Breztri Aerosphere

Maintenance treatment in adults w/ moderate to severe COPD who are not adequately treated by combination of inhaled corticosteroid & long-acting β2-agonist or combination of long-acting β2-agonist & long-acting muscarinic antagonist.

Recommended & max dose: 2 inhalations bid (2 inhalations in the morning & 2 inhalations in the evening). Rinse mouth out w/ water after inhaling dose to minimise risk of oropharyngeal thrush. Do not swallow.

Hypersensitivity.

Not indicated for acute episodes of bronchospasm eg, as rescue therapy. Discontinue treatment immediately if paradoxical bronchospasm occurs; signs or symptoms of acute narrow-angle glaucoma develop. Avoid abrupt discontinuation. Paradoxical bronchospasm w/ immediate wheezing & shortness of breath after dosing; CV effects eg, cardiac arrythmias (eg, atrial fibrillation & tachycardia); visual disturbances; central serous chorioretinopathy; increased incidence of pneumonia including pneumonia requiring hospitalisation; serious hypokalaemia; increased plasma glucose. Sudden & progressive deterioration in symptoms of COPD. Systemic effects at high doses for long periods eg, Cushing's syndrome, Cushingoid features, adrenal suppression, decreased bone mineral density, cataract & glaucoma. Bone density effects in patients on high doses for prolonged periods who have co-existing risk factors for osteoporosis. Patients w/ clinically significant uncontrolled & severe CV disease eg, unstable ischemic heart disease, acute MI, cardiomyopathy, cardiac arrhythmias, & severe heart failure; known or suspected QTc interval prolongation (QTc >450 millisec for males or >470 millisec for females), either congenital or induced by medicinal products; thyrotoxicosis; symptomatic prostatic hyperplasia, urinary retention or w/ narrow-angle glaucoma; transferring from oral steroids; who have required high dose corticosteroid therapy or prolonged treatment at highest recommended dose of inhaled corticosteroids. Smoking, old age, low BMI, severe COPD. Monitor blood glucose during treatment in patients w/ diabetes. Refer patient to ophthalmologist for evaluation of possible cause of visual disturbance. Consider additional systemic corticosteroid during periods of stress or elective surgery. Not recommended to co-administer w/ other anticholinergic medicinal products. Concomitant treatment w/ medicinal products that can induce hypokalaemia eg, xanthine derivatives, steroids & diuretics. May affect ability to drive & use machines. Severe renal impairment (CrCl <30 mL/min) & ESRD requiring dialysis. Severe hepatic impairment. Pregnancy & lactation. No relevant use in childn & adolescent <18 yr for COPD.

Oral candidiasis, pneumonia; hyperglycaemia; anxiety, insomnia; headache; palpitations; dysphonia, cough; nausea; muscle spasms; UTI.

Increased risk of systemic side effects w/ strong CYP3A inhibitors eg, itraconazole, ketoconazole, HIV PIs & cobicistat-containing products. Potentiated adverse reactions w/ other anticholinergic &/or long-acting-β2-adrenergic agonist. Additive effects w/ β-adrenergic medicinal products. Potentiated hypokalaemia w/ xanthine derivatives, steroids & non-K-sparing diuretics. Prolonged QT interval & increased risk of ventricular arrhythmias w/ quinidine, disopyramide, procainamide, antihistamines, MAOIs, TCAs & phenothiazines. May precipitate hypertensive reactions w/ MAOIs including medicinal products w/ similar properties eg, furazolidone & procarbazine. Elevated risk of arrhythmias w/ anaesth w/ halogenated hydrocarbons. Budesonide: Increased plasma levels w/ itraconazole. Glycopyrronium: Increased total systemic exposure & decreased renal clearance w/ cimetidine. Formoterol: Weakened or inhibited effect w/ β-adrenergic blockers. Impaired cardiac tolerance w/ L-dopa, L-thyroxine, oxytocin & alcohol.

Antiasthmatic & COPD Preparations

R03BB06 - glycopyrronium bromide ; Belongs to the class of other inhalants used in the treatment of obstructive airway diseases, anticholinergics.
R03BA02 - budesonide ; Belongs to the class of other inhalants used in the treatment of obstructive airway diseases, glucocorticoids.
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.

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