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Fluticasone propionate (top)
and salmeterol (bottom)
|Salmeterol||Long-acting β2 agonist (LABA)|
|Trade names||Advair, Seretide|
|ATC code||R03AK06 (WHO)|
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 (in the US and Canada), Seretide (Brazil, India, Australia, Colombia, EU, Russia, México, New Zealand, South Africa, South Korea, Turkey, UK, Estonia), Viani (Germany), Adoair (Japan) and Foxair (South Africa). In India it is marketed by Intas under the trade name Quikhale SF. Annual worldwide sales were approximately US$7 billion in 2009. Patent protection in the US expired in 2010, and European patent protection expired in 2013. However, the availability of a generic form of Advair in the United States may be significantly delayed because the Food and Drug Administration has not determined a standard for the bioequivalence of inhaled steroids in multi-dose inhalers or dry powder inhalers.
Fluticasone, a corticosteroid, is the anti-inflammatory component of the combination, while salmeterol treats constriction of the airways. Together, they help prevent symptoms of coughing, wheezing and shortness of breath.
Advair is available in several dosage strengths, depending on the patient's country, as a DPI (dry-powder inhaler). The smallest dosage is 100 μg fluticasone/50 μg salmeterol, the intermediate dosage is 250/50 μg and the highest dosage is 500/50 μg.
Advair HFA aerosol as a MDI (metered-dose inhaler) is available in Canada and the U.S. and now in Australia and New Zealand as Advair HFA 45/21 μg, Advair HFA 115/21 μg, and Advair HFA 230/21 μg. 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 (named Evohaler in Mexico and UK) or dry-powder devices (termed Accuhaler in Australia and the UK, Diskus in France and the U.S. and Multidisk in Russia). These purple disk-shaped containers are about 3.5 inches (8.9 cm) across and about 1 inch thick (2.5 cm). The disc container uses 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 outermost layer exposing the medication that is ready to be inhaled.
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 (commonly known as yeast infection, or thrush). It is recommended to rinse and gargle with water after inhaling the medication. This decreases the risk of developing a candidiasis infection.
Whilst the use of inhaled steroids and long acting beta-adrenoceptor agonist (LABA) are recommended in asthma guidelines for the resulting improved symptom control, 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. This seems to occur because although LABAs relieve asthma symptoms, they also promote bronchial inflammation and sensitivity without warning. Other side effects from this drug combination may include increased blood pressure, change in heart rate, an irregular heartbeat, increased risk of osteoporosis, cataracts, and glaucoma.
Although Advair lost US patent protection in 2010, no generic equivalent is imminent in the US. On November 8, 2010, Teva Pharmaceutical Industries said the regulatory hurdles were too high for a US generic. Teva said they would work on a branded competitor that should be ready by 2014 and might receive US approval by 2016. Seroflo, manufactured by Cipla, is a generic form of Advair available outside of the US.
In 2012, Advair was part of a larger civil settlement agreement between GlaxoSmithKline (GSK) and the United States, in which GSK agreed to pay $1.043 billion. The United States alleges that GSK promoted off-label uses of Advair and paid kickbacks to healthcare professionals to sell this drug. The price of an Advair Discus in the USA has risen from $200 in 2010 to $419 in January 2015.
- Medco Health Solutions. "Estimated Dates of Generic Availablity" (PDF). Retrieved 1 August 2011.
- "Guideline 101: British Guideline on the Management of Asthma". British Thoracic Society & Scottish Intercollegiate Guidelines Network (SIGN).
- 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. doi:10.7326/0003-4819-144-12-200606200-00126. 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. Retrieved 2011-08-30.
- "Asthma Treatment and COPD. Treatment with ADVAIR". GlaxoSmithKline. Retrieved 2011-08-30.
- "Long-Term Safety of Mometasone Furoate/Formoterol Combination for Treatment of Patients with Persistent Asthma". P04139 Study Group. The Journal of Asthma. Retrieved 9 July 2012.
- Biospace.com 11/8/2010
- "GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data". http://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report. Department of Justice: Office of Public Affairs. External link in