Breztri Aerosphere

Per actuation (delivered dose, ex-actuator) Budesonide 160 mcg, glycopyrronium 7.2 mcg, formoterol fumarate dihydrate 5 mcg

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

Recommended & max dose: 2 inhalations bd (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 to the active substances or any of the excipients.

Not indicated for treatment of acute episodes of bronchospasm ie, as rescue therapy. Immediately discontinue treatment if paradoxical bronchospasm occurs. Do not abruptly stop treatment in case of disease deterioration. CV effects may be seen after administration of muscarinic receptor antagonists & sympathomimetics, including glycopyrronium & formoterol. Caution in patients w/ clinically significant uncontrolled & severe CV disease, & patients w/ known or suspected prolongation of the QTc interval. Systemic effects may occur w/ any inhaled corticosteroid, particularly at high doses prescribed for long periods. Consider potential effects on bone density particularly in patients on high doses for prolonged periods that have co-existing risk factors for osteoporosis. Visual disturbance may be reported w/ systemic & topical corticosteroid use. Risk of impaired adrenal function in patients transferring from oral steroids &/or those who have required high-dose corticosteroid therapy or prolonged treatment at the highest recommended dose of inhaled corticosteroids. Increased incidence of pneumonia in COPD patients receiving inhaled corticosteroids. Potentially serious hypokalaemia may result from β₂-agonist therapy. Inhalation of high-dose β₂-adrenergic agonists may produce increases in plasma glucose; monitor blood glucose during treatment. Co-administration w/ other anticholinergic-containing medicinal products is not recommended. Caution in patients w/ thyrotoxicosis; symptomatic prostatic hyperplasia, urinary retention, or narrow-angle glaucoma. Can be used at the recommended dose in patients w/ severe renal or hepatic impairment or ESRD requiring dialysis only if expected benefit outweighs potential risk. Administration to pregnant women should only be considered if expected benefit to mother justifies potential risk to foetus. Administration to breast-feeding women should only be considered if expected benefit to mother is greater than any possible risk to child. No relevant use in childn & adolescents <18 yr.

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; avoid co-treatment unless benefit outweighs increased risk of systemic corticosteroid adverse reactions. Potential drug interaction w/ medicinal products affecting renal excretion mechanisms eg, cimetidine (probe inhibitor of OCT2 & MATE1). Co-administration w/ other medicinal products containing anticholinergic &/or long-acting β₂-adrenergic agonist may potentiate known adverse reactions of inhaled muscarinic antagonist or β₂-adrenergic agonist. Potentially additive effects w/ other β-adrenergic medicinal products. Possible initial hypokalaemia may be potentiated by concomitant medicinal products, including xanthine derivatives, steroids & non-K-sparing diuretics. Hypokalaemia may increase the disposition towards arrhythmias w/ digitalis glycosides. Weakened or inhibited effect of formoterol w/ β-adrenergic blockers (including eye drops); avoid concurrent use unless expected benefit outweighs potential risk. Prolonged QT interval & increased risk of ventricular arrhythmias w/ quinidine, disopyramide, procainamide, antihistamines, MAOIs, TCAs & phenothiazines. L-dopa, L-thyroxine, oxytocin & alcohol can impair cardiac tolerance towards β₂-sympathomimetics. Concomitant treatment w/ MAOIs (including medicinal products w/ similar properties eg, furazolidone & procarbazine) may precipitate hypertensive reactions. Elevated risk of arrhythmias w/ halogenated hydrocarbons.

Antiasthmatic & COPD Preparations

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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