Catium

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

Adverse reactions that have been associated with muscarinic antagonists include cardiovascular effects (atrial arrhythmias and tachycardia), ocular disorders (e.g., blurred vision), urinary retention, gastrointestinal disorders, dry mouth and cough. Adverse reactions that have been associated with β2-agonists include immediate hypersensitivity reactions (urticaria, rash, bronchospasm, edema and angioedema), cardiovascular effects (tachycardia, arrhythmia, palpitations, myocardial ischaemia, hypertension or. hypotension), hypokalemia, hyperglycemia, headache, nervousness, insomnia, muscle spasms, fatigue, malaise and tremor. The most common adverse drug reactions related to the drug product (reported >3% and greater than placebo) were cough and oropharyngeal pain (including throat irritation).

LABA monotherapy increases the risk of serious asthma-related events.
Do not initiate in acutely deteriorating COPD or asthma. Do not use to treat acute symptoms.
Do not use in combination with additional therapy containing a LABA because of risk of overdose.
If paradoxical bronchospasm occurs, discontinue and institute alternative therapy.
Use with caution in patients with cardiovascular disorders because of beta-adrenergic stimulation.
Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.
Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a healthcare provider immediately if symptoms occur.
Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction contact a physician immediately if symptoms occur.
Be alert to hypokalemia and hyperglycemia.

This is an inhalation powder drug product for delivery of a combination of Glycopyrronium (an anticholinergic) and Indacaterol (a LABA) to patients by oral inhalation. The pharmacologic effects of beta2-adrenoceptor agonist drugs, including Indacaterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3, 5-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells. Glycopyrronium is a long-acting muscarinic antagonist, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation.