Budesonide – glycopyrrolate - formoterol is a combination of three medications. Together they are used to reduce the symptoms of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Budesonide belongs to a group of medications known as corticosteroids. Corticosteroids reduce inflammation in the lungs and help reduce the swelling and irritation in the walls of the small air passages in the lungs. This helps keep the airways open and improve breathing. Glycopyrrolate is a long-acting muscarinic antagonist (LAMA). Formoterol is a long-acting beta2-agonist (LABA). These medications work in different ways to open the airways, making it easier to breathe. 

Budesonide - glycopyrrolate - formoterol should not be used as a rescue medication to relieve sudden attacks of COPD symptoms such as wheezing or shortness of breath. Consult your doctor or pharmacist for advice about rescue medications that are appropriate for you.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The recommended dose of budesonide - glycopyrrolate - formoterol is two inhalations taken twice daily. Try to use the inhaler at the same time every day to get the most benefit from it and to help you remember to use it.

Have your doctor or pharmacist explain how to use the inhaler and read the instructions carefully before using the inhaler. If you have any questions about how to use the inhaler, check with your health care professional.

After inhaling the dose of medication, rinse your mouth with water and spit it out. This reduces the chances of developing thrush.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Leave the inhaler in the sealed foil pouch until you are ready to begin using it. Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Each actuation of the inhaler device delivers 160 µg of budesonide, 9.0 µg of glycopyrronium bromide, equivalent to 7.2 µg of glycopyrronium, and 5.0 µg of formoterol fumarate dihydrate, equivalent to 4.8 µg of formoterol fumarate. Nonmedicinal ingredients: hydrofluoroalkane (HFA-134a) and porous particles (comprised of 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) and calcium chloride) that form a co-suspension with the drug crystals.

Do not take this medication if you are allergic to budesonide-glycopyrrolate-formoterol or any ingredients of the medication.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• agitation
• anxiety
• cough
• dizziness
• dry mouth
• headache
• hoarseness
• muscle spasms
• nausea
• nervousness
• restlessness
• throat irritation
• tremors
• trouble sleeping

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• changes in behaviour
• chest pain
• fast, slow, pounding, or fluttering heartbeat
• inability to pass urine or empty bladder
• increased bruising
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• symptoms of cataracts (e.g., clouding of the lens of the eye, blurred vision, dim vision, eye pain)
• symptoms of decreased adrenal function (e.g., tiredness, weakness, nausea and vomiting, low blood pressure)
• symptoms of glaucoma (e.g., blurred vision, seeing halos of bright colours around lights, red eyes, increased pressure in your eyes, eye pain or discomfort)
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• symptoms of pneumonia (e.g., fever, chills, shortness of breath, cough)
• symptoms of a urinary tract infection (e.g., pain or burning when urinating, frequent urination, blood in the urine, strong smelling or cloudy urine)
• thrush (yeast infection in the mouth; e.g., white patches in the mouth, tongue, or throat, sore throat)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• sudden difficulty breathing, wheezing or coughing, especially after using the inhaler
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• symptoms of too much medication (e.g., blurred vision, dry mouth, nausea, muscle spasms, tremor, headache, increased heart rate and blood pressure)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Adrenal gland problems: Adrenal glands produce chemical messengers that are responsible for the normal function of the body's organs, including how your body responds to injury or stress. When corticosteroids such as budesonide are used at high doses or for long periods of time, it may cause your adrenal gland to function improperly. Your doctor may monitor your adrenal gland condition especially if you have experienced stress such as surgery, injury, or severe infection.

Asthma-related death: The safety and effectiveness of using this medication to treat asthma symptoms have not been determined. Studies have shown an increase in deaths caused by severe asthma symptoms when LABA medications have been used without a corticosteroid. This medication should not be used by people with asthma.

Diabetes: Budesonide - glycopyrrolate - formoterol may cause an increase in blood sugar levels and glucose tolerance may change. If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

Driving: Budesonide - glycopyrrolate - formoterol may cause blurred vision or headaches, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how this medication affects you.

