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.
Symbicort (Budesonide / Formoterol) 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 Symbicort (Budesonide / Formoterol) if:
you are allergic to any ingredient in Symbicort (Budesonide / Formoterol)
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
Before using Symbicort (Budesonide / Formoterol):
Some medical conditions may interact with Symbicort (Budesonide / Formoterol). 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 Symbicort (Budesonide / Formoterol). Tell your doctor 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 Symbicort (Budesonide / Formoterol)'s side effects
Barbiturates (eg, phenobarbital), beta-blockers (eg, propranolol), carbamazepine, hydantoins (eg, phenytoin), oral contraceptives, or rifampin because they may decrease Symbicort (Budesonide / Formoterol)'s effectiveness or worsen your condition
Mifepristone because the risk of its side effects may be increased by Symbicort (Budesonide / Formoterol)
This may not be a complete list of all interactions that may occur. Ask your doctor if Symbicort (Budesonide / Formoterol) may interact with other medicines that you take. Check with your doctor before you start, stop, or change the dose of any medicine.
How to use Symbicort (Budesonide / Formoterol):
Use Symbicort (Budesonide / Formoterol) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Symbicort (Budesonide / Formoterol) comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Symbicort (Budesonide / Formoterol) refilled.
Store Symbicort (Budesonide / Formoterol) 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 Symbicort (Budesonide / Formoterol), remove the inhaler from the foil pouch. Write the date that you open the foil pouch on the dose tracker card that comes with Symbicort (Budesonide / Formoterol).
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 Symbicort (Budesonide / Formoterol). 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 Symbicort (Budesonide / Formoterol) 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 Symbicort (Budesonide / Formoterol) even if you feel well. Do not miss any doses.
If you miss a dose of Symbicort (Budesonide / Formoterol), skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your doctor any questions you may have about how to use Symbicort (Budesonide / Formoterol).
Important safety information:
Symbicort (Budesonide / Formoterol) may cause dizziness. This effect may be worse if you use it with alcohol or certain medicines. Use Symbicort (Budesonide / Formoterol) 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 Symbicort (Budesonide / Formoterol) 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 doctor if a spacing device may help.
The risk of serious heart problems (eg, irregular heartbeat) may be greater if you use Symbicort (Budesonide / Formoterol) 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 Symbicort (Budesonide / Formoterol). 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.
Symbicort (Budesonide / Formoterol) 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 Symbicort (Budesonide / Formoterol). Talk with your doctor before you receive any vaccine.
Symbicort (Budesonide / Formoterol) 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 Symbicort (Budesonide / Formoterol) (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 Symbicort (Budesonide / Formoterol). Short-acting bronchodilators are normally only used with Symbicort (Budesonide / Formoterol) to treat breathing problems that may occur between doses.
If your symptoms do not get better within 1 to 2 weeks of starting Symbicort (Budesonide / Formoterol) 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 Symbicort (Budesonide / Formoterol). These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Symbicort (Budesonide / Formoterol) 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 Symbicort (Budesonide / Formoterol).
Symbicort (Budesonide / Formoterol) 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 Symbicort (Budesonide / Formoterol) while you are pregnant. Symbicort (Budesonide / Formoterol) is found in breast milk. Do not breast-feed while taking Symbicort (Budesonide / Formoterol).
Possible side effects of Symbicort (Budesonide / Formoterol):
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:
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. Call your doctor for medical advice about side effects.
If OVERDOSE is suspected:
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 Symbicort (Budesonide / Formoterol):
Store Symbicort (Budesonide / Formoterol) 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 Symbicort (Budesonide / Formoterol) with the mouthpiece down. Keep Symbicort (Budesonide / Formoterol) out of the reach of children and away from pets.
General information:
If you have any questions about Symbicort (Budesonide / Formoterol), please talk with your doctor.
Symbicort (Budesonide / Formoterol) 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 Symbicort (Budesonide / Formoterol). If you have questions about the medicine you are taking or would like more information, check with your doctor.
