Label Changes for:

Vytorin (ezetimibe/simvastatin) Tablets

February 2014

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

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

 

February 2014

4 CONTRAINDICATIONS

  • Added…cobicistat-containing products

5 WARNINGS AND PRECAUTIONS

5.2 Myopathy/Rhabdomyolysis
  • Drug Interactions… paragraph added
  • Table 1 updated with cobicistat-containing products

7 DRUG INTERACTIONS

  • Added… cobicistat-containing products to the existing list of strong CYP3A4 inhibitors

MEDICATION GUIDE

Do not take [drug name] if you take:
  • medicines containing cobicistat…added 

 

 

February 2012

 

CONTRAINDICATIONS

Concomitant administration of strong CYP3A4 inhibitors
  • boceprevir
  • telaprevir
 
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