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Breztri Aerosphere
budesonide/ glycopyrrolate/ formoterol inhaled
Adult Dosing .
Dosage forms: MDI: 160 mcg/9 mcg/4.8 mcg per actuation; 160 mcg/18 mcg/4.8 mcg per actuation
COPD, maintenance tx
- [2 puffs (160 mcg/9 mcg/4.8 mcg per actuation) inhaled bid]
- Max: 640 mcg/36 mcg/19.2 mcg/day; Info: search 'gold' for epocrates COPD GOLD decision tools
asthma, maintenance tx
- [2 puffs (160 mcg/18 mcg/4.8 mcg per actuation) inhaled bid]
- Max: 640 mcg/72 mcg/19.2 mcg/day; Info: search 'asthma' for epocrates Asthma Long-Term Management NIH/NHLBI decision tools
renal dosing
- [see below]
- renal impairment: not defined; Info: caution advised if CrCl <30
- HD/PD: not defined, caution advised
hepatic dosing
- [see below]
- mild-moderate impairment: not defined; severe impairment: not defined, caution advised
Peds Dosing .
- Dosage forms: MDI: 160 mcg/18 mcg/4.8 mcg per actuation
asthma, maintenance tx
- [12 yo and older]
- Dose: 2 puffs (160 mcg/18 mcg/4.8 mcg per actuation) inhaled bid; Max: 640 mcg/72 mcg/19.2 mcg/day; Info: search 'asthma' for epocrates Asthma Long-Term Management NIH/NHLBI decision tools
renal dosing
- [see below]
- renal impairment: not defined; Info: caution advised if CrCl <30
- HD/PD: not defined, caution advised
hepatic dosing
- [see below]
- mild-moderate impairment: not defined; severe impairment: not defined, caution advised
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- status asthmaticus
- COPD, acute deteriorating
- asthma, acute
- bronchospasm, acute
- caution: hypersensitivity to corticosteroids
- caution: hepatic impairment, severe
- caution: CrCl <30
- caution: MAO inhibitor use within 14 days
- caution: TCA use within 14 days
- caution: long-term systemic corticosteroid use, recent
- caution: immunosuppressed patients
- caution: infection, active
- caution: TB infection, active
- caution: TB infection, latent
- caution: measles exposure
- caution: varicella exposure
- caution: osteoporosis
- caution: osteoporosis risk
- caution: cataract
- caution: glaucoma, angle-closure
- caution: glaucoma risk
- caution: ocular HSV
- caution: urinary retention risk
- caution: prostatic hypertrophy
- caution: bladder neck obstruction
- caution: electrolyte abnormalities
- caution: long QT syndrome, congenital
- caution: QT prolongation
- caution: QT prolongation family history
- caution: torsades de pointes history
- caution: arrhythmia
- caution: bradycardia
- caution: MI, recent
- caution: CHF
- caution: cardiovascular disease
- caution: patients unusually responsive to sympathomimetic amines
- caution: diabetes mellitus
- caution: seizure disorder
- caution: ketoacidosis
- caution: hyperthyroidism
- caution: labor and delivery
Drug Interactions .
Overview
budesonide inhaled
corticosteroid inhaled
- CYP3A4 substrate
- immunomodulatory effects
- interferes w/ ACTH analog test
formoterol inhaled
beta-2 agonist
- hypertensive effects
- hypokalemia
- prolongs QT interval (conditional)
- tachycardia
glycopyrrolate inhaled
anticholinergic inhaled
- anticholinergic effects
Contraindicated
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction
- anaphylaxis
- bronchospasm, paradoxical
- eosinophilia
- Churg-Strauss syndrome
- HTN
- angina
- arrhythmia
- hypokalemia
- hyperglycemia
- adrenal suppression (long-term use)
- hypercorticism (long-term use)
- immunosuppression (long-term use)
- glaucoma, acute angle-closure
- glaucoma (long-term use)
- cataracts (long-term use)
- osteoporosis (long-term use)
- growth suppression (long-term use in peds patients)
Common Reactions
- URI
- pneumonia
- dysphonia
- muscle spasm
- back pain
- oral candidiasis
- influenza
- UTI
- cough
- sinusitis
- diarrhea
- headache
Safety/Monitoring .
Monitoring Parameters
BMD at baseline, then periodically; height in children/adolescents; oral cavity exam periodically; consider ophthalmic exam if long-term use, change in vision, IOP/glaucoma/cataracts history
Pregnancy/Lactation .
Pregnancy
Clinical Summary
budesonide inhaled: may use during pregnancy; drug of choice for asthma use during pregnancy; risk of teratogenicity low based on human data
glycopyrrolate inhaled: weigh risk/benefit during pregnancy; no human data available, though risk of fetal harm not expected based on limited human data with oral form; no known risk of teratogenicity based on animal data at 135-270x MRHD
formoterol inhaled: weigh risk/benefit during pregnancy, especially during labor and delivery; inadequate human data available; risk of fetal harm low, though possible risk of delayed ossification based on animal data at 50x MRHD; risk of interference with uterine contractility based on drug's mechanism of action
Lactation
Clinical Summary
budesonide inhaled: may use while breastfeeding; no known risk of infant harm based on human data and minimal drug excretion into milk; no human data available to assess effects on milk production
glycopyrrolate inhaled: may use while breastfeeding; no human data available, though risk of infant harm not expected based on minimal systemic absorption in breastfeeding patients and drug properties; no human data available to assess effects on milk production
formoterol inhaled: may use while breastfeeding; no human data available, though risk of infant harm not expected based on minimal systemic absorption in breastfeeding patients; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for budesonide: liver extensively; CYP450: 3A4 substrate; for glycopyrrolate: minimal; CYP450: 2D6 substrate; for formoterol: liver extensively; CYP450: 2A6, 2C9/19, 2D6 substrate; UGT: 1A1, 1A8, 1A9, 2B7, 2B15 substrate; Info: minimal systemic absorption
Excretion: for budesonide: urine 60% (none unchanged), feces; Half-life: 5h; for glycopyrrolate: urine 85%, bile; Half-life: 15h; for formoterol: urine 62%, feces 24%; Half-life: 10h
Subclass: Beta-2 Agonists, Inhaled Long-Acting (LABAs) ; Corticosteroids, Inhaled ; Muscarinic Antagonists, Inhaled Long-Acting (LAMAs)
Mechanism of Action
for budesonide: exact mechanism of anti-inflammatory action unknown; inhibits multiple inflammatory cytokines; produces multiple glucocorticoid and mineralocorticoid effects; for glycopyrrolate: antagonizes acetylcholine receptors, producing bronchodilation; for formoterol: selectively stimulates beta-2 adrenergic receptors, relaxing airway smooth muscle
Formulary .
No Formulary Selected
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