Product Description

Indications: This combination is indicated for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is not suitable for the treatment of acute bronchospasm or asthma.

Composition: Each inhalation capsule contains Indacaterol 110 mcg (as Indacaterol Maleate) and Glycopyrronium 50 mcg (as Glycopyrronium Bromide), both in micronized form for inhalation use.

Pharmacology: This inhalation therapy combines a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA). Indacaterol stimulates beta2-adrenergic receptors, increasing intracellular cyclic AMP levels, resulting in relaxation of bronchial smooth muscle and bronchodilation. Glycopyrronium blocks muscarinic M3 receptors in airway smooth muscle, preventing bronchoconstriction and promoting sustained bronchodilation. The combined action provides enhanced and prolonged airway relaxation.

Dosage & Administration: The recommended dose for adults is one inhalation capsule once daily using the inhaler device, preferably at the same time each day. It should not be used more than once within 24 hours. This therapy is not indicated for children or adolescents under 18 years. No dose adjustment is required for elderly patients. In patients with mild to moderate renal or hepatic impairment, standard dosing may be used; however, caution is advised in severe renal or hepatic impairment.

Administration: Remove the protective cap and open the inhaler device. Place one capsule into the capsule chamber and close the device. Press the side buttons once to pierce the capsule. Exhale gently away from the device, then inhale deeply and steadily through the mouthpiece. Hold breath for 5–10 seconds before exhaling. After use, discard the empty capsule and rinse the mouth. Clean the inhaler regularly by wiping and ensuring it remains dry.

Interaction: No dedicated interaction studies are available for this combination. Concomitant use with beta-blockers, other anticholinergics, or sympathomimetic agents is not recommended. Sympathomimetics may enhance adverse effects of Indacaterol, and caution is required when used with drugs that may cause hypokalemia.

Contraindications: Contraindicated in patients with hypersensitivity to Indacaterol, Glycopyrronium, or any component of the formulation. It is also contraindicated in patients with severe hypersensitivity to milk proteins and in asthma patients without appropriate long-term control therapy.

Side Effects: Common adverse effects include cough and throat irritation. Anticholinergic-related effects may include dry mouth, urinary retention, blurred vision, and tachycardia. Beta2-agonist-related effects may include tremor, palpitations, headache, nervousness, insomnia, hypokalemia, hyperglycemia, and arrhythmias. Hypersensitivity reactions such as rash or bronchospasm may occur.

Pregnancy & Lactation: Classified as pregnancy category C. There is insufficient data in pregnant women, so use only if the potential benefit outweighs the risk. It is unknown whether the components are excreted in breast milk; use during breastfeeding only if clearly necessary.

Precautions & Warnings: Not for use in acute COPD exacerbations or asthma attacks. LABA monotherapy increases the risk of asthma-related complications. Avoid combining with other LABA-containing medications. Use cautiously in patients with cardiovascular disorders, thyroid disorders, diabetes, or seizure disorders. Monitor for worsening glaucoma or urinary retention. Be cautious of hypokalemia and hyperglycemia. Discontinue if paradoxical bronchospasm occurs.

Overdose Effects: Overdose may lead to exaggerated beta2-agonist effects such as tachycardia, tremor, palpitations, arrhythmias, hypokalemia, and hyperglycemia, or anticholinergic effects such as increased intraocular pressure and urinary retention. Management is supportive, and severe cases may require hospitalization.

Therapeutic Class: Combined bronchodilators

Storage Conditions: Store in a cool, dry place away from heat and direct sunlight. Keep out of reach of children and avoid contact with eyes.