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Breztri Aerosphere
budesonide/ glycopyrrolate/ formoterol inhaled
Adult Dosing .
Dosage forms: MDI: 160 mcg/9 mcg/4.8 mcg per actuation
COPD, maintenance tx
- [2 puffs inhaled bid]
- Max: 640 mcg/36 mcg/19.2 mcg/day; Info: search 'gold' for epocrates COPD GOLD 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 .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- asthma use
- COPD, acute deteriorating
- 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
- desmopressin
- pimozide
- thioridazine
Avoid/Use Alternative
- aclidinium inhaled
- albuterol
- amantadine
- arformoterol inhaled
- arsenic trioxide
- atropine ophthalmic
- bedaquiline
- botulinum toxin
- budesonide inhaled
- carvedilol
- chlophedianol
- chlorcyclizine
- cisapride
- cladribine oral
- clozapine
- cobicistat
- cocaine
- crizotinib
- cyclopentolate ophthalmic
- darifenacin
- darunavir
- desipramine
- dexbrompheniramine
- dexchlorpheniramine
- domperidone
- doxepin topical
- dronabinol
- dronedarone
- ephedra
- epinephrine
- epinephrine inhaled
- fesoterodine
- fexinidazole
- fluphenazine
- formoterol inhaled
- fosfomycin injection
- furosemide
- glucagon
- glycopyrrolate
- glycopyrronium topical
- hydroxychloroquine
- ipratropium nasal
- labetalol
- landiolol
- lefamulin
- lonafarnib
- lopinavir/ritonavir
- midodrine
- mobocertinib
- molindone
- nadolol
- natalizumab
- nebivolol
- olanzapine
- olodaterol inhaled
- oxybutynin
- phenelzine
- pimecrolimus topical
- pindolol
- pramlintide
- propranolol
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- quizartinib
- revefenacin inhaled
- ritonavir
- rivastigmine
- salmeterol inhaled
- sofpironium topical
- sotalol
- thiothixene
- timolol
- tolterodine
- toremifene
- trihexyphenidyl
- tropicamide ophthalmic
- trospium
- vandetanib
- vilanterol inhaled
- ziprasidone
Monitor/Modify Tx
- abiraterone acetate
- acebutolol
- acetazolamide
- adagrasib
- albuterol inhaled
- aliskiren
- almotriptan
- aloe
- amiloride
- aminophylline
- amiodarone
- amitriptyline
- amlodipine
- amoxapine
- amphetamine
- amphotericin
- anagrelide
- angiotensin II
- apalutamide
- apomorphine
- aprocitentan
- armodafinil
- artemether/lumefantrine
- asciminib
- asenapine
- asparaginase
- atenolol
- atogepant
- atomoxetine
- atropine
- axitinib
- azilsartan medoxomil
- azithromycin
- benazepril
- benzphetamine
- benztropine
- betamethasone
- betaxolol
- bevacizumab
- bismuth subsalicylate
- bisoprolol
- brigatinib
- budesonide
- bumetanide
- bupropion
- cabozantinib
- caffeine
- caffeine citrate
- candesartan cilexetil
- cannabis
- captopril
- carfilzomib
- celecoxib
- ceritinib
- cetuximab
- chloroquine
- chlorothiazide
- chlorthalidone
- cisplatin
- citalopram
- clarithromycin
- clevidipine
- clofazimine
- clomipramine
- clonidine
- copanlisib
- corticotropin
- cortisone
- cosyntropin
- cyclosporine
- danazol
- darbepoetin alfa
- decitabine
- deflazacort
- degarelix
- desflurane
- desvenlafaxine
- dexamethasone
- dexmedetomidine
- dexmedetomidine injection
- dexmethylphenidate
- dextroamphetamine
- dichlorphenamide
- diclofenac
- diclofenac topical
- dicyclomine
- diethylpropion
- diflunisal
- digoxin
- dihydroergotamine
- diltiazem
- dinutuximab
- disopyramide
- dobutamine
- dofetilide
- donepezil
- dopamine
- dordaviprone
- doxapram
- doxazosin
- doxepin
- droperidol
- droxidopa
- eletriptan
- emapalumab
- enalapril
- enalaprilat
- encorafenib
- ephedrine injection
- ephedrine oral
- epirubicin
- eplerenone
- epoetin alfa
- eptinezumab
- erenumab
- ergotamine
- eribulin
- erythromycin
- esketamine
- esmolol
- estetrol (contraceptive)
- estradiol (contraceptive)
- ethacrynic acid
- ethanol (alcoholic beverage)
- ethinyl estradiol (contraceptive)
- etodolac
- etrasimod
- everolimus
- felodipine
- fenfluramine
- fenoldopam
- fenoprofen
- fingolimod
- flecainide
- fludrocortisone
- fluorouracil
- flurbiprofen
- foscarnet
- fosinopril
- fostamatinib
- fremanezumab
- frovatriptan
- fruquintinib
