Indications
The inhalation capsules are recommended for:
- Long-term, once-daily maintenance treatment to alleviate airflow obstruction and minimize exacerbations in individuals with chronic obstructive pulmonary disease (COPD).
- Once-daily management of asthma in adults aged 18 and older.
Important Limitation: This medication is not intended for the immediate relief of acute bronchospasm.
Composition
25/100 Inhalation Capsule: Each capsule contains 25 mcg of Vilanterol (as Vilanterol Trifenatate INN) and 100 mcg of Fluticasone Furoate INN.
25/200 Inhalation Capsule: Each capsule contains 25 mcg of Vilanterol (as Vilanterol Trifenatate INN) and 200 mcg of Fluticasone Furoate INN.
Description
Vilanterol Trifenatate is a long-acting beta-2 agonist specifically designed for treating asthma and other airway obstructions. Fluticasone Furoate is a corticosteroid that primarily acts as a glucocorticoid, providing localized effects on the lungs while minimizing systemic exposure at standard dosages.
Pharmacology
This formulation combines Fluticasone Furoate and Vilanterol, which work synergistically. The beta-2 agonist, Vilanterol, stimulates intracellular adenyl cyclase, promoting the conversion of ATP to cyclic AMP. Elevated cyclic AMP levels lead to relaxation of bronchial smooth muscles and reduced release of mediators from mast cells, thus enhancing respiratory function. Although the exact mechanism of Fluticasone Furoate’s action in treating COPD and asthma symptoms remains unclear, it is known to influence various inflammatory cell types and mediators, essential in managing these conditions.
Dosage & Administration
Administration Instructions: Inhalation capsules must not be swallowed and should only be used with the designated inhalation device. Remove the capsule from the blister only just before use. After inhalation, rinse your mouth with water without swallowing to decrease the risk of oral candidiasis.
- For COPD Maintenance: Inhale 1 capsule of 25/100 mcg once daily.
- For Asthma Management: Inhale 1 capsule of either 25/100 mcg or 25/200 mcg once daily.
- Indications: Long-term management of chronic obstructive pulmonary disease (COPD) and asthma in adults.
- Active Ingredients: Combines Vilanterol (a long-acting beta-2 agonist) and Fluticasone Furoate (a corticosteroid).
- Administration: Taken once daily for effective maintenance treatment.
- Benefits: Improves airflow, reduces inflammation, and minimizes the risk of acute bronchospasm.
- Usage Guidance: Follow your healthcare provider’s instructions for optimal results.
Interactions
- Caution with Strong CYP3A4 Inhibitors: (e.g., ketoconazole) may increase the risk of systemic corticosteroid and cardiovascular effects.
- Monoamine Oxidase Inhibitors and Tricyclic Antidepressants: Extreme caution is advised as these may enhance Vilanterol’s vascular effects.
- Beta-blockers: Use with caution; they can negate the bronchodilatory effects of beta-agonists and may cause severe bronchospasm.
- Diuretics: Caution advised as they can exacerbate ECG changes and hypokalemia associated with non-potassium-sparing diuretics.
Contraindications
- Not suitable for treating status asthmaticus or acute COPD/asthma episodes requiring intensive intervention.
- Severe allergic reactions to milk proteins or other components.
Side Effects
COPD: Common side effects (≥3% incidence) include nasopharyngitis, upper respiratory tract infections, headaches, oral candidiasis, pneumonia, and bronchitis.
Asthma: Common side effects (≥2% incidence) include nasopharyngitis, oral candidiasis, headaches, influenza, and bronchitis.
Pregnancy & Lactation
Data on the safety of this medication during pregnancy and lactation is insufficient.
Precautions & Warnings
- Risk of Serious Events: LABA monotherapy may increase the risk of severe asthma-related incidents. Do not initiate treatment during acute exacerbations of COPD or asthma.
- Monitor for oral thrush; advise rinsing the mouth post-inhalation.
- Increased pneumonia risk in COPD patients; monitor for symptoms.
- Special caution is required for patients with existing infections, cardiovascular issues, and those transitioning from systemic corticosteroids.
Use in Special Populations
- Children & Adolescents: Not recommended for those under 18; safety and efficacy are unestablished in this group.
- Hepatic Impairment: Patients with moderate to severe liver impairment may experience increased systemic exposure to Fluticasone Furoate.
Overdose Effects
Currently, there is no available clinical trial data regarding overdose with this inhalation capsule.
Therapeutic Class
Respiratory Corticosteroids
Storage Conditions
Store in a cool, dry place away from direct sunlight and heat. Keep out of reach of children and avoid contact with eyes.
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