Label Changes for:

Advair HFA 115/21 (fluticasone propionate 115 mcg and salmeterol 21 mcg*) Inhalation Aerosol

March 2008

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.


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

  • Potential drug interaction with CYP 3A4 inhibitors

PRECAUTIONS

  • Drug Interactions
    • Inhibitors of Cytochrome P450
      • Salmeterol and Ketoconazole

MEDICATION GUIDE

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

WARNINGS

Potential drug interaction with CYP 3A4 inhibitors

Both fluticasone propionate and salmeterol are substrates of CYP 3A4.

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