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.
