Indications
Live Pharmacy offers a long-term, once-daily maintenance bronchodilator specifically designed for individuals experiencing airflow obstruction due to Chronic Obstructive Pulmonary Disease (COPD), which encompasses chronic bronchitis and emphysema. This medication is not suitable for treating acute bronchospasm and is not indicated for asthma.
Composition
Each capsule in this dry powder inhaler contains:
- Indacaterol 110 mcg (as Indacaterol Maleate INN, micronized)
- Glycopyrronium 50 mcg (as Glycopyrronium Bromide BP, micronized)
Pharmacology
This inhalation powder delivers a combination of Glycopyrronium, an anticholinergic, and Indacaterol, a long-acting beta-agonist (LABA), via oral inhalation. The pharmacological activity of Indacaterol is largely due to its stimulation of intracellular adenyl cyclase, which converts ATP to cyclic-3,5-adenosine monophosphate (cyclic AMP). Increased levels of cyclic AMP lead to relaxation of bronchial smooth muscle and reduced release of mediators involved in immediate hypersensitivity from mast cells. Glycopyrronium works as a long-acting muscarinic antagonist, effectively inhibiting M3 receptors in airway smooth muscle to promote bronchodilation.
Dosage & Administration
Adults (18 years and older): For oral inhalation only, administer at the same time daily—no more than once every 24 hours.
- Maintenance Treatment for COPD: Inhale 1 dose once daily.
Limitations: This medication is not intended for immediate relief of acute bronchospasm or for asthma treatment.
Geriatric Use: Safe for elderly patients (65 years and older) at the recommended dosage.
Pediatric Use: Not recommended for children or adolescents; safety and efficacy have not been established for those under 17.
Renal Impairment: Can be used at the recommended dosage for mild to moderate renal impairment. In cases of severe renal impairment (GFR < 30 mL/min/1.73 m²), use only if benefits outweigh risks.
Hepatic Impairment: Safe for mild to moderate hepatic impairment; caution is advised for severe hepatic impairment due to lack of data.
Always consult a registered healthcare professional before use.
Interactions
No specific interaction studies have been conducted for the Glycopyrronium and Indacaterol combination. Potential interactions are derived from each individual component. It is not recommended to use this combination alongside beta-adrenergic blockers, other anticholinergics, or sympathomimetic agents, as these may enhance adverse effects. Exercise caution with treatments that can cause hypokalemia.
Contraindications
This medication is contraindicated for individuals with known hypersensitivity to Glycopyrronium, Indacaterol, or any other components of the formulation. It is also not suitable for patients with severe milk protein allergies or asthma without concurrent long-term control therapy.
Side Effects
Common adverse effects associated with this medication may include cardiovascular issues (such as tachycardia), ocular disturbances (e.g., blurred vision), urinary retention, gastrointestinal issues, dry mouth, and cough. Other reported reactions include hypersensitivity reactions, cardiovascular effects, and symptoms like headache and tremors. The most frequently reported side effects (over 3% occurrence) are cough and throat irritation.
Pregnancy & Lactation
Pregnancy Category C: There is limited data regarding the safety of this combination in pregnant women. Use only if the anticipated benefits justify potential risks to the fetus. The excretion of Indacaterol and Glycopyrronium in human milk is unknown, so breastfeeding women should consider potential risks versus benefits.
Precautions & Warnings
- LABA monotherapy may increase the risk of severe asthma-related complications.
- Do not initiate treatment during acute exacerbations of COPD or asthma; this medication is not for acute symptom relief.
- Avoid combining with other LABA therapies due to overdose risks.
- Discontinue if paradoxical bronchospasm occurs and seek alternative treatment.
- Caution is advised for patients with cardiovascular disorders due to beta-adrenergic effects.
- Monitor patients with convulsive disorders, thyrotoxicosis, diabetes, or ketoacidosis closely.
- Be aware of potential worsening of narrow-angle glaucoma and urinary retention; contact a healthcare provider if symptoms occur.
- Watch for signs of hypokalemia and hyperglycemia.
Overdose Effects
While clinically significant overdose information is limited, potential symptoms may include severe effects typically associated with β2-adrenergic stimulants, such as tachycardia, tremors, and metabolic disturbances. Supportive treatment is recommended; hospitalization may be necessary in severe cases.
Therapeutic Class
Combined Bronchodilators
Storage Conditions
Store in a cool, dry place away from direct sunlight and heat. Keep out of reach of children and avoid contact with eyes.
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