This combination inhalation capsule is indicated for:

• Long-term, once-daily maintenance treatment of airflow obstruction and reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD).
• Once-daily treatment of asthma in patients aged 18 years and older.

Important limitation of use: Not indicated for relief of acute bronchospasm.

Vilanterol Trifenatate is a selective long-acting beta-2 agonist used in asthma and other forms of chronic airway obstruction. Fluticasone Furoate is a corticosteroid with mainly glucocorticoid activity. It exerts a local anti-inflammatory effect in the lungs with minimal systemic effects at recommended doses.

25/50 inhalation capsule: Each dry powder inhaler capsule contains Vilanterol 25 mcg (as Vilanterol Trifenatate INN) & Fluticasone Furoate INN 50 mcg.

25/100 inhalation capsule: Each dry powder inhaler capsule contains Vilanterol 25 mcg (as Vilanterol Trifenatate INN) & Fluticasone Furoate INN 100 mcg.

25/200 inhalation capsule: Each dry powder inhaler capsule contains Vilanterol 25 mcg (as Vilanterol Trifenatate INN) & Fluticasone Furoate INN 200 mcg.

This preparation contains fluticasone furoate and vilanterol, each acting through different mechanisms. Vilanterol, a LABA, stimulates beta-2 adrenergic receptors, activating intracellular adenyl cyclase, which converts 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. Fluticasone furoate acts as an anti-inflammatory agent, although its exact mechanism in COPD and asthma is not fully understood. Inflammation plays a key role in both diseases. Corticosteroids act on multiple inflammatory cells such as mast cells, eosinophils, neutrophils, macrophages, and lymphocytes, and also inhibit mediators like histamine, leukotrienes, cytokines, and eicosanoids.

This inhalation capsule must not be swallowed. Only to be used with the device. Remove the capsule from the blister pack only immediately before using it in the inhalation device. After inhalation, rinse your mouth with water without swallowing to reduce the risk of oropharyngeal candidiasis.

Route of administration: Oral inhalation.

Maintenance treatment of COPD: 1 inhalation of 25/100 mcg once daily.

Asthma: 1 inhalation of 25/100 mcg or 25/200 mcg 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 potentiate the effect of vilanterol on the vascular system.
• 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.

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

COPD: Common adverse reactions (≥3%) include nasopharyngitis, upper respiratory tract infection, headache, oral candidiasis, back pain, pneumonia, bronchitis, sinusitis, cough, oropharyngeal pain, arthralgia, hypertension, influenza, pharyngitis, and pyrexia.

Asthma: Common adverse reactions (≥2%) include nasopharyngitis, oral candidiasis, headache, influenza, upper respiratory tract infection, bronchitis, sinusitis, oropharyngeal pain, dysphonia, and cough.

There are insufficient data on use in pregnant or lactating women.

• 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 mouth rinsing after inhalation.
• Increased pneumonia risk in COPD patients; monitor for symptoms.
• May worsen existing infections (TB, fungal, bacterial, viral, parasitic, ocular herpes).
• Risk of adrenal suppression when switching from systemic corticosteroids; taper slowly.
• High doses may cause hypercorticism and adrenal suppression.
• Stop gradually if such effects occur.
• Paradoxical bronchospasm may occur; discontinue if it happens.
• Use cautiously in cardiovascular disorders due to beta-adrenergic stimulation.
• Monitor bone mineral density periodically.
• Long-term use may cause glaucoma or cataracts.
• Use cautiously in seizure disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.
• May increase blood glucose and cause hypokalemia.

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

Hepatic impairment: Increased fluticasone furoate exposure may occur in moderate to severe hepatic impairment. Monitor for systemic corticosteroid effects.

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

Respiratory corticosteroids

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