Generic Name: fluticasone and vilanterol (floo TIK a sone and vye LAN ter ol)Brand Names: Breo Ellipta What is Breo Ellipta? Breo Ellipta inhalation powder contains a combination of fluticasone and vilanterol. Fluticasone is a steroid that prevents the release of substances in the body that cause inflammation. Vilanterol is a bronchodilator that works by relaxing muscles in the airways to improve breathing. Breo Ellipta is a once-daily combination medicine used in adults with asthma or COPD (chronic obstructive pulmonary disease), to improve symptoms and prevent bronchospasm or asthma attacks. In people with COPD, Breo Ellipta is for long-term treatment. In people with asthma, this medicine is for short-term treatment until symptoms are well-controlled with with other medicines. Important information You should not use Breo Ellipta if you are allergic to fluticasone, vilanterol, or milk proteins. Breo Ellipta is not a rescue medicine. It will not work fast enough to treat an asthma or bronchospasm attack. Vilanterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Seek medical attention if your breathing problems do not improve, or if your symptoms get worse quickly. Before taking this medicine You should not use Breo Ellipta if you are allergic to fluticasone, vilanterol, or milk proteins. Fluticasone can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks. To make sure Breo Ellipta is safe for you, tell your doctor if you have: a weak immune system; heart disease, high blood pressure; liver disease; glaucoma or cataracts; a thyroid disorder; seizures; diabetes; any type of infection, including tuberculosis or herpes infection
CLINICAL PHARMACOLOGY Mechanism Of Action BREO ELLIPTA Since BREO ELLIPTA contains both fluticasone furoate and vilanterol, the mechanisms of action described below for the individual components apply to BREO ELLIPTA. These drugs represent 2 different classes of medications (a synthetic corticosteroid and a LABA) that have different effects on clinical and physiological indices. Fluticasone Furoate Fluticasone furoate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Fluticasone furoate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is approximately 29.9 times that of dexamethasone and 1.7 times that of fluticasone propionate. The clinical relevance of these findings is unknown. The precise mechanism through which fluticasone furoate affects COPD and asthma symptoms is not known. Inflammation is an important component in the pathogenesis of COPD and asthma. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation. Specific effects of fluticasone furoate demonstrated in in vitro and in vivo models included activation of the glucocorticoid response element, inhibition of pro-inflammatory transcription factors such as NFkB, and inhibition of antigen-induced lung eosinophilia in sensitized rats. These anti-inflammatory actions of corticosteroids may contribute to their efficacy. Vilanterol Vilanterol is a LABA. In vitro tests have shown the functional selectivity of vilanterol was similar to salmeterol. The clinical relevance of this in vitro finding is unknown. Although beta2-receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1-receptors are the predominant receptors in the heart, there are also beta2-receptors in the human heart comprising 10% to 50% of the total beta-adrenergic receptors. The precise function of these receptors has not been established, but they raise the possibility that even highly selective beta2-agonists may have
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