- Fluticasone/salmeterol
Drugbox
type = combo
component1 = Fluticasone
class1 = Glucocorticoid
component2 = Salmeterol
class2 = Long-Acting Beta2 Agonist
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pregnancy_AU =
pregnancy_US = C
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legal_UK = POM
legal_US = Rx-only
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routes_of_administration = InhaledThe combination preparation fluticasone/salmeterol is a formulation containing fluticasone propionate and salmeterol xinafoate used in the management ofasthma andchronic obstructive pulmonary disease (COPD). It is marketed byGlaxoSmithKline under various trade names including Advair (USA), Seretide (EU, Australia), Viani (Germany), Adoair (Japan), and ForAir (India).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 better than either fluticasone or salmeterol taken on its own.
Formulations
Advair is available in 3 or 4 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 the US and Canada and now in New Zealand and Australia as Advair HFA 45mcg/21mcg, Advair HFA 115mcg/21mcg, and Advair HFA 230mcg/21mcg. These contain 120 inhalations and are generally prescribed as a 30 day supply. (2 inhalations 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 the UK) or dry-powder devices termed "Accuhaler" in the UK and Australia, and "Diskus" in the U.S. 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.
On August 8, 2007 the FDA issued a "not approvable" letter to GlaxoSmithKline (GSK) on the 500/50 strength for the treatment of patients with chronic obstructive pulmonary disease (
COPD ). [http://us.gsk.com/ControllerServlet?appId=4&pageId=402&newsid=1133 The GSK internal notice]ide 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, British Thoracic Society & Scottish Intercollegiate Guidelines Network (SIGN). "British Guideline on the Management of Asthma". Guideline No. 63. Edinburgh:SIGN; 2004. ( [http://www.sign.ac.uk/guidelines/fulltext/63/index.html HTML] , [http://www.sign.ac.uk/pdf/sign63.pdf Full PDF] , [http://www.sign.ac.uk/pdf/qrg63.pdf Summary PDF] )] 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. [cite journal | author = Salpeter S, Buckley N, Ormiston T, Salpeter E | title = Meta-analysis: effect of long-acting beta-agonists on severe asthma exacerbations and asthma-related deaths | journal = Ann Intern Med | volume = 144 | issue = 12 | pages = 904–12 | year = 2006 | pmid = 16754916] This seems to occur because although LABAs relieve asthma symptoms, they also promote bronchial inflammation and sensitivity without warning. [cite news | author=Krishna Ramanujan | title=Common asthma inhalers cause up to 80 percent of asthma-related deaths, Cornell and Stanford researchers assert | month=June 9 | year=2006 | publisher=ChronicalOnline - Cornell University]In a clinical trial, thirteen people died out of a group of 13,176 people taking salmeterol.
Other side effects include increased blood pressure, increase of aggression, change in heart rate, or an irregular heartbeat.
Footnotes
External links
* [http://www.advair.com/ Advair.com]
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