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Trimbow

Trimbow

Manufacturer:

Chiesi

Distributor:

Zuellig Pharma

Marketer:

Orient Europharma
Concise Prescribing Info
Contents
Per actuation Beclometasone dipropionate 100 mcg, formoterol fumarate dihydrate 6 mcg, glycopyrronium Br 10 mcg
Indications/Uses
Maintenance treatment of moderate to severe COPD in patients not adequately treated by combination of inhaled corticosteroids & long-acting β2-agonists.
Dosage/Direction for Use
Adult 2 inhalations bd. Max: 4 inhalations daily.
Contraindications
Special Precautions
Discontinue use if immediate hypersensitivity reactions & paradoxical bronchospasm occur. Not indicated for acute bronchospasm epidoses or COPD exacerbation. Pneumonia in patients w/ COPD. Cardiac arrhythmias especially 3rd-degree AV block & tachyarrhythmias, idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart disease (eg, acute MI, ischaemic heart disease, CHF), occlusive vascular diseases (eg, arteriosclerosis), arterial HTN, aneursym; known or suspected QTc interval prolongation; thyrotoxicosis, DM, pheochromocytoma, untreated hypokalaemia; Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma, psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in childn); active or quiescent pulmonary TB, fungal & viral airway infections; narrow-angle glaucoma, prostatic hyperplasia or urinary retention. Risk of oropharyngeal Candida infection. Evaluate for possible causes of visual disturbances. Monitor serum K & blood glucose levels. Avoid abrupt w/drawal. High-dose & long-term use. Not to be administered for at least 12 hr prior to halogenated anaesth. Not recommended w/ other anticholinergic-containing medicinal products. Concomitant use w/ xanthine derivatives, steroids & diuretics. Severe hepatic & renal impairment; end-stage renal disease requiring dialysis. Avoid use during pregnancy & labour. Lactation. Paed <18 yr.
Adverse Reactions
Pneumonia (COPD patients), pharyngitis, oral candidiasis, UTI, nasopharyngitis; headache; dysphonia.
Drug Interactions
Increased total systemic exposure & decreased renal clearance w/ cimetidine. Systemic effects w/ strong CYP3A inhibitors eg, ritonavir, cobicistat. Reduced or abolished effect w/ non-cardioselective β-blockers including eye drops. 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, furazolidone, procarbazine. Elevated risk of arrhythmias w/ halogenated hydrocarbon-containing anaesth. Potentiated hypokalaemic effect w/ xanthine derivatives, steroids or diuretics. Increased arrhythmic disposition w/ digitalis glycosides. Not recommended w/ other anticholinergic-containing medicinal products. Disulfiram, metronidazole.
MIMS Class
Antiasthmatic & COPD Preparations
ATC Classification
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.
Presentation/Packing
Form
Trimbow inhalation soln
Packing/Price
120 actuation x 1's
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