Fluticasone Propionate (floo-TIK-a-sone PROE-pee-oh-nate), Salmeterol Xinafoate (sal-ME-ter-ol zye-NAF-oh-ate)

Treats and prevents symptoms of asthma and chronic obstructive pulmonary disease (COPD). This medicine contains a corticosteroid.

Brand Name(s):

Advair Diskus, Advair Diskus 100/50, Advair Diskus 250/50, Advair Diskus 500/50, Advair HFA 115/21, Advair HFA 230/21, Advair HFA 45/21, Wixela Inhub

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid Under Pressure, Powder Under Pressure, Disk

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Never use more medicine than your doctor prescribed.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Advair Diskus®:
  • The powder medicine is held in a foil blister package inside the Diskus® inhaler. The Diskus® pokes a hole in each blister one at a time when you push the lever.
  • Do not use a spacer with the Diskus®.
  • Keep the Diskus® inhaler closed when you are not using it. Keep the inhaler dry at all times. Do not blow into it.
  • Before you inhale your dose, breathe out fully, trying to get as much air out of the lungs as possible. Hold the Diskus® level and away from your mouth.
  • Open your mouth and breathe in quickly and deeply through the Diskus®. Do not breathe in through your nose.
  • Remove the Diskus® from your mouth. Hold your breath for about 10 seconds or as long as possible, then breathe out slowly.
  • Throw the inhaler away 1 month after you remove it from the foil pouch or when the dose indicator reaches 0.
• Advair® HFA:
  • You will use this medicine with a device called a metered-dose inhaler. The inhaler fits on the medicine canister and turns the medicine into a fine spray that you breathe in through your mouth and to your lungs. You may be told to use a spacer, which is a tube that is placed between the inhaler and your mouth. Your caregiver will show you how to use your inhaler and the spacer (if needed).
  • Shake the inhaler well just before each use. Avoid spraying this medicine into your eyes.
  • Prime the inhaler before you use it for the first time. Shake well, then spray into the air, away from your face. Shake and spray a total of 4 times. If the inhaler has been dropped or has not been used for more than 4 weeks, do 2 sprays into the air before use.
  • To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece just in front of your mouth with the canister upright.
  • Open your mouth and breathe in slowly and deeply (like yawning), and at the same time firmly press down on the top of the canister once.
  • Hold your breath for about 5 to 10 seconds, and then breathe out slowly.
  • If you are supposed to use more than one puff, wait 1 to 2 minutes before inhaling the second puff. Repeat these steps for the next puff, starting with shaking the inhaler.
  • Clean your inhaler at least once a week.
  • Throw away the inhaler when the dose counter reaches 000.
• Rinse your mouth out with water after you inhale your medicine. Do not swallow the water.
• Airduo™ Respiclick®:
  • You will use this medicine with a device called a metered-dose inhaler. The inhaler fits on the medicine canister and turns the medicine into a fine spray that you breathe in through your mouth and to your lungs. You may be told to use a spacer, which is a tube that is placed between the inhaler and your mouth. Your caregiver will show you how to use your inhaler and the spacer (if needed).
  • Take the inhaler out of the pouch before you use it for the first time.
  • Do not use the inhaler for this medicine with any other medicine.
  • This medicine does not require priming. Do not use it with a spacer or volume holding chamber.
  • Hold the inhaler upright and open the yellow cap all the way until it clicks. Do not open the yellow cap until you are ready to take a dose of this medicine.
  • To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece just in front of your mouth with the canister upright.
  • Inhale slowly.
  • Hold your breath for about 5 to 10 seconds, and then breathe out slowly.
  • Close the yellow cap after each inhalation.
  • Rinse your mouth with water without swallowing after each inhalation.
  • Keep the inhaler dry and clean at all times. Gently wipe the mouthpiece with a dry cloth or tissue as needed.
  • The inhaler has a window that shows the number of doses remaining. This tells you when you are getting low on medicine. The doses counting down from 20 to 0 will show up in red to remind you to refill your prescription. Throw away the inhaler when the dose counter displays 0, 30 days after opening the pouch.
• Missed dose: If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
• Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.
• Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of the used medicine container and any leftover medicine. You will also need to throw away old medicine after the expiration date has passed.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how fluticasone/salmeterol works. Tell your doctor if you are using any of the following:
  • Blood pressure medicine
  • Diuretic (water pill)
  • Medicine to treat depression or an MAO inhibitor within the past 2 weeks (including nefazodone)
  • Medicine to treat HIV or AIDS (including atazanavir, indinavir, nelfinavir, ritonavir, saquinavir)
  • Medicine to treat an infection (including clarithromycin, itraconazole, ketoconazole, telithromycin)
  • Seizure medicine

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, cataracts, diabetes, glaucoma, heart disease, high blood pressure, heart rhythm problems, thyroid problems, seizures, or osteoporosis. Tell your doctor about any immune system problems or infections, including herpes simplex in your eye, tuberculosis, or parasites. Tell your doctor if you have been exposed to chickenpox or measles.
• This medicine may cause the following problems:
  • Increased risk of asthma-related hospital stays, intubations, and death
  • Increased trouble breathing right after use (paradoxical bronchospasm)
  • Increased risk of pneumonia in people who have COPD
  • Increased risk of infection, including fungus infection in the mouth (thrush)
  • Low bone mineral density, which may lead to osteoporosis
  • Cataracts, glaucoma, or other vision problems
  • Slow growth in children
  • Adrenal gland problems
• This medicine will not stop an asthma attack that has already started. You should have another medicine to use in case of an acute asthma attack or COPD flare-up. Tell your doctor right away if your condition gets worse or you need to use your other medicine more often than usual.
• If any of your asthma medicines do not seem to be working as well as usual, call your doctor right away. Do not change your doses or stop using your medicines without asking your doctor.
• Tell any doctor or dentist who treats you that you are using this medicine.
• Call your doctor if your symptoms do not improve or if they get worse.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Changes in skin color, dark freckles, easy bruising, muscle weakness, round or puffy face
• Chest pain, trouble breathing
• Dry mouth, increased thirst, muscle cramps, nausea, vomiting
• Eye pain or trouble seeing
• Fast, pounding, or uneven heartbeat
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Tremors, nervousness, or shaking
• Unusual tiredness or weakness
• Worsening of breathing problems

If you notice these less serious side effects, talk with your doctor:

• Headache
• Hoarseness, voice changes
• White patches inside the mouth or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088