Beclometasone, Formoterol and Glycopyrronium, Inhaler

Bronchodilator & Anti-asthma Preps: Inhalants · Antimuscarinic/Beta-2 agonist/Corticosteroid

Indications

Maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist. Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.

Dosage

Adults: Two inhalations twice daily.

Administration

For inhalation only. For method of administration, read ‘Package leaflet’ carefully. To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler correctly by a physician or other healthcare professional, who should also regularly check the adequacy of the patient's inhalation technique. There is a dose counter or dose indicator on the back of the inhaler, which shows how many actuations are left. For the 60 and 120 actuation pressurized containers, each time the patient presses the container a puff of the solution is released and the counter counts down by one. For the 180 actuation pressurized container, each time the patient presses the pressurized container a puff of the solution is released and the counter rotates by a small amount; the number of puffs remaining is displayed in intervals of 20. Patients should be advised not to drop…

Adverse Effects

Dysphonia, oral candidiasis, muscle spasms, dry mouth, pneumonia (in COPD patients), pharyngitis, nasopharyngitis, UTI, headache.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Contraindicated in pregnancy. Lactation: Caution advised or effect undetermined. Contraindications: Acute episodes of bronchospasm. Precautions: Severe renal impairment, severe hepatic impairment. ESRD requiring dialysis (esp. if associated with significant body wt. reduction). Cardiac arrhythmias (esp. 3rd degree AV block and tachyarrhythmias (accelerated and/or irregular heartbeat, including atrial fibrillation), idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart disease (particularly acute myocardial infarction, ischaemic heart disease, congestive heart failure), occlusive vascular diseases (particularly arteriosclerosis), arterial hypertension and aneurysm. Known or suspected prolongation of the QTc interval (either congenital or induced by medicinal products). Thyrotoxicosis, diabetes mellitus, pheochromocytoma, untreated…

Interactions

Xanthine derivatives, steroids, diuretics, quinidine, disopyramide, procainamide, antihistamines, MAOIs, tricyclic antidepressants, phenothiazines, L-dopa, L-thyroxine, oxytocin, alcohol, furazolidone, procarbazine, non-cardioselective beta blockers (including eye drops), beta adrenergics.

Advice to Patient

Take medicine every day even when asymptomatic. Get a new inhaler when the dose counter or indicator shows the number 20. Stop using the inhaler when the counter or indicator shows 0 as any puffs left in the device may not be enough to release a full actuation. For the regular cleaning of the inhaler, remove weekly the cap from the mouthpiece and wipe the outside and inside of the mouthpiece with a dry cloth. Do not remove the pressurised container from the actuator and do not use water or other liquids to clean the mouthpiece. Discontinue treatment and seek medical attention immediately if there are signs suggesting allergic reactions, in particular, angioedema (including difficulties in breathing or swallowing, swelling of the tongue, lips and face), urticaria or skin rash. In order to reduce the risk of oropharyngeal candida infection, you should rinse your mouth or gargle with water…

Pharmacokinetics

BECLOMETHASONE: Absorption: Rapidly absorbed through the lungs. Metabolism: Hydrolyzed via esterase enzymes to an active metabolite beclomethasone 17-monopropionate. Bioavailability: Absolute: Dipropionate: 2%. 17-monopropionate: 62%. Half-life elimination: Terminal: Dipropionate: 0.5 hrs. 17-monopropionate: 2.7 hrs. Excretion: Via faeces. FORMOTEROL: Absorption: Absorbed via both the lung and GI tract. Metabolism: Hepatic. Half-life elimination: Terminal: 10 hrs. Time to peak, plasma: 0.5-1 hr. Excretion: Urine (majorly). Faeces (remainder). GLYCOPYRRONIUM: Absorption: Slow, variable and incomplete GI absorption. Metabolism: Hepatic via CYP2D6. Bioavailability: Absolute: 12.8%. Half-life Elimination: 5-12 hrs. Excretion: Urine (13%-14.5%).

Compiled by Healify Pharmacy from published drug references. How we compile it →

Always consult a pharmacist or doctor.