Enerzair Breezhaler

Indacaterol (as acetate) 150 mcg, glycopyrronium 50 mcg, mometasone furoate 160 mcg

Asthma maintenance treatment in adults inadequately controlled w/ a maintenance combination of a long-acting β₂-agonist & a high-dose inhaled corticosteroid who experienced ≥1 asthma exacerbations in the previous yr.

Inhalation 1 cap once daily using the provided inhaler, administered at the same time of the day each day. Max: 150/50/160 mcg once daily.

Hypersensitivity.

Discontinue immediately in case of signs suggesting allergic reactions (eg, angioedema, urticaria or skin rash); paradoxical bronchospasm. Do not swallow cap. Do not use to treat acute asthma symptoms, including acute episodes of bronchospasm. Do not abruptly stop treatment. Risk of hypokalaemia w/ β-agonists. Plasma glucose should be monitored more closely in diabetic patients upon treatment initiation. Rinse mouth or gargle w/ water w/o swallowing after inhalation to reduce the risk of oropharyngeal candida infection. Systemic effects (eg, Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in childn & adolescents, decrease in bone mineral density, cataracts, glaucoma, & psychological or behavioural effects) of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. Patients w/ CV disorders (CAD, acute MI, cardiac arrhythmias, HTN), convulsive disorders or thyrotoxicosis & who are unusually responsive to β₂-adrenergic agonists; known or suspected QT interval prolongation or who are being treated w/ medicinal products affecting the QT interval; type I or uncontrolled Type II DM; narrow-angle glaucoma or urinary retention; pulmonary TB or chronic or untreated infections; rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption; severe renal impairment (estimated GFR <30 mL/min/1.73 m²) or end-stage renal disease requiring dialysis; severe hepatic impairment. Pregnancy & lactation. Paed patients <18 yr.

Nasopharyngitis; asthma exacerbation. Upper resp tract infection, candidiasis, UTI; hypersensitivity; headache; tachycardia; oropharyngeal pain, cough, dysphonia; gastroenteritis; musculoskeletal pain, muscle spasms; pyrexia.

Potentiated effect on QT interval w/ MAOIs or TCAs. Increased risk of ventricular arrhythmia w/ medicinal products known to prolong the QT interval. Methylxanthine derivatives, steroids, or non-K-sparing diuretics may potentiate the possible hypokalaemic effect of β₂-adrenergic agonists. β-adrenergic blockers may weaken or antagonise the effect of β₂-adrenergic agonists. Potential for increased systemic exposure to mometasone furoate w/ strong CYP3A4 inhibitors eg, ketoconazole, itraconazole, nelfinavir, ritonavir, cobicistat. Possible potentiation of adverse reactions w/ other medicinal products containing long-acting muscarinic antagonists or long-acting β₂-adrenergic agonists.

Antiasthmatic & COPD Preparations

R03AL12 - indacaterol, glycopyrronium bromide and mometasone ; Belongs to the class of combination of adrenergics with anticholinergics, that may also include a corticosteroid. Used in the treatment of obstructive airway diseases.

P₁S₁S₃