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Advair HFA (Fluticasone Propionate / Salmeterol Xinafoate) - Summary

 

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WARNING

Long-acting beta2-adrenergic agonists, such as salmeterol, one of the active ingredients in ADVAIR HFA, may increase the risk of asthma-related death. Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR HFA for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies. Data from a large placebo-controlled US study that compared the safety of salmeterol (SEREVENT® Inhalation Aerosol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 patients treated for 28 weeks on salmeterol versus 3 deaths out of 13,179 patients on placebo) (see WARNINGS).

 

ADVAIR HFA SUMMARY

ADVAIR HFA 45/21 Inhalation Aerosol, ADVAIR HFA 115/21 Inhalation Aerosol, and ADVAIR HFA 230/21 Inhalation Aerosol are combinations of fluticasone propionate and salmeterol xinafoate.

ADVAIR HFA is indicated for the long-term, twice-daily maintenance treatment of asthma in patients 12 years of age and older.

Long-acting beta2-adrenergic agonists, such as salmeterol, one of the active ingredients in ADVAIR HFA, may increase the risk of asthma-related death (see WARNINGS). Therefore, when treating patients with asthma, physicians shouldonly prescribe ADVAIR HFA for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies. ADVAIR HFA is not indicated in patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of inhaled, short-acting beta2-agonists.

ADVAIR HFA is NOT indicated for the relief of acute bronchospasm.

ADVAIR HFA NEWS HIGHLIGHTS

Published Studies Related to Advair HFA (Fluticasone / Salmeterol)

The effects of fluticasone with or without salmeterol on systemic biomarkers of inflammation in chronic obstructive pulmonary disease. [2008.06.01]

Early bronchodilatory effects of budesonide/formoterol pMDI compared with fluticasone/salmeterol DPI and albuterol pMDI: 2 randomized controlled trials in adults with persistent asthma previously treated with inhaled corticosteroids. [2008.05]

Lower inhaled steroid requirement with a fluticasone/salmeterol combination in family practice patients with asthma or COPD. [2007.04]

Lower inhaled steroid requirement with a fluticasone/salmeterol combination in family practice patients with asthma or COPD. [2007.04]

Can inhaled fluticasone alone or in combination with salmeterol reduce systemic inflammation in chronic obstructive pulmonary disease? Study protocol for a randomized controlled trial [NCT00120978]. [2006.02.06]

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Clinical Trials Related to Advair HFA (Fluticasone / Salmeterol)

A Study In Pediatric Subjects With Asthma Using ADVAIR HFA, ADVAIR HFA With Spacer, And ADVAIR DISKUS [Completed]

Atlantis Symbicort [Completed]

SERETIDE Plus Tiotropium Versus Individual Components [Completed]

Symbicort Onset of Action 1 [Completed]

Effects of AdvairŪ in Outpatients With Chronic Obstructive Pulmonary Disease (COPD) Acute Exacerbation [Not yet recruiting]

more>>

Page last updated: 2008-06-22

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