Trimbow

Maintenance treatment of moderate to severe COPD in adults who are inadequately treated by combination of inhaled corticosteroid & long-acting β2-agonist, or long-acting β2-agonist & long-acting muscarinic antagonist; asthma in adults who are inadequately controlled w/ maintenance combination of long-acting β2-agonist & medium dose of inhaled corticosteroid, & who experienced ≥1 asthma exacerbations in previous yr.

Recommended & max dose: 2 inhalations bid.

Hypersensitivity.

Immediately discontinue treatment if signs suggesting allergic reactions, particularly angioedema (including difficulties in breathing or swallowing, swelling of tongue, lips & face), urticaria or skin rash; paradoxical bronchospasm occur. Avoid abrupt discontinuation of treatment. Not indicated for acute bronchospasm episodes or acute disease exacerbation (ie, as rescue therapy). Sudden or progressive symptom deterioration. Increased incidence of pneumonia in patients w/ COPD. Possible systemic effects (particularly at high doses for long periods) including Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation, decreased bone mineral density & range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in childn). Patients w/ cardiac arrhythmias especially 3rd-degree AV block & tachyarrhythmias (accelerated &/or irregular heartbeat including atrial fibrillation), idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart disease (particularly acute MI, ischemic heart disease, CHF), occlusive vascular diseases (particularly arteriosclerosis), arterial HTN & aneurysm; known or suspected prolongation of QTc interval; thyrotoxicosis, DM, pheochromocytoma & untreated hypokalemia; active or quiescent pulmonary TB, fungal & viral infections in the airways; narrow-angle glaucoma, prostatic hyperplasia or urinary retention. Monitor serum K levels when reliever bronchodilators are used; blood glucose levels in patients w/ diabetes. Rinse mouth or gargle w/ water w/o swallowing or brush teeth after dose inhalation to reduce risk of oropharyngeal Candida infection. Consider referral to ophthalmologist for evaluation of possible causes (cataract, glaucoma or rare diseases eg, central serous chorioretinopathy) if patient presents w/ symptoms eg, blurred vision or other visual disturbances. Regularly reassess patients for stepping-down treatment. Not to be administered for at least 12 hr prior to start of halogenated anaesth. Not recommended in long-term co-administration w/ other anticholinergic-containing medicinal products. Concomitant use w/ other medicinal products which can induce hypokalemia eg, xanthine derivatives, steroids & diuretics. Contains ethanol which may have potential interaction in particularly sensitive patients taking disulfiram or metronidazole. Severe renal impairment or ESRD requiring dialysis. Severe hepatic impairment. Avoid use during pregnancy & labour. Lactation. Paed <18 yr.

Pneumonia (in COPD patients), pharyngitis, oral candidiasis, UTI, nasopharyngitis; headache; dysphonia.

Beclometasone: Possible systemic effects w/ strong CYP3A inhibitors (eg, ritonavir, cobicistat). Formoterol: Reduced or abolished effect w/ non-cardioselective β-blockers (including eye drops). Potentially additive effects w/ other β-adrenergic medicinal products. Prolonged QT interval & increased risk of ventricular arrhythmias w/ quinidine, disopyramide, procainamide, antihistamines, MAOIs, TCAs & phenothiazines. Impaired cardiac tolerance w/ L-dopa, L-thyroxine, oxytocin & alcohol. Precipitated hypertensive reactions w/ MAOIs, including medicinal products w/ similar properties eg, furazolidone & procarbazine. Elevated risk of arrhythmias w/ halogenated hydrocarbon anaesth. Potentiated possible hypokalaemic effect w/ xanthine derivatives, steroids, or diuretics. Increased arrhythmic disposition w/ digitalis glycosides. Glycopyrronium: Potential interaction w/ medicinal products affecting renal excretion mechanisms. Limited increase in total systemic exposure & slight decrease in renal clearance w/ cimetidine (probe inhibitor of OCT2 & MATE1 transporters). Not recommended w/ long-term co-administration w/ other anticholinergic-containing medicinal products.

Antiasthmatic & COPD Preparations

R03AL09 - formoterol, glycopyrronium bromide and beclometasone ; 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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