Label Changes for:

Gelnique (oxybutynin chloride) 10% gel

January 2011

Changes have been made to the CONTRAINDICATIONS and WARNINGS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2011

 

4 CONTRAINDICATIONS

  • Known hypersensitivity to Gelnique, including skin hypersensitivity. Known serious hypersensitivity reaction to Gelnique, oxybutynin, or to any of components of Gelnique [see Warnings and Precautions  (5.3, 5.4)]


5 WARNINGS AND PRECAUTIONS

5.3 Angioedema
  • Angioedema requiring hospitalization and  emergency medical treatment has occurred with the first or subsequent doses of oral oxybutynin. In the event of angioedema, oxybutynin containing products should be  discontinued and appropriate therapy promptly provided.
     
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