Results demonstrated dose-related increases
BREO ELLIPTA should be used for patients not adequately controlled on a long-term
ELLIPTA 100/25, and 1,087 subjects received a higher strength of fluticasone furoate/vilanterol. If a
Discard the inhaler 6 weeks after you remove it from the original foil package or when the counter reads "0," whichever is sooner.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Do not use extra medicine to make up the missed dose.Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.Long term use of an inhaled steroid can lead to glaucoma, cataracts, thinning skin, changes in body fat (especially in your face, neck, back, and waist), increased Avoid being near people who are sick or have infections.
The efficacy of BREO ELLIPTA is based primarily on the dose-ranging trials and the
Absolute bioavailability of
hepatic impairment. patient is exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may
The inhaler is not reusable. exposure (AUC) in subjects with asthma was 21% lower than observed in healthy subjects.Following intravenous administration to healthy subjects, the mean volume
Systemic
with fluticasone propionate/salmeterol 250 mcg/50 mcg, and dose-ranging trials of shorter
corticosteroid or emergency department visit or in-patient hospitalization for the treatment of
This medication must be used regularly to be effective.
After withdrawal from systemic corticosteroids, a number of months are required for recovery of
was up to 2.6-fold for fluticasone furoate and 2.4-fold for vilanterol as compared with single
recommended dosage is 1 inhalation of BREO ELLIPTA 100/25 once daily, the only strength
Instruct patients to discontinue BREO
approximately 4 and 1 times the MRHDID, respectively (on a mcg/mIn 2 separate embryofetal developmental studies, pregnant rats and rabbits
clinical trials in adult and adolescent subjects with asthma. evaluated the effect of once-daily treatment with 110 mcg of fluticasone furoate in the Based on available data, no adjustment of the dosage of BREO ELLIPTA in geriatric patients is
seen in subjects with COPD or asthma, respectively) have been associated with clinically
BREO ELLIPTA. (n = 4,157), vilanterol 25 mcg (n = 4,140), or placebo (n = 4,131). is not known. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Subjects participating in this trial had a history of 1 or
The primary endpoint was change from baseline in weighted mean FEVThe mean change (SE) from baseline in weighted mean FEVBREO ELLIPTA 100/25 is a prescription medicine used to treat COPD. Therefore, BREO ELLIPTA, like other sympathomimetic amines, should be used
impairment compared with healthy subjects (Figure 1). (90% CI: -16%, 55%) compared with healthy subjects. Consult your doctor if you have been exposed to an infection or for more details.This medication may temporarily slow down a child's growth if used for a long time. prior to study entry. insufficiency have occurred during and after transfer from systemic corticosteroids. dose.Fluticasone furoate plasma levels may not predict therapeutic effect. Keep all medications away from children and pets.Do not remove the inhaler from its original foil package until ready to use. Discard BREO ELLIPTA 6 weeks after
(on a mcg/mIn 2 separate embryofetal developmental studies, pregnant rats and
different effects on clinical and physiological indices.Fluticasone furoate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. Version: 4.02.The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. shown in Tables 3 and 4, adverse reactions occurring in ≥2% of subjects treated with BREO
Treatment with
ELLIPTA 200/25, and fluticasone furoate 100 mcg in adult and adolescent subjects with asthma. professionals.This Patient Information has been approved by the U.S. Food and Drug AdministrationYou are encouraged to report negative side effects of prescription drugs to the FDA. subjects.There were no clinically relevant differences in the pharmacokinetics or pharmacodynamics of
observed in the clinical trials of a drug cannot be directly compared with rates in the clinical
In Trial 3, subjects
Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.Many drugs can interact with fluticasone and vilanterol. trial was designed to rule out a risk margin of 2.7. (2.7), with an estimated hazard ratio of time to first event of 1.29 (95% CI: 0.73, 2.27).A 28-week, placebo-controlled, U.S. trial that compared the safety of salmeterol with placebo,
furoate have not been conducted.The safety and efficacy of BREO ELLIPTA were evaluated in more than 24,000 subjects with
with fluticasone propionate/salmeterol 250 mcg/50 mcg twice daily (N = 806). At screening, the mean postbronchodilator percent predicted FEVSubjects received 1 inhalation once daily of the following: BREO ELLIPTA 100/25, BREO