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U.S. Department of Health and Human Services

Safety

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Gelnique (oxybutynin chloride) 10% gel

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

 

Summary View

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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