Generic Name: fluticasone/salmeterol (floo-TIK-a-sone/sal-MEE-ter-ol)
Brand Name: Advair Diskus
Long-acting beta-agonists, such as one of the active ingredients in fluticasone/salmeterol powder (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. Fluticasone/salmeterol powder should only be used to treat asthma in patients who are not controlled by using other long-term asthma-control medicine. Fluticasone/salmeterol powder should not be used in patients whose asthma can be controlled by inhaled corticosteroids (eg, fluticasone).
Fluticasone/salmeterol powder 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.
Fluticasone/salmeterol powder is an inhaled corticosteroid and long-acting bronchodilator combination. The corticosteroid works by reducing inflammation and the bronchodilator works by widening the airways in the lungs. This helps you breathe more easily.
Do NOT use fluticasone/salmeterol powder if:
- you are allergic to any ingredient in fluticasone/salmeterol powder or to milk proteins
- you are having an asthma attack or severe breathing problems (eg, sudden, severe onset or worsening of asthma or COPD symptoms, such as chest tightness, cough, shortness of breath, wheezing)
- you are using another type of long-acting inhaled bronchodilator (eg, formoterol, salmeterol)
- you are taking certain azole antifungals (eg, itraconazole, ketoconazole), clarithromycin, cobicistat, nefazodone, protease inhibitors (eg, atazanavir, boceprevir, indinavir, ritonavir), or telithromycin
- you have asthma that is already well controlled with the use of a long-term asthma-control medicine (eg, inhaled corticosteroid)
Contact your doctor or health care provider right away if any of these apply to you.
Before using fluticasone/salmeterol powder:
Some medical conditions may interact with fluticasone/salmeterol powder. 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, 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, or an adrenal gland tumor
- 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
- 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 or if you are taking a medicine to suppress the immune system (eg, tacrolimus); or if you have had a recent vaccination
- if you have weak bones (osteoporosis) or have 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)
- 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 an oral corticosteroid (eg, prednisone) or an inhaled corticosteroid (eg, fluticasone)
- if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or tricyclic antidepressant (eg, amitriptyline), or if you have taken either of these medicines within the last 14 days
Some MEDICINES MAY INTERACT with fluticasone/salmeterol powder. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Diuretics (eg, hydrochlorothiazide, furosemide) or other long-acting inhaled bronchodilators (eg, salmeterol inhalation powder, formoterol inhalation powder ) because the risk of low blood potassium or irregular heartbeat may be increased
- Beta-blockers (eg, propranolol) because they may decrease fluticasone/salmeterol powder's effectiveness
- Azole antifungals (eg, fluconazole), catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), cobicistat, delavirdine, linezolid, macrolide antibiotics (eg, clarithromycin), MAOIs (eg, phenelzine), nefazodone, protease inhibitors (eg, atazanavir, boceprevir, indinavir, ritonavir), short-acting beta-agonist bronchodilators (eg, albuterol), telithromycin, or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of fluticasone/salmeterol powder's side effects
This may not be a complete list of all interactions that may occur. Ask your health care provider if fluticasone/salmeterol powder 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 fluticasone/salmeterol powder:
Use fluticasone/salmeterol powder as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Fluticasone/salmeterol powder comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get fluticasone/salmeterol powder refilled.
- Always activate and use this device in a level, horizontal position. Do NOT try to use a spacer device with fluticasone/salmeterol powder.
- Hold the device in one hand and put the thumb of your other hand on the thumb grip. Push your thumb away from you as far as it will go until the mouthpiece appears and snaps into position.
- Hold the device in a level, flat position with the mouthpiece toward you. Slide the lever away from you as far as it will go until it clicks.
- Do NOT close or tilt the device, play with the lever, or move the lever more than 1 time. This may release or waste extra doses.
- Hold the device away from your mouth and breathe out fully. Do NOT breathe into the inhaler. Put the mouthpiece to your lips. Breathe in quickly and deeply through the device.
- Remove the device from your mouth. Hold your breath for about 10 seconds, or as long as is comfortable. Then breathe out slowly.
- Close the device. Put your thumb on the thumb grip and slide it back toward you as far as it will go. The device will click shut and the lever will return to its original position.
- 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 fluticasone/salmeterol powder. DO NOT swallow the rinse solution. Spit the rinse water out.
- If you are using other inhaled medicines, wait a few minutes between using fluticasone/salmeterol powder and other inhalers, unless directed otherwise by your doctor.
