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