Bronchodilator treatment to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD).

Combined bronchodilators

Glycopyrronium: Long-acting muscarinic antagonist (LAMA); often referred to as an anticholinergic; produces bronchodilation by inhibiting acetylcholine’s effect on muscarinic receptors in the airway smooth muscle

Indacaterol: Long-acting β2-agonist (LABA); stimulates intracellular adenyl cyclase, causing conversion of ATP to cyclic AMP; increased cyclic AMP levels cause relaxation of bronchial smooth muscle

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.

For inhalation use only. The capsules must not be swallowed.

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.

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.

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.

Renal Impairment: This can be used at the recommended dose in patients with mild to moderate renal impairment. In patients with severe renal impairment or end-stage renal disease requiring dialysis it should be used only if the expected benefit outweighs the potential risk.

Hepatic Impairment: This can be used at the recommended dose in patients with mild and moderate hepatic impairment. There are no data available for the use of Indacaterol + Glycopyrronium Breezhaler in patients with severe hepatic impairment, therefore caution should be observed in these patients.

Elderly: Indacaterol & Glycopyrronium Breezhaler can be used at the recommended dose in elderly patients