Ditropan XL (oxybutynin chloride) Extended Release Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.

Summary View

Sections Modified

PRECAUTIONS

• Central Nervous System Effects
  • Oxybutynin is associated with anticholinergic central nervous system (CNS) effects. A variety of CNS anticholinergic effects have been reported, including hallucinations, agitation, confusion and somnolence.
  • Ditropan XL should be used with caution in patients with preexisting dementia treated with cholinesterase inhibitors due to the risk of aggravation of symptoms.

ADVERSE REACTIONS (see highlighted section)

• ...The following adverse events were reported by >1 to < 5% of all patients who received Ditropan XL in the 6 adjustable and fixed dose efficacy and safety studies...
  • Infections and Infestations
  • Psychiatric Disorders
  • Nervous System Disorders
  • Eye Disorders
  • Cardiac Disorders
  • Vascular Disorders
  • Respiratory, Thoracic and Mediastinal Disorders
  • Gastrointestinal Disorders
  • Skin and Subcutaneous Tissue Disorders
  • Musculoskeletal and Connective Tissue Disorders
  • Renal and Urinary Disorders
  • General Disorders and Administration Site Conditions
  • Investigations
• Postmarketing Surveillance
  • Psychiatric Disorders
  • Nervous System Disorders
  • Cardiac Disorders
  • Vascular Disorders
  • Skin and Subcutaneous Tissue Disorders
  • Renal and Urinary Disorders
  • Injury, Poisoning, and Procedural Complications