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Safety

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Sanctura (trospium chloride) and Sanctura XR (trospium chloride extended release)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2009

 

Summary View

 

PRECAUTIONS

Patients with Hepatic Impairment

The term "moderate" added (moderate or severe hepatic)

  • Caution should be used when administering Sanctura in patients with moderate or severe hepatic dysfunction.
  • Hepatic Insufficiency: There is no information regarding the effect of moderate to severe hepatic impairment

 

    
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