NEW
Atectura Breezhaler

Atectura Breezhaler

Manufacturer:

Novartis

Distributor:

DKSH
Concise Prescribing Info
Contents
Per 150 mcg/80 mcg inhalation powd cap Indacaterol acetate 150 mcg, mometasone furoate 80 mcg. Per 150 mcg/160 mcg inhalation powd cap Indacaterol acetate 150 mcg, mometasone furoate 160 mcg. Per 150 mcg/320 mcg inhalation powd cap Indacaterol acetate 150 mcg, mometasone furoate 320 mcg
Indications/Uses
Maintenance treatment of asthma in adults & adolescents ≥12 yr not adequately controlled w/ inhaled corticosteroids & short-acting β2-agonists.
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; pulmonary TB, chronic or untreated infections. Systemic effects eg, Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in childn & adolescents, decreased bone mineral density, cataracts, glaucoma, psychological or behavioural effects; 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 hepatic impairment. Pregnancy & lactation. Childn <12 yr.
Adverse Reactions
Nasopharyngitis; asthma exacerbation. Upper resp tract infection; hypersensitivity; headache; oropharyngeal pain, dysphonia; musculoskeletal pain.
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
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.
Presentation/Packing
Form
Atectura Breezhaler 150 mcg/160 mcg inhalation powd cap
Packing/Price
30's
Form
Atectura Breezhaler 150 mcg/320 mcg inhalation powd cap
Packing/Price
30's
Form
Atectura Breezhaler 150 mcg/80 mcg inhalation powd cap
Packing/Price
30's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in