Fluticasone Furoate and Vilanterol (Inhalation)
Brand Name: Breo Ellipta
Common Dosage Forms:
Inhalation Powder 100/25: Each dose contains one foil blister containing fluticasone furoate 100 mcg blister containing vilanterol 25 mcg.
Inhalation Powder 200/25: Each dose contains one foil blister containing fluticasone furoate 100 mcg blister containing vilanterol 25 mcg.
FDA Indications/Dosages:
For the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including bronchitis and/or emphysema: One inhalation of BREO ELLIPTA 100/25 once daily.
To reduce the exacerbations of COPD in patients with a history of exacerbations: One inhalations of BREO ELLIPTA 100/25 once daily.
For the once-daily treatment of asthma in patients aged 18 years and older: One inhalation of BREO ELLIPTA 100/25 or 200/25 once daily.
Follow these directions for proper use:
Load a dose by fully opening the cover of the inhaler until you hear a “click.” Do not open the cover until you are ready to use it. If you close the cover before using the inhaler, the loaded dose will be lost.
Breathe out fully (do not breathe into the mouthpiece).
Put the mouthpiece between your lips and close your lips around it (do not cover the vents on the inhaler).
Take a long, steady, deep breath in through your mouth (do not breathe in through your nose).
Remove the inhaler and hold your breath for about 3-4 seconds.
Breathe out slowly and gently.
Close the cover (you may clean the mouthpiece with a dry tissue before closing).
Monitor: K, BMD, FEV
Pharmacology/Pharmacokinetics: Fluticasone propionate is a synthetic, trifluorinated corticosteroid. Corticosteroids binds to certain receptor proteins found in the cytoplasm of sensitive cells to form a steroid-receptor complex. Thos steroid-receptor complex enters the nucleus of the cell where it reacts with chromatin, or DNA. The steroid, or possibly the receptor, then uses stored information to stimulate, or in some cases inhibit, the transcription the mRNA. The stimulation of mRNA results in the synthesis of specific enzymes that carry out its anti-allergy and anti-inflammatory actions. Fluticasone propionate’s glucocorticoid receptor agonist affinity is 18 times greater than dexamethasone and twice that of beclomethasone. Vilanterol stimulates adenyl cyclase, the enzyme which catalyzes the formation of cAMP (cyclic 3′5′ adenosine monophosphate) from ATP (adenosine triphosphate). Increased cAMP is associated with relaxation of bronchial, uterine, and vascular smooth muscle through stimulation of beta-2-adrenergic receptors. In addition, increased cAMP levels inhibit the release of mediators of immediate hypersensitivity from cells, especially from mast cells. Onset of action occurs in 20 minutes with a duration of action of 12 hours.
Drug Interactions: Additive effects occur with systemic corticosteroids. Other sympathomimetics, tricyclic antidepressants, and monoamine oxidase inhibitors may increase the toxicity of this medication. Beta-blockers may decrease the effectiveness of vilanterol. Long-term use of strong CYP3A4 inhibitors (ketoconazole, ritonavir, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, and voriconazole) may increase systemic exposure to both fluticasone furoate and vilanterol.
Contraindications/Precautions: Contraindicated for the primary treatment of status asthmaticus or other acute episodes of COPD and in patients with a severe hypersensitivity to milk proteins. LONG-ACTING BETA-2-ADRENERGIC AGONISTS INCREASE THE RISK OF ASTHMA-RELATED DEATHS. Do not use for acute symptoms or initiate in patients with rapidly deteriorating episodes of COPD. Discontinue if paradoxical bronchospasm occur after use and immediately treat with an inhaled, short-acting bronchodilator. Use caution in patients who are being transferred from systemic corticosteroids because deaths due to adrenal insufficiency have occurred during and after transfer to aerosolized steroids. Systemic steroids should be administered to these patients during times of stress or during an acute asthma attack. Secondary fungal infections of the oral cavity may occur and may require antifungal treatment. Response of the hypothalamic-pituitary-adrenal (HPA) function is highly individualized. Use caution in patients with cardiovascular disorders, hypertension, hyperthyroidism, diabetes mellitus, in nursing mothers or during pregnancy.
Adverse Effects: Adverse effects are usually mild to moderate in severity and include upper respiratory tract infection, nasopharyngitis, and headache. Rare but more serious effects include bronchospasm, pneumonia, immunosuppression, decreased bone mineral density, cataracts, hypokalemia, tachycardia, high blood pressure, and cardiac arrhythmias.
Patient Consultations:
Avoid contact with eyes.
Rinse mouth after each use.
Contact a physician if the above side effects are severe or persistent.
Contact a physician if symptoms worsen or if the effectiveness of short-acting beta-2-agonists decreases.
If a dose is missed, skip it and return to normal dosing schedule.
Not intended to provide immediate relief of bronchospasm.
To receive the full benefits of therapy, use on a regular basis. Although benefits can be seen after 2 days of treatment, up to 4 weeks may be needed to observe benefits.