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U.S. Department of Health and Human Services

Safety

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Advair Diskus (fluticasone propionate and salmeterol inhalation powder)


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 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. Read about the new physician labeling format.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

  • Deterioration of Disease and Acute Episodes
  • Pneumonia
  • Drug Interactions With Strong Cytochrome P450 3A4 Inhibitors

ADVERSE REACTIONS

  • Clinical Trials Experience in Asthma
    • Adult and Adolescent Patients 12 Years of Age and Older
    • Table 2
  • Clinical Trials Experience in Chronic Obstructive Pulmonary Disease
    • Short-Term (6 Months to 1 Year) Trials
    • Table 3
  • Postmarketing Experience
    • Musculoskeletal, Connective Tissue, and Bone Disorders
      • Arthralgia
    • Psychiatric Disorders
      • Behavioral changes, including hyperactivity and irritability, have been reported very rarely and primarily in children.

DRUG INTERACTIONS

  • Inhibitors of Cytochrome P450 3A4
    • Initial Paragraph
    • Ketoconazole: Salmeterol
  • Beta-Adrenergic Receptor Blocking Agents

USE IN SPECIFIC POPULATIONS

  • Pregnancy
  • Pediatric Use
  • Geriatric Use
  • Hepatic Impairment
  • Renal Impairment

PATIENT COUNSELING INFORMATION

  • Pneumonia

MEDICATION GUIDE

  • What is Advair Diskus
    • Chronic Obstructive Pulmonary Disease
  • Who should not use Advair Diskus?
  • What should I tell my healthcare provider before using Advair Diskus?
    • ...are allergic to any of the ingredients in Advair Diskus...
  • How do I use Advair Diskus?
  • What are the possible side effects with Advair Diskus?
  • The most common side effects with Advair Diskus include...

CONTRAINDICATIONS

Severe hypersensitivity to milk proteins...

WARNINGS AND PRECAUTIONS

Deterioration of Disease and Acute Episodes

Advair Diskus should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma or COPD. Advair Diskus has not been studied in patients with acutely deteriorating asthma or COPD...

Pneumonia

Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbations frequently overlap.

Lower respiratory tract infections, including pneumonia, have been reported in patients with COPD following the inhaled administration of corticosteroids, including fluticasone propionate and Advair Diskus. In 2 replicate 12-month studies of 1,579 patients with COPD, there was a higher incidence of pneumonia reported in patients receiving Advair Diskus 250/50 (7%) than in those receiving salmeterol 50 mcg (3%). The incidence of pneumonia in the patients treated with Advair Diskus was higher in patients over 65 years of age (9%) compared with the incidence in patients less than 65 years of age (4%)...

Drug Interactions With Strong Cytochrome P450 3A4 Inhibitors

The use of strong CYP 3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with Advair Diskus is not recommended because increased systemic corticosteroid and increased cardiovascular adverse effects may occur...
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