Fluticasone/salmeterol, sold under the brand name Advair among others, is a combination medication containing fluticasone propionate and salmeterol. It is used in the management of asthma and chronic obstructive pulmonary disease (COPD). It is used by breathing the medication into the lungs.
Common side effects include thrush, headache, and cough. Serious side effects may include worsening asthma, anaphylaxis, seizures, and heart problems. Safety in pregnancy and breastfeeding is unclear. Fluticasone, a steroid, works by decreasing inflammation while salmeterol, a LABA, works by activating beta-2 adrenergic receptors.
The combination was approved for medical use in the United States in 2000. A generic version was approved in the United States in 2019. A two month supply in the United Kingdom costs the NHS about 35.00 £ per month as of 2019. In the United States the wholesale cost of this amount is about 89.00 USD. In 2016, it was the 62nd most prescribed medication in the United States, with more than 12 million prescriptions.
Fluticasone, a corticosteroid, is the anti-inflammatory component of the combination which decreases inflammation in the lungs. This leads to better breathing. Salmeterol, a long acting beta-adrenoceptor agonist (LABA), treats constriction of the airways. The combination of both is meant to be used as maintenance therapy and not as a rescue therapy for sudden symptoms.
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 Candida infection.
While the use of inhaled steroids and long acting beta-adrenoceptor agonists (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. 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.
With available studies, the safety of inhaled fluticasone propionate cannot be questioned for its effect on growth of asthmatic children. A systematic review published in year 2013 could not derive any significant adverse effect on the function of the hypothalamic–pituitary–adrenal axis, growth, and bone mineral density in asthmatic children when inhaled fluticasone is used for a long duration and followed for up to three months.
On January 30, 2019, the FDA granted Mylan N.V. the first generic approval for Advair Diskus.
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 said that GSK promoted off-label uses of Advair and paid kickbacks to healthcare professionals to sell this drug, among others.