美国FDA于2013年5月10日批准Breo Ellipta吸入性粉末用于治疗慢性阻塞性肺病（COPD,包括慢性支气管炎和肺气肿）的长期维持性治疗（1日1次）,也可用于减少和预防COPD急性加重疾病。

BREO ELLIPTA
Generic Name and Formulations:
Fluticasone furoate 100mcg, vilanterol 25mcg; per inhalation; dry pwd for oral inhalation.

Company:
GlaxoSmithKline Pharmaceuticals
Indications for BREO ELLIPTA:
Long term maintenance treatment of airflow obstruction in COPD, including chronic bronchitis and/or emphysema. To reduce exacerbations of COPD in patients with a history of exacerbations. Limitations of use: not indicated for relief of acute bronchospasm or for treatment of asthma.

Adult Dose for BREO ELLIPTA:
1 inhalation once daily. Rinse mouth after use.

Children's Dose for BREO ELLIPTA:
Not established.

Pharmacological Class:
Corticosteroid + long-acting β2 agonist.

Contraindications:
Severe hypersensitivity to milk proteins.

Warnings/Precautions:
Increased risk of asthma-related deaths. Do not initiate in rapidly or acutely deteriorating COPD. Not for relief of acute bronchospasm. Not for use with other long-acting β2-agonists. Do not exceed recommended dose. Prescribe a short-acting, inhaled β2-agonist for acute symptoms; monitor for increased need. Monitor for signs/symptoms of pneumonia. Immunosuppressed. Tuberculosis. Systemic infections. Ocular herpes simplex. If exposed to chickenpox or measles, consider immune globulin or antiviral ­prophylactic therapies. Monitor for adrenal insufficiency when transferring from systemic steroids. Reeva luate periodically. Monitor for hypercorticism and HPA axis suppression (if occurs, discontinue gradually), intraocular pressure, glaucoma, or cataracts. Discontinue if paradoxical bronchospasm occurs; use alternative therapy. Cardiovascular disease (esp. coronary insufficiency, arrhythmias, hypertension). Convulsive disorders. Thyrotoxicosis. Hyperresponsiveness to sympathomimetics. Diabetes. Ketoacidosis. Hypokalemia. Hyperglycemia. Moderate or severe hepatic impairment; monitor. Assess bone mineral density if risk factors exist (eg, osteoporosis, postmenopausal). Labor and delivery. Pregnancy (Cat. C). Nursing mothers.

Interactions:
Caution with concomitant strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole). Caution with concomitant MAOIs, tricyclic antidepressants, or drugs known to prolong the QT interval or within 2 weeks of discontinuing such agents (increased cardiac effects), K+-depleting diuretics. Antagonized by β-blockers.

Adverse Reactions:
Nasopharyngitis, upper respiratory tract infection, headache, oral candidiasis; risk of asthma-related death.

How Supplied:
Dry pwd inhaler—30 doses