This medicine is a combination of a corticosteroid and a long-acting beta-agonist bronchodilator. This medicine is used for treating asthma in certain patients. It may also be used for long-term treatment of chronic obstructive pulmonary disease (COPD) in certain patients. It may also be used to treat other breathing conditions as determined by your doctor.
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. Refer to the illustrated directions provided for instruction on the correct use of this device. YOUR DOSE OF MEDICINE IS A VERY FINE POWDER. MOST, BUT NOT ALL, PATIENTS CAN TASTE OR FEEL THE DOSE. DO NOT USE ANOTHER DOSE IF YOU DO NOT TASTE OR FEEL THE MEDICINE. If you are not sure if you are receiving your dose, contact your doctor or pharmacist. Rinse your mouth with water after using this medicine. Do NOT swallow the rinse solution. Spit the rinse water out. IF YOU ARE USING other inhaled medicines, wait a few minutes between using this medicine and other inhalers, unless directed otherwise by your doctor. YOU MAY BREATHE MORE EASILY after you use the first dose of this medicine. However, it may take 1 week or longer before you get the most benefit. USE THIS MEDICINE ON A REGULAR SCHEDULE to get the most benefit from it, unless your doctor tells you otherwise. Using this medicine at the same times each day will help you remember to use it. TAKE YOUR DOSES OF THIS MEDICINE about 12 hours apart, unless your doctor tells you otherwise. NEVER WASH THE MOUTHPIECE or any other part of the inhaler. Keep it dry. IF YOU HAVE BEEN REGULARLY USING A SHORT-ACTING BRONCHODILATOR INHALER (such as albuterol), talk with your doctor about how to use it with this medicine. Short-acting bronchodilators are normally only used with this medicine to treat breathing problems that may occur between doses. 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. STORE THIS MEDICINE at room temperature between 68 and 77 degrees F (20 and 25 degrees C) away from heat, moisture, or light. Throw this medicine away 1 month after you remove it from the foil pouch, or after the dose indicator reads "0", whichever comes first. KEEP THIS MEDICINE out of the reach of children and away from pets. CONTINUE TO USE THIS MEDICINE even if you feel well. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, skip the missed dose and go back to your regular dosing schedule. Do NOT use 2 doses at once.
WARNING: Long-acting beta-agonists, such as one of the active ingredients in this medicine (salmeterol), have been rarely associated with an increased risk of asthma-related death. They may also increase the risk of asthma-related hospitalizations in CHILDREN and TEENAGERS. This medicine should only be used to treat asthma in patients who are not controlled by using other long-term asthma-control medicine. This medicine should not be used in patients whose asthma can be controlled by inhaled corticosteroids (eg, fluticasone). 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 using another type of long-acting inhaled bronchodilator (eg, formoterol, salmeterol) or you are taking certain azole antifungals (eg, itraconazole, ketoconazole), a macrolide antibiotic (eg, clarithromycin), nefazodone, protease inhibitors (eg, atazanavir, boceprevir, indinavir, ritonavir), or telithromycin. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking azole antifungals (eg, fluconazole), beta-blockers (eg, propranolol), catechol-O-methyl transferase (COMT) inhibitors (eg, entacapone), delavirdine, diuretics (eg, furosemide, hydrochlorothiazide), inhaled corticosteroids (eg, fluticasone), linezolid, oral corticosteroids (eg, prednisone), short-acting beta-agonist bronchodilators (eg, albuterol), or medicine to suppress the immune system (eg, tacrolimus). Tell your doctor 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. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of diabetes; eye problems (eg, cataracts, glaucoma, increased pressure in the eye); heart problems (eg, fast or irregular heartbeat, heart blood vessel problems); high blood pressure; nervous system problems; liver problems; low blood potassium levels; high blood acid levels (eg, ketoacidosis); seizures; thyroid problems; an adrenal gland tumor; or an unusual reaction to a sympathomimetic medicine (eg, albuterol, pseudoephedrine), such as fast or irregular heartbeat, overexcitement, or severe trouble sleeping. Tell your doctor if you have a fungal, bacterial, or parasitic infection; a viral infection (eg, measles, chickenpox, shingles); herpes virus infection of the eye; tuberculosis (TB); a history of a positive TB skin test; an immune system problem; a recent vaccination; allergies; pregnancy; or breast-feeding. Tell your doctor if you have weak bones (osteoporosis) or risk factors of osteoporosis (eg, a family history of osteoporosis, tobacco use, long-term alcohol use, long-term use of corticosteroids or certain seizure medicines, limited physical exercise, poor nutrition). Tell your doctor if you are having a COPD flare-up, 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. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are having an asthma attack or severe breathing problems (eg, sudden, severe onset or worsening of asthma symptoms or COPD symptoms, such as chest tightness, cough, shortness of breath, wheezing) or if you have asthma that is already well controlled with the use of a long-term asthma-control medicine (eg, inhaled corticosteroid). Use of this medicine in CHILDREN under age 4 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 using this medicine.
SIDE EFFECTS that may occur while taking this medicine include: diarrhea; dizziness; headache; mild muscle or bone pain; nausea; nervousness; throat irritation; tremor; vomiting. If they continue or are bothersome, check with your doctor. THIS MEDICINE MAY SOMETIMES CAUSE severe breathing problems right after you use a dose. If this happens, use your short-acting bronchodilator inhaler. Seek medical care at once if your breathing does not improve after you use the short-acting bronchodilator. THE RISK OF SERIOUS HEART PROBLEMS (eg, irregular heartbeat) may be greater if you use this medicine in high doses. Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor. SEEK MEDICAL ATTENTION RIGHT AWAY if any of these SEVERE side effects occur: behavior changes; blurred vision or other vision changes; burning, numbness, or tingling; chest pain; choking; fast or irregular heartbeat; overexcitement; seizures; severe muscle weakness, cramps, or spasms; severe or persistent bone pain; severe or persistent dizziness, headache, nervousness, or tremor; signs of infection (eg, fever, chills, cough, persistent sore throat, ear pain, increased mucus production, change in mucus color); swelling or tightness in the throat; symptoms of high blood sugar (eg, increased thirst, urination, or hunger; unusual weakness or drowsiness; confusion); trouble sleeping; unusual tiredness or weakness; vaginal odor or discharge; weight gain; white patches or sores on the tongue or mouth; worsening of asthma or COPD symptoms (eg, increased wheezing, coughing, chest tightness, shortness of breath). AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness. 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.
IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms may include chest pain; fainting; fast or irregular heartbeat; muscle cramping, pain, or weakness; seizures; or severe or persistent dizziness, dry mouth, fatigue, headache, nausea, nervousness, tremor, or trouble sleeping.
IF YOUR SYMPTOMS DO NOT GET BETTER WITHIN 1 WEEK or if they get worse after you start using this medicine, check with your doctor. Carry an identification card at all times that states you are taking this medicine. Consult your doctor for more information. TALK TO YOUR DOCTOR about how to use a peak flow meter to monitor your lung function. Use it daily and promptly report worsening asthma (such as readings in the yellow or red range or increased use of quick-relief inhalers). Try to avoid irritants that may trigger an asthma attack such as smoke, pollen, pet dander, dust, or molds. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.