Indicated for:

Treatment of Asthma:

• The treatment of asthma in patients 6 years of age and older.

SYMBICORT should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta2-adrenergic agonist (LABA).

Maintenance Treatment of Chronic Obstructive Pulmonary Disease:

• The maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. SYMBICORT 160/4.5 is also indicated to reduce exacerbations of COPD. SYMBICORT 160/4.5 is the only strength indicated for the treatment of COPD.

Long-acting beta2-adrenergic agonists (LABA), such as formoterol, one of the active ingredients in SYMBICORT, increase the risk of asthma-related death. A placebo-controlled study with another LABA (salmeterol) showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including formoterol. Currently available data are inadequate to determine whether concurrent use of an inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA may increase the risk of asthma-related hospitalization in pediatric and adolescent patients.

When treating patients with asthma, prescribe SYMBICORT only for patients not adequately controlled on a long-term asthma-control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue SYMBICORT) if possible without loss of asthma control, and maintain the patient on a long- term asthma control medication, such as an inhaled corticosteroid. Do not use SYMBICORT for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids

Use of LABA as monotherapy (without ICS) for asthma is associated with an increased risk of asthma-related death.

Patients using SYMBICORT should not use additional LABA for any reason.

SYMBICORT is NOT indicated for the relief of acute bronchospasm.

SYMBICORT is contraindicated for primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures.

SYMBICORT should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma or COPD. SYMBICORT has not been studied in patients with acutely deteriorating asthma or COPD. The initiation of SYMBICORT in this setting is not appropriate.

Patients using SYMBICORT should not use an additional LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate) for any reason, including prevention of exercise-induced bronchospasm (EIB) or the treatment of asthma or COPD.

Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbations frequently overlap. Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids.

Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids.

Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids.

Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving SYMBICORT routinely (e.g., via stadiometry).

Glaucoma, increased intraocular pressure, and cataracts have been reported in patients with asthma and COPD following the long-term administration of inhaled corticosteroids, including budesonide, a component of SYMBICORT.

In clinical studies, the development of localized infections of the mouth and pharynx with Candida albicans has occurred in patients treated with SYMBICORT.

As with other inhaled medications, SYMBICORT can produce paradoxical bronchospasm, which may be life threatening.

Excessive beta-adrenergic stimulation has been associated with seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, palpitation, nausea, dizziness, fatigue, malaise, and insomnia.Therefore, SYMBICORT, like all products containing sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

In rare cases, patients on inhaled corticosteroids may present with systemic eosinophilic conditions. Some of these patients have clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition that is often treated with systemic corticosteroid therapy.

SYMBICORT, like all medications containing sympathomimetic amines, should be used with caution in patients with convulsive disorders or thyrotoxicosis and in those who are unusually responsive to sympathomimetic amines. Doses of the related beta2-adrenoceptor agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

Beta-adrenergic agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects.

Particular care is needed for patients who have been transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function. Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn.

Caution should be exercised when considering the coadministration of SYMBICORT with ketoconazole, and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin).

Beta-blockers (including eye drops) may not only block the pulmonary effect of beta-agonists, such as formoterol, a component of SYMBICORT, but may produce severe bronchospasm in patients with asthma. Therefore, patients with asthma should not normally be treated with beta-blockers.

SYMBICORT should be administered with caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of formoterol, a component of SYMBICORT, on the vascular system may be potentiated by these agents.

The ECG changes and/or hypokalemia that may result from the administration of non-potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded.

There are no adequate and well-controlled studies of SYMBICORT or one of its individual components, formoterol fumarate, in pregnant women; however studies are available for the other component budesonide. Animal studies: teratogenic, embryocidal, and reduced fetal weights.

Budesonide, like other corticosteroids, is secreted in human milk.

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• Use in patients under the age of 6. GoToSource

• Relief of acute bronchospasm. GoToSource

Life-threatening exacerbation of asthma symptoms. GoToSource

Thrush, infections, tremor and tachycardia (rapid heart rate). GoToSource

Increased risk of pneumonia when used for chronic obstructive pulmonary disease. GoToSource

Adrenal suppression and growth suppression. GoToSource

Loss of bone mineral density. GoToSource

Increased risk of asthma-related death. GoToSource

Hypertension (high blood pressure), angina (chest pain) and insomnia. GoToSource

Anaphylaxis (life-threatening allergic reaction), angioedema (swelling in deep layers of skin), arrhythmias, bronchospasm, hypokalemia (low blood potassium level) and hypotension (low blood pressure). GoToSource   

Glaucoma and cataracts. GoToSource

Lawsuits filed for death.