Learn more about usage, cautions, and possible side effects .
Chemical Name: BUDESONIDE (bu-DES-on-ide) AND FORMOTEROL (for-MOE-ter-ol)
This medicine is a combination of a synthetic corticosteroid and a long-acting beta-agonist bronchodilator used for long-term treatment of asthma and chronic obstructive pulmonary disorder (COPD) in certain patients. It may also be used to treat other conditions as determined by your doctor.
LONG-ACTING BETA-AGONISTS SUCH AS THIS MEDICINE 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 (SUCH AS INHALED CORTICOSTEROIDS). Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking mifepristone or if you are using a long-acting beta agonist (such as salmeterol). DO NOT USE THIS MEDICINE if you are having an asthma attack (such as sudden, severe onset or worsening of asthma or COPD symptoms such as wheezing, cough, chest tightness, shortness of breath). TELL YOUR DOCTOR IF YOU ARE TAKING a monoamine oxidase inhibitor (MAOI) (such as phenelzine), a tricyclic antidepressant (such as amitriptyline), or if you have taken any of these medicines within the last 14 days. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking beta agonists (such as albuterol), corticosteroids (such as prednisone), diuretics (such as furosemide, hydrochlorothiazide), xanthines (such as theophylline), ritodrine, catechol-O-methyltransferase (COMT) inhibitors (such as entacapone), clarithromycin, HIV protease inhibitors (eg, atazanavir, ritonavir), itraconazole, ketoconazole, nefazodone, telithromycin, barbiturates (such as phenobarbital), beta-blockers (such as propranolol), carbamazepine, hydantoins (such as phenytoin), oral contraceptives, or rifampin. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor if you have a history of diabetes, heart problems (such as fast or irregular heartbeat, heart blood vessel problems), high blood pressure, low blood potassium levels, lung infection (eg, pneumonia), seizures, tuberculosis, weakened bones (such as osteoporosis), a weakened immune system, liver or thyroid problems, frequent hospitalizations or recent emergency room visits for asthma, or if you have ever had a life-threatening asthma attack. Inform your doctor of any other medical conditions such as glaucoma; cataracts; increased eye pressure; a fungal, bacterial, viral, or parasitic infection; chickenpox or measles; herpes infection in your eye; an unusual reaction to a sympathomimetic medicine (such as albuterol, pseudoephedrine); allergies; pregnancy; or breast-feeding. Use of this medicine in children under age 12 is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
Follow the directions for using this medicine provided by your doctor. This medicine comes with a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully each time you refill this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. Be sure to keep your reliever medicine with you at all times to treat any breathing problems (such as sudden, severe wheezing or shortness of breath) that may occur between doses of this medicine. If you have questions about how to treat an asthma attack, check with your doctor or pharmacist. BEFORE USING YOUR INHALER FOR THE FIRST TIME, you will need to prime it. 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. Write the date that you open the foil pouch on the dose tracker card that comes with the medicine. TO USE THIS MEDICINE, remove the inhaler from the foil pouch. First check the dose tracker card to make sure a dose is available. Shake the inhaler well for 5 seconds. Remove the mouthpiece cover. Check the mouthpiece for foreign objects. Breathe out fully. Place the white mouthpiece between your teeth and rest your tongue flat. Be sure that the inhaler is upright. Close your lips around the mouthpiece. While breathing in the medicine deeply and slowly, press down firmly on the grey top of the inhaler to release the medicine. Continue to breathe in and hold your breath for as long as comfortable. Before breathing out, release your finger from the grey top. Remove the inhaler from your mouth. Exhale slowly and completely through pursed lips or through the nose. DO NOT breathe out through the mouthpiece. If you are using more than 1 inhalation, wait a few minutes and repeat the above process. Close the mouthpiece cover after each use. 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. If the inhaler is not used for more than 7 days or it is dropped, it will need to be reprimed again before you use it. USE THE DOSE TRACKER CARD TO TRACK THE NUMBER OF PUFFS you have taken by marking off each of your doses. Use a dry cloth to wipe the mouthpiece clean at least once a week. DISCARD THIS MEDICINE when the labeled number of inhalations have been used or within 3 months of opening the foil pouch. The container may not feel empty. Never wash the mouthpiece or any other part of the inhaler. Always keep it dry and store it in a dry place. Do NOT try to take the inhaler apart. STORE THIS MEDICINE at room temperature between 68 and 77 degrees F (20 and 25 degrees C) away from heat, moisture, and light. Use this medicine regularly to receive the most benefit from it. CONTINUE TO USE THIS MEDICINE even if you feel better. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. DO NOT use 2 doses at once.
DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to formoterol, budesonide, or any ingredient in this medicine. THIS MEDICINE MAY SOMETIMES CAUSE SUDDEN BREATHING PROBLEMS RIGHT AFTER YOU USE A DOSE. If this happens, seek medical attention immediately. DO NOT EXCEED THE RECOMMENDED DOSE or use this medicine for longer than prescribed without checking with your doctor. CONTACT YOUR DOCTOR AT ONCE if this medicine does not work as well, if you feel the need to use it more often than prescribed, or if you have a decrease in your peak flow meter results. SEEK MEDICAL CARE RIGHT AWAY if you have breathing problems that worsen quickly or if you use your reliever medicine and it does not work. Laboratory and/or medical tests, including lung function, blood pressure, and eye exams may be performed to monitor your progress or to check for side effects. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using this medicine. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine. This medicine may cause dizziness. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. USE CAUTION IF YOU SWITCH FROM AN ORAL STEROID (such as prednisone) to this medicine. 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 again. THIS MEDICINE MAY LOWER YOUR ABILITY to fight infection. Avoid contact with people who have colds or infections. 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 or mumps) while you are using this medicine. Talk with your doctor before you receive any vaccine. DO NOT START, STOP, OR CHANGE THE DOSE OF ANY ASTHMA MEDICINE UNLESS YOUR DOCTOR TELLS YOU TO. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. CORTICOSTEROID MEDICINES MAY AFFECT growth rate in children and adolescents in some cases; their growth may need to be checked regularly. FOR WOMEN: IF YOU BECOME PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. THIS MEDICINE IS EXCRETED in breast milk. DO NOT BREAST-FEED while taking this medicine. IF YOU HAVE DIABETES, this medicine may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
SIDE EFFECTS that may occur while using this medicine include dizziness; dry mouth; headache; nausea; nervousness; stomach pain or upset; stuffy nose; throat irritation; tiredness; tremor; trouble sleeping; or vomiting. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience back pain; bone pain; chest pain; fast or irregular heartbeat; fever, chills, or persistent sore throat; new or worsening asthma or COPD symptoms (such as increased chest tightness, coughing, shortness of breath, or wheezing); severe or persistent headache, dizziness, tremor, or nervousness; seizures; severe or persistent muscle pain or cramps; trouble speaking; vision changes; white patches in your mouth or throat. An allergic reaction to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, or trouble breathing. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other. Check drug interactions
IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms of overdose may include trembling, severe headache, or rapid heartbeat.
If your symptoms do not improve within a week or if they become worse, check with your doctor. Carry an identification card at all times that says you have asthma. LEARN TO USE A PEAK FLOW METER, use it daily, and promptly report worsening asthma (such as readings in the yellow or red range, or increased use of quick-relief inhalers). IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out.
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