Zuellig Pharma


Orient Europharma
Concise Prescribing Info
Beclometasone dipropionate 100 mcg, formoterol fumarate dihydrate 6 mcg
Regular treatment of asthma for patients not adequately controlled w/ inhaled corticosteroids & as needed inhaled rapid-acting β2-agonist or patients on both inhaled corticosteroids & long-acting β2-agonists. Symptomatic treatment of patients w/ severe COPD & history of repeated exacerbations who have significant symptoms despite regular therapy w/ long-acting bronchodilators.
Dosage/Direction for Use
Adult ≥18 yr Maintenance therapy 1 or 2 inhalations bd. Max daily dose: 4 inhalations. Maintenance & reliever therapy 1 inhalation bd, may take 1 additional inhalation as needed in response to symptoms. If symptoms persist after few min, an additional inhalation should be taken. Max daily dose: 8 inhalations. COPD 2 inhalations bd.
Special Precautions
Discontinue use if paradoxical bronchospasm occurs. Not to be used for initial management, 1st treatment & regular prophylaxis of asthma. Not to be initiated during exacerbation or in patients w/ significantly worsening or acutely deteriorating asthma. Cardiac arrhythmias especially 3rd degree AV block & tachyarrhythmias; idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart disease particularly acute MI, ischaemic heart disease, CHF, occlusive vascular diseases particularly arteriosclerosis, arterial HTN & aneurysm; known or suspected QTc interval. Thyrotoxicosis, DM, phaeochromocytoma & untreated hypokalaemia. Unstable asthma; active or quiescent pulmonary TB, fungal & viral airway infections. Cushing's syndrome, Cushingoid features, adrenal suppression decreased bone mineral density, cataract, glaucoma, psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression. Risk of oropharyngeal Candida infections. Transferring patients from previous systemic steroid therapy. Monitor serum K & blood glucose levels. Not to be administered for at least 12 hr prior to anaesth. Avoid abrupt w/drawal. High-dose & prolonged use. Concomitant use w/ xanthine derivatives, steroids & diuretics. Not recommended during pregnancy. Lactation. Growth retardation in childn & adolescents. Not recommended in childn & adolescents <18 yr.
Adverse Reactions
Pharyngitis, oral candidiasis; headache; dysphonia.
Drug Interactions
Reduced or abolished effect w/ β-blockers. Additive effect w/ theophylline or other β-adrenergic drugs. Increased risk of ventricular arrhythmias w/ quinidine, disopyramide, procainamide, phenothiazines, antihistamines, MAOIs, TCAs. Impaired cardiac tolerance w/ l-dopa, l-thyroxine, oxytocin & alcohol. Precipitated hypertensive reactions w/ 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. Potential interaction w/ disulfiram or metronidazole.
MIMS Class
Antiasthmatic & COPD Preparations
ATC Classification
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.
Foster MDI
120 actuation x 1's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in