Generic Name: fluticasone/salmeterol (floo-TIK-a-sone/sal-MEE-ter-ol)
Brand Name: Advair HFA Inhaler
Long-acting beta-agonists, such as one of the active ingredients in fluticasone/salmeterol inhaler (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 inhaler should only be used to treat asthma patients who are not controlled by using other long-term asthma-control medicine. Fluticasone/salmeterol inhaler should not be used in patients whose asthma can be controlled by inhaled corticosteroids (eg, fluticasone).
Fluticasone/salmeterol inhaler is used for:
Treating asthma in certain patients. It may also be used to treat other breathing conditions as determined by your doctor.
Fluticasone/salmeterol inhaler 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 inhaler if:
- you are allergic to any ingredient in fluticasone/salmeterol inhaler
- you are having an asthma attack (eg, sudden, severe onset or worsening of asthma symptoms, such as wheezing, cough, chest tightness, shortness of breath)
- you are using another type of long-acting inhaled bronchodilator (eg, formoterol, salmeterol)
- you are taking certain azole antifungals (eg, itraconazole, ketoconazole), clarithromycin, cobicistat, protease inhibitors (eg, atazanavir, boceprevir, indinavir, ritonavir), nefazodone, 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 inhaler:
Some medical conditions may interact with fluticasone/salmeterol inhaler. 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, liver problems, low blood potassium levels, high blood acid levels (eg, ketoacidosis), nervous system problems, seizures, thyroid problems, or an adrenal gland tumor
- 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 a fungal, bacterial, or parasitic infection; a viral infection (eg, chickenpox, measles, 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 inhaler. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Diuretics (eg, furosemide, hydrochlorothiazide) or other long-acting inhaled bronchodilators (eg, formoterol inhalation powder, salmeterol inhalation powder) because the risk of low blood potassium or irregular heartbeat may be increased
- 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 inhaler's side effects
- Beta-blockers (eg, propranolol) because they may decrease fluticasone/salmeterol inhaler's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if fluticasone/salmeterol inhaler 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 inhaler:
Use fluticasone/salmeterol inhaler as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Fluticasone/salmeterol inhaler comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get fluticasone/salmeterol inhaler refilled.
- You must prime the inhaler before you use it for the first time. To prime the inhaler, shake it well for 5 seconds, then pump 1 test spray into the air away from your face. Repeat this 3 more times to be sure the inhaler is fully primed.
- You will need to reprime the inhaler if you drop it or if you have not used it in more than 4 weeks. To reprime the inhaler, shake it well for 5 seconds, then pump 1 test spray into the air away from your face. Repeat this step 1 more time to be sure the inhaler is fully primed.
- Before using fluticasone/salmeterol inhaler, be sure that the canister is properly placed in the inhaler unit. Be sure the medicine is at room temperature and that there are no foreign objects inside the inhaler unit. Shake well for 5 seconds before each use. 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 your 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 fluticasone/salmeterol inhaler. Continue breathing in slowly and deeply and hold for as long as comfortable, then breathe out slowly through pursed lips or your nose. If you are using more than 1 inhalation, wait about 30 seconds. Shake the inhaler again and repeat the above steps. Keep the spray away from your eyes.
- Place the cap over the mouthpiece of the inhaler after use.
- Rinse your mouth with water after using fluticasone/salmeterol inhaler. Do NOT swallow the rinse solution. Spit the rinse water out.
- Clean the inhaler once a week according to the directions in the Medication Guide.
- Do NOT put fluticasone/salmeterol inhaler in water to estimate how much medicine is left in the canister. Fluticasone/salmeterol inhaler is made to deliver either 60 or 120 sprays. Be sure you know how many sprays your canister holds. Keep track of how many sprays you use. Throw fluticasone/salmeterol inhaler away after you have used the appropriate number of sprays, even if the canister is not empty. You may no longer get the right amount of medicine in each spray.
- You may breathe more easily after you use the first dose of fluticasone/salmeterol inhaler; however, it may take 1 week or longer before you get the most benefit.
- Use fluticasone/salmeterol inhaler on a regular schedule to get the most benefit from it. Using fluticasone/salmeterol inhaler at the same time each day will help you remember to use it. Do not stop using fluticasone/salmeterol inhaler even if you feel better unless your doctor tells you to.
- If you miss a dose of fluticasone/salmeterol inhaler, 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 inhaler.
Important safety information:
- Fluticasone/salmeterol inhaler may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use fluticasone/salmeterol inhaler with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Fluticasone/salmeterol inhaler 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 inhaler (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 inhaler. Short-acting bronchodilators are normally used only with fluticasone/salmeterol inhaler to treat breathing problems that may occur between doses.
- Fluticasone/salmeterol inhaler 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 inhaler, check with your doctor.
- Tell your doctor or dentist that you take fluticasone/salmeterol inhaler 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 inhaler in high doses. Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Fluticasone/salmeterol inhaler 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. Tell your doctor about this reaction.
- Use caution if you switch from an oral steroid (eg, prednisone) to fluticasone/salmeterol inhaler. 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 inhaler.
- Diabetes patients - Fluticasone/salmeterol inhaler 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 inhaler. 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 inhaler 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 inhaler.
- Fluticasone/salmeterol inhaler should not be used in CHILDREN younger than 12 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 inhaler while you are pregnant. It is not known if fluticasone/salmeterol inhaler is found in breast milk. If you are or will be breast-feeding while you use fluticasone/salmeterol inhaler, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of fluticasone/salmeterol inhaler:
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 or change in mucus color); swelling or tightness in the throat; symptoms of high blood sugar (eg, confusion; increased thirst, urination, or hunger; unusual weakness or drowsiness); trouble sleeping; unusual tiredness or weakness; vaginal odor or discharge; weight gain; white patches or sores on the tongue or mouth; worsening of asthma symptoms (eg, chest tightness, coughing, increased wheezing, 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, headache, nausea, nervousness, tremor, or trouble sleeping.Proper storage of fluticasone/salmeterol inhaler:
Store fluticasone/salmeterol inhaler at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store the inhaler with the mouthpiece down. Store away from heat, direct sunlight, and open flame. Do not puncture, break, or burn the canister, even if it appears to be empty. Do not store in the bathroom. Keep fluticasone/salmeterol inhaler out of the reach of children and away from pets.
- If you have any questions about fluticasone/salmeterol inhaler, please talk with your doctor, pharmacist, or other health care provider.
- Fluticasone/salmeterol inhaler 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 inhaler 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 inhaler. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to fluticasone/salmeterol inhaler. 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 inhaler.
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.