Fluticasone/salmeterol

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(USA), Seretide(EU), Viani(Germany), Adoair(Japan), and ForAir(India).

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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 500/50. (mcg refers to micrograms)

Advair HFA inhalation aerosol as a MDI (metered dose inhaler) is now available in the US and Canada 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 cleverly designed discus container utilizes a machined 2 piece long foil ribbon with each unit dose held in a 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 approved" letter to GlaxoSmithKline (GSK) on the 500/50 strength for the treatment of patients with chronic obstructive pulmonary disease (COPD). The GSK internal notice

Side effects

Main article: Salmeterol

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]

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.