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FLOVENT® HFA 44 mcg
[flo' vent]
(fluticasone propionate 44 mcg) Inhalation Aerosol

FLOVENT® HFA 110 mcg
(fluticasone propionate 110 mcg) Inhalation Aerosol

FLOVENT® HFA 220 mcg
(fluticasone propionate 220 mcg) Inhalation Aerosol

FOR ORAL INHALATION ONLY

Read this leaflet carefully before you start to use FLOVENT HFA Inhalation Aerosol.

Keep this leaflet because it has important summary information about FLOVENT HFA. This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about something, you should ask your doctor or pharmacist.

Read the new leaflet that comes with each refill of your prescription because there may be new information.

What is FLOVENT HFA?

FLOVENT HFA contains a medicine called fluticasone propionate, which is a synthetic corticosteroid. Corticosteroids are natural substances found in the body that help fight inflammation. Corticosteroids are used to treat asthma because they reduce airway inflammation.

FLOVENT HFA is used to treat asthma in patients 4 years and older. When inhaled regularly, FLOVENT HFA also helps to prevent symptoms of asthma.

FLOVENT HFA comes in 3 strengths. Your doctor has prescribed the one that is best for your condition.

Who should not use FLOVENT HFA?

Do not use FLOVENT HFA if you:

• are allergic to any of the ingredients in FLOVENT HFA or other inhaled corticosteroids. See “What are the ingredients in FLOVENT HFA?” below.
• have an acute asthma attack or status asthmaticus. FLOVENT HFA is not a bronchodilator and should not be used to give you fast relief from your breathing problems during an asthma attack. Always use a short-acting bronchodilator (rescue medicine), such as albuterol inhaler, during a sudden asthma attack. You must take FLOVENT HFA at regular times as recommended by your doctor, and not as an emergency medicine.

What should I tell my doctor before taking FLOVENT HFA?

Tell your doctor if you:

• have liver problems.
• have been exposed to chickenpox or measles.
• have any other medical conditions.
• are pregnant or planning to become pregnant. It is not known if FLOVENT HFA will harm
• unborn baby.
• are breastfeeding a baby. It is not known if FLOVENT HFA passes into your breast milk.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. FLOVENT HFA may affect the way other medicines work, and other medicines may affect how FLOVENT HFA works. Especially, tell your doctor if you take:

• a medicine containing ritonavir (commonly used to treat HIV infection or AIDS). The anti HIV medicines NORVIR® (ritonavir capsules) Soft Gelatin, NORVIR (ritonavir oral solution), and KALETRA® (lopinavir/ritonavir) tablets contain ritonavir.
• any other corticosteroid medicines.
• ketoconazole (NIZORAL®), an antifungal medicine.

How should I use FLOVENT HFA?

1. It is important that you inhale each dose as your doctor has prescribed. The prescription label provided by your pharmacist will usually tell you what dose to take and how often. If it doesn't or if you aren't sure, ask your doctor or pharmacist. DO NOT inhale more doses or use your FLOVENT HFA more often than your doctor has prescribed.
2. It may take 1 to 2 weeks or longer for this medicine to work, and it is very important that you use it regularly. Do not stop taking FLOVENT HFA, even if you are feeling better, unless your doctor tells you to.
3. If you miss a dose, just take your next scheduled dose when it is due. Do not double the dose.
4. Your doctor may prescribe additional medicine (such as fast-acting bronchodilators) for emergency relief if a sudden asthma attack occurs. Contact your doctor if:
   • an asthma attack does not respond to the additional medicine or
   • you need more of the additional medicine than usual.
5. If you also use another medicine by inhalation, you should ask your doctor for instructions on when to use it while you are also using FLOVENT HFA.
6. Children should use FLOVENT HFA with an adult's help, as instructed by the child's healthcare provider. A valved holding chamber (a kind of spacer) and face mask may be used to deliver FLOVENT HFA to young patients.

What should I avoid while taking FLOVENT HFA?

If you have not had or not been vaccinated against chickenpox, measles, or active tuberculosis, you should stay away from people who are infected.

What are the possible side effects of FLOVENT HFA?

