Beclometasone dipropionate, formoterol fumarate dihydrate.
Each MDI contains beclometasone dipropionate 100 mcg, formoterol fumarate dihydrate 6 mcg (equiv to a delivered dose of 84.6 mcg and 5 mcg, respectively).
Pharmacotherapeutic Class: Antiasthmatic & COPD Preparations. ATC Code: R03AK08.
Treatment of asthma in patients adequately and not adequately controlled with inhaled corticosteroids, short- and long-acting β2-acting agonist. 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.
Asthma: Adult ≥18 year: Maintenance therapy: 1 or 2
inhalations twice daily. Max daily dose: 4 inhalations.
Maintenance and reliever
therapy: 1 inhalation twice
daily (one inhalation in the morning and one inhalation in the evening). 1
additional inhalation as needed in response to symptoms. If symptoms persist
after a few minutes, an additional inhalation should be taken. Max daily dose:
Chronic Obstructive Pulmonary Disease: 2 inhalations twice daily.
Cardiac arrhythmias especially 3rd-degree AV block and tachyarrhythmias, idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart and occlusive vascular disease. Known or suspected prolongation of the QTc interval either congenital or drug induced (QTc >0.44 sec). Thyrotoxicosis, DM, phaeochromocytoma and untreated hypokalaemia. Severe asthma; monitor serum K levels in unstable asthma. Monitor blood glucose closely in diabetics. Do not administer at least 12 hour prior to anesthetic. Active or quiescent pulmonary TB, fungal and viral infections in the airways. Avoid abrupt withdrawal. Discontinue use if paradoxical bronchospasm occurs. Transfer to Foster therapy of patients with impaired adrenal function from previous systemic steroid therapy. Children and adolescents <18 year. Pregnancy and lactation.
Foster should be used in caution with pregnant and lactating women.
Pharyngitis, oral candidiasis, headache, dysphonia.
Reduced effect of formoterol with β-blockers. Additive effects of formoterol with theophylline or other β-adrenergic drugs. Prolonged QTc-interval & increased risk of ventricular arrhythmias with quinidine, disopyramide, procainamide, phenothiazines, antihistamines, MAOIs, TCAs. Impaired cardiac tolerance with L-dopa, L-thyroxine, oxytocin, alcohol. May precipitate hypertensive reactions with furazolidone, procarbazine. Hypokalaemic effect with xanthine derivatives, steroids, diuretics. Disulfiram, metronidazole.
Prior to Dispensing: Store in a refrigerator (2-8°C) (for a maximum of 15 months).
After Dispensing: Do not store above 30°C (for a maximum of 2 months).
The canister contains a pressurised liquid. Do not expose to temperatures >50°C. Do not pierce the canister.
R03AK08 - formoterol and beclometasone ; Belongs to the class of adrenergics in combination with corticosteroids or other drugs, excluding anticholinergics. Used in the treatment of obstructive airway diseases.