"The U.S. Food and Drug Administration today approved Anoro Ellipta (umeclidinium and vilanterol inhalation powder) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease ("...
ANORO ELLIPTA is a combination anticholinergic/long-acting beta2-adrenergic agonist (anticholinergic/LABA) indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Important Limitations of Use
ANORO ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma.
DOSAGE AND ADMINISTRATION
ANORO ELLIPTA (umeclidinium/vilanterol 62.5 mcg/25 mcg) should be administered as 1 inhalation once daily by the orally inhaled route only.
ANORO ELLIPTA should be taken at the same time every day. Do not use ANORO ELLIPTA more than 1 time every 24 hours.
Dosage Forms And Strengths
Inhalation Powder. Disposable light grey and red plastic inhaler containing 2 double-foil blister strips, each with 30 blisters containing powder intended for oral inhalation only. One strip contains umeclidinium (62.5 mcg per blister), and the other strip contains vilanterol (25 mcg per blister). An institutional pack containing 7 blisters per strip is also available.
Storage And Handling
ANORO ELLIPTA is supplied as a disposable light grey and red plastic inhaler containing 2 double-foil blister strips with 30 blisters each. The inhaler is packaged in a moisture-protective foil tray with a desiccant and a peelable lid (NDC 0173-0869-10).
ANORO ELLIPTA is also supplied in an institutional pack of a disposable light grey and red plastic inhaler containing 2 double-foil blister strips with 7 blisters each. The inhaler is packaged in a moisture protective foil tray with a desiccant and a peelable lid (NDC 0173-086906).
Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store in a dry place away from direct heat or sunlight. Keep out of reach of children.
ANORO ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use. Discard ANORO ELLIPTA 6 weeks after opening the foil tray or when the counter reads “0” (after all blisters have been used), whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.
GlaxoSmithKline, Research Triangle Park, NC 27709. December 2013
Last reviewed on RxList: 12/30/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Anoro Ellipta Information
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