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U.S. Department of Health and Human Services


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Theophylline in 5% Dextrose in the Excel Plastic Container

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2012


Summary View



  • There have been reports of non-convulsive status epilepticus in patients receiving theophylline, and this possibility should be considered in patients with abnormal central nervous system function and a history of theophylline administration.