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Breztri Aerosphere

Breztri Aerosphere

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per actuation Budesonide 160 mcg, glycopyrronium 7.2 mcg, formoterol fumarate dihydrate 5 mcg
Indications/Uses
Maintenance treatment in adults w/ moderate to very severe COPD who are inadequately treated by combination of inhaled corticosteroid & long-acting β2-agonist or combination of long-acting β2- & muscarinic antagonist.
Dosage/Direction for Use
Recommended & max dose: 2 inhalations bd (in the morning & evening).
Special Precautions
Discontinue use if paradoxical bronchospasm occurs. Not for acute bronchospasm episodes ie, rescue therapy. Clinically significant uncontrolled & severe CV disease eg, unstable ischemic heart disease, acute MI, cardiomyopathy, cardiac arrhythmias, severe heart failure; congenital or medicinally-induced known or suspected QTc interval prolongation; Cushing's syndrome, Cushingoid features, adrenal suppression, decreased bone mineral density, cataract, glaucoma; thyrotoxicosis; symptomatic prostatic hyperplasia, urinary retention or narrow-angle glaucoma. Pneumonia in patients w/ COPD. Ensure to rinse out w/ water after dose to minimise risk of oropharyngeal thrush. Perform ophth evaluation if blurred vision or other visual disturbances occur. Consider additional systemic corticosteroid cover during periods of stress or elective surgery. Monitor blood glucose during treatment. Transferring from oral steroids; high-dose & prolonged use in patients w/ co-existing risk factors for osteoporosis. Not to be swallowed or discontinued abruptly. Not recommended to be co-administered w/ other anticholinergics. Concomitant use w/ other hypokalaemia-inducing medicinal products eg, xanthine derivatives, steroids, diuretics. May affect ability to drive & use machines. Severe hepatic & renal impairment, ESRD requiring dialysis. Pregnancy & lactation. Not to be used in childn & adolescents <18 yr.
Adverse Reactions
Oral candidiasis, pneumonia; hyperglycaemia; anxiety, insomnia; headache; palpitations; dysphonia, cough; nausea; muscle spasms; UTI.
Drug Interactions
Increased budesonide systemic side effects w/ strong CYP3A inhibitors eg, itraconazole, ketoconazole, HIV PIs, cobicistat-containing products. Increased glycopyrronium total systemic exposure & decreased renal clearance w/ cimetidine. Potentiated adverse reactions w/ other anticholinergics &/or long-acting β2-adrenergics. Potentially additive effects w/ other β2-adrenergics. Potentiated hypokalaemia w/ xanthine derivatives, steroids, non-K-sparing diuretics. Weakened or inhibited formoterol effect w/ β-adrenergics. Prolonged QT interval & increased risk of ventricular arrhythmias w/ quinidine, disopyramide, procainamide, antihistamines, MAOIs, TCAs, phenothiazines. Impaired cardiac tolerance towards β2-sympathomimetics w/ L-dopa, L-thyroxine, oxytocin, alcohol. Precipitated hypertensive reactions w/ MAOIs, furazolidone, procarbazine. Elevated risk of arrhythmias in concomitant anaesth w/ halogenated hydrocarbons.
MIMS Class
Antiasthmatic & COPD Preparations
ATC Classification
R03AL11 - formoterol, glycopyrronium bromide and budesonide ; 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
Breztri Aerosphere susp for inhalation (pressurised MDI)
Packing/Price
(pressurised MDI) 120 actuation x 1's
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