- Take your doses of fluticasone/salmeterol powder about 12 hours apart unless your doctor tells you otherwise.
- Never wash the mouthpiece or any other part of the inhaler. Keep it dry. Store fluticasone/salmeterol powder in a dry place.
- Throw fluticasone/salmeterol powder away 1 month after you remove it from the foil pouch, or after the dose indicator reads "0," whichever comes first.
- You may breathe more easily after the first dose of fluticasone/salmeterol powder. However, it may take 1 week or longer to achieve the most benefit.
- Use fluticasone/salmeterol powder on a regular schedule to get the most benefit from it. Using fluticasone/salmeterol powder at the same times each day will help you remember to use it. Do not stop using fluticasone/salmeterol powder even if you feel better unless your doctor tells you to.
- If you miss a dose of fluticasone/salmeterol powder, 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 fluticasone/salmeterol powder.
Important safety information:
- Fluticasone/salmeterol powder may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use fluticasone/salmeterol powder with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Fluticasone/salmeterol powder will not stop an asthma attack once one has started. Be sure to carry a short-acting bronchodilator inhaler (eg, albuterol) with you at all times to treat any breathing problems that may occur between doses of fluticasone/salmeterol powder (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, talk with your doctor about how to use it with fluticasone/salmeterol powder. Short-acting bronchodilators are normally only used with fluticasone/salmeterol powder to treat breathing problems that may occur between doses.
- Fluticasone/salmeterol powder should be used to treat asthma only if your asthma is not well controlled while you are using a certain long-term asthma-control medicine (eg, inhaled corticosteroid) or if you have severe asthma. Contact your doctor if you have questions about this information.
- Talk with your doctor or pharmacist about all of your asthma medicines and how to use them. Your doctor may make changes to your asthma-control medicines once your asthma is well controlled. Do not start, stop, or change the dose of any asthma medicine unless your doctor tells you to.
- If your symptoms do not get better within 1 week or if they get worse after you start using fluticasone/salmeterol powder, check with your doctor.
- Tell your doctor or dentist that you take fluticasone/salmeterol powder before you receive any medical or dental care, emergency care, or surgery.
- Tell your doctor at once if you notice your short-acting bronchodilator inhaler does not work as well, if you need to use it more often (eg, more than 4 times a day for more than 2 days in a row, or 1 whole canister within 8 weeks' time), or if you have a decrease in your peak meter flow results.
- The risk of serious heart problems (eg, irregular heartbeat) may be greater if you use fluticasone/salmeterol powder in high doses. Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Fluticasone/salmeterol powder may sometimes causes 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. Tell your doctor about this reaction.
- Use caution if you switch from an oral steroid (eg, prednisone) to fluticasone/salmeterol powder. 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, a sudden asthma attack, or severe fluid or electrolyte loss. 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.
- If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does. Contact your doctor at once if you have contact with anyone who has these infections.
- Check with your doctor before you receive any vaccine while you are using fluticasone/salmeterol powder.
- Diabetes patients - Fluticasone/salmeterol powder may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Lab tests, including lung function, bone density, and eye exams, may be performed while you use fluticasone/salmeterol powder. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use fluticasone/salmeterol powder with caution in the ELDERLY; they may be more sensitive to its effects, especially pneumonia, decreased bone density, and effects on the heart.
- Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use fluticasone/salmeterol powder.
- Fluticasone/salmeterol powder should not be used in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using fluticasone/salmeterol powder while you are pregnant. It is not known if fluticasone/salmeterol powder is found in breast milk. If you are or will be breast-feeding while you use fluticasone/salmeterol powder, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of fluticasone/salmeterol powder:
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:
Dizziness; headache; mild muscle or bone pain; nausea; nervousness; throat irritation; tremor; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); behavior changes; blurred vision or other vision changes; burning, numbness, or tingling; chest pain; choking; fast or irregular heartbeat; hoarseness or voice changes; 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).
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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), 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; severe or persistent dizziness, dry mouth, fatigue, headache, nausea, nervousness, tremor, or trouble sleeping.Proper storage of fluticasone/salmeterol powder:
Store fluticasone/salmeterol powder between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep fluticasone/salmeterol powder out of the reach of children and away from pets.
- If you have any questions about fluticasone/salmeterol powder, please talk with your doctor, pharmacist, or other health care provider.
- Fluticasone/salmeterol powder 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take fluticasone/salmeterol powder or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about fluticasone/salmeterol powder. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to fluticasone/salmeterol powder. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using fluticasone/salmeterol powder.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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