Caduet (amlodipine/atorvastatin) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2012
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.
- Hepatitis C protease inhibitor (boceprevir): Do not exceed 40 mg atorvastatin daily
- Atorvastatin: There have been rare reports of immune-mediated necrotizing myopathy associated with statin use.
- 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
- ...particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing Caduet.