Ultibro Breezhaler Indacaterol Glycopyrronium 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.
Not for Acute Use: Not indicated for the relief of acute bronchospasm (rescue medication) .
2. Dosage and Administration
Administration: Oral inhalation only. Must be used with the specific Neohaler device. Capsules should never be swallowed.
Recommended Dose: One capsule (containing 110 mcg indacaterol maleate and 50 mcg glycopyrronium bromide) inhaled once daily at the same time each day.
Procedure:
1. Pierce the capsule in the device immediately before use.
2. Inhale deeply and forcefully through the mouthpiece until the capsule is empty.
3. Check for residual powder and repeat if necessary.
Missed Dose: If a dose is missed, take it as soon as possible unless it is close to the next scheduled dose. Do not take two doses on the same day .
3. Mechanism of Action
This is a fixed-dose combination of a Long-Acting Beta2-Agonist (LABA) and a Long-Acting Muscarinic Antagonist (LAMA):
Indacaterol (LABA): Selective agonist of beta2-adrenergic receptors on bronchial smooth muscle, causing muscle relaxation and bronchodilation.
Glycopyrronium (LAMA): Competitive antagonist of muscarinic (M3) receptors, inhibiting acetylcholine-mediated bronchoconstriction.
Combined Effect: The two components act via different mechanisms to provide additive bronchodilation over 24 hours .
4. Safety and Warnings
Asthma-Related Death: LABA monotherapy increases the risk of asthma-related death. Safety and efficacy have not been established in asthma. Do not use in asthma unless the patient is also taking an inhaled corticosteroid (ICS) .
Paradoxical Bronchospasm: Can occur immediately after inhalation. Discontinue use immediately if it happens.
Cardiovascular Effects: May cause clinically significant cardiovascular effects (tachycardia, arrhythmia, blood pressure changes) due to beta-adrenergic stimulation. Use with caution in patients with cardiovascular disorders.
Anticholinergic Effects: Use with caution in patients with narrow-angle glaucoma, prostatic hyperplasia (BPH), or bladder neck obstruction.
Hypokalemia & Hyperglycemia: LABAs can cause transient hypokalemia and hyperglycemia, which usually resolve without intervention.
5. Adverse Reactions
Common adverse reactions (incidence ≥1% and greater than placebo) include:
Gastrointestinal: Diarrhea, nausea, vomiting.
Respiratory: Cough, nasal congestion, upper respiratory tract infection, pharyngitis.
General: Nasal irritation, headache.
6. Drug Interactions
Beta-Blockers: Non-selective beta-blockers can block the pulmonary effects of indacaterol. Generally avoid unless necessary for life-threatening conditions.
CYP450 Inducers/Inhibitors: Indacaterol is a substrate of CYP3A4 and P-gp. Concomitant use with strong inducers (e.g., rifampicin) may decrease efficacy; strong inhibitors (e.g., ketoconazole) may increase systemic exposure.
Other Sympathomimetics: Concomitant use with other sympathomimetic agents may potentiate adverse cardiovascular effects.
7. Pharmaceutical Information
Chemical Name (Indacaterol):(R)-5-[2-(5,6-diethyl-2,3-dihydro-1H-inden-2-ylamino)-1-hydroxyethyl]-8-hydroxy-1H-quinolin-2-one

Chemical Name (‌Glycopyrronium‌):(R,S)-2,2′-[1,3-propanediylbis(oxy)]bis[1-(cyclopentylmethyl)-1-methylpyrrolidinium] dibromide