Atectura Breezhaler

Per 150/80 mcg inhalation powd hard cap Indacaterol (as acetate) 150 mcg, mometasone furoate 80 mcg. Per 150/160 mcg inhalation powd hard cap Indacaterol (as acetate) 150 mcg, mometasone furoate 160 mcg. Per 150/320 mcg inhalation powd hard cap Indacaterol (as acetate) 150 mcg, mometasone furoate 320 mcg

Asthma maintenance treatment in adults & adolescents ≥12 yr inadequately controlled w/ inhaled corticosteroids & inhaled short-acting β₂-agonists.

Inhalation Adult & adolescent ≥12 yr 1 cap once daily using the provided inhaler, administered at the same time of the day each day. Max: 150/320 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; pulmonary TB or chronic or untreated infections; rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption; severe hepatic impairment. Pregnancy & lactation. Paed patients <12 yr.

Nasopharyngitis; asthma exacerbation. Upper resp tract infection; hypersensitivity; headache; oropharyngeal pain, dysphonia; musculoskeletal pain.

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 β₂-adrenergic agonists.

Antiasthmatic & COPD Preparations

R03AK14 - indacaterol and mometasone ; Belongs to the class of adrenergics in combination with corticosteroids or other drugs, excluding anticholinergics. Used in the treatment of obstructive airway diseases.

P₁S₁S₃