| Medication Name | Ultibro Breezhaler |
| Generic Name | Indacaterol/Glycopyrronium |
| Boxed/Label Warning | (For LABA component): Increased risk of asthma-related death. Use only as additional therapy for patients with COPD not adequately controlled on a long-term asthma control medication (e.g., inhaled corticosteroid). |
| Purpose | Long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
| Mechanism of Action | Indacaterol is a long-acting beta2-adrenergic agonist (LABA) that relaxes bronchial smooth muscle. Glycopyrronium is a long-acting muscarinic antagonist (LAMA) that blocks acetylcholine’s action on muscarinic receptors, leading to bronchodilation. |
| Dosage Forms | Inhalation powder in a capsule for use with the Breezhaler inhaler. |
| Available Strengths | Indacaterol 27.5 mcg / Glycopyrronium 15.6 mcg per capsule |
| Dosage Frequency | Once daily |
| Common Side Effects | Cough, upper respiratory tract infection, sore throat, runny nose, increased blood pressure, dry mouth. |
| Serious Side Effects | Paradoxical bronchospasm, severe allergic reactions, new or worsening eye problems (narrow-angle glaucoma), new or worsening urinary retention, increased heart rate, irregular heart rhythm, hypokalemia (low potassium), hyperglycemia (high blood sugar). |
| Drug Interactions | Other beta-adrenergic agonists, anticholinergics, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, certain diuretics (non-potassium sparing), beta-blockers. |
| Important Notes | Not for the treatment of acute symptoms of COPD. Use with caution in patients with cardiovascular disorders, narrow-angle glaucoma, or urinary retention. Do not swallow the capsules; use only with the Breezhaler inhaler. Rinse mouth after inhalation to reduce the risk of oral thrush. |
| Storage | Store capsules in a dry place at room temperature, protected from light and moisture. |
| Missed Dose | If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at once. |
| Alternatives | Spiriva (tiotropium), Anoro Ellipta (umeclidinium/vilanterol), Incruse Ellipta (umeclidinium), Stiolto Respimat (tiotropium/olodaterol). |