Classes
DEA Class; Rx
Common Brand Names; Breztri
- COPD Agents;
- Respiratory Inhalant Combos;
- Corticosteroids, Inhalants;
- Beta2 Agonists
Description
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
Indications
Indicated for maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD)
Contraindications
Hypersensitivity
Adverse Effects
- 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%)
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
2 oral inhalations BID
Pediatric
Safety and efficacy not established