Serevent (Salmeterol Xinafoate) - Summary

SEREVENT SUMMARY

SEREVENT®
(salmeterol xinafoate)
Inhalation Aerosol
Bronchodilator Aerosol
For Oral Inhalation Only

SEREVENT (salmeterol xinafoate) Inhalation Aerosol contains salmeterol xinafoate as the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. The active component of the formulation is salmeterol base, a highly selective beta₂-adrenergic bronchodilator.

SEREVENT (salmeterol xinafoate) Inhalation Aerosol is indicated for the following:

Asthma

SEREVENT Inhalation Aerosol is indicated for long-term, twice-daily (morning and evening) administration in the maintenance treatment of asthma and in the prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease, including patients with symptoms of nocturnal asthma, who require regular treatment with inhaled, short-acting beta₂-agonists. It should not be used in patients whose asthma can be managed by occasional use of inhaled, short-acting beta₂-agonists.

SEREVENT Inhalation Aerosol may be used alone or in combination with inhaled or systemic corticosteroid therapy.

SEREVENT Inhalation Aerosol is also indicated for prevention of exercise-induced bronchospasm in patients 12 years of age and older.

Chronic Obstructive Pulmonary Disease

SEREVENT Inhalation Aerosol is indicated for long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchospasm associated with COPD (including emphysema and chronic bronchitis).

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SEREVENT NEWS HIGHLIGHTS

Published Studies Related to Serevent (Salmeterol Xinafoate)

Efficacy and tolerability of salmeterol/fluticasone propionate versus montelukast in childhood asthma: A prospective, randomized, double-blind, double-dummy, parallel-group study. [2008.08]

Comparison of a Combination of Tiotropium Plus Formoterol to Salmeterol Plus Fluticasone in Moderate COPD. [2008.08]

Superiority of "triple" therapy with salmeterol/fluticasone propionate and tiotropium bromide versus individual components in moderate to severe COPD. [2008.07]

Fluticasone and ibuprofen do not add to the effect of salmeterol on organic dust-induced airway inflammation and bronchial hyper-responsiveness. [2008.07]

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

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Clinical Trials Related to Serevent (Salmeterol Xinafoate)

Study Of Asthma And Genetics In Patients To Be Treated With Fluticasone Propionate/Salmeterol Or Salmeterol Xinafoate [Completed]

Repeat Dose Study of Fluticasone Propionate/Salmeterol Versus Fluticasone Propionate + Salmeterol In Asthmatics [Completed]

ADVAIR DISKUS (Fluticasone Propionate/Salmeterol) Versus SEREVENT DISKUS (Salmeterol) On Inflammatory Cells And Markers In Chronic Obstructive Pulmonary Disease [Terminated]

Advair® DISKUS® (Fluticasone Propionate/Salmeterol) Versus Serevent® DISKUS® (Salmeterol) For The Treatment Of Chronic Obstructive Pulmonary Disease Exacerbations [Completed]

Effects of Salmeterol on Walking Capacity in Patients With COPD [Completed]

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