Trelegy Ellipta Fluticasone Furoate Umeclidinium Bromide and Vilanterol Trifenatate Inhalation Powder

1. Indications and Usage
Asthma: Indicated for the regular treatment of asthma in patients aged 12 years and older who are inadequately controlled with their current medication, or for whom treatment with an ICS, LAMA, and LABA is considered appropriate.
COPD: Indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including bronchitis and emphysema. It reduces the risk of exacerbations.
2. Dosage and Administration
Recommended Dosage: One inhalation once daily at the same time each day.
Administration: This device is breath-actuated. Patients should follow the specific instructions provided with the inhaler (e.g., Ellipta) to ensure proper drug delivery.
Missed Dose: If a dose is missed, take it as soon as possible on the same day. The next dose should be taken at the regular time the following day. Do not take more than one inhalation in a day.
3. Mechanism of Action
Fluticasone Furoate: An inhaled corticosteroid (ICS) that reduces inflammation in the airways by inhibiting the release of inflammatory mediators.
Umeclidinium Bromide: A long-acting muscarinic antagonist (LAMA) that blocks muscarinic receptors, leading to bronchodilation.
Vilanterol Trifenatate: A long-acting beta2-adrenergic agonist (LABA) that relaxes the smooth muscles of the airways, causing bronchodilation.
4. Safety and Warnings
Not for Acute Symptoms: This medication is not a rescue medication and should not be used for the relief of acute bronchospasm.
Paradoxical Bronchospasm: May occur; discontinue immediately if it happens.
Infections: Increased risk of local candidiasis (oral/throat); rinse mouth with water after use. Systemic effects, including hypokalemia and increased blood glucose, may occur.
Cardiovascular Effects: Parasympatholytic/anticholinergic effects may cause urinary retention. LABA component may cause QTc prolongation and requires caution in cardiovascular disorders.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: The most common adverse reactions include nasopharyngitis, headache, upper respiratory tract infection, cough, and oral candidiasis.
Serious Risks: Pneumonia (especially in COPD patients), paradoxical bronchospasm, and cardiovascular effects.
6. Drug Interactions
Strong CYP3A4 Inhibitors: Co-administration with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase systemic exposure to fluticasone furoate, increasing the risk of systemic corticosteroid effects.
Beta-Blockers: May block the effect of beta2-agonists. Non-selective beta-blockers should be used with caution.
7. Pharmaceutical Information
Composition: Contains fluticasone furoate, umeclidinium bromide, and vilanterol trifenatate. The powder contains lactose.
Appearance: Available as a breath-actuated inhaler delivering the specific doses per inhalation.
Storage: Store in the original packaging to protect from moisture. Do not store in the bathroom.