Label Changes for:
Ditropan XL (oxybutynin chloride) Extended Release Tablets
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)
WARNINGS AND PRECAUTIONS
Central Nervous System Effects
- Ditropan XL should be used with caution in patients with Parkinson’s disease due to the risk of aggravation of symptoms.
Worsening of Symptoms of Decreased Gastrointestinal Motility in Patients with Autonomic Neuropathy
- Ditropan XL should be used with caution in patients with autonomic neuropathy due to the risk of aggravation of symptoms of decreased gastrointestinal motility.
- Anticholinergic agents may also antagonize the effects of prokinetic agents, such as metoclopramide.
- anorexia, fluid retention, hot flush, dysphonia, dysphagia, frequent bowel movements, chest discomfort, and thirst.
- 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.
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.