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U.S. Department of Health and Human Services

Safety

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Sanctura XR (Trospium Chloride) Extended-Release Capsules

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

Summary View

 

WARNINGS AND PRECAUTIONS

Central Nervous System Effects
  • Sanctura XR and Sanctura are associated with anticholinergic central nervous system (CNS) effects. A variety of CNS anticholinergic effects have been reported, including dizziness, confusion, hallucinations and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how Sanctura XR affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered
 

ADVERSE REACTIONS

Post-marketing Experience
  • The following adverse reactions have been identified during post-approval use of trospium chloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure….