Trimbow

Trimbow

Manufacturer:

Chiesi Farmaceutici

Distributor:

Zuellig

Marketer:

OEP Phils
Concise Prescribing Info
Contents
Per actuation Beclometasone dipropionate 100 mcg, formoterol fumarate dihydrate 6 mcg, glycopyrronium Br 12.5 mcg
Indications/Uses
Maintenance treatment of moderate to severe COPD in adults not adequately treated by combination of inhaled corticosteroid & long-acting β2-agonist or combination of long-acting β2-agonist & long-acting muscarinic antagonist. Maintenance treatment of asthma in adults not adequately controlled w/ maintenance combination of long-acting β2-agonist & medium dose of inhaled corticosteroid & who experienced ≥1 asthma exacerbations in the previous yr.
Dosage/Direction for Use
Recommended & max dose: 2 inhalations bid.
Contraindications
Special Precautions
Discontinue use if signs suggesting allergic reactions [particularly angioedema (including difficulties in breathing or swallowing, swelling of tongue, lips & face), urticaria or skin rash] or paradoxical bronchospasm occurs. Avoid abrupt discontinuation of treatment. Not indicated for acute bronchospasm episodes or acute disease exacerbation (ie, as rescue therapy). 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. Pneumonia in patients w/ COPD. Possible systemic effects (particularly at high doses) including Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation, decreased bone mineral density & more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in childn). Stepping-down treatment. Monitor serum K levels; blood glucose levels in patients w/ diabetes. Rinse mouth or gargle w/ water w/o swallowing or brush the teeth after inhalation of dose to reduce risk of oropharyngeal Candida infection. Consider referral to ophthalmologist for evaluation of possible causes if patient presents w/ symptoms eg, blurred vision or other visual disturbances. Not to be administered for at least 12 hr prior to start of halogenated anesth. 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 (GFR <30 mL/min/1.73 m2) or ESRD (GFR <15 mL/min/1.73 m2) requiring dialysis. Severe hepatic impairment (Child-Pugh class C). Avoid use during pregnancy & labour. Lactation. Childn <18 yr.
Adverse Reactions
Pneumonia (COPD patients), pharyngitis, oral candidiasis, UTI, nasopharyngitis; headache; dysphonia.
Drug Interactions
Glycopyrronium: Increased total systemic exposure (AUC0-t) & decreased renal clearance w/ cimetidine. 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. May precipitate hypertensive reactions w/ MAOIs, furazolidone & procarbazine. Elevated risk of arrhythmias w/ anesth w/ halogenated hydrocarbons. Hypokalemic effect may be potentiated w/ xanthine derivatives, steroids or diuretics which may increase disposition towards arrhythmias in patients treated w/ digitalis glycosides. Not recommended in long-term co-administration w/ other anticholinergic-containing medicinal products.
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 MDI
Packing/Price
120 actuation x 1's
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