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U.S. Department of Health and Human Services

Safety

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Caduet (amlodipine/atorvastatin) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Myopathy and rhabodmyolysis
  • Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness. Caduet therapy should be discontinued if myopathy is diagnoses or suspected
  • There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use.
Table 2
  • Hepatitis C protease inhibitor (boceprevir): Do not exceed 40 mg atorvastatin daily
 

ADVERSE REACTIONS

Postmarketing Experience
  • Atorvastatin: There have been rare reports of immune-mediated necrotizing myopathy associated with statin use.
 

DRUG INTERACTIONS

Atorvastatin
  • Strong Inhibitors of CYP3A4: In patients taking the HIV protease inhibitor nelfinavir or the hepatitis C protease inhibitor boceprevir, the dose of Lipitor should not exceed 40 mg and close clinical monitoring is recommended.
 

PATIENT COUNSELING INFORMATION

Muscle Pain
  • ...particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing Caduet.