Description
Budesonide, glycopyrrolate, and formoterol combination is used as long-term maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. This medicine helps improve and reduce the number of flare-ups of the symptoms of COPD.
Inhaled budesonide belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It works by preventing inflammation (swelling) in the lungs that causes an asthma attack.
Glycopyrrolate and formoterol are long-acting bronchodilators. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, and trouble breathing by increasing the flow of air through the bronchial tubes.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Aerosol Liquid
Before Using
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
- Benzhydrocodone
- Benzthiazide
- Benztropine
- Berotralstat
- Besifloxacin
- Betaxolol
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.
Proper Use
Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Do not stop using this medicine without telling your doctor. To do so may make your condition worse.
This medicine comes with a patient information leaflet or patient instructions. Read the instructions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, have your doctor show you what to do. Also, ask your doctor to check how you use the inhaler to make sure you are using it properly.
When you use the inhaler for the first time, it may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, prime it by spraying the medicine 4 times into the air away from the face, and shaking it well before each spray. If you have not used it for 7 days or longer or if you've dropped it, re-prime by spraying the medicine 2 times into the air away from the face, and shaking it well before each spray.
To use the inhaler:
- This medicine comes in a sealed foil pouch. Do not open the foil pouch until you are ready to use a dose of this medicine.
- Once opened, remove the inhaler from the pouch.
- Take the cap off the mouthpiece. Check the mouthpiece to make sure it is clear.
- Press the center of the dose indicator all the way down and release it. You may hear a soft click from the dose indicator as it counts down during use.
- To inhale this medicine, breathe out fully and try to get as much air out of your lungs as possible. Put your lips tightly around the mouthpiece and breathe in quickly and deeply until the canister stops moving in the actuator and a puff of medicine has been released.
- Remove the inhaler from your mouth and hold your breath for as long as is comfortable, and then breathe out slowly through your nose.
- Gargle and rinse your mouth with water after each dose. This will help prevent hoarseness, throat irritation, and infection in the mouth. Do not swallow the water after rinsing.
- Clean the inhaler 1 time each week by taking the canister out of the actuator and allow warm water to run through it for about 30 seconds. Turn the actuator upside down and rinse again for about 30 seconds. Let the actuator air-dry overnight.
The dose display window of the inhaler will turn red when the inhaler has 20 or fewer doses left. Throw the inhaler when it reaches 0, or if it has been 3 weeks (for the 28 inhalation canister) or 3 months (for the 120 inhalation canister) since you last opened the foil pouch.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For inhalation dosage form (aerosol):
- For COPD:
- Adults—Two puffs in the morning and another 2 puffs in the evening. Each puff contains 160 micrograms (mcg) budesonide, 9 mcg glycopyrrolate and 4.8 mcg formoterol.
- Children—Use is not recommended.
- For COPD:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.
Tell your doctor if you are also using any other medicine for your COPD. Your doctor may want you to use it only during a severe COPD attack. Follow your doctor's instructions on how you should take your medicine.
This medicine should not be used if you are having a sudden COPD attack, or if symptoms of COPD attack has already started. Your doctor will give you a short-acting inhaler to use for this condition. If the short-acting inhaler is not working, tell your doctor right away.
Talk to your doctor or get medical care right away if:
- Your symptoms do not improve after using this medicine for a few days or if they become worse.
- Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often.
Do not use this medicine together with other inhaled medicines for COPD, including arformoterol (Brovana®), formoterol (Foradil®, Perforomist®), indacaterol (Arcapta® Neohaler®), olodaterol, salmeterol (Serevent®), or vilanterol.
This medicine may increase the risk of worsening asthma, which may lead to hospitalization, intubation, and death, especially in patients with asthma who take bronchodilators without an inhaled steroid medicine. Talk to your doctor if you have concerns about this.
You may get infections more easily while using this medicine. Tell your doctor right away if you have been exposed to someone with chickenpox or measles.
This medicine may cause fungus infection of the mouth or throat (thrush). Tell your doctor right away if you have white patches in the mouth or throat, or pain when eating or swallowing.
Patients with COPD may be more likely to have pneumonia when using this medicine. Check with your doctor if you start having increased sputum (spit) production, change in sputum color, fever, chills, increased cough, or an increase in breathing problems.
Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
This medicine may cause paradoxical bronchospasm, which may be life-threatening. Check with your doctor right away if you or your child are having a cough, difficulty with breathing, or wheezing.
If you develop a skin rash, hives, swelling of the tongue, lips, or face, or any allergic reaction to this medicine, check with your doctor right away.
This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.
This medicine may cause heart or blood vessel problems, including heart rhythm problems. Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain.
Call your doctor right away if blurred vision, difficulty in reading, seeing halos around lights, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
This medicine may affect blood sugar and potassium levels. If you notice a change in the results of your blood or urine sugar or potassium tests or if you have any questions, check with your doctor.
Check with your doctor right away if you have a decrease in urine volume, decrease in the frequency of urination, difficulty in passing urine, or painful urination.
Your doctor may want you to carry a medical identification (ID) card stating that you are using this medicine and that you may need additional medicine during times of emergency, a severe COPD attack or other illness, or unusual stress.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Bladder pain
- bloody or cloudy urine
- blurred vision
- chest pain or tightness
- chills
- cough
- darkening of the skin
- decrease in urine volume and frequency of urination
- diarrhea
- difficult, burning, or painful urination
- difficulty breathing
- dizziness
- dry mouth
- fainting
- fast, pounding, or irregular heartbeat or pulse
- fever
- flushed, dry skin
- fruit-like breath odor
- general feeling of discomfort or illness
- headache
- hives, itching, skin rash
- hoarseness
- increased hunger
- increased thirst
- increased urination
- irritation
- joint pain, stiffness, or swelling
- loss of appetite
- lower back or side pain
- mental depression
- muscle aches and pains
- nausea
- noisy breathing
- pain or tenderness around the eyes and cheekbones
- redness of the skin
- shivering
- sneezing
- sore mouth, throat, or tongue
- stomach pain
- stuffy or runny nose
- sweating
- swelling of the eyelids, face, lips, hands, or feet
- tremor
- trouble sleeping
- trouble swallowing
- unexplained weight loss
- unusual tiredness or weakness
- vomiting
- white patches in the mouth or on the tongue
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Agitation
- anxiety
- back pain
- bruising
- muscle spasms
- nervousness
- restlessness
- throat irritation
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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