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Advair Diskus (Fluticasone Propionate / Salmeterol Xinafoate Inhalation) - Summary

 

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WARNING

Long-acting beta2-adrenergic agonists, such as salmeterol, one of the active ingredients in ADVAIR DISKUS, may increase the risk of asthma-related death. Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS 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 DISKUS SUMMARY

ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, and ADVAIR DISKUS 500/50 are combinations of fluticasone propionate and salmeterol xinafoate.

Asthma: ADVAIR DISKUS is indicated for the long-term, twice-daily, maintenance treatment of asthma in patients 4 years of age and older.

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

Chronic Obstructive Pulmonary Disease Associated With Chronic Bronchitis: ADVAIR DISKUS 250/50 is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with COPD associated with chronic bronchitis.

ADVAIR DISKUS 250/50 mcg twice daily is the only approved dosage for the treatment of COPD associated with chronic bronchitis. Higher doses, including ADVAIR DISKUS 500/50, are not recommended (see DOSAGE AND ADMINISTRATION: Chronic Obstructive Pulmonary Disease Associated With Chronic Bronchitis).

The benefit of treating patients with COPD associated with chronic bronchitis with ADVAIR DISKUS 250/50 for periods longer than 6 months has not been evaluated. Patients who are treated with ADVAIR DISKUS 250/50 for COPD associated with chronic bronchitis for periods longer than 6 months should be reevaluated periodically to assess the continuing benefits and potential risks of treatment.

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

ADVAIR DISKUS NEWS HIGHLIGHTS

Media Articles Related to Advair Diskus (Fluticasone / Salmeterol Xinafoate)

fluticasone and salmeterol oral inhaler, Advair Diskus
Source: MedicineNet fluticasone propionate nasal inhaler-spray Specialty [2006.07.27]

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Published Studies Related to Advair Diskus (Fluticasone / Salmeterol Xinafoate)

Comparison of the effects of salmeterol/fluticasone propionate with fluticasone propionate on airway physiology in adults with mild persistent asthma. [2007.07.14]

Initiation of maintenance therapy with salmeterol/fluticasone propionate combination therapy in moderate asthma: a comparison with fluticasone propionate. [2007.07]

The safety of twice-daily treatment with fluticasone propionate and salmeterol in pediatric patients with persistent asthma. [2005.07]

Efficacy and safety of salmeterol/fluticasone propionate delivered via a hydrofluoroalkane metered dose inhaler in Chinese patients with moderate asthma poorly controlled with inhaled corticosteroids. [2005.07]

Withdrawal of fluticasone propionate from combined salmeterol/fluticasone treatment in patients with COPD causes immediate and sustained disease deterioration: a randomised controlled trial. [2005.06]

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Clinical Trials Related to Advair Diskus (Fluticasone / Salmeterol Xinafoate)

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]

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Page last updated: 2007-10-18

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