Label Changes for:
Sanctura (trospium chloride) and Sanctura XR (trospium chloride extended release)
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)
- 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.
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