Trade Names:Symbicort 80/4.5- Inhalation aerosol budesonide 80 mcg and formoterol 4.5 mcg/actuation
Trade Names:Symbicort 160/4.5- Inhalation aerosol budesonide 160 mcg and formoterol 4.5 mcg/actuation
Budesonide is an anti-inflammatory corticosteroid that exhibits potent glucocorticoid activity and weak mineralocorticoid activity.
Formoterol fumarate is a long-acting selective beta-2 adrenergic agonist (beta-2 agonist) with a rapid onset of action. Inhaled formoterol fumarate acts locally in the lung as a bronchodilator.
Long-term maintenance treatment of asthma; maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema.
Primary treatment of status asthmaticus or other acute episodes of asthma in which intensive measures are required; hypersensitivity to any component of the product.
Oral Inhalation Recommended starting dose is 2 inhalations of budesonide/formoterol (80/4.5 or 160/4.5) twice daily approximately 12 h apart, depending upon asthma severity.COPDAdults
Oral Inhalation Recommended dose is 2 inhalations of budesonide 160 mcg/formoterol 4.5 mcg twice daily. If shortness of breath occurs between doses, an inhaled short-acting beta-2 agonist should be taken for immediate relief.
Store at 68° to 77°F. Store with the mouthpiece down.
If possible, avoid coadministration because beta-blockers may block the pulmonary effect of formoterol, in addition to producing severe bronchospasm in asthmatic patients.Inhibitors of CYP3A4 (eg, ketoconazole)
Use with caution because budesonide plasma levels may be increased.Loop diuretics (eg, furosemide), thiazide diuretics (eg, hydrochlorothiazide)
ECG changes and/or hypokalemia resulting from non–potassium-sparing diuretics can be worsened by formoterol.MAOIs (eg, phenelzine), tricyclic antidepressants (eg, amitriptyline)
Use with caution in patients treated with MAOIs or tricyclic antidepressants, or within 2 wk of discontinuing these agents, because action of formoterol on the vascular system may be potentiated.Salmeterol
Do not use in combination.
None well documented.
Angina pectoris, atrial fibrillation, atrial and ventricular tachyarrhythmias, extrasystoles, hypertension, hypotension, palpitations, tachycardia (postmarketing).
Headache (11%); agitation, behavior disturbances, depression, dizziness, nervousness, restlessness, sleep disturbances, tremor (postmarketing).
Nasopharyngitis (11%); pharyngolaryngeal pain (9%); nasal congestion (3%); cataract, glaucoma, IOP (postmarketing).
Stomach discomfort (7%); oral candidiasis (6%); vomiting (3%); nausea, oropharyngeal candidiasis (postmarketing).
Growth velocity reduction in children, hypercorticism (postmarketing).
Delayed and immediate hypersensitivity reactions, including anaphylactic reaction, angioedema, bronchospasm, dermatitis, exanthema, pruritus, and urticaria (postmarketing).
Hyperglycemia, hypokalemia (postmarketing).
Back pain (3%); muscle cramps (postmarketing).
Upper respiratory tract infection (11%); sinusitis (6%); bronchitis (5%); cough, dysphonia, throat irritation (postmarketing).
Long-acting beta-2 adrenergic agonists, such as formoterol, may increase the risk of asthma-related death. Therefore, only use for patients not adequately managed on other asthma-controller medications or whose disease severity warrants treatment with 2 maintenance agents.
Monitor for increasing use of inhaled short-acting beta-2 agonist, which may indicate deterioration of asthma.
Observe patients for evidence of systemic corticosteroid effects. Closely monitor patients with a change in vision or with a history of increased IOP, glaucoma, and/or cataracts. Closely monitor use in patients with hepatic disease.
Category C .
Safety and efficacy not established in asthmatic children younger than 12 yr of age. May cause reduction in growth velocity when administered to children.
Use with caution in elderly patients who have concomitant CV disease that could be adversely affected by beta-2 agonists.
Immediate hypersensitivity reactions, such as urticaria, angioedema, rash, and bronchospasm, may occur.
Use with caution and closely monitor patients.
Use with caution in patients with CV disorders, especially coronary insufficiency, cardiac arrhythmias, hypertension, convulsive disorders, untreated hypokalemia, thyrotoxicosis, active or quiescent tuberculosis of the respiratory tract, untreated systemic fungal, bacterial, viral, or parasitic infection, or ocular herpes simplex, and in patients taking daily or alternate-day steroid therapy because of increased likelihood of hypothalmic-pituitary axis suppression.
Not indicated for the relief of acute bronchospasm.
Adrenal suppression (including adrenal crisis) and hypercorticism may appear in a small number of patients.
Do not initiate treatment in patients during rapidly deteriorating or potentially life-threatening episodes of asthma or COPD. Do not use as rescue treatment of acute episodes of bronchospasm.
In rare cases, systemic eosinophilic conditions may occur in patients receiving inhaled corticosteroids.
CV effects and fatalities have been reported with excessive use of inhaled sympathomimetic agents.
Changes in blood glucose and/or serum potassium may occur.
Patients receiving immunosuppressive agents are more susceptible to infections than healthy individuals. If patient is exposed to measles or chickenpox, appropriate prophylaxis and treatment may be warranted.
Lower respiratory tract infections, including pneumonia, have been reported following inhaled administration of corticosteroids. Localized Candida albicans infections occurred in the mouth and pharynx.
Long-term use of orally inhaled corticosteroids may affect normal bone metabolism, resulting in loss of bone mineral density.
Glaucoma, increased IOP, and cataracts have been reported with following the long-term use of corticosteroids, including budesonide.
Life-threatening paradoxical bronchospasm may occur.
Transferring patients from systemic corticosteroid therapy to inhaled corticosteroids may unmask conditions previously suppressed by systemic corticosteroid therapy (eg, arthritis, eczema). Budesonide/formoterol should not be used for transferring patients from systemic corticosteroids.
Adrenal suppression, hypercorticism.Formoterol
Angina, arrhythmias, cardiac arrest, death, dizziness, dry mouth, fatigue, headache, hyperglycemia, hypertension, hypokalemia, hypotension, insomnia, malaise, metabolic acidosis, muscle cramps, nausea, nervousness, palpitation, prolonged QTc interval, seizures, tachycardia, tremor, vomiting.
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