"The US Food and Drug Administration (FDA) has approved the first long-acting muscarinic antagonist/long-acting beta-2 agonist combination in a pressurized metered-dose inhaler (pMDI), using novel co-suspension technology for chronic obstructive p"...
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 used at the same time every day. Do not use ANORO ELLIPTA more than 1 time every 24 hours.
No dosage adjustment is required for geriatric patients, patients with renal impairment, or patients with moderate hepatic impairment [see CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
Inhalation Powder. Disposable light grey and red plastic inhaler containing 2 foil blister strips of 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).
Storage And Handling
ANORO ELLIPTA is supplied as a disposable light grey and red plastic inhaler containing 2 foil strips, each with 30 blisters (or 7 blisters for the institutional pack. One strip contains umeclidinium (62.5 mcg per blister), and the other strip contains vilanterol (25 mcg per blister). A blister from each strip is used to create 1 dose. The inhaler is packaged in a moisture-protective foil tray with a desiccant and a peelable lid in the following packs:
NDC 0173-0869-10 30 inhalations (60 blisters)
NDC 0173-0869-06 7 inhalations (14 blisters), institutional pack
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. Revised: February 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/7/2016
Additional Anoro Ellipta Information
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