SYMBICORT Full Prescribing Information

Indications and Important Safety Information, including boxed WARNING

• SYMBICORT is indicated for the long-term maintenance treatment of asthma in patients 12 years and older
• SYMBICORT is NOT indicated for the relief of acute bronchospasm and should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma
• SYMBICORT is not indicated in patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of inhaled short-acting beta₂-agonists
• WARNING: Long-acting beta₂-adrenergic agonists may increase the risk of asthma-related death. SYMBICORT should only be used for patients with asthma not adequately controlled on other asthma-controller medications (eg, low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. Data from a large placebo-controlled US study that compared the safety of another long-acting beta₂-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a long-acting beta₂-adrenergic agonist), one of the active ingredients in SYMBICORT (see WARNINGS in full Prescribing Information)
• SYMBICORT does NOT replace fast-acting inhalers and should not be used to treat acute symptoms of asthma
• Particular care is needed for patients who are transferred from systemically active corticosteroids to inhaled corticosteroids. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids
• Patients who are receiving SYMBICORT should not use additional formoterol or other long-acting inhaled beta₂-agonists for any reason
• SYMBICORT should be used with caution in patients with cardiovascular disorders. Some patients may experience an increase in blood pressure or heart rate
• SYMBICORT, like all medications containing sympathomimetic amines, should be used with caution in patients with cardiovascular disorders (especially coronary insufficiency, cardiac arrhythmias, and hypertension), untreated hypokalemia, thyrotoxicosis, convulsive disorders, and in patients who are unusually responsive to sympathomimetic amines
• Long-term use of orally inhaled corticosteroids, such as budesonide, a component of SYMBICORT, may affect normal bone metabolism resulting in a loss of bone mineral density. In patients with major risk factors for decreased bone mineral content, such as tobacco use, advanced age, sedentary lifestyle, poor nutrition, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (eg, anticonvulsants and corticosteroids), orally inhaled corticosteroids may pose an additional risk
• Rare instances of glaucoma, increased intraocular pressure, and cataracts have been reported following the inhaled administration of corticosteroids, including budesonide, a component of SYMBICORT
• Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids, including budesonide, a component of SYMBICORT. In three placebo-controlled US clinical studies, the incidence of lower respiratory tract infections, including pneumonia, was low, with no consistent evidence of increased risk with SYMBICORT, compared to placebo
• SYMBICORT should be administered with caution to patients being treated with MAO inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents
• The most common adverse events ≥5% reported in clinical trials included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, and stomach discomfort

Please see full Prescribing Information, including boxed WARNING.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

  This product information is intended for US health care professionals only.

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