Foster

Beclometasone dipropionate 100 mcg, formoterol fumarate dihydrate 6 mcg

Asthma in patients not adequately controlled w/ inhaled corticosteroids & 'as needed' inhaled rapid-acting β₂-agonist or patients already adequately controlled on both inhaled corticosteroids & long-acting β₂-agonists. Symptomatic treatment of severe COPD (FEV₁ <50% predicted normal) & history of repeated exacerbations w/ significant symptoms despite regular therapy w/ long-acting bronchodilators.

Asthma Individualized dosage. Adult ≥18 yr 1 or 2 inhalations bid. Max: 4 inhalations daily. Maintenance: 1 inhalation bid (morning & evening). If needed, 1 additional inhalation may be taken. Max: 8 inhalations. COPD 2 inhalations bid.

Hypersensitivity.

Monitor patients w/ cardiac arrhythmias especially 3rd-degree AV-block & tachyarrhythmias (accelerated &/or irregular heartbeat), 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 QTc interval prolongation (>0.44 sec); thyrotoxicosis, DM, pheochromocytoma, untreated hypokalemia; active or quiescent pulmonary TB, fungal & viral airway infections. Severe or unstable asthma; serious asthma-related adverse effects & exacerbations. Medically assess patients w/ sudden & progressive deterioration in control of asthma or COPD. Monitor K & glucose levels. Do not administer for at least 12 hr before halogenated anesth. Use the lowest effective dose. Systemic effects may occur at high doses for longer periods. Avoid abrupt w/drawal. Caution in pregnancy & lactation. Childn & adolescents <18 yr.

Pharyngitis, oral candidiasis; headache; dysphonia. Reduction of blood cortisol & atrial fibrillation; paradoxical bronchospasm. Rash, urticaria, pruritus & erythema, & edema of the eyes, face, lips & throat. Formoterol: Hypokalaemia, headache, tremor, palpitations, cough, muscle spasms & prolongation of QTc interval. Beclometasone dipropionate: Oral fungal infections, oral candidiasis, dysphonia, throat irritation. Adrenal suppression, decrease in bone mineral density, growth retardation in childn & adolescents, cataract & glaucoma.

Prolonged QTc interval & increased risk of ventricular arrhythmias w/ quinidine, disopyramide, procainamide, phenothiazines, antihistamines, MAOIs, TCAs. Precipitate hypertensive reactions w/ MAOIs including agents w/ similar properties eg, furazolidone & procarbazine. Increased risk of arrhythmias in anesth w/ halogenated hydrocarbons. Concomitant use w/ disulfiram or metronidazole. Additive effects w/ theophylline or other β-adrenergic drugs. May impair cardiac tolerance w/ L-dopa, L-thyroxine, oxytocin & alcohol. May potentiate possible hypokalemic effect w/ xanthine derivatives, steroids or diuretics & increased disposition towards arrhythmias w/ digitalis glycosides. Formoterol: Reduced effect w/ β-blockers (including eye drops).

Antiasthmatic & COPD Preparations

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.

Rx