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Umeclidinium

    DEA Class; Rx

    Common Brand Names; Incruse Ellipta

    •  Anticholinergics, Respiratory

    Inhaled long-acting muscarinic antagonist (LAMA); used once per day
    Used in adults for maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
    NOT indicated for the relief of acute bronchospasm or for the treatment of asthma

    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

    Severe hypersensitivity to milk proteins

    Demonstrated hypersensitivity to umeclidinium or any of the excipients

    • Nasopharyngitis (8%)
    • Upper respiratory tract infection (5%)
    • Cough (3%)
    • Arthralgia (2%
    • Toothache (1%)
    • Pharyngitis (1%)
    • Viral upper respiratory tract infection (1%)
    • Tachycardia (1%)
    • Atrial fibrillation

    Anaphylactic reactions reported in patients with severe milk protein allergy after inhalation of other powder products containing lactose (see Contraindications)

    Hypersensitivity reactions such as anaphylaxis, angioedema, pruritus, rash, and urticaria may occur; discontinue if reactions occur

    Do not initiate in patients during rapidly deteriorating or potentially life-threatening episodes of COPD; not be used for the relief of acute symptoms (ie, as rescue inhaler) from acute episodes of bronchospasm

    Paradoxical bronchospasm reported; discontinue and treat immediately with an inhaled, prompt-acting bronchodilator (eg, albuterol)

    Worsening of narrow-angle glaucoma may occur

    Worsening of urinary retention may occur; caution in patients with prostatic hyperplasia or bladder-neck obstruction

    There are insufficient data on use in pregnant women to inform a drug-associated risk

    There is no information available on presence of drug in human milk, effects on breastfed child, or on milk production

    Adults

    62.5 mcg/day via oral inhalation.

    Geriatric

    62.5 mcg/day via oral inhalation.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Umeclidinium bromide

    powder for inhalation

    • 62.5mcg/actuation