ADVAIR DISKUS ADVAIR - GlaxoSmithKline

Pr ADVAIR ® DISKUS ®
salmeterol xinafoate/fluticasone propionate dry powder for inhalation
Pr ADVAIR ®
salmeterol xinafoate/fluticasone propionate inhalation aerosol
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
Route of
Administration
Oral Inhalation
Oral Inhalation
Dosage Form / Strength
Dry Powder for inhalation/
50 mcg salmeterol/
100, 250, 500 mcg fluticasone
propionate/blister
Inhalation aerosol/
25 mcg salmeterol/
50, 125, 250 mcg fluticasone
propionate/metered dose
Nonmedicinal Ingredients
Lactose and milk protein
1,1,1,2-tetrafluoroethane
(HFA-134a)
INDICATIONS AND CLINICAL USE
ASTHMA
ADVAIR ® (salmeterol xinafoate/fluticasone propionate) is indicated for the maintenance
treatment of asthma (in patients with reversible obstructive airways disease).
ADVAIR ® /ADVAIR ® DISKUS ® is not indicated for patients whose asthma can be
managed by occasional use of a rapid onset, short duration, inhaled beta 2 -agonist, or for
patients whose asthma can be successfully managed by inhaled corticosteroids along with
occasional use of a rapid onset, short duration, inhaled beta 2 -agonist.
Long-acting beta 2 -adrenergic agonists (LABA), such as salmeterol, one of the active
ingredients in ADVAIR ® and ADVAIR ® DISKUS ® , increase the risk of asthma-related
death. Available data from controlled clinical trials suggest that LABA increase the risk
of asthma-related hospitalization in pediatric and adolescent patients (see WARNINGS
AND PRECAUTIONS). Therefore, when treating patients with asthma, physicians
should only prescribe ADVAIR ® or ADVAIR ® DISKUS ® for patients not adequately
July 29, 2014
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