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U.S. Department of Health and Human Services

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Caduet (amlodipine besylate/atorvastatin calcium) Tablets


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS

  • Skeletal Muscle

PRECAUTIONS

  • Drug Interactions
    • Studies with Atorvastatin
    • The risk of myopathy during treatment with HMG-CoA reductase inhibitors is increased...

WARNINGS

Skeletal Muscle

The risk of myopathy during treatment with drugs in the HMG-CoA reductase inhibitor class is increased with concurrent administration of cyclosporine, fibric acid derivatives, erythromycin, clarithromycin, combination of ritonavir plus saquinavir or lopinavir plus ritonavir, niacin, or azole antifungals...

 

Label approved 05/29/2008 is not available on Drugs@FDA