Label Changes for:

Sanctura (trospium chloride)

July 2012

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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

 

July 2012

WARNINGS AND PRECAUTIONS

Central Nervous System Effects
  • Sanctura is 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 affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.

ADVERSE REACTIONS

Postmarketing Surveillance
  • dizziness and confusion 

 

 

January 2011 

 

WARNINGS

  • Angioedema of the face, lips, tongue and/or larynx has been reported with trospium chloride. In one case, angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life threatening. If involvement of tongue, hypopharynx, or larynx occurs, trospium chloride should be promptly discontinued and appropriate therapy and or measures necessary to ensure a patent airway should be promptly provided.

PRECAUTIONS

Information for Patients
  • Patients should be informed that trospium chloride may produce angioedema which could result in life-threatening airway obstruction. Patients should be advised to promptly discontinue trospium chloride and seek immediate medical attention if they experience edema of tongue, edema of laryngopharynx, or difficulty breathing.
     
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