Enerzair Breezhaler

Enerzair Breezhaler

Manufacturer:

Novartis

Distributor:

DKSH
Concise Prescribing Info
Contents
Indacaterol acetate 150 mcg, glycopyrronium Br 50 mcg, mometasone furoate 160 mcg
Indications/Uses
Maintenance treatment of asthma in adults not adequately controlled w/ maintenance combination of long-acting β2-agonist & high-dose inhaled corticosteroid w/ ≥1 asthma exacerbations.
Dosage/Direction for Use
1 cap once-daily inhalation at the same time each day.
Special Precautions
Discontinue use if hypersensitivity reactions & paradoxical bronchospasm occurs. Not to be used for acute asthma & bronchospasm episodes. CV disorders (CAD, acute MI, cardiac arrhythmias, HTN), convulsive disorders or thyrotoxicosis, unusually responsive to β2-adrenergic agonists; unstable ischaemic heart disease, history of MI w/in last 12 mth, NYHA class III/IV left ventricular failure, arrhythmia, uncontrolled HTN, cerebrovascular disease; known or suspected QT interval prolongation or patients treated w/ medicinal products affecting QT interval; hypokalaemia; hyperglycaemia, type I or uncontrolled type II DM; narrow-angle glaucoma or urinary retention; pulmonary TB, chronic or untreated infections. Systemic effects eg, Cushing's syndrome, Cushingoid features, adrenal suppression, decreased bone mineral density, cataracts, glaucoma, psychological or behavioural effects, psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression; visual disturbance. Rinse mouth or gargle w/ water w/o swallowing to reduce risk of oropharyngeal candida infection. Avoid abrupt w/drawal. High-dose & prolonged use. Not to be used in galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Severe renal (GFR <30 mL/min/1.73 m2) or hepatic impairment; ESRD requiring dialysis. Pregnancy & lactation. Childn <18 yr; growth retardation in childn & adolescents.
Adverse Reactions
Nasopharyngitis; asthma exacerbation. URTI, candidiasis, UTI; hypersensitivity; headache; tachycardia; oropharyngeal pain, cough, dysphonia; gastroenteritis; musculoskeletal pain, muscle spasms; pyrexia.
Drug Interactions
Potentiated effect on QT interval w/ MAOIs, TCAs or medicinal products prolonging QT interval. Potentiated hypokalaemic effect w/ methylxanthine derivatives, steroids or non-K-sparing diuretics. Weakened or antagonised effect by β-adrenergic blockers. Increased systemic exposure to mometasone furoate w/ strong CYP3A4 inhibitors eg, ketoconazole, itraconazole, nelfinavir, ritonavir, cobicistat. Increased risk of systemic side effects w/ cobicistat-containing products. Potentiated AR w/ long-acting β2-adrenergic agonists.
MIMS Class
Antiasthmatic & COPD Preparations
ATC Classification
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.
Presentation/Packing
Form
Enerzair Breezhaler inhalation powd cap
Packing/Price
30's
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