BREZTRI

BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE

Manufacturer: AstraZeneca Pharmaceuticals LP

Score: 141.0

Quick Summary

BREZTRI AEROSPHERE is a combination inhalation aerosol used for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). It contains budesonide, an inhaled corticosteroid, glycopyrrolate, an anticholinergic, and formoterol fumarate, a long-acting beta2-adrenergic agonist. The recommended dosage is 2 inhalations of BREZTRI AEROSPHERE 160 mcg/9 mcg/4.8 mcg twice daily. Important safety information includes warnings about serious asthma-related events, oropharyngeal candidiasis, increased risk of pneumonia, and hypersensitivity reactions. Contraindications include hypersensitivity to budesonide, glycopyrrolate, or formoterol fumarate.

Key Clinical Findings and Indications

Maintenance treatment of COPD
Combination of budesonide, glycopyrrolate, and formoterol fumarate
Not indicated for relief of acute bronchospasm or treatment of asthma

Important Safety Information

Warning

Serious asthma-related events, oropharyngeal candidiasis, and increased risk of pneumonia

Contraindications

Hypersensitivity to budesonide, glycopyrrolate, or formoterol fumarate

Adverse Reactions

Upper respiratory tract infection
Pneumonia
Back pain
Oral candidiasis
Influenza
Muscle spasms
Urinary tract infection
Cough
Sinusitis
Diarrhea

Dosing Recommendations

General Guidance

No dose adjustment is necessary for geriatric patients

COPD

Adult Dose

2 inhalations of BREZTRI AEROSPHERE 160 mcg/9 mcg/4.8 mcg twice daily

Pediatric Dose

Not indicated for use in children

Special Population Considerations

Pregnancy

There are no adequate and well-controlled studies with BREZTRI AEROSPHERE in pregnant women
Use with caution and only if the benefits clearly outweigh the risks

Nursing Mothers

It is not known whether budesonide, glycopyrrolate, or formoterol fumarate are excreted in human milk

Pediatric Use

Not indicated for use in children
Safety and effectiveness have not been established

Geriatric Use

No overall differences in safety or effectiveness were observed between geriatric and younger subjects
Greater sensitivity in some older individuals cannot be ruled out

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