Description
Albuterol and budesonide combination is used treat or prevent symptoms of asthma. It is also used to prevent asthma attacks.
Albuterol belongs to the family of medicines known as bronchodilators. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs.
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.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Aerosol Powder
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
Appropriate studies have not been performed on the relationship of age to the effects of albuterol and budesonide combination in the pediatric population. Safety and efficacy have not been established because budesonide may cause slowed growth in children.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of albuterol and budesonide combination in geriatric patients. However, elderly patients are more likely to have age-related heart or kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
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.
- Desmopressin
- Isocarboxazid
- Levoketoconazole
- Rotavirus Vaccine, Live
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
- Adagrasib
- Amineptine
- Amiodarone
- Amitriptyline
- Amitriptylinoxide
- Amoxapine
- Amphetamine
- Amprenavir
- Aprepitant
- Aspirin
- Atazanavir
- Atenolol
- Atomoxetine
- Avacopan
- Balofloxacin
- Bemetizide
- Bemiparin
- Bendroflumethiazide
- Benzthiazide
- Berotralstat
- Besifloxacin
- Betaxolol
- Bisoprolol
- Boceprevir
- Bumetanide
- Bupropion
- Carbamazepine
- Carteolol
- Carvedilol
- Celiprolol
- Ceritinib
- Chlorothiazide
- Chlorthalidone
- Cilostazol
- Cimetidine
- Ciprofloxacin
- Clarithromycin
- Clofazimine
- Clomipramine
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.
- Apalutamide
- Auranofin
- Erythromycin
- Mavacamten
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:
- Chickenpox (including recent exposure) or
- Diabetes or
- Heart or blood vessel disease (eg, coronary insufficiency) or
- Heart rhythm problems (eg, arrhythmia) or
- Herpes simplex (virus) infection of the eye or
- Hypertension (high blood pressure) or
- Hyperthyroidism (overactive thyroid) or
- Hypokalemia (low potassium in the blood) or
- Infection (eg, bacteria, virus, fungus) or
- Ketoacidosis (high ketones in the blood) or
- Measles (including recent exposure) or
- Osteoporosis (thin bones), history of or
- Seizures or
- Tuberculosis, active or history of or
- Weakened immune system—Use with caution. May make these conditions worse.
- Liver disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.
- Stress or
- Surgery or
- Trauma—Use with caution. May increase risk for adrenal gland problems.
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, if you've dropped it, or after cleaning 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.
- Remove the cap off and look at the mouthpiece to make sure it is clean.
- To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put your lips tightly around the mouthpiece and breathe in slowly and deeply while spraying a puff of medicine.
- Hold your breath for about 10 seconds, then breathe out slowly.
- Immediately repeat these steps for the second puff, starting with shaking the inhaler.
- When you have finished all of your doses, rinse your mouth with water. Do not swallow.
- Clean the actuator at least once a week with warm water for 30 seconds. Shake off the excess water. Let the actuator air-dry overnight. Do not use soap and do not dry with towel or tissue. Do not let the canister get wet.
Throw away this medicine 12 months after opening the foil pouch, when the dose counter reaches "0", whichever comes first.
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 treatment and prevention of asthma and asthma attacks:
- Adults—Two puffs as needed. Each puff contains 180 micrograms (mcg) albuterol and 160 mcg budesonide. Do not take more than 6 doses (12 puffs) in a 24 hour period.
- Children—Use is not recommended.
- For treatment and prevention of asthma and asthma attacks:
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.
This medicine may cause paradoxical bronchospasm, which may be life-threatening. Check with your doctor right away if you have cough, difficulty with breathing, or wheezing.
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, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, unusual tiredness or weakness, or weight gain.
This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, bronchospasm, oropharyngeal edema, rash, and urticaria, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, swelling of the mouth or throat, throat tightness, trouble breathing, or unusual tiredness or weakness.
You may get infections more easily while using this medicine. Avoid people who are sick or have infections. Tell your doctor right away if you have been exposed to someone with chickenpox or measles.
Check with your doctor right away if you have decreased urine, dry mouth, irregular heartbeat, increased thirst, loss of appetite, mood changes, muscle pain or cramps, nausea or vomiting, numbness or tingling in the hands, feet, or lips, seizures, trouble breathing, or unusual tiredness or weakness. These may be symptoms of hypokalemia (low potassium in the blood).
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.
Call your doctor right away if blindness, blurred vision, decreased vision, eye pain, headache, nausea or vomiting, or tearing occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
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 mouth and throat infection. Check with your doctor right away if you have creamy white, curd-like patches in the mouth or throat or pain when eating or swallowing.
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
- Sore mouth or tongue
- white patches in the mouth or on the tongue
Incidence not known
- Anxiety
- blindness
- blistering, burning, crusting, dryness, or flaking of the skin
- blurred vision
- body aches or pain
- change in vision
- chest pain, discomfort, or tightness
- chills
- confusion
- cough
- darkening of the skin
- decreased urine
- decreased vision
- diarrhea
- difficulty swallowing
- dizziness
- drowsiness
- dry mouth
- dryness or soreness of the throat
- earache
- extra heartbeats
- eye pain
- fainting
- fast, pounding, or irregular heartbeat or pulse
- fever
- flushing
- fracture
- general feeling of discomfort or illness
- headache
- headache, severe and throbbing
- hives, itching, skin rash
- increased thirst
- irritability
- itching, scaling, severe redness, soreness, or swelling of the skin
- joint pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- loss of vision
- mood changes
- muscle aches, pains, or cramps
- nausea
- nervousness
- noisy breathing
- numbness or tingling in the hands, feet, or lips
- pain or discomfort in the arms, jaw, back, or neck
- pain or tenderness around the eyes and cheekbones
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, or lips
- redness or swelling in the ear
- restlessness
- seizures
- shakiness in the legs, arms, hands, or feet
- shivering
- sneezing
- sore throat
- stomach pain or cramps
- stuffy or runny nose
- sweating
- tearing
- tender, swollen glands in the neck
- throat tightness
- trembling or shaking of the hands or feet
- trouble breathing
- trouble in swallowing
- trouble sitting still
- trouble sleeping
- unusual tiredness or weakness
- voice changes
- vomiting
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:
Incidence not known
- Acid or sour stomach
- belching
- bone pain
- bruising
- change in taste bad unusual or unpleasant (after) taste
- difficulty in moving
- excessive muscle tone
- heartburn
- indigestion
- joint pain
- large, flat, blue, or purplish patches in the skin
- muscle stiffness, tension, or tightness
- stomach discomfort or upset
- swollen joints
- weight gain
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.
DRG-20543662
