Budesonide/Formoterol AerosolGeneric Name:
Budesonide/Formoterol (bue-DES-oh-nide/for-MOE-ter-ol)Brand Name:
Long-acting beta-agonists such as Budesonide/Formoterol Aerosol have been rarely associated with an increased risk of asthma-related death. It should only be used by certain patients with severe asthma or by patients who cannot get adequate control of asthma symptoms by using other asthma controller medicines (eg, inhaled corticosteroids).
Budesonide/Formoterol Aerosol is used for:
Long-term treatment of asthma and chronic obstructive pulmonary disease (COPD) in certain patients. It may also be used for other conditions as determined by your doctor.
Budesonide/Formoterol Aerosol is a combination of a synthetic corticosteroid and a long-acting beta-agonist bronchodilator. It works by decreasing irritation and inflammation in the lungs; it widens the airways in the lungs, which helps you breathe more easily.
Do NOT use Budesonide/Formoterol Aerosol if:
- you are allergic to any ingredient in Budesonide/Formoterol Aerosol
- you are using another medicine that has a long-acting beta-agonist (eg, salmeterol) in it
- you are having an asthma attack (eg, sudden, severe onset or worsening of asthma or COPD symptoms such as wheezing, cough, chest tightness, shortness of breath)
- you are taking mifepristone
Contact your doctor or health care provider right away if any of these apply to you.
Before using Budesonide/Formoterol Aerosol:
Some medical conditions may interact with Budesonide/Formoterol Aerosol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of diabetes, heart problems (eg, fast or irregular heartbeat, heart blood vessel problems), high blood pressure, low blood potassium levels, seizures, tuberculosis, a weakened immune system, liver problems, or thyroid problems
- if you have weakened bones (eg, osteoporosis), a family history of weakened bones, or have other risk factors for weak bones (eg, smoking, poor nutrition)
- if you have a history of eye problems (eg, glaucoma, cataracts, increased eye pressure)
- if you have a fungal, bacterial, or parasitic infection; a viral infection (eg, chickenpox, measles); herpes infection of the eye; or a lung infection (eg, pneumonia)
- if you have recently been to an emergency room for asthma, have a history of frequent hospitalizations for asthma, or have ever had a life-threatening asthma attack
- if you have had an unusual reaction to a sympathomimetic medicine (eg, albuterol, pseudoephedrine), such as fast or irregular heartbeat, overexcitement, or severe trouble sleeping
- if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or a tricyclic antidepressant (eg, amitriptyline), or if you have taken either of these medicines within the last 14 days
Some MEDICINES MAY INTERACT with Budesonide/Formoterol Aerosol. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Beta agonists (eg, albuterol), corticosteroids (eg, prednisone), diuretics (eg, furosemide, hydrochlorothiazide), or xanthines (eg, theophylline) because the risk of low blood potassium or irregular heartbeat may be increased
- Ritodrine because the risk of maternal lung edema may be increased
- Catechol-o-methyltransferase (COMT) inhibitors (eg, entacapone), clarithromycin, HIV protease inhibitors (eg, atazanavir, ritonavir), itraconazole, ketoconazole, long-acting beta-agonists (eg, salmeterol), MAOIs (eg, phenelzine), nefazodone, telithromycin, or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Budesonide/Formoterol Aerosol's side effects
- Barbiturates (eg, phenobarbital), beta-blockers (eg, propranolol), carbamazepine, hydantoins (eg, phenytoin), oral contraceptives, or rifampin because they may decrease Budesonide/Formoterol Aerosol's effectiveness or worsen your condition
- Mifepristone because the risk of its side effects may be increased by Budesonide/Formoterol Aerosol
This may not be a complete list of all interactions that may occur. Ask your health care provider if Budesonide/Formoterol Aerosol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Budesonide/Formoterol Aerosol:
Use Budesonide/Formoterol Aerosol as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Budesonide/Formoterol Aerosol comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Budesonide/Formoterol Aerosol refilled.
- Store Budesonide/Formoterol Aerosol in the foil package until right before use.
- You will need to prime the inhaler before using it for the first time. To prime the inhaler, shake it for 5 seconds, then release a test spray into the air away from your face. Shake well again for 5 seconds and release a second test spray into the air.
- To use Budesonide/Formoterol Aerosol, remove the inhaler from the foil pouch. Write the date that you open the foil pouch on the dose tracker card that comes with Budesonide/Formoterol Aerosol.
- Be sure that the canister is properly placed in the inhaler unit. Shake well. Remove the mouthpiece cover. Check the mouthpiece for foreign objects. Breathe out slowly and completely. Place the mouthpiece between your lips and try to rest your tongue flat, unless your doctor has told you otherwise. Your doctor may have told you to hold the inhaler 1 or 2 inches (2 or 3 centimeters) away from the open mouth or to use a special spacing device. As you start to take a slow, deep breath, press the canister and mouthpiece together at exactly the same time. This will release a dose of Budesonide/Formoterol Aerosol. Continue breathing in slowly and deeply and hold for as long as comfortable, then breathe out slowly through pursed lips or your nose. If more than 1 inhalation is to be used, wait a few minutes and repeat the above steps. Keep the spray away from your eyes. Close the mouthpiece cover after each use.
- If the inhaler is not used for more than 7 days or if it is dropped, it will need to be reprimed again before you use it.
- Wipe the mouthpiece clean with a dry cloth at least once a week.
