Product Description.:
Important Safety Information, including boxed warning
* 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 is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms
* 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
* Caution should be exercised when considering the coadministration of Symbicort with long-term ketoconazole and other known potent CYP3A4 inhibitors
* Excessive beta-adrenergic stimulation has been associated with central nervous system and cardiovascular effects. Symbicort, like all products containing sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension
* 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
* Glaucoma, increased intraocular pressure, and cataracts have been reported following the inhaled administration of corticosteroids, including budesonide, a component of Symbicort
* 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
Additional Information Specific to Asthma
* The most common adverse events ��% reported in clinical trials included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, and stomach discomfort
Additional Information Specific to COPD
* For patients with COPD, the approved dosage of Symbicort is 160/4.5 mcg, 2 inhalations twice daily
* The most common adverse events ��% reported in COPD clinical trials included nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection
* Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids
o In 2 placebo-controlled Symbicort COPD clinical studies, pneumonia did not occur with greater incidence in the Symbicort 160/4.5 group, compared with placebo, while the incidence of lung infections other than pneumonia (eg, bronchitis) was higher for Symbicort than placebo
Indications
* SYMBICORT is indicated for the long-term maintenance treatment of asthma in patients 12 years and older
* SYMBICORT 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
* 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
* SYMBICORT is NOT indicated for the relief of acute bronchospasm