- galcanezumab
- gilteritinib
- glasdegib
- goserelin
- guanfacine
- haloperidol
- histrelin
- hoodia
- hydralazine
- hydrochlorothiazide
- hydrocortisone
- hydroxocobalamin IV
- hydroxyzine
- hyoscyamine
- ibrutinib
- ibuprofen
- ibutilide
- imipramine
- indapamide
- indomethacin
- inotuzumab ozogamicin
- insulin
- irbesartan
- isocarboxazid
- isoflurane
- isoproterenol
- isradipine
- ivosidenib
- ketamine
- ketoprofen
- ketorolac
- lanreotide
- leflunomide
- lenalidomide
- lenvatinib
- leuprolide
- levalbuterol inhaled
- levofloxacin
- levoketoconazole
- levomilnacipran
- levothyroxine
- licorice
- lifileucel
- linezolid
- liothyronine
- liraglutide
- lisdexamfetamine
- lisinopril
- lofexidine
- lorlatinib
- losartan
- lumacaftor/ivacaftor
- luspatercept
- macimorelin
- magnesium citrate
- magnesium salicylate
- mannitol
- meclofenamate
- mefenamic acid
- meloxicam
- methacholine inhaled
- methadone
- methamphetamine
- methazolamide
- methoxy polyethylene glycol-epoetin beta
- methscopolamine
- methyldopa
- methylergonovine
- methylphenidate
- methylprednisolone
- methyltestosterone
- metoclopramide
- metolazone
- metoprolol
- metyrapone
- mifepristone
- milnacipran
- minoxidil
- mirabegron
- mitomycin
- modafinil
- moexipril
- motixafortide
- moxifloxacin
- nabumetone
- naproxen
- naratriptan
- naxitamab
- necitumumab
- nicardipine
- nifedipine
- nilotinib
- nimodipine
- niraparib
- nisoldipine
- norepinephrine
- nortriptyline
- obinutuzumab
- oliceridine
- olmesartan medoxomil
- ondansetron
- orphenadrine
- osilodrostat
- osimertinib
- oxaprozin
- oxymetazoline nasal
- oxytocin
- ozanimod
- pacritinib
- paliperidone
- palonosetron
- pamidronate
- panitumumab
- pasireotide
- pazopanib
- pentamidine
- perindopril
- pexidartinib
- phendimetrazine
- phenoxybenzamine
- phentermine
- phentolamine
- phenylephrine
- phenylephrine injection
- phenylephrine nasal
- phenylephrine ophthalmic
- phenylephrine rectal
- piroxicam
- polyethylene glycol
- polyethylene glycol/electrolytes
- ponatinib
- ponesimod
- posaconazole
- pralsetinib
- prazosin
- prednisolone
- prednisone
- procainamide
- procarbazine
- propafenone
- protriptyline
- pseudoephedrine
- quetiapine
- quinapril
- quinine
- ramipril
- ramucirumab
- rasagiline
- regorafenib
- revumenib
- ribociclib
- rimegepant
- ripretinib
- rizatriptan
- romidepsin
- ropinirole
- rotigotine transdermal
- rucaparib
- sacituzumab govitecan
- safinamide
- salsalate
- selegiline
- selegiline transdermal
- selinexor
- selpercatinib
- sevoflurane
- siponimod
- sirolimus albumin-bound
- sodium benzoate
- sodium phenylacetate
- sodium phenylbutyrate
- sodium polystyrene sulfonate
- sodium thiosulfate
- solriamfetol
- sorafenib
- spironolactone
- sulfate bowel prep
- sulindac
- sumatriptan
- sunitinib
- tacrolimus
- tafasitamab
- tagraxofusp
- taletrectinib
- telavancin
- telmisartan
- terazosin
- terbutaline
- teriflunomide
- testosterone
- tetrabenazine
- theophylline
- thyroid
- tivozanib
- tolmetin
- topiramate
- torsemide
- tramadol
- trametinib
- trandolapril
- tranylcypromine
- triamcinolone
- triamterene
- triclabendazole
- trifluridine
- trimipramine
- triptorelin
- ubrogepant
- vadadustat
- valsartan
- vamorolone
- vasopressin
- vemurafenib
- venlafaxine
- verapamil
- viloxazine
- voclosporin
- yohimbe
- zavegepant
- ziftomenib
- ziv-aflibercept
- zolmitriptan
- zonisamide
Caution Advised
- abatacept
- abemaciclib
- abrocitinib
- acalabrutinib
- aceclidine ophthalmic
- adalimumab
- afamitresgene autoleucel
- aldesleukin
- alemtuzumab
- alfentanil
- alosetron
- anakinra
- anifrolumab
- anti-thymocyte globulin
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- aripiprazole monthly injection
- aripiprazole oral
- atazanavir
- atidarsagene autotemcel
- avacopan
- axicabtagene ciloleucel
- azacitidine
- azathioprine
- baricitinib
- basiliximab
- beclomethasone inhaled
- beclomethasone nasal
- belatacept
- belimumab
- belinostat
- belladonna alkaloids
- bendamustine
- bethanechol
- bimekizumab
