Trio

Indications for Use

This medication is indicated for the following:

• Chronic Obstructive Pulmonary Disease (COPD): For the long-term management of COPD.
• Asthma: For the maintenance treatment of asthma in adults aged 18 and older.

Limitation of Use: This medication is not intended for the relief of acute bronchospasm.

Important Note: Always use this medication as directed by a registered healthcare professional.

Composition

Each dry powder inhaler capsule contains:

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

Or, alternatively:

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

Pharmacology

This inhalation capsule delivers a combination of Fluticasone Furoate (a corticosteroid), Umeclidinium (an anticholinergic), and Vilanterol (a long-acting beta-agonist, LABA) through oral inhalation.

• Vilanterol: Acts as a beta-2 adrenoceptor agonist, promoting relaxation of bronchial smooth muscle by increasing cyclic AMP levels, helping to relieve bronchoconstriction and preventing the release of mediators from mast cells.
• Fluticasone Furoate: While the exact mechanism is not fully understood, this corticosteroid reduces inflammation, a key factor in asthma and COPD. It works across various inflammatory cells (mast cells, eosinophils, macrophages) to control symptoms and prevent exacerbations.
• Umeclidinium: A long-acting muscarinic antagonist (LAMA), it works by blocking M3 receptors in the smooth muscles of the airways, leading to bronchodilation and improved airflow.

Dosage & Administration

Important: This capsule should not be swallowed. Use only with the provided inhalation device. Always remove the capsule from the blister pack immediately before use.

• Adults (18 years and older): Take 1 capsule daily at the same time each day, no more than once in 24 hours.
• If you experience symptoms of shortness of breath or worsening asthma during the day, use a Short-Acting Beta-Agonist (SABA) for quick relief.

COPD Treatment:

• 1 inhalation capsule once daily.

Asthma Treatment:

• 1 inhalation capsule once daily.

After inhaling the medication, rinse your mouth with water (do not swallow) to reduce the risk of oropharyngeal infections such as oral candidiasis.

Drug Interactions

• Strong Cytochrome P450 3A4 Inhibitors (e.g., ketoconazole): Use cautiously, as these may intensify the effects of the medication, including potential systemic side effects.
• Monoamine Oxidase Inhibitors (MAOIs) & Tricyclic Antidepressants: Use with extreme caution, as they may enhance the vascular effects of Vilanterol.
• Beta-Blockers: May counteract the bronchodilatory effects of Vilanterol, leading to severe bronchospasm.
• Diuretics: Use with caution, as non-potassium-sparing diuretics may increase the risk of hypokalemia when used with beta-agonists.
• Anticholinergics: Use with caution, as combined use with other anticholinergic medications may intensify effects.

Contraindications

• Not recommended for the primary treatment of acute asthma or COPD exacerbations.
• Severe allergy to milk proteins or any of the ingredients in this medication.

Side Effects

Common side effects in COPD patients (≥1% incidence) include:

• Upper respiratory tract infections, pneumonia, bronchitis
• Oral candidiasis, headache, back pain
• Sinusitis, pharyngitis, dysgeusia, urinary tract infections, and more.

For Asthma patients (≥2% incidence):

• Pharyngitis/nasopharyngitis, upper respiratory infections, bronchitis
• Sinusitis, headache, back pain, urinary tract infections, and more.

Pregnancy & Lactation

Limited data on the use of this medication during pregnancy and lactation. Consult your healthcare provider for guidance.

Precautions & Warnings

• LABA Monotherapy: Increases the risk of severe asthma-related events. It is not recommended as monotherapy for asthma treatment.
• Not for use during acute COPD or asthma episodes. Do not use for immediate symptom relief.
• Avoid using with other LABA-containing therapies due to the risk of overdose.
• Oral Candidiasis: Regular monitoring is required, and mouth rinsing after inhalation is advised.
• Increased risk of pneumonia in COPD patients. Regular monitoring is recommended.
• Paradoxical bronchospasm: If this occurs, discontinue and consider alternative therapy.
• Use cautiously in patients with cardiovascular conditions, urinary retention, diabetes, or thyroid issues.

Use in Special Populations

• Children & Adolescents: Not recommended for use in children under 18 years. Safety and efficacy have not been established.
• Elderly: No dosage adjustment is typically required, though individual sensitivity may vary.
• Renal & Hepatic Impairment: Has not been studied in patients with renal or hepatic impairments.

Overdose

There is limited data on overdose in clinical trials for this inhalation capsule. In case of overdose, seek immediate medical attention.

Therapeutic Class

Combined bronchodilators.

Storage Instructions

• Store in a cool, dry place away from direct sunlight and heat.
• Keep the product out of reach of children and avoid contact with eyes.