Adult Dosing

Chronic obstructive pulmonary disease (COPD)

• 1 INH (62.5 mcg) inhalation daily
• Therapy should be taken at the same time every day. Max: 62.5 mcg every 24 hours

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Long-term, once daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema

• Hypersensitivity to any of the ingredients of the product
• Severe hypersensitivity to milk proteins

• N/A

Renal Dose Adjustment

• Renal impairment: No dose adjustments

Hepatic Dose Adjustment

• Hepatic impairment: No dose adjustments

• Do not initiate in patients during rapidly deteriorating or potentially life-threatening episodes of COPD
• If paradoxical bronchospasm occurs, discontinue treatment and institute alternative therapy
• Hypersensitivity reactions may occur after administration of umeclidinium. Contraindicated in patients with severe milk protein allergy, therefore, patients with severe milk protein allergy should not use umeclidinium
• Worsening of narrow-angle glaucoma has been reported with therapy. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a physician immediately if symptoms occur
• Worsening of urinary retention has been reported with therapy. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to contact a physician immediately if symptoms occur

Pregnancy Category:C

Breastfeeding: Safety and efficacy during lactation have not been established. Because of the potential for serious adverse reactions in infants this drug should be used cautiously in lactation only if the potential benefits justify the potential risks

• CV: Tachycardia
• RESP: Nasopharyngitis, paradoxical bronchospasm, upper respiratory tract infection, viral upper respiratory tract infection, cough, paradoxical bronchospasm
• MUSC: Arthralgia, myalgia
• GI: Abdominal pain, toothache
• EENT: Narrow-angle glaucoma
• GU: Urinary retention

• Muscarinic antagonist; blocks action of acetylcholine at muscarinic receptors (M1 to M5) in the bronchial airways (M3), leading to relaxation of airway smooth muscle, improved lung function, and decreased mucous secretion
• Extensively metabolized by the liver, CYP450: 2D6 and is a substrate for the P-gp transporter
• Excretion: Intravenous: 58% feces; 22% urine, Oral: 92% feces; <1% urine
• Half-life: 11 hrs

US Trade Name(s)

• Incruse ellipta

US Availability

Incruse ellipta

• PWDR for INH: 62.5mcg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Pulmonary

Anticholinergics, Inhaled

Muscarinic Antagonist