Label Changes for:

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

September 2011

Changes have been made to the PRECAUTIONS sections of the safety label.

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

 

September 2011

PRECAUTIONS

Drug-Drug Interactions
  • addition of data from Study MA-SXR-09-002, a drug-drug interaction study with metformin.
Carcinogenesis, Mutagenesis, Impairment of Fertility, Pregnancy
  • Teratogenic Effects, Pregnancy Category C subsections: alignment of labeling for all products of the same drug class and to be consistent with all Sanctura labels.

 

June 2009

 

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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