Monitor patients for corticosteroid-related side effects (fluticasone furoate and vilanterol inhalation powder)If you open and close the cover without inhaling the medicine, you will lose the dose.The lost dose will be securely held inside the inhaler, but it will no longer be available to be inhaled.It is not possible to accidentally take a double dose or an extra dose in 1 inhalation.Wait to open the cover until you are ready to take your dose.Step 1.

If it is near the time of the next dose, skip the missed dose. Copy the URL below and paste it into your RSS Reader application. Three (3) trials included adult and adolescent subjects aged 12 years and older: 1 trial compared budesonide/formoterol with budesonide, 1 trial compared fluticasone propionate/salmeterol inhalation powder with fluticasone propionate inhalation powder, and 1 trial compared mometasone furoate/formoterol with mometasone furoate. Of the 511 patients in Trial 6, 68% were male and 94% were white; mean age was 62 years; average smoking history was 35 pack years, with 52% identified as current smokers. Additionally, inform patients that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. BREO ELLIPTA should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA, as an overdose may result. In Trial 1, subjects were randomized to BREO ELLIPTA 100/25, fluticasone furoate 100 mcg, or placebo. The primary endpoint of each study was change from baseline in weighted mean FEV There were no additional clinically relevant effects of the fluticasone furoate/vilanterol combinations on heart rate or serum potassium in subjects with mild or moderate hepatic impairment (vilanterol 25 mcg combination) or with severe hepatic impairment (vilanterol 12.5 mcg combination) compared with healthy subjects.There were no clinically relevant differences in the pharmacokinetics or pharmacodynamics of either fluticasone furoate or vilanterol when administered in combination compared with administration alone. Mean growth velocity over the 52-week treatment period was lower in the subjects receiving fluticasone furoate nasal spray (5.19 cm/year) compared with placebo (5.46 cm/year).
BREO ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS), and vilanterol, a long-acting beta

BREO ELLIPTA has not been studied in subjects with acutely deteriorating COPD or asthma. Vilanterol trifenatate is a white powder with a molecular weight of 774.8, and the empirical formula is C Subjects reporting symptoms and/or rescue beta Therefore, BREO ELLIPTA, like other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.In a mortality trial with a median treatment duration of 1.5 years in 16,568 subjects with moderate COPD and cardiovascular disease, the annualized incidence rate of adjudicated cardiovascular events (composite of myocardial infarction, stroke, unstable angina, transient ischemic attack, or on-treatment death due to cardiovascular events) was 2.5 per 100 patient-years for BREO ELLIPTA 100/25, 2.7 for placebo, 2.4 for fluticasone furoate 100 mcg, and 2.6 for vilanterol 25 mcg. Concomitant administration of the strong CYP3A4 inhibitor ketoconazole increases the systemic exposure to fluticasone furoate and vilanterol. In clinical trials evaluating BREO ELLIPTA in subjects with COPD or asthma, there was no evidence of a treatment effect on serum potassium. It may take several days before you get the full benefit of this drug. Original Approvals or Tentative Approvals.
https://www.webmd.com/drugs/2/drug-148273/fluticasone-furoate-nasal If the cap has been left off the bottle for at least 5 days, or spray has not been used for more than 30 days, prime the pump again until a fine mist appears.

In Trial 2, subjects were randomized to BREO ELLIPTA 100/25, BREO ELLIPTA 200/25, or fluticasone furoate 100 mcg.

Open the cover of the inhaler.