Classes
DEA Class; Rx
Common Brand Names; Incruse Ellipta
- Anticholinergics, Respiratory
Description
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
Indications
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
Contraindications
Severe hypersensitivity to milk proteins
Demonstrated hypersensitivity to umeclidinium or any of the excipients
Adverse Effects
- 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
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
62.5 mcg/day via oral inhalation.
62.5 mcg/day via oral inhalation.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Umeclidinium bromide
powder for inhalation
- 62.5mcg/actuation