Adult Dosing

Chronic obstructive pulmonary disease (COPD)

• 1 INH (62.5 mcg/25 mcg) inhalation daily
• Therapy should be taken at the same time every day. Max: 62.5 mcg/25 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

• Severe hypersensitivity to milk proteins
• Relief of acute bronchospasm
• Asthma Treatment
• Hypersensitivity to any of the ingredients of the product

• Increased risk of asthma-related death has been reported with long-acting beta2-adrenergic agonists
• Safety and efficacy not established in patients with asthma; not approved for treatment of asthma

Renal Dose Adjustment

• Renal impairment: No dose adjustments

Hepatic Dose Adjustment

• Hepatic impairment: No dose adjustments

• Increased risk of asthma-related death has been reported with long-acting beta2-adrenergic agonists. Therapy is not indicated for the treatment of asthma
• Do not initiate in patients during rapidly deteriorating or potentially life-threatening episodes of COPD
• Therapy should not be used in combination with an additional medicine containing a long-acting beta2-adrenergic agonists because of the risk of overdose
• Use cautiously when considering the coadministration with long-term ketoconazole and other known strong cytochrome P450 3A4 (CYP3A4) inhibitors because increased cardiovascular adverse effects may occur
• If paradoxical bronchospasm occurs, discontinue treatment and institute alternative therapy
• Beta2-agonists can produce clinically significant cardiovascular effects including increased pulse rate or increased systolic or diastolic blood pressure
• Use cautiously in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis
• 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
• During treatment be alert of hypokalemia and hyperglycemia, as therapy has potential for beta2-agonists to produce significant hypokalemia

Cautions: Use cautiously in

• Hepatic impairment
• Renal impairment
• Coadministration with strong cytochrome P450 3A4 inhibitors
• Cardiovascular disorders
• Convulsive disorders
• Thyrotoxicosis
• Diabetes mellitus
• Ketoacidosis
• Sympathomimetic amines

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: Chest pain
• GI: Constipation, diarrhea
• GU: Urinary retention
• EENT: Narrow-angle glaucoma, pharyngitis, sinusitis
• RESP: Paradoxical bronchospasm, lower respiratory tract infection
• MISC: Pain in extremity, muscle spasms, neck pain

Umeclidinium

• 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

Vilanterol

• Beta2-adrenergic agonist; stimulates intracellular adenyl cyclase resulting in increased cAMP levels causing bronchial smooth muscle relaxation; also inhibits release of mediators of immediate hypersensitivity from cells, especially from mast cells
• Extensively metabolized by the liver, CYP450: 3A4 and is a substrate for the P-gp transporter
• Excretion: 30% feces; 70% urine
• Half-life: 11 hrs

US Trade Name(s)

• Anoro ellipta

US Availability

Anoro ellipta (umeclidinium/vilanterol)

• PWDR for INH: (62.5mcg/25mcg)/actuation

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

Respiratory Agents; Inhaled