Breo Ellipta

BREO ELLIPTA is a combination inhaled corticosteroid/long-acting beta2-adrenergic agonist (ICS/LABA) indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. BREO ELLIPTA is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.

Important Limitations of Use: BREO ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma.

Breo Ellipta Description

BREO ELLIPTA is a combination of fluticasone furoate (an ICS) and vilanterol (a LABA).

One active component of BREO ELLIPTA is fluticasone furoate, a synthetic trifluorinated corticosteroid having the chemical name (6?,11?,16?,17?)-6,9-difluoro-17-{[(fluoro-methyl)thio]carbonyl}-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl 2-furancarboxylate and the following chemical structure:

Fluticasone furoate is a white powder with a molecular weight of 538.6, and the empirical formula is C27H29F3O6S. It is practically insoluble in water.

The other active component of BREO ELLIPTA is vilanterol trifenatate, a LABA with the chemical name triphenylacetic acid-4-{(1R)-2-[(6-{2-[2,6-dicholorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol (1:1) and the following chemical structure:

Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C24H33Cl2NO5C20H16O2. It is practically insoluble in water.

BREO ELLIPTA is a light grey and pale blue plastic inhaler containing 2 double-foil blister strips. Each blister on one strip contains a white powder mix of micronized fluticasone furoate (100 mcg) and lactose monohydrate (12.4 mg), and each blister on the other strip contains a white powder mix of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol), magnesium stearate (125 mcg), and lactose monohydrate (12.34 mg). The lactose monohydrate contains milk proteins. After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece.

Under standardized in vitro test conditions, BREO ELLIPTA delivers 92 mcg of fluticasone furoate and 22 mcg of vilanterol per blister when tested at a flow rate of 60 L/min for 4 seconds.

In adult subjects with obstructive lung disease and severely compromised lung function (COPD with FEV1/FVC less than 70% and FEV1 less than 30% predicted or FEV1 less than 50% predicted plus chronic respiratory failure), mean peak inspiratory flow through the ELLIPTA inhaler was 66.5 L/min (range: 43.5 to 81.0 L/min).

The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.

Breo Ellipta Reviews

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Review:
After having great results with Spiriva for over a year and a half, my wife seen the commercial for Breo Ellipta and asked her respiratory specialist about it. The doctor gave her a two-week sampler inhaler and ordered a 90 day,very expensive, prescription of Breo for her. By just using the sampler inhaler for two weeks the Breo gave my wife the mother of all yeast infections in her mouth and throat. Four treatments with Mycostatin at the hospital as outpatient cleared up the infection. This cost an additional $124 as Medicare does not cover this self-administerable drug as outpatient. She went back to Spiriva and all is well.

Active Breo Ellipta Ingredients

  1. Fluticasone Furoate
  2. Vilanterol Trifenatate

Breo Ellipta NDC Codes

NDC Quantity Package
00173-0859-10 30 1 Inhaler
00173-0859-14 14 1 Inhaler
00173-0859-61 14 1 Inhaler

Breo Ellipta Structured Product Labels

SPL Manufacturer
96428df1-ea05-431a-98d3-1ec2c4b63878 GlaxoSmithKline LLC

Breo Ellipta Overview

Overall Rating
Medication Type
Prescription
Approval Date
Aug 26, 2013
DEA Schedule
Not Classified

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