"The US Food and Drug Administration (FDA) has expanded the indication for the short-acting beta-agonist albuterol sulfate inhalation powder (ProAir RespiClick, Teva) to children aged 4 to 11 years, the company announced today.
DOSAGE AND ADMINISTRATION
INCRUSE ELLIPTA (umeclidinium 62.5 mcg) should be administered as 1 inhalation once daily by the orally inhaled route only.
INCRUSE ELLIPTA should be taken at the same time every day. Do not use INCRUSE 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 light green plastic inhaler containing a double-foil blister strip with 30 blisters containing powder intended for oral inhalation only. Each blister contains umeclidinium 62.5 mcg. An institutional pack containing a blister strip with 7 blisters is also available.
Storage And Handling
INCRUSE ELLIPTA is supplied as a disposable light grey and light green plastic inhaler containing a double-foil blister strip with 30 blisters. The inhaler is packaged in a moisture-protective foil tray with a desiccant and a peelable lid (NDC 0173-0873-10).
INCRUSE ELLIPTA is also supplied in an institutional pack of a disposable light grey and light green plastic inhaler containing a double-foil blister strip with 7 blisters. The inhaler is packaged in a moisture-protective foil tray with a desiccant and a peelable lid (NDC 0173-0873-06).
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.
INCRUSE ELLIPTA should be stored inside the unopened moisture-protective foil tray and only removed from the tray immediately before initial use. Discard INCRUSE 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: June 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/7/2016
Additional Incruse Ellipta Information
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