Before Using

Drug information provided by: Merative, Micromedex®

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Inhaled budesonide, glycopyrrolate, and formoterol combination is not indicated for use in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of inhaled budesonide, glycopyrrolate, and formoterol combination in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Bepridil
  • Cisapride
  • Desmopressin
  • Dronedarone
  • Levoketoconazole
  • Mesoridazine
  • Pimozide
  • Piperaquine
  • Potassium Citrate
  • Rotavirus Vaccine, Live
  • Saquinavir
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acebutolol
  • Aclidinium
  • Adagrasib
  • Alfuzosin
  • Amantadine
  • Amifampridine
  • Amineptine
  • Amiodarone
  • Amisulpride
  • Amitriptyline
  • Amitriptylinoxide
  • Amoxapine
  • Amphetamine
  • Amprenavir
  • Anagrelide
  • Apomorphine
  • Aprepitant
  • Aripiprazole
  • Aripiprazole Lauroxil
  • Arsenic Trioxide
  • Asenapine
  • Aspirin
  • Astemizole
  • Atazanavir
  • Atenolol
  • Atropine
  • Avacopan
  • Azithromycin
  • Balofloxacin
  • Bedaquiline
  • Belladonna
  • Bemetizide
  • Bemiparin
  • Bendroflumethiazide
  • Benzthiazide
  • Benztropine
  • Berotralstat
  • Besifloxacin
  • Betaxolol
  • Biperiden
  • Bisoprolol
  • Boceprevir
  • Brompheniramine
  • Bumetanide
  • Buprenorphine
  • Bupropion
  • Buserelin
  • Carbamazepine
  • Carbinoxamine
  • Carisoprodol
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Ceritinib
  • Chloroquine
  • Chlorothiazide
  • Chlorpheniramine
  • Chlorpromazine
  • Chlorthalidone
  • Cilostazol
  • Cimetidine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clemastine
  • Clidinium
  • Clofazimine
  • Clomipramine
  • Clopamide
  • Clothiapine
  • Clozapine
  • Cobicistat
  • Codeine
  • Conivaptan
  • Cosyntropin
  • Crizotinib
  • Cyclobenzaprine
  • Cyclopenthiazide
  • Cyclopentolate
  • Cyclosporine
  • Cyclothiazide
  • Cyproheptadine
  • Dabrafenib
  • Darifenacin
  • Darunavir
  • Dasatinib
  • Degarelix
  • Delamanid
  • Delavirdine
  • Desipramine
  • Deslorelin
  • Deutetrabenazine
  • Dexmedetomidine
  • Dextroamphetamine
  • Diazoxide
  • Dibenzepin
  • Dicyclomine
  • Diltiazem
  • Dimenhydrinate
  • Diphenhydramine
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Doxepin
  • Dronedarone
  • Droperidol
  • Duvelisib
  • Ebastine
  • Efavirenz
  • Encorafenib
  • Enoxacin
  • Entrectinib
  • Eribulin
  • Erythromycin
  • Escitalopram
  • Esmolol
  • Ethacrynic Acid
  • Etozolin
  • Etrasimod
  • Famotidine
  • Fedratinib
  • Felbamate
  • Fentanyl
  • Fesoterodine
  • Fexinidazole
  • Fingolimod
  • Flavoxate
  • Flecainide
  • Fleroxacin
  • Fluconazole
  • Flumequine
  • Fluoxetine
  • Fluphenazine
  • Fluvoxamine
  • Fosamprenavir
  • Fosaprepitant
  • Foscarnet
  • Fosnetupitant
  • Fosphenytoin
  • Fostemsavir
  • Furosemide
  • Galantamine
  • Gatifloxacin
  • Gemifloxacin
  • Gepirone
  • Givinostat
  • Glasdegib
  • Glucagon
  • Glycopyrronium Tosylate
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Histrelin
  • Homatropine
  • Hydrochlorothiazide
  • Hydroflumethiazide
  • Hydroquinidine
  • Hydroxychloroquine
  • Hydroxyzine
  • Hyoscyamine
  • Ibutilide
  • Idelalisib
  • Iloperidone
  • Imatinib
  • Imipramine
  • Indapamide
  • Indinavir
  • Inotuzumab Ozogamicin
  • Ipratropium
  • Isocarboxazid
  • Itraconazole
  • Ivabradine
  • Ivacaftor
  • Ivosidenib
  • Ketoconazole
  • Labetalol
  • Lapatinib
  • Larotrectinib
  • Lefamulin
  • Lenacapavir
  • Lenvatinib
  • Letermovir
  • LetibotulinumtoxinA-wlbg
  • Leuprolide
  • Levobunolol
  • Levofloxacin
  • Linezolid
  • Lisdexamfetamine
  • Lofepramine
  • Lofexidine
  • Lomefloxacin
  • Lomitapide
  • Lonafarnib
  • Lopinavir
  • Lorlatinib
  • Loxapine
  • Lumacaftor
  • Lumefantrine
  • Lutetium Lu 177 Dotatate
  • Macimorelin
  • Maribavir
  • Mavacamten
  • Meclizine
  • Mefloquine
  • Melitracen
  • Mepenzolate
  • Methacholine
  • Methadone
  • Methotrimeprazine
  • Methyclothiazide
  • Methylene Blue
  • Metipranolol
  • Metolazone
  • Metoprolol
  • Metronidazole
  • Mifepristone
  • Mirtazapine
  • Mizolastine
  • Mobocertinib
  • Moricizine
