ACME LABORATORIES LTD.
BECLOMETASONE DIPROPIONATE + FORMOTEROL FUMARATE
Asthma: Beclomethasone dipropionate/Formoterol fumarate dihydrate is indicated in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting 82-agonist) is appropriate: patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled rapid-acting 82-agonist or patients already adequately controlled on both inhaled corticosteroids and long-acting 82-agonists. COPD: Symptomatic treatment of patients with severe COPD (FEV1 <50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators
Beclomethasone dipropionate given by inhalation at recommended doses has a glucocorticoid antiinflammatory action within the lungs, resulting in reduced symptoms and exacerbations of asthma with less adverse effects than when corticosteroids are administered systemically. Formoterol is a selective 82-adrenergic agonist that produces relaxation of bronchial smooth muscle in patients with reversible airways obstruction. The bronchodilating effect sets in rapidly, within 1-3 minutes after inhalation, and has a duration of 12 hours after a single dose
Dose recommendations for adults 18 years and above: One or two inhalations twice daily. The maximum daily dose is 4 inhalations. Dose recommendations for children and adolescents under 18 years: The safety and efficacy in children and adolescents under 18 years of age have not been established yet. No data are available with the drug in children under 12 years of age. Therefore the drug is not recommended for children and adolescents under 18 years until further data become available.
Beta-blockers (including eye drops) should be avoided in asthmatic patients. If beta-blockers are administered for compelling reasons, the effect of formoterol will be reduced or abolished. On the other hand, concomitant use of other beta adrenergic drugs can have potentially additive effects, therefore caution is required when theophylline or other beta adrenergic drugs are prescribed concomitantly with formoterol. Concomitant treatment with quinidine, disopyramide, procainamide, phenothiazines, antihistamines, monoamine oxidase inhibitors and tricyclic antidepressants can prolong the QTc-interval and increase the risk of ventricular arrhythmias.
Contraindicated in patients with hypersensitivity to any component of this product.
As the drug contains beclometasone dipropionate and formoterol fumarate dihydrate, the type and severity of adverse reactions associated with each of the compounds may be expected. Common side effects are pharyngitis, oral candidiasis, headache, dysphonia.
There are no relevant clinical data on the use of the drug in pregnant women. Animal studies using beclometasone dipropionate and formoterol combination showed evidence of toxicity to reproduction after high systemic exposure. There are no relevant clinical data on the use of the drug in lactation in humans. Although no data from animal experiments are available, it is reasonable to assume that beclometasone dipropionate is secreted in milk, like other corticosteroids
The drug should be used with caution (which may include monitoring) in patients with cardiac arrhythmias, especially third degree atrioventricular block and tachyarrhythmias (accelerated and/or irregular heart beat), 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. Caution should also be observed when treating patients with known or suspected prolongation of the QTc interval, either congenital or drug induced (QTc >0.44 seconds). Formoterol itself may induce prolongation of the QTc interval
Prior to dispensing to the patient: Store in a refrigerator (2-88C) (for a maximum of 15 months). After dispensing: Store at temperatures not exceeding 308C (for a maximum of 2 months).