Transcription of BREZTRI Full Prescribing Information
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BREZTRI Full Prescribing Information
HIGHLIGHTS OF Prescribing INFORMATIONT hese highlights do not include all the Information needed to use BREZTRI AEROSPHERE safely and effectively. See full Prescribing Information for BREZTRI AEROSPHERE (budesonide, glycopyrrolate, and formoterol fumarate) inhalation aerosol, for oral inhalation use Initial Approval: 2020------------------------------- INDICATIONS AND USAGE ------------------------------- BREZTRI AEROSPHERE is a combination of budesonide, an inhaled corticosteroid (ICS); glycopyrrolate, an anticholinergic; and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA), indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). (1)Limitations of Use: Not indicated for the relief of acute bronchospasm or for the treatment of asthma.
patient’s inhaled, short-acting beta. 2-agonist becomes less effective or the patient needs more inhalations of short-acting beta. 2-agonist than usual, these may be markers of deterioration of disease. In this setting, re-evaluate the patient and the COPD treatment regimen at once. The daily dosage of BREZTRI AEROSPHERE
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