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Budesonide inhaled/Formoterol/Glycopyrrolate Inhaled

    DEA Class;  Rx

    Common Brand Names; Breztri

    •  COPD Agents; 
    • Respiratory Inhalant Combos; 
    • Corticosteroids, Inhalants; 
    • Beta2 Agonists

    Budesonide: Anti-inflammatory corticosteroid; has potent glucocorticoid activity and weak mineralocorticoid activity

    Formoterol: Long-acting selective beta-2 agonist with rapid onset of action; acts locally as bronchodilator; stimulates intracellular adenyl cyclase, which results in increased cyclic adenosine monophosphate levels, causing relaxation of bronchial smooth muscle and inhibition of release of mast cell mediators

    Glycopyrrolate: Long-acting muscarinic antagonist; often referred to as an anticholinergic; produces bronchodilation by inhibiting acetylcholine’s effect on muscarinic receptors in the airway smooth muscle

    Indicated for maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD)


    • Cough (4%)
    • Urinary tract infection (2.6%)
    • Arthralgia (<2%)
    • Chest pain (<2%)
    • Tooth abscess (<2%)
    • Muscle spasms (<2%)
    • Headache (<2%)
    • Oropharyngeal pain (<2%)
    • Vomiting (<2%)
    • Pain in extremity (<2%)
    • Dizziness (<2%)
    • Anxiety (<2%)
    • Dry mouth (<2%)
    • Fall (<2%)
    • Influenza (<2%)
    • Fatigue (<2%)
    • Acute sinusitis (<2%)
    • Contusion (<2%)

    Safety and efficacy not established for asthma; use of long-acting beta2-adrenergic agonists (LABAs) as monotherapy (ie, without inhaled corticosteroids) for asthma is associated with increased risk asthma-related death; data do not suggest an increased risk of death with LABAs in patients with COPD

    Do not initiate in patients with acutely deteriorating COPD, which may be a life-threatening condition; use only for maintenance and not as a rescue therapy

    Patients who have been taking inhaled, short-acting beta2 agonists on a regular basis should discontinue these drugs when budesonide/formoterol/glycopyrrolate inhaled is initiated

    Excess use or use with other long-acting beta2 agonists may result in overdose, clinically significant cardiovascular effects, and fatalities

    Data are not available for glycopyrrolate or formoterol fumarate in pregnant women; however, studies are available for budesonide

    Data are not available for glycopyrrolate or formoterol fumarate in lactating women; however, studies are available for budesonide


    2 oral inhalations BID


    Safety and efficacy not established


    Inhalation aerosol

    • 160mcg/9mcg/4.8mcg per inhalation