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U.S. Department of Health and Human Services

Safety

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Serevent Diskus (salmeterol xinafoate inhalation powder)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- December 2010

Summary View

 

USE IN SPECIFIC POPULATIONS

Nursing Mothers
  • Plasma levels of salmeterol, a component of Serevent Diskus, after inhaled therapeutic doses are very low.

 

March 2008

Summary View

 

Sections ModifiedSummary of Changes to Contraindications and Warnings

WARNINGS

  • Potential Drug Interactions

PRECAUTIONS

  • Drug Interactions
    • Inhibitors of Cytochrome P450 3A4

MEDICATION GUIDE

  • How do I use Serevent Diskus?
    • While you are using Serevent Diskus twice a day, do not use other medicines that contain a long-acting beta2-agonist or LABA for any reason...

WARNINGS

Potential Drug Interactions

Because of the potential for drug interactions and the potential for increased risk of cardiovascular adverse events, the concomitant use of Servent Diskus with strong CYP 3A4 inhibitors (e.g., ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) is not recommended (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Drug Interactions).