This is indicated for:

• The maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
• The maintenance treatment of asthma in patients aged 18 years and older.

Limitation of use: Not indicated for relief of acute bronchospasm.

Each dry powder inhaler capsule contains:

• Vilanterol 25 mcg (as Vilanterol Trifenatate INN), Fluticasone Furoate INN 100 mcg, and Umeclidinium 62.5 mcg (as Umeclidinium Bromide INN).
• Vilanterol 25 mcg (as Vilanterol Trifenatate INN), Fluticasone Furoate INN 200 mcg, and Umeclidinium 62.5 mcg (as Umeclidinium Bromide INN).

This capsule is an inhalation powder combination product delivering fluticasone furoate (ICS), umeclidinium (anticholinergic), and vilanterol (LABA) via oral inhalation. Vilanterol, a beta-2 agonist, stimulates intracellular adenyl cyclase, converting ATP to cyclic AMP. Increased cyclic AMP leads to relaxation of bronchial smooth muscle and inhibition of mediator release from mast cells involved in hypersensitivity reactions.

The exact mechanism of fluticasone furoate in COPD and asthma is not fully understood, but inflammation plays a key role in both diseases. Corticosteroids act on multiple inflammatory cells (mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (histamine, leukotrienes, cytokines, eicosanoids) to reduce inflammation.

Umeclidinium is a long-acting muscarinic antagonist (LAMA) with affinity for M1–M5 receptors. In the airways, it blocks M3 receptors on smooth muscle, leading to bronchodilation.

This inhalation capsule must not be swallowed. It is intended for use only with the inhalation device. Remove the capsule from the blister pack only immediately before placing it into the inhalation device. After inhalation, rinse your mouth with water without swallowing to reduce the risk of oropharyngeal candidiasis.

Adults (18 years or older): It should be used at the same time every day, not more than once every 24 hours. If shortness of breath or other asthma symptoms occur between doses, an inhaled SABA (Short Acting β-Agonist) should be used for immediate relief.

Maintenance treatment of COPD: 1 inhalation capsule once daily.

Maintenance treatment of Asthma: 1 inhalation capsule once daily.

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

Monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants: Use with extreme caution, as they may enhance the vascular effects of vilanterol.

Beta-blockers: Use with caution. May reduce bronchodilatory effects 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 concurrent use with other anticholinergic-containing drugs.

• Primary treatment of status asthmaticus or acute episodes of COPD or asthma requiring intensive care measures.
• Severe hypersensitivity to milk proteins or any ingredient.

COPD: Common adverse reactions (≥1%) include upper respiratory tract infection, pneumonia, bronchitis, oral candidiasis, headache, back pain, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, dysgeusia, constipation, urinary tract infection, diarrhea, gastroenteritis, oropharyngeal pain, cough, and dysphonia.

Asthma: Common adverse reactions (≥2%) include pharyngitis/nasopharyngitis, upper respiratory tract infection/viral infection, bronchitis, respiratory tract infection, sinusitis/acute sinusitis, urinary tract infection, rhinitis, influenza, headache, and back pain.

There are insufficient data on the use of this preparation in pregnant women and lactating mothers.

• LABA monotherapy increases the risk of serious asthma-related events.
• Do not initiate in acutely deteriorating COPD or asthma. Not for acute symptom relief.
• Do not use with another LABA-containing medicine due to overdose risk.
• Oral and pharyngeal Candida infections may occur; advise patients to rinse mouth after inhalation.
• Increased risk of pneumonia in COPD patients; monitor for symptoms.
• If paradoxical bronchospasm occurs, discontinue and switch to alternative therapy.
• Use with caution in cardiovascular disorders due to beta-adrenergic stimulation.
• May worsen urinary retention; caution in prostatic hyperplasia or bladder neck obstruction.
• Use with caution in convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.

Use in Children & Adolescents: Not indicated for patients aged 17 years or younger. Safety and efficacy have not been established.

Elderly: No dosage adjustment required, though increased sensitivity cannot be ruled out.

Renal impairment: Not studied in patients with renal impairment.
Hepatic impairment: Not studied in patients with hepatic impairment.

No clinical trial data are available regarding overdose with this inhalation capsule.

Combined bronchodilators

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