Transcription of SYMBICORT Prescribing Information
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SYMBICORT Prescribing Information
HIGHLIGHTS OF Prescribing INFORMATIONT hese highlights do not include all the Information needed to use SYMBICORT safely and effectively. See full Prescribing Information for (budesonide and formoterol fumarate dihydrate)Inhalation Aerosol, for oral inhalation useInitial Approval: 2006------------------------------------ ---- INDICATIONS AND USAGE ---------------------------------------- SYMBICORT is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for: Treatment of asthma in patients 6 years of age and older. ( ) Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. ( )Important limitations: Not indicated for the relief of acute bronchospasm.
Candida albicans. infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk. (5.4) • Pneumonia: Increased risk in patients with COPD.
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