This combination is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Each dry powder inhaler capsule contains:

• Vilanterol 25 micrograms (as Vilanterol Trifenatate INN) and
• Umeclidinium 62.5 micrograms (as Umeclidinium Bromide INN).

This dry powder inhaler capsule contains a combination of umeclidinium (an anticholinergic) and vilanterol (a LABA) for inhalation use. The pharmacological effects of beta-2 adrenergic agonists such as vilanterol are mainly due to stimulation of intracellular adenyl cyclase, which converts adenosine triphosphate (ATP) into cyclic-3,5-adenosine monophosphate (cyclic AMP). Increased cyclic AMP leads to relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity, especially from mast cells. Umeclidinium is a long-acting muscarinic antagonist (anticholinergic). It acts on muscarinic receptors M1 to M5. In the airways, it blocks the M3 receptor on smooth muscle, leading to bronchodilation.

This inhalation capsule must not be swallowed. This dry powder inhaler capsule should be used only with the inhaler device. Remove the capsule from the blister pack immediately before use. After each inhalation, rinse the mouth with water without swallowing to reduce the risk of oropharyngeal candidiasis.

For adults (18 years and older): It should be taken at the same time every day and not used more than once every 24 hours.

Maintenance therapy for COPD: One inhalation capsule of 25/62.5 micrograms once daily as directed.

Limitations of use: It is not indicated for relief of acute shortness of breath or for asthma treatment.

Use in children and adolescents: It is not indicated for use in children and adolescents. Safety and efficacy in younger patients (17 years and below) have not been established.

Geriatric, renal, or moderate hepatic impairment: No dose adjustment is required.

Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution. May cause systemic corticosteroid and cardiovascular effects.

Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May increase the vascular effects of vilanterol.

Beta-blockers: Use with caution. May block the bronchodilatory effect of beta-agonists and may cause severe bronchospasm.

Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with non–potassium-sparing diuretics may be worsened with concomitant beta-agonists.

Anticholinergics: Additive effects may occur with other anticholinergic medicines. Avoid use with other anticholinergic-containing drugs.

• Hypersensitivity to milk proteins or any component of the product.
• Use without inhaled corticosteroids in asthma patients is contraindicated when LABA is used.

COPD: Most common adverse reactions (≥1% and more than placebo) include pharyngitis, sinusitis, lower respiratory tract infection, constipation, diarrhea, pain in extremities, muscle spasm, neck pain, and chest pain.

There are insufficient data regarding the use of this medicine in pregnant women and lactating mothers.

Long-acting beta2-agonist monotherapy increases the risk of serious asthma-related events.

Do not initiate in acutely deteriorating COPD or asthma. Not for relief of acute symptoms.

Do not use with other LABA-containing medicines due to overdose risk.

If paradoxical bronchospasm occurs, discontinue and switch to alternative therapy.

Use with caution in patients with cardiovascular disease due to beta-adrenergic stimulation.

Use cautiously in seizure disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.

May worsen narrow-angle glaucoma; monitor patients and advise immediate medical attention if symptoms occur.

May cause urinary retention; use with caution in patients with prostatic hyperplasia or bladder-neck obstruction.

Monitor for hypokalemia and hyperglycemia.

There is limited clinical experience with overdose of this dry powder inhaler capsule.

Respiratory corticosteroids

Store away from direct sunlight or heat in a cool, dry place. Keep away from eyes. Keep out of reach of children.