Eye problems: Budesonide may increase the risk of developing cataracts or glaucoma. Glycopyrrolate may cause symptoms of glaucoma (increased pressure in the eyes), such as blurred vision or eye pain or pressure to become worse. If you have glaucoma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart conditions: Formoterol and glycopyrrolate can cause an increase in blood pressure or heart rate as well as changes to the heart rhythm. If you have any heart conditions, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart rhythm: Beta-2 agonists, such as formoterol, can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., people with heart failure, angina, low potassium or magnesium levels), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Infections: This medication, like other medications that contain corticosteroids, may prevent the early signs of a serious infection from being noticed. Try to limit the amount of time you spend around others who have recently had infections such as chickenpox or measles. If you do come into contact with someone who has one of these infections, contact your doctor for advice.

Speak to your doctor or pharmacist about the importance of receiving an annual influenza vaccination.

Inhalation-induced bronchospasm: Inhaled forms of medications may cause spasms of the airways, which make breathing difficult. If you experience this problem when using budesonide - glycopyrrolate - formoterol stop using this medication immediately. Speak to your doctor if you experience any problems with breathing while taking this or any other inhaled medication.

Kidney function: Kidney disease or decreased kidney function may cause glycopyrrolate to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause budesonide to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Oral hygiene: Budesonide may cause a thrush infection in the mouth and throat. Adequate oral hygiene is very important in minimizing the overgrowth of microorganisms such as candidiasis (thrush). To reduce the risk of infection, gargle with water after each use of this medication.

Osteoporosis: Long-term use of medications like budesonide may increase your risk of developing osteoporosis. If you have osteoporosis or are at risk for developing osteoporosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pneumonia: People using budesonide - glycopyrrolate - formoterol to treat COPD may be at an increased risk of developing pneumonia. If you experience symptoms of pneumonia, such as fever, chills, shortness of breath, cough, or chest pain, get medical attention as soon as possible.

Thyroid disease: This medication may increase the symptoms of an overactive thyroid gland. If you have a history of thyroid disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Urinary tract problems: This medication can cause the symptoms of some urinary tract problems to become worse. If you have an enlarged prostate or other condition that causes urination to be difficult, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Worsening symptoms: If you find you need to use your short-acting ("rescue") inhaler more often or if your condition seems to worsen, call your doctor. It is very important that you have your "rescue" medication with you at all times. If you have not been given instructions beforehand, contact your doctor immediately about what to do if any of the following situations occur (they may be signs of seriously worsening COPD):

• decreased effectiveness of short-acting, inhaled bronchodilators such as salbutamol, or terbutaline, (less than 4 hours of relief)
• need for more inhalations than usual of short-acting, inhaled bronchodilators

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately. 

Breast-feeding: Budesonide passes into breast milk in small amounts. It is not known whether glycopyrrolate or formoterol pass into breast milk. If you are a breast-feeding mother and are using this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children or people under the age of 18.

There may be an interaction between budesonide – glycopyrrolate – formoterol and any of the following:

• acetylcholinesterase inhibitors (e.g., donepezil, galantamine, rivastigmine)
• aclidinium
• aldesleukin
• amantadine
• amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
• fast acting bronchodilators (e.g., salbutamol, indacaterol, terbutaline)
• long acting bronchodilators (e.g., formoterol, olodaterol, salmeterol)
• antiarrhythmic medications (e.g., amiodarone, disopyramide, dronedarone, procainamide, quinidine, sotalol)
• antihistamines (e.g., azelastine, cetirizine, doxylamine, diphenhydramine, hydroxyzine, ketotifen, loratadine, rupatadine)
• antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
• aprepitant
• atomoxetine
• atropine
• "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
• belladonna
• benztropine
• beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
• betahistine
• botulinum toxin-containing products
• caffeine
• cannabis
• clidinium
• cobicistat
• cyclobenzaprine
• darifenacin
• decongestant cold medications (e.g., phenylephrine, pseudoephedrine)
• decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)
• dexmethylphenidate
• diltiazem
• desmopressin
• diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
• domperidone
• eluxadoline
• epinephrine
• glucagon
• grapefruit juice
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• ipratropium
• ketotifen
• linezolid
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• methadone
• methylphenidate
• metoclopramide
• mifepristone
• modafinil
• monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
• narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone, tramadol)
• nitroglycerin
• orphenadrine
• oxybutynin
• ozanimod
• potassium chloride
• protein kinase inhibitors (e.g., ceritinib, imatinib, nilotinib)
• quinine
• scopolamine
• solifenacin
• solriamfetol
• theophyllines (e.g., aminophylline, oxtriphylline, theophylline)
• tiotropium
• tolterodine
• tobacco (smoked)
• topiramate
• tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
• umeclidinium
• verapamil

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.