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).
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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.
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NEWS HIGHLIGHTSMedia 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]
Title: fluticasone and salmeterol oral inhaler, Advair Diskus
Category: Medications
Created: 1/22/2002 7:43:00 PM
Last Editorial Review: 7/27/2006
Published Studies Related to Advair Diskus (Fluticasone / Salmeterol Xinafoate)
Deterioration in asthma control when subjects receiving fluticasone propionate/salmeterol 100/50 mcg Diskus are "stepped-down". [2008.10]
In this study, 647 subjects stable on fluticasone propionate/salmeterol Diskus 100/50 mcg BID (FSC) were randomized to continue FSC 100/50 mcg BID or "step down" to either fluticasone propionate (FP) 100 mcg BID, salmeterol (SAL) 50 mcg BID, or montelukast (MON) 10 mg once daily for 16 weeks.
Comparison of the effects of salmeterol/fluticasone propionate with fluticasone propionate on airway physiology in adults with mild persistent asthma. [2007.07.14]
BACKGROUND: This study compared the effect of inhaled fluticasone propionate (FP) with the combination of salmeterol/fluticasone propionate (SFC) on lung function parameters in patients with mild asthma... CONCLUSION: SFC is superior to FP in reducing airway resistance in mild asthmatics with near normal FEV1 values. This study provides evidence that changes in pulmonary function in patients with mild asthma are detected more sensitively by plethysmography compared to spirometry TRIAL REGISTRATION NUMBER: NCT00370591.
Initiation of maintenance therapy with salmeterol/fluticasone propionate combination therapy in moderate asthma: a comparison with fluticasone propionate. [2007.07]
The objective of this study was to investigate initial maintenance treatment with salmeterol/fluticasone propionate (Seretide) 50/250 mu g twice daily (SFC) compared with fluticasone propionate (Flixotide) 250 mu g twice daily (FP) (both via Diskus inhaler, GlaxoSmithKline, Greenford, UK) in patients with moderate persistent asthma currently only treated with inhaled short-acting beta(2)-agonists...
The safety of twice-daily treatment with fluticasone propionate and salmeterol in pediatric patients with persistent asthma. [2005.07]
BACKGROUND: For children older than 5 years with asthma who remain symptomatic despite inhaled corticosteroid (ICS) therapy, the preferred treatment is to add an inhaled long-acting beta2-agonist vs increasing the ICS dose. OBJECTIVE: To compare the safety of twice-daily treatment with inhaled fluticasone propionate plus the inhaled long-acting beta2-agonist salmeterol with that of fluticasone propionate used alone in children aged 4 to 11 years with persistent asthma... CONCLUSIONS: In pediatric patients with persistent asthma, fluticasone propionate-salmeterol twice daily was well tolerated, with a safety profile similar to that of fluticasone propionate used alone.
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]
A randomised, open-label, multicentre study compared the efficacy and tolerability of salmeterol 25 microg/fluticasone propionate 125 microg (two puffs, twice daily) delivered via a hydrofluoroalkane metered-dose inhaler (HFA-MDI) and salmeterol 50microg/fluticasone propionate 250 microg (one puff, twice daily) delivered via a Diskus inhaler in Chinese patients with moderate asthma uncontrolled with inhaled corticosteroids (ICSs)...
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]
Collect PK/PD data for this age group to compare ADVAIR DISKUS with ADVAIR HFA
Atlantis Symbicort [Completed]
The purpose of this study is to determine whether Symbicort compared with Advair, will be
more effective in controlling asthma in adults and adolescents.
SERETIDE Plus Tiotropium Versus Individual Components [Completed]
This study was designed to evaluate the effects on lung function of a combination of
SERETIDE 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the
individual treatments (tiotropium bromide 18mcg once daily alone and SERETIDE 50/500mcg twice
daily alone) in subjects with COPD. The study will utilise a three-way cross-over design
with a 2-week wash-out period between each 2-week consecutive treatment period.
Symbicort Onset of Action 1 [Completed]
The purpose of this study is to compare the early onset of effect of Symbicort compared to
Advair Diskus and Ventolin in adults with asthma
The Effect of Advair Diskus Treatment on Depression in Nursing Home Residents With Chronic Obstructive Pulmonary Disease (COPD) [Not yet recruiting]
The purpose of this study is to assess the effect of treatment with Advair Diskus on
depression using the Cornell depression scale in COPD patients in the nursing home.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 7 ratings/reviews, Advair Diskus has an overall score of 8. The effectiveness score is 7.71 and the side effect score is 8.57. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Advair Diskus review by 44 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | Asthma |
| Dosage & duration: | | 250/50 (dosage frequency: twice a day) for the period of 7 years and continuing |
| Other conditions: | | Seasonal Allergies |
| Other drugs taken: | | Allegra as needed | | |
Reported Results |
| Benefits: | | I am able to breath more easily. Taking the medication keeps my airways open and keeps me alive. |
| Side effects: | | More easy bruising than when not on the medication. This isn't a big deal. |
| Comments: | | The medication comes in a plastic disk, which contains 60 measured doses in a blister pack. This lasts 30 days. Each morning and evening the plastic disk is opened and the next dose is opened. One must exhale and then place the disc with the mouth covering the opening and evenly and steadily inhale. Close the disc. I hold me breathe for about 30 seconds and then exhale. Then you need to rinse your mouth so that the medication does not cause oral thrush. |
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| | Advair Diskus review by 30 year old male patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | asthma |
| Dosage & duration: | | 250/50 (dosage frequency: 2 times daily) for the period of 1 month |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Much greater ability to breathe. |
| Side effects: | | I didn't observe any significant side effects aside from a little bit of dry mouth which is alleviated by drinking some water. |
| Comments: | | I took this for maintenance to prevent asthma exacerbations. I used it every morning by exhaling first then inhaling the medication from the disc. It worked well when I used it. |
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| | Advair Diskus review by 35 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | asthma |
| Dosage & duration: | | 250/50 (dosage frequency: twice per day) for the period of four months |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Slight initial improvement of viral aggravated asthma. |
| Side effects: | | heart palpitations and coughing began in the second month. These side affects continued to get worse over time. |
| Comments: | | I have already completed a survey about the advair and unfortunately did not get the download due to some kind of glitch. I am resubmitting this information again. |
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Page last updated: 2008-11-03
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