt is important to note that early manifestations of hypersensitivitye.gfeverlymphadenopathymay be present eventhough rash is not evidentIf such signs or symptoms are presentthe patient should be evaluated immediatelyTRILEPTAL should be discontinued if an alternative etiology for the signs or symptoms cannot be established.

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