  • Moxifloxacin
  • Nadifloxacin
  • Nadolol
  • Nadroparin
  • Nafarelin
  • Nebivolol
  • Nefazodone
  • Nelfinavir
  • Netupitant
  • Nilotinib
  • Nirmatrelvir
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Olanzapine
  • Oliceridine
  • Olutasidenib
  • Omaveloxolone
  • Ondansetron
  • Opipramol
  • Orphenadrine
  • Osilodrostat
  • Osimertinib
  • Oxaliplatin
  • Oxitropium Bromide
  • Oxprenolol
  • Oxybutynin
  • Oxycodone
  • Ozanimod
  • Pacritinib
  • Palbociclib
  • Paliperidone
  • Panobinostat
  • Papaverine
  • Paritaprevir
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pazufloxacin
  • Pefloxacin
  • Penbutolol
  • Pentamidine
  • Perphenazine
  • Phenelzine
  • Phenobarbital
  • Pimavanserin
  • Pimozide
  • Pindolol
  • Pipamperone
  • Pipenzolate Bromide
  • Pirenzepine
  • Piretanide
  • Pirtobrutinib
  • Pitolisant
  • Polythiazide
  • Ponesimod
  • Posaconazole
  • Primidone
  • Probucol
  • Procainamide
  • Procarbazine
  • Prochlorperazine
  • Procyclidine
  • Promethazine
  • Propafenone
  • Propantheline
  • Propiverine
  • Propranolol
  • Protriptyline
  • Prulifloxacin
  • Quetiapine
  • Quinethazone
  • Quinidine
  • Quinine
  • Quizartinib
  • Ranitidine
  • Ranolazine
  • Rasagiline
  • Relugolix
  • Revefenacin
  • Ribociclib
  • Risperidone
  • Ritlecitinib
  • Ritonavir
  • Rufloxacin
  • Safinamide
  • Saquinavir
  • Sargramostim
  • Schisandra sphenanthera
  • Scopolamine
  • Secretin Human
  • Selegiline
  • Selpercatinib
  • Sertindole
  • Sertraline
  • Sevoflurane
  • Siponimod
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Somatrogon-ghla
  • Sorafenib
  • Sotalol
  • Sparfloxacin
  • Stramonium
  • Sufentanil
  • Sulpiride
  • Sultopride
  • Sunitinib
  • Tacrolimus
  • Tamoxifen
  • Tapentadol
  • Telaprevir
  • Telavancin
  • Telithromycin
  • Terodiline
  • Tetrabenazine
  • Thioridazine
  • Thiothixene
  • Tianeptine
  • Timolol
  • Tiotropium
  • Tizanidine
  • Tolterodine
  • Toremifene
  • Torsemide
  • Tosufloxacin
  • Tramadol
  • Tranylcypromine
  • Trazodone
  • Trichlormethiazide
  • Triclabendazole
  • Trifluoperazine
  • Trihexyphenidyl
  • Trimipramine
  • Triptorelin
  • Trofinetide
  • Troleandomycin
  • Tropicamide
  • Trospium
  • Tucatinib
  • Umeclidinium
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Venlafaxine
  • Verapamil
  • Vilanterol
  • Vinflunine
  • Voclosporin
  • Vonoprazan
  • Voriconazole
  • Vorinostat
  • Voxelotor
  • Xipamide
  • Zotepine
  • Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Auranofin
  • Erythromycin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergies (eg, arthritis, conjunctivitis, eczema, eosinophilia, rhinitis)—Use with caution. May cause these conditions to reappear in patients who have been previously treated with oral corticosteroids.
  • Asthma attack, acute or
  • Bronchospasm (difficulty with breathing), acute or
  • COPD flare-up—Should not be used in patients with these conditions.
  • Bladder problems or
  • Diabetes or
  • Enlarged prostate or
  • Glaucoma, narrow-angle or
  • Heart or blood vessel disease or
  • Heart rhythm problems (eg, arrhythmia) or
  • Hyperglycemia (high blood sugar) or
  • Hypertension (high blood pressure) or
  • Hypokalemia (low potassium in the blood) or
  • Ketoacidosis (high ketones in the blood) or
  • Osteoporosis, history of or
  • Seizures or
  • Thyroid problems (eg, thyrotoxicosis) or
  • Trouble urinating—Use with caution. May make these conditions worse.
  • Chickenpox (including recent exposure) or
  • Herpes simplex (virus) infection of the eye or
  • Infections (eg, virus, bacteria, or fungus) or
  • Measles (including recent exposure) or
  • Tuberculosis, active or history of—Can reduce the body's ability to fight off these infections.
  • Electrolyte imbalance or
  • Infection (eg, gastroenteritis) or
  • Stress or
  • Surgery or
  • Trauma—Use with caution. May increase risk for adrenal gland problems. Supplementary oral corticosteroids may be needed. Check with your doctor.
  • Kidney disease, severe (eg, end-stage kidney disease) or
  • Liver disease, severe—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.