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 to relieve symptoms & prevent exacerbations in adult patients w/ moderate to very severe COPD.
Dosage/Direction for Use
Recommended & max dose: 2 inhalations bd (in the morning & evening).
Special Precautions
Potentially life threatening sudden & progressive deterioration in control of COPD; patient should undergo urgent medical assessment. Patients transferring from oral steroids may remain at risk of impaired adrenal function for considerable time. Discontinue treatment & consider other treatments if paradoxical bronchospasm occurs. Not indicated for acute episodes of bronchospasm or acute COPD exacerbation (ie, as rescue therapy). Patients w/ thyrotoxicosis, severe CV disorder eg, ischemic heart disease, tachyarrythmias or severe heart failure & prolonged QTc-interval. Possible systemic effects include Cushing's syndrome, cushingoid features, adrenal suppression, decreased bone mineral density, cataract & glaucoma in high doses for long periods. High doses may cause hyperglycaemia & hypokalaemia. Patients w/ symptomatic prostatic hyperplasia, urinary retention or narrow-angle glaucoma. Severe renal & hepatic impairment. Possible development of pneumonia in patients w/ COPD; infections can overlap w/ the symptoms of COPD exacerbation. Pregnancy & lactation. No relevant use in childn & adolescent <18 yr for COPD.
Adverse Reactions
Oral candidiasis, pneumonia; hyperglycaemia; anxiety, insomnia; headache; palpitations; dysphonia, cough; nausea; UTI; muscle spasms.
Drug Interactions
Co-administration w/ other anticholinergic &/or long-acting β2-adrenergic agonist is not recommended. Possible initial hypokalemia may be potentiated by concomitant medications including non K-sparing diuretics. Concomitant use w/ QTc interval-prolonging medicinal products. Budesonide: Increase risk of systemic side effects w/ strong CYP3A inhibitors eg, itraconazole, ketoconazole, HIV PIs & cobicistat-containing products. Glycopyrronium: Slight decreased renal clearance by 23% w/ cimetidine. Formoterol: Weakened or inhibited effect w/ β-adrenergic blockers.
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 metered aerosol 160 mcg/7.2 mcg/5 mcg
Packing/Price
((120 actuation)) 1's
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