Bronchodilator treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD).
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.
The recommeded Dose is One capsule once daily. Indacaterol & Glycopyrronium Breezhaler is recommended to be administered at the same time of the day each day. If a dose is missed, it should be taken as soon as possible on the same day. Patients should be instructed not to take >1 dose in a day.
No specific interaction studies were conducted for Glycopyrronium and Indacaterol combination. Information on the potential for interactions is based on the potential for each individual component. The concomitant use of Glycopyrronium and Indacaterol with β-adrenergic blockers, anticholinergics or sympathomimetic agents is not recommended. Sympathomimetic agents may potentiate the adverse events of Indacaterol. Caution is required with the concomitant use of hypokalemic treatment.
Hypersensitivity to indacaterol, glycopyrronium or to any of the excipients of Indacaterol & Glycopyrronium. All LABAs are contraindicated in patients with asthma without use of a long-term asthma control medication Indacaterol or glycopyrrolate is not indicated for the treatment of asthma Use in children: This should not be used in patients <18 years. Concomitant use with long-acting beta-agonists or long-acting muscarinic antagonists. Not for the treatment of asthma. Immediately discontinue use if hypersensitivity & paradoxical bronchospasm occurs. Narrow-angle glaucoma, urinary retention, CV disorders (CAD, acute Ml, cardiac arrhythmia, HTN), convulsive disorders or thyrotoxicosis, severe renal impairment; hypokalaemia; hyperglycaemia. Pregnancy & lactation.
Nasopharyngitis (4.1%), Hypertension (2%), Back pain (1.8%), Oropharyngeal pain (1.6%)
Pregnancy Category- Not Classified. FDA has not yet classified the drug into a specified pregnancy category.
There is no information on clinically relevant overdosing with this combination. An overdose could lead to exaggerated effects typical of β2-adrenergic stimulants, i.e. tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalemia and hyperglycaemia or could induce anticholinergic effects such as increased intraocular pressure (causing pain, vision disturbances or reddening of the eye), obstipation or difficulties in voiding. Supportive and symptomatic treatment is indicated. In serious cases, patients should be hospitalized.
Avoid storage in direct sunlight or heat. Store in a cool & dry place. Keep away from eyes. Keep all medicines out of reach of children.
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