Drug Safety-related Labeling Changes (SrLC)

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ERYC (NDA-050536)

(ERYTHROMYCIN)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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04/23/2018 (SUPPL-26)

Approved Drug Label (PDF)

4 Contraindications

(Additions and/or revisions are underlined)

Do not use erythromycin concomitantly with HMG CoA reductase inhibitors (statins) that are extensively metabolized by CYP 3A4 (lovastatin or simvastatin), due to the increased risk of myopathy, including rhabdomyolysis.

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information
druginfo@fda.hhs.gov.

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