Fortra

Per actuation Budesonide 200 mcg, formoterol fumarate dihydrate 6 mcg

Treatment of asthma in patients ≥12 yr. Maintenance treatment of COPD including chronic bronchitis & emphysema.

Asthma Adult & adolescent ≥12 yr 2 inhalations bid (morning & evening, approx. 12 hr apart). COPD 2 inhalations bid.

Hypersensitivity. Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required.

Immediate hypersensitivity reactions (eg, urticaria, angioedema, rash, bronchospasm). Do not use for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids. Do not initiate in patients during rapidly deteriorating or potentially life-threatening episodes of asthma or COPD. Do not use for the relief of acute symptoms, ie, as rescue therapy for the treatment of acute episodes of bronchospasm. Discontinue regular use of oral or inhaled, short-acting β₂ agonists when beginning treatment. Clinically significant CV effects & fatalities w/ excessive use of inhaled sympathomimetic drugs. Do not use additional LABA (eg, salmeterol, formoterol fumarate, arformoterol tartrate) for any reason, including prevention of exercise-induced bronchospasm or the treatment of asthma or COPD. Candida albicans infection of the mouth & pharynx may occur; monitor periodically for signs of adverse effects on oral cavity. Advise patient to rinse mouth following inhalation. Monitor for signs & symptoms of pneumonia & other potential lungs infections. Patients w/ active or quiescent TB infections of the resp tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex; more serious or fatal course of chicken pox or measles. Taper slowly if transferring from systemic corticosteroids to inhaler. Discontinue slowly if hypercorticism & adrenal suppression (including adrenal crisis) occur. Discontinue & institute alternate therapy if paradoxical bronchospasm & upper airway symptoms occur. Patients w/ CV disorders especially coronary insufficiency, cardiac arrhythmias & HTN. Assess patients for bone mineral density initially & periodically thereafter. Monitor growth of ped patients receiving inhaler routinely; patients w/ change in vision or w/ history of increased IOP, glaucoma, &/or cataracts. May present systemic eosinophilic conditions & Churg-Strauss syndrome. Convulsive disorders or thyrotoxicosis, DM & ketoacidosis. May produce significant hypokalemia. Consider additional blood glucose controls in diabetic patients. Monitor patients w/ hepatic disease. Pregnancy & lactation. Adolescents 12-17 yr & childn <11 yr. Elderly.

Candida infection in the oropharynx, pneumonia (in COPD patients); headache, tremor; palpitations; mild irritation in the throat, coughing, dysphonia including hoarseness. Aggression, psychomotor hyperactivity, anxiety, sleep disorders; dizziness; blurred vision; tachycardia; nausea; bruises; muscle cramps.

Increase plasma levels of budesonide w/ ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone & HIV PIs. May not only block the pulmonary effect of β agonists, eg, formoterol but may produce severe bronchospasm in patients w/ asthma w/ β-blockers (including eye drops). Increase risk of ventricular arrhythmias & prolong QTC-interval w/ quinidine, disopyramide, procainamide, phenothiazines & TCAs. May impair cardiac tolerance towards β2 sympathomimetics w/ L-dopa, L-thyroxine, oxytocin & alcohol. Potentiated action of formoterol on the vascular system w/ MAOIs or TCAs, or w/in 2 wk of discontinuation of these agents. Elevated risk of arrhythmias in patients receiving concomitant anesth w/ halogenated hydrocarbons. Potentially additive bronchodilating effect w/ concomitant use of other β-adrenergic drugs or anticholinergic drugs. Hypokalemia may increase the disposition towards arrhythmias in patients treated w/ digitalis glycosides. β agonists can acutely worsened the ECG changes &/or hypokalemia that resulted from non-K-sparing diuretics (eg, loop or thiazide diuretics) administration.

Antiasthmatic & COPD Preparations

R03AK07 - formoterol and budesonide ; Belongs to the class of adrenergics in combination with corticosteroids or other drugs, excluding anticholinergics. Used in the treatment of obstructive airway diseases.

Rx