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Fluticasone/salmeterol
Combination of
Fluticasone Glucocorticoid
Salmeterol Long-Acting Beta2 Agonist
Identifiers
CAS number  ?
ATC code R03AK06
PubChem  ?
Therapeutic considerations
Pregnancy cat. C(US)
Legal status POM (UK) -only (US)
Routes Inhaled

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 (EU, Australia), Viani (Germany), Adoair (Japan), and ForAir (India). Annual sales approx $3.8B. Patent expires 2010.

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.

Contents

Formulations

The Diskus device
Inner Workings of Diskus
The Evohaler device, which uses gas to deliver the medicine

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 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 60 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. and France. 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).

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,[1] 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.[2] This seems to occur because although LABAs relieve asthma symptoms, they also promote bronchial inflammation and sensitivity without warning.[3]

Other side effects may include increased blood pressure, change in heart rate, an irregular heartbeat, increased risk of osteoporosis, cataracts, and glaucoma.[4]

Footnotes

  1. ^ British Thoracic Society & Scottish Intercollegiate Guidelines Network (SIGN). British Guideline on the Management of Asthma. Guideline No. 63. Edinburgh:SIGN; 2004.
  2. ^ Salpeter S, Buckley N, Ormiston T, Salpeter E (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.  
  3. ^ Krishna Ramanujan (June 9 2006). "Common asthma inhalers cause up to 80 percent of asthma-related deaths, Cornell and Stanford researchers assert". ChronicalOnline - Cornell University.  
  4. ^ [1]

External links

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