Label Changes for:
Sanctura (trospium chloride) tablets
January 2011
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – 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.
