Advair HFA 230/21 (fluticasone propionate 230 mcg and salmeterol 21 mcg*) Inhalation Aerosol

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.