Fluticasone/salmeterol
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| Combination of | |
| Fluticasone | Glucocorticoid |
| Salmeterol | Long-Acting Beta2 Agonist |
| Clinical data | |
| Trade names | Advair |
| AHFS/Drugs.com | entry |
| MedlinePlus | a699063 |
| Pregnancy cat. | C(US) |
| Legal status | POM (UK) ℞-only (US) |
| Routes | Inhaled |
| Identifiers | |
| ATC code | R03AK06 |
| PubChem | CID 9811567 |
| ChemSpider | 7987322  |
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The combination preparation fluticasone/salmeterol is a formulation containing fluticasone propionate and salmeterol xinafoate used in the management of asthma and chronic obstructive pulmonary disease (COPD). It is marketed by GlaxoSmithKline under various trade names including Advair (US, CA), Seretide (Australia, Colombia, EU, México, New Zealand, South Africa, South Korea, UK), Viani (Germany), Adoair (Japan), ForAir (India) and Foxair (South Africa). Annual worldwide sales approx $7B in 2009. Its US patent expired in 2010 and European patent in 2013. The availability of a generic form of Advair in the United States may be significantly delayed after the expiration of the patent because the Food and Drug Administration has not determined a standard for the bioequivalence for inhaled steroids in multi-dose inhalers or dry powder inhalers.[1]
Fluticasone, a corticosteroid, is the anti-inflammatory component of the combination, while salmeterol treats constriction of the airways. Together, they relieve the symptoms of coughing, wheezing and shortness of breath.
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[edit] Formulations
Advair is available in several dosage strengths, depending on the patient's country, as a DPI (dry powder inhaler). The smallest dosage is 100mcg/50mcg, the intermediate dosage is 250mcg/50mcg and the highest dosage is 500mcg/50mcg (mcg refers to micrograms).
Advair HFA inhalation aerosol as a MDI (metered dose inhaler) is available in Canada and the US and now in Australia and New Zealand as Advair HFA 45mcg/21mcg, Advair HFA 115mcg/21mcg, and Advair HFA 230mcg/21mcg. These contain 60 inhalations and are generally prescribed as a 30 day supply. (1 inhalation twice a day)
Internationally the fluticasone/salmeterol combination is delivered by a number of devices, including standard aerosol metered dose inhalers (brand name "Evohaler" in México and UK) or dry-powder devices termed "Accuhaler" in Australia and the UK, and "Diskus" in France and the US. These purple disk-shaped containers are about 3.5 inches (8.9 cm) across and about 1 inch thick (2.5 cm). The discus container utilizes a machined 2 piece long foil ribbon with each unit dose held in small caplet-shaped depressions along the entire dose-count-length. Once the lever is actuated the dose is advanced by peeling away the flat outer most layer exposing the medication that is ready to be breathed in.
[edit] Side effects
The common and minor side effects of this combination are those of its individual drugs. For instance, the use of inhaled corticosteroids is associated with oral candidiasis.
Whilst the use of inhaled steroids and long acting beta-adrenoceptor agonist (LABA) are recommended in asthma guidelines for the resulting improved symptom control,[2] concerns have been raised that salmeterol may increase the small risks of asthma deaths and this additional risk is not reduced with the additional use of inhaled steroids.[3] This seems to occur because although LABAs relieve asthma symptoms, they also promote bronchial inflammation and sensitivity without warning.[4] Other side effects may include increased blood pressure, change in heart rate, an irregular heartbeat, increased risk of osteoporosis, cataracts, and glaucoma.[5] No increase in bone loss or osteoporosis was noted in one study of 658 patients on high dose Advair (500 micrograms fluticasone/50 micrograms salmeterol twice daily), although the 57% dropout rate over three years may have biased the reported outcome. [6][7]
[edit] No Generic Equivalent
Although Advair lost US patent protection in 2010, no generic equivalent is imminent. On November 8, 2010, Teva Pharmaceutical Industries said the hurdles were too high for a US copy. Teva said they would work on a branded competitor that should be ready by 2014 and might receive US approval by 2016.[8]
[edit] References
- ^ Medco Health Solutions. "Estimated Dates of Generic Availablity". http://www.medcohealth.com/art/corporate/anticipatedfirsttime_generics.pdf. Retrieved 1 August 2011.
- ^ "Guideline 101: British Guideline on the Management of Asthma". British Thoracic Society & Scottish Intercollegiate Guidelines Network (SIGN). http://www.sign.ac.uk/guidelines/fulltext/101/index.html.
- ^ Salpeter SR, Buckley NS, Ormiston TM, Salpeter EE (June 2006). "Meta-analysis: effect of long-acting beta-agonists on severe asthma exacerbations and asthma-related deaths". Ann. Intern. Med. 144 (12): 904–12. PMID 16754916.
- ^ Ramanujan K (2006-06-09). "Common asthma inhalers cause up to 80 percent of asthma-related deaths, Cornell and Stanford researchers assert". Chronicle Online. Cornell University. http://www.news.cornell.edu/stories/June06/AsthmaDeaths.kr.html. Retrieved 2011-08-30.
- ^ "Asthma Treatment and COPD. Treatment with ADVAIR". GlaxoSmithKline. http://www.advair.com/. Retrieved 2011-08-30.
- ^ Ferguson GT, Calverley PM, Anderson JA, Jenkins CR, Jones PW, Willits LR, Yates JC, Vestbo J, Celli B. Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study. Chest. 2009 Dec;136(6):1456-65.
- ^ Vestbo J, Anderson JA, Calverley PM, Celli B, Ferguson GT, Jenkins C, Yates JC, Jones PW. Bias due to withdrawal in long-term randomised trials in COPD: evidence from the TORCH study. Clin Respir J. 2011 Jan;5(1):44-9.
- ^ Biospace.com 11/8/2010
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