Label Changes for:

Ditropan XL (oxybutynin chloride) Extended Release Tablets

November 2012

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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

 

 

November 2012 

ADVERSE REACTIONS

  • anorexia, fluid retention, hot flush, dysphonia, dysphagia, frequent bowel movements, chest discomfort, and thirst.  

 

March 2012

ADVERSE REACTIONS

Postmarketing Experience
  • glaucoma

 

June 2011

 

WARNINGS

  • Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. In some cases, angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, oxybutynin 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 oxybutynin may produce angioedema that could result in lifethreatening airway obstruction. Patients should be advised to promptly discontinue oxybutynin therapy and seek immediate medical attention if they experience edema of the tongue, edema of the laryngopharynx, or difficulty breathing.
Hide
(web1)