fluticasone furoate and vilanterol inhalation powder (Breo Ellipta) (cont.)

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PREGNANCY: Adequate and well-controlled studies regarding the use of with Breo Ellipta during pregnancy have not been performed.

NURSING MOTHERS: It is not known if fluticasone or vilanterol are secreted in breast milk. Other medications in the same class as fluticasone or vilanterol are secreted into breast milk.

SIDE EFFECTS: The most common side effects of Breo Ellipta are headache, upper respiratory tract infections, cold symptoms, and oral candidiasis or thrush (a fungal infection). Breo Ellipta also may cause bronchospasms (wheezing). Bronchospasm should be treated with a rescue inhaler.

High doses of inhaled fluticasone may decrease formation and increase breakdown of bone thereby weakening bones and promoting fractures. Higher doses of fluticasone also may cause suppression of the body's ability to make its own natural glucocorticoid in the adrenal gland. People with suppression of their own adrenal glands (which can be diagnosed by a doctor) would need increased amounts of glucocorticoids, probably by the oral or intravenous route, during periods of high physical stress when glucocorticoids are particularly important.

Inhaled steroids may cause growth suppression, weaken the immune system, and may increase the risk of glaucoma, increased eye pressure, and cataracts.

Allergic reactions, including swelling of face, throat and tongue, rash, hives, and breathing problems may occur. Use of long acting drugs like vilanterol may increase the risk of asthma-related death. Breo Ellipta should not be used for treatment of asthma. Vilanterol can increase heart rate, blood pressure, and cause abnormal heart rhythms.

Medically Reviewed by a Doctor on 6/12/2013

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