Anoro Ellipta Umeclidinium Bromide and Vilanterol Trifenatate Inhalation Powder

1. Indications and Usage
Chronic Obstructive Pulmonary Disease (COPD):
Maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.
Important Safety Limitation: Not indicated for the relief of acute bronchospasm (rescue inhaler).
Contraindication: Not indicated for the treatment of asthma.
2. Dosage and Administration
Route of Administration:
For Oral Inhalation ONLY.
Recommended Dosage:
Standard Dose: One inhalation (62.5 mcg umeclidinium / 25 mcg vilanterol) once daily.
Critical Administration Instructions:
Timing: Administer at approximately the same time every 24 hours.
Device: The inhaler (ELLIPTA) is breath-actuated. Do not shake the inhaler.
Missed Dose: If a dose is missed, inhale as soon as the patient remembers, then resume the regular schedule the next day.
3. Mechanism of Action
The drug combines two distinct pharmacological classes of bronchodilators:
Umeclidinium Bromide (LAMA):
A long-acting muscarinic antagonist. It blocks the action of acetylcholine on M3 receptors in the airways, preventing bronchoconstriction.
Vilanterol Trifenatate (LABA):
A long-acting selective β2-adrenergic receptor agonist. It relaxes bronchial smooth muscle by increasing intracellular cAMP, providing bronchodilation for up to 24 hours.
Synergistic Effect:
The combination provides greater bronchodilation than either agent alone.
4. Safety and Warnings
Not for Acute Episodes:
Not indicated for the initial treatment of acute episodes of bronchospasm.
Increased Risk of Asthma-Related Events:
Contraindicated for asthma. Using LABAs without ICS in asthma patients increases the risk of asthma-related death.
Cardiovascular Effects:
LABA components may cause transient cardiovascular effects (e.g., increased heart rate, palpitations, QTc prolongation).
Glaucoma and Urinary Retention:
Anticholinergic components may cause or worsen narrow-angle glaucoma or urinary retention.
Hypokalemia:
Beta-agonists may produce significant hypokalemia in some patients.
5.Adverse Reactions
Most Common:
Nasopharyngitis, upper respiratory tract infection, headache, diarrhea, dizziness, and cough.
6.Drug Interactions
Beta-Blockers:
May block the pulmonary effects of Vilanterol. Generally contraindicated unless there are compelling reasons for their use.
CYP3A4 Inhibitors:
Vilanterol is a substrate of CYP3A4. Strong inhibitors (e.g., ketoconazole, ritonavir) may increase systemic exposure.
Anticholinergics:
Avoid concomitant use with other inhaled anticholinergic drugs (e.g., tiotropium) to avoid additive side effects.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredients: Umeclidinium Bromide, Vilanterol Trifenatate.
Excipients: Contains Lactose (Monohydrate).
Appearance: White to off-white powder in a pre-loaded, breath-actuated inhaler (ELLIPTA).
Storage: Store in a dry place at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). Keep in a sealed foil tray.