Label Changes for:
Sanctura XR (trospium chloride extended release capsules)
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
5 WARNINGS AND PRECAUTIONS
- Angioedema of the face, lips, tongue and/or larynx has been reported with trospium chloride. In one case, angioedema occurred after the first dose of trospium chloride. 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.
17 PATIENT COUNSELING INFORMATION
- Patients should be informed that Sanctura XR may produce angioedema which could result in life-threatening airway obstruction. Patients should be advised to promptly discontinue Sanctura XR therapy and seek immediate medical attention if they experience edema of tongue, edema of laryngopharynx, or difficulty breathing.