Atectura Breezhaler Indacaterol Acetate and Mometasone Furoate Powder for Inhalation (II)

1. Indications and Usage
Asthma Maintenance: Treatment of adults and adolescents aged 12 years and older with asthma, who are not adequately controlled with inhaled corticosteroids (ICS) alone, or who are on a fixed combination of ICS and long-acting beta2-agonist (LABA) and remain uncontrolled.
Note: This specific product (Powder for Inhalation, II) is indicated for asthma maintenance and should not be used for the treatment of acute bronchospasm.
2. Dosage and Administration
Route of Administration: For Oral Inhalation ONLY. The capsules must NOT be swallowed or used with nebulizers.
Recommended Dosage: The recommended dose is one capsule inhaled once daily. Available strengths include 150/80 μg, 150/160 μg, and 150/320 μg (Indacaterol Acetate/Mometasone Furoate). The dose should be titrated based on disease severity and individual response.
Critical Administration Instructions:
Device: Must always be used with the provided specific inhaler (e.g., breezhaler).
Procedure: Do not store the inhaler with capsules inside. Keep the capsule in the blister until just before use, then load it into the inhaler and pierce both sides to release the powder for inhalation.
Missed Dose: If a dose is missed, take it as soon as remembered on the same day. Do not double the dose to make up for a missed one.
Post-Inhalation: Rinse the mouth with water and spit it out after each treatment to reduce the risk of local fungal infections and dysphonia.
3. Mechanism of Action
β2-Agonism: Indacaterol acetate is a long-acting selective β2-adrenergic receptor agonist that binds to β2-receptors on bronchial smooth muscle cells, leading to increased intracellular cAMP and causing smooth muscle relaxation and bronchodilation.
Anti-inflammatory Activity: Mometasone furoate is a glucocorticoid that binds to cytosolic glucocorticoid receptors, translocates to the nucleus, and modulates gene expression to inhibit the synthesis of multiple inflammatory mediators, thereby reducing airway inflammation.
4. Safety and Warnings
Not for Acute Episodes: This medication is not indicated for the treatment of acute asthma symptoms or acute bronchospalsm. A short-acting bronchodilator must be available for rescue therapy.
Paradoxical Bronchospasm: If paradoxical bronchospasm occurs, the drug must be discontinued immediately and alternative therapy initiated.
Cardiovascular Effects: β2-agonists can cause clinically significant cardiovascular effects (e.g., increased pulse rate, blood pressure elevation). Use with caution in patients with cardiovascular disorders.
Immune System Effects: Prolonged administration of systemic corticosteroids may result in suppression of the hypothalamic-pituitary-adrenal (HPA) axis and increased susceptibility to infections.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: The most common adverse reaction is headache. Other frequent reactions include nasopharyngitis, back pain, and upper respiratory tract infections. Local effects such as oral candidiasis and dysphonia are also observed.
Clinical Research Highlights: Key Phase 3 clinical trials (e.g., PALLADIUM, QUARTZ) demonstrated that this fixed-dose combination significantly improved lung function and reduced asthma exacerbations compared to monotherapy.
6. Drug Interactions
Beta-Blockers: May blunt the effect of β2-agonists. Non-selective beta-blockers should generally be avoided.
CYP3A4 Inhibitors: Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may result in increased systemic exposure to mometasone furoate, potentially increasing the risk of systemic corticosteroid effects.
Other QTc-延长ing Drugs: Caution is advised when administering with other drugs known to prolong the QTc interval.
7. Pharmaceutical Information
Chemical Composition: Active Ingredients: Indacaterol Acetate and Mometasone Furoate. Excipients: Lactose monohydrate.
Appearance: The capsules are hard gelatin capsules containing free-flowing powder.
Packaging: Aluminum-Aluminum blister packaging (10 or 30 capsules per box), supplied with a specific dry powder inhaler.
Storage: Store the capsules in the original blister packaging to protect from moisture. The inhaler should be kept at room temperature.