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U.S. Department of Health and Human Services

Safety

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Flovent HFA (fluticasone propionate) Inhalation Aerosol for Oral Inhalation Only July 2008


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

PRECAUTIONS

  • Pediatric Use
    • Children Less Than 4 Years of Age: Pharmacokinetics
    • Pharmacodynamics
    • Safety
    • In Vitro Testing of Dose Delivery With Holding Chambers
    • Table 1 (and text following Table 1)

PATIENT PACKAGE INSERT

  • Who should not use Flovent HFA?
  • What should I tell my doctor before taking Flovent HFA?
  • How should I use Flovent HFA?
  • What are the possible side effects of Flovent HFA?
  • What are the ingredients in Flovent HFA?
  • Using Your Flovent HFA...
    • Priming the Inhaler