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Breo Ellipta Inhaler 2x30 By Glaxo Smith Kline.

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Breo Ellipta Inhaler 2x30 By Glaxo Smith Kline.

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Breo Ellipta Inhaler 2x30 By Glaxo Smith Kline. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXB10121735/RXD4896676
Size : 2X30
Selling UoM : EA
NDC: 00173-0859-10
UPC Barcode : 301730859105
Supplier: 0050003878 GLAXOSMITHKLINE/KDC
Supplier Material : 085910
Generic Code : 070972 FLUTICASONE/VILANTEROL INHALATION BLST W
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : BRX Branded RX

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Product Description.:

These highlights do not include all the information needed to use the BREO ELLIPTA inhaler safely and effectively. See full prescribing information for BREO ELLIPTA.
BREO ELLIPTA (fluticasone furoate and vilanterol inhalation powder) FOR ORAL INHALATION USE Initial U.S. Approval: 2013
WARNING: ASTHMA-RELATED DEATH
See full prescribing information for complete boxed warning.
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Long-acting beta2-adrenergic agonists (LABA), such as vilanterol, one of the active ingredients in BREO ELLIPTA, increase the risk of asthma-related death. A placebo-controlled trial with another LABA (salmeterol) showed an increase in asthma-related deaths in subjects receiving salmeterol. This finding with salmeterol is considered a class effect of all LABA, including vilanterol. (5.1)
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The safety and efficacy of BREO ELLIPTA in patients with asthma have not been established. BREO ELLIPTA is not indicated for the treatment of asthma. (5.1)
----------------------------INDICATIONS AND USAGE---------------------------BREO ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS), and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for long-term, once-daily, maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1)
Important limitations: Not indicated for relief of acute bronchospasm or for treatment of asthma. (1, 5.2)
-----------------------DOSAGE AND ADMINISTRATION ----------------------?
For oral inhalation only. (2)
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Maintenance treatment of COPD: 1 inhalation of BREO ELLIPTA 100 mcg/25 mcg once daily. (2)
---------------------DOSAGE FORMS AND STRENGTHS --------------------Inhalation Powder. Inhaler containing 2 double-foil blister strips of powder formulation for oral inhalation. One strip contains fluticasone furoate 100 mcg per blister and the other contains vilanterol 25 mcg per blister. (3)
-------------------------------CONTRAINDICATIONS------------------------------Severe
hypersensitivity to milk proteins or any ingredients. (4)
------------------------WARNINGS and PRECAUTIONS -----------------------?
LABA increase the risk of asthma-related death. (5.1)
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Do not initiate in acutely deteriorating COPD or to treat acute symptoms.
(5.2)
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Do not use in combination with an additional medicine containing LABA because of risk of overdose. (5.3)
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Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth without swallowing after inhalation to help reduce the risk. (5.4)
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Increased risk of pneumonia in patients with COPD taking BREO ELLIPTA. Monitor patients for signs and symptoms of pneumonia. (5.5)
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Potential worsening of infections (e.g., existing tuberculosis fungal, bacterial, viral, or parasitic infection ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. (5.6)
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Risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to BREO ELLIPTA. (5.7)
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Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue BREO ELLIPTA slowly. (5.8)
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If paradoxical bronchospasm occurs, discontinue BREO ELLIPTA and institute alternative therapy. (5.10)
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Use with caution in patients with cardiovascular disorders because of beta-adrenergic stimulation. (5.12)
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Assess for decrease in bone mineral density initially and periodically thereafter. (5.13)
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Close monitoring for glaucoma and cataracts is warranted. (5.14)
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Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis. (5.15)
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Be alert to hypokalemia and hyperglycemia. (5.16)
------------------------------ADVERSE REACTIONS -----------------------------Most common adverse reactions (incidence 𕟵%) are nasopharyngitis, upper respiratory tract infection, headache, and oral candidiasis. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
-------------------------------DRUG INTERACTIONS------------------------------?
Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution. May cause systemic corticosteroid and cardiovascular effects.
(7.1)
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Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of vilanterol on vascular system.
(7.2)
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Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. (7.3)
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Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non?potassium-spar