- blinatumomab
- bortezomib
- brentuximab vedotin
- brexpiprazole
- brexucabtagene autoleucel
- brodalumab
- brompheniramine
- budesonide nasal
- budesonide rectal
- buprenorphine
- busulfan
- butorphanol
- cabazitaxel
- canakinumab
- carbinoxamine
- carboplatin
- cariprazine
- carmustine
- certolizumab pegol
- cevimeline
- chlorambucil
- chloramphenicol
- chlorpheniramine
- chlorpromazine
- ciclesonide
- ciltacabtagene autoleucel
- cladribine injection
- clemastine
- clidinium
- clobetasol ophthalmic
- clofarabine
- codeine
- crovalimab
- cyclobenzaprine
- cyclophosphamide
- cyproheptadine
- cytarabine
- dactinomycin
- danicopan
- daratumumab
- daunorubicin
- delgocitinib topical
- deucravacitinib
- deuruxolitinib
- dexamethasone ophthalmic
- difenoxin
- difluprednate ophthalmic
- dihydrocodeine
- dimenhydrinate
- dimethyl fumarate
- diphenhydramine
- diphenoxylate
- diroximel fumarate
- docetaxel
- doxorubicin
- doxylamine
- dupilumab
- duvelisib
- eculizumab
- efgartigimod alfa
- elivaldogene autotemcel
- elotuzumab
- elranatamab
- epcoritamab
- etanercept
- etoposide
- etuvetidigene autotemcel
- fentanyl
- flavoxate
- floxuridine
- fludarabine
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluticasone furoate
- fluticasone propionate
- galantamine
- gemtuzumab ozogamicin
- gepotidacin
- glofitamab
- golimumab
- guselkumab
- homatropine
- hydrocodone
- hydrocortisone ophthalmic
- hydromorphone
- hydroxyurea
- ibritumomab tiuxetan
- icotrokinra
- idarubicin
- idecabtagene vicleucel
- idelalisib
- ifosfamide
- iloperidone
- inebilizumab
- infliximab
- ipratropium inhaled
- iptacopan
- irinotecan
- isatuximab
- itraconazole
- ixabepilone
- ixekizumab
- ketoconazole
- lebrikizumab
- levorphanol
- linvoseltamab
- lisocabtagene maraleucel
- lomustine
- loncastuximab tesirine
- loperamide
- loteprednol ophthalmic
- loxapine
- lumateperone
- lurasidone
- lymphocyte immune globulin, anti-thymocyte globulin
- meclizine
- melphalan
- meperidine
- mercaptopurine
- methotrexate
- milsaperidone
- mirikizumab
- mirtazapine
- mitoxantrone
- mogamulizumab
- momelotinib
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- morphine
- mosunetuzumab
- mycophenolate mofetil
- mycophenolic acid
- nalbuphine
- narsoplimab
- nefazodone
- nelarabine
- nelfinavir
- neostigmine
- nipocalimab
- obecabtagene autoleucel
- ocrelizumab
- ofatumumab
- oxaliplatin
- oxycodone
- oxymorphone
- paclitaxel
- pegcetacoplan
- pentazocine
- pentostatin
- perphenazine
- pheniramine
- pilocarpine
- pilocarpine ophthalmic
- pirtobrutinib
- polatuzumab vedotin
- pomalidomide
- pozelimab
- prednisolone ophthalmic
- prochlorperazine
- promethazine
- pyridostigmine
- pyrilamine
- ravulizumab
- relacorilant
- remifentanil
- rilonacept
- rilzabrutinib
- risankizumab
- risperidone
- ritlecitinib
- rituximab
- ropeginterferon alfa-2b
- rozanolixizumab
- ruxolitinib
- ruxolitinib topical
- sarilumab
- satralizumab
- scopolamine
- secukinumab
- sibeprenlimab
- siltuximab
- sirolimus
- solifenacin
- spesolimab
- sufentanil
- sulfasalazine
- sutimlimab
- talquetamab
- tapentadol
- tarlatamab
- teclistamab
- temozolomide
- temsirolimus
- teplizumab
- thioguanine
- thiotepa
- tildrakizumab
- tiotropium inhaled
- tipranavir
- tisagenlecleucel
- tocilizumab
- tofacitinib
- topotecan
- trabectedin
- tralokinumab
- trifluoperazine
- triprolidine
- tucatinib
- ublituximab
- umeclidinium inhaled
- upadacitinib
- ustekinumab
- vedolizumab
- venetoclax
- vibegron
- vilobelimab
- vinblastine
- vincristine
- vinorelbine
- voriconazole
- zanubrutinib
- zilucoplan
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)
Common Reactions
- URI
- pneumonia
- dysphonia
- muscle spasm
- back pain
- oral candidiasis
- influenza
- UTI
- cough
- sinusitis
- diarrhea
Safety/Monitoring .
Monitoring Parameters
BMD at baseline, then periodically; 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 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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