- Rinse your mouth with water after you finish using the medicine (do not swallow). This will help remove excess medicine and decrease your risk of developing an oral fungal infection.
- Use the enclosed dose tracker card to keep track of the number of puffs you have used. Throw the inhaler away after you have used the labeled number of puffs or after it has been removed from the foil pouch for longer than 3 months, even if the container does not feel empty.
- Use the new inhaler that comes with each refill. Do not reuse an old inhaler. Do not use Budesonide/Formoterol Aerosol with a different kind of inhaler.
- Never wash the mouthpiece or any other part of the inhaler with water. Keep it dry and always store in a dry place. Do NOT try to take the inhaler apart.
- Continue to use Budesonide/Formoterol Aerosol even if you feel well. Do not miss any doses.
- If you miss a dose of Budesonide/Formoterol Aerosol, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Budesonide/Formoterol Aerosol.
Important safety information:
- Budesonide/Formoterol Aerosol may cause dizziness. This effect may be worse if you use it with alcohol or certain medicines. Use Budesonide/Formoterol Aerosol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Some patients may have trouble using Budesonide/Formoterol Aerosol correctly. Some may also get mouth sores or a bad taste in the mouth after using it. If you have any of these problems, ask your health care provider if a spacing device may help.
- The risk of serious heart problems (eg, irregular heartbeat) may be greater if you use Budesonide/Formoterol Aerosol in high doses. Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Use caution if you switch from an oral steroid (eg, prednisone) to Budesonide/Formoterol Aerosol. It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, loss of blood electrolytes, or a sudden asthma attack. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid (eg, prednisone) again. Carry a card at all times that says you may need an oral steroid (eg, prednisone) if any of these events occur.
- Budesonide/Formoterol Aerosol may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does. Tell your doctor right away if you are exposed to anyone who has these infections.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking Budesonide/Formoterol Aerosol. Talk with your doctor before you receive any vaccine.
- Budesonide/Formoterol Aerosol will not stop an asthma attack once it has already started. Be sure to carry a short-acting bronchodilator inhaler with you at all times to treat any breathing problems that may occur between doses of Budesonide/Formoterol Aerosol (eg, severe or sudden onset of wheezing or shortness of breath). If you have any questions about which medicines stop asthma attacks, check with your doctor or pharmacist.
- If you have been regularly using a short-acting bronchodilator inhaler (eg, albuterol), talk with your doctor about how to use it with Budesonide/Formoterol Aerosol. Short-acting bronchodilators are normally only used with Budesonide/Formoterol Aerosol to treat breathing problems that may occur between doses.
- If your symptoms do not get better within 1 to 2 weeks of starting Budesonide/Formoterol Aerosol or if they get worse, contact your doctor right away.
- Tell your doctor at once if you notice that your short-acting bronchodilator inhaler does not work as well, if you need to use it often (eg, 4 or more times a day for more than 2 days in a row, more than 1 canister in 8 weeks), or if you have a decrease in your peak flow meter results.
- Contact your doctor or seek medical care right away if you have breathing problems that worsen quickly, or if you use your short-acting bronchodilator and do not get relief.
- Talk with your doctor or pharmacist about all of your asthma medicines and how to use them. Do not start, stop, or change the dose of any asthma medicine unless your doctor tells you to.
- The medicine may sometimes cause breathing problems right after you use a dose. If this happens, use your short-acting bronchodilator. Contact your doctor or seek other medical care at once.
- Lab tests, including lung function tests, blood pressure, and eye exams, may be performed while you use Budesonide/Formoterol Aerosol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Budesonide/Formoterol Aerosol with caution in the ELDERLY; they may be more sensitive to its effects, especially weakened bones.
- Corticosteroids may affect the growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Budesonide/Formoterol Aerosol.
- Budesonide/Formoterol Aerosol should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Budesonide/Formoterol Aerosol while you are pregnant. Budesonide/Formoterol Aerosol is found in breast milk. Do not breast-feed while taking Budesonide/Formoterol Aerosol.
Possible side effects of Budesonide/Formoterol Aerosol:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Dizziness; dry mouth; headache; nausea; nervousness; stomach pain or upset; stuffy nose; throat irritation; tiredness; tremor; trouble sleeping; vomiting.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, tongue, or throat; unusual hoarseness); back pain; bone pain; chest pain; fast or irregular heartbeat; fever, chills, or persistent sore throat; increased mucus production or change in color of mucus; new or worsening asthma or COPD symptoms (eg, coughing, increased chest tightness, shortness of breath, wheezing); seizures; severe or persistent dizziness, headache, nervousness, or tremor; severe or persistent muscle pain or cramps; trouble speaking; vision changes; white patches in your mouth or throat.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include chest pain; fast or irregular heartbeat; fatigue; headache; increased thirst or urination; muscle pain or cramps; nausea; nervousness; seizures; severe or persistent dizziness; tremors; trouble sleeping; vomiting.Proper storage of Budesonide/Formoterol Aerosol:
Store Budesonide/Formoterol Aerosol at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and direct sunlight. Do not store in the bathroom. Do not puncture, break, or burn the canister even if it appears to be empty. Store Budesonide/Formoterol Aerosol with the mouthpiece down. Keep Budesonide/Formoterol Aerosol out of the reach of children and away from pets.
- If you have any questions about Budesonide/Formoterol Aerosol, please talk with your doctor, pharmacist, or other health care provider.
- Budesonide/Formoterol Aerosol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Budesonide/Formoterol Aerosol. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.