Generic Name

Indacaterol + Glycopyrronium

Precaution

Concomitant use w/ 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 MI, cardiac arrhythmia, HTN), convulsive disorders or thyrotoxicosis, severe renal impairment; hypokalaemia; hyperglycaemia. Pregnancy & lactation.

Indication

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

Contra Indication

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/glycopyrrolate is not indicated for the treatment of asthma Use in children: This should not be used in patients <18 years.

Dose

N/A

Side Effect

1-10% Nasopharyngitis (4.1%),Hypertension (2%),Back pain (1.8%),Oropharyngeal pain (1.6%)

Pregnancy Category

Mode of Action

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 beta2-agonist (LABA); stimulates intracellular adenyl cyclase, causing conversion of ATP to cyclic AMP; increased cyclic AMP levels cause relaxation of bronchial smooth muscle

Interaction

Decreases levodopa effects. Effects may be enhanced by using drugs with antimuscarinic properties or MAOIs concurrently. May antagonise the GI effects of cisapride, metoclopramide and dompeidone. Potentially Fatal: IV admin in the presence of cyclopropane anesth can result in ventricular arrhythmias.

Pregnancy Category Note

Pregnancy There are no adequate and well-controlled studies in humans with Utibron Neohaler or its individual components Animal studies have not shown teratogenicity Lactation Unknown if distributed in human breast milk Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Adult Dose

Adult Chronic Obstructive Pulmonary Disease (COPD) Inhale 1 cap with inhaler once daily. 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.

Child Dose

Safety and efficacy not established

Renal Dose

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.

Administration

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