FLOVENT HFA can cause serious side effects, including:

• fungal infections (thrush) in your mouth and throat. Tell your doctor if you have any redness or white-colored coating in your mouth
• decreased ability to fight infections. Symptoms of infection may include: fever, pain, aches, chills, feeling tired, nausea and vomiting. Tell your doctor about any signs of infection while you use FLOVENT HFA.
• decreased adrenal function (adrenal insufficiency). Symptoms of decreased adrenal function include tiredness, weakness, nausea and vomiting, and low blood pressure. Decreased adrenal function can lead to death
• allergic reaction (anaphylaxis). Call your doctor and stop FLOVENT HFA right away if you have any symptoms of an allergic reaction:
  • swelling of the face, throat and tongue
  • hives
  • rash
  • breathing problems
• lower bone mineral density. This may be a problem for people who already have a higher chance of low bone density (osteoporosis).
• slow growth in children. The growth of children using FLOVENT HFA should be checked regularly.
• eye problems including glaucoma and cataracts. Tell your doctor about any vision changes while using FLOVENT HFA. Your doctor may tell you to have your eyes checked.
• increased wheezing (bronchospasm). Increased wheezing can happen right away after using FLOVENT HFA. Always have a rescue inhaler with you to treat sudden wheezing.

Tell your doctor right away if you have any of the serious side effects listed above or if you have worsening lung symptoms.

The most common side effects of FLOVENT HFA include:

• a cold or upper respiratory tract infection
• throat irritation
• headache
• fever
• diarrhea
• ear infection

Tell your doctor if you have any side effects that bother you or that do not go away. These are not all the possible side effects of FLOVENT HFA. For more information ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or 1-800-332-1088.

How should I store FLOVENT HFA?

Store FLOVENT HFA at room temperature between 59°and 86°F (15°-30°C). Store the inhaler with the mouthpiece down. For best results, the inhaler should be at room temperature before use.

Keep FLOVENT HFA and all medicines out of the reach of children.

This Patient Information leaflet summarizes the most important information about FLOVENT HFA. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or doctor for information about FLOVENT HFA that is written for health professionals. You can also contact the company that makes FLOVENT HFA (toll free) at 1 888-825-5249.

What are the ingredients in FLOVENT HFA?

Active ingredient: fluticasone propionate (micronized)

Inactive ingredient: propellant HFA-134a

Instructions for Using FLOVENT HFA

The parts of your FLOVENT HFA

There are 2 main parts to your FLOVENT HFA inhaler—the metal canister that holds the medicine and the dark orange plastic actuator that sprays the medicine from the canister (see Figure 1).

The canister has a counter to show how many sprays of medicine you have left. The number shows through a window in the back of the actuator. The counter starts at 124. The number will count down by 1 each time you spray the inhaler. The counter will stop counting at 000.

Figure 1

Never try to change the numbers or take the counter off the metal canister. The counter cannot be reset, and it is permanently attached to the canister.

The mouthpiece of the actuator is covered by a cap. A strap on this cap keeps it attached to the actuator.

Do not use the actuator with a canister of medicine from any other inhaler. And do not use a FLOVENT HFA canister with an actuator from any other inhaler.

Using your FLOVENT HFA

• The inhaler should be at room temperature before you use it.
• Take your FLOVENT HFA inhaler out of the moisture-protective foil pouch just before you use it for the first time. Safely throw away the foil pouch and the drying packet that comes inside the pouch.
• Priming the inhaler:
  Before you use FLOVENT HFA for the first time, you must prime the inhaler so that you will get the right amount of medicine when you use it. To prime the inhaler, take the cap off the mouthpiece and shake the inhaler well for 5 seconds. Then spray the inhaler into the air away from your face. Avoid spraying in eyes. Shake and spray the inhaler like this 3 more times to finish priming it. The counter should now read 120.
  You must prime the inhaler again if you have not used it in more than 7 days or if you drop it. Take the cap off the mouthpiece and shake the inhaler well for 5 seconds. Then spray it 1 time into the air away from your face.

• If a child needs help using the inhaler, an adult should help the child use the inhaler with or without a valved holding chamber, which may also be attached to a face mask. The adult should follow the instructions that came with the valved holding chamber. An adult should watch a child use the inhaler to be sure it is used correctly.

Read the following 7 steps before using FLOVENT HFA and follow them at each use. If you have any questions, ask your doctor or pharmacist.

1. Take the cap off the mouthpiece of the actuator (see Figure 2).

Look inside the mouthpiece for foreign objects, and take out any you see.

Make sure the canister fits firmly in the actuator.

Shake the inhaler well for 5 seconds.

2. Hold the inhaler with the mouthpiece down (see Figure 2). Breathe out through your mouth and push as much air from your lungs as you can. Put the mouthpiece in your mouth and close your lips around it.

Figure 2

3. Push the top of the canister all the way down while you breathe in deeply and slowly through your mouth (see Figure 3).

Figure 3

Right after the spray comes out, take your finger off the canister. After you have breathed in all the way, take the inhaler out of your mouth and close your mouth.

4. Hold your breath as long as you can, up to 10 seconds. Then breathe normally.

5. Wait about 30 seconds and shake the inhaler well for 5 seconds. Repeat steps 2 through 4.

6. After you finish taking this medicine, rinse your mouth with water. Spit out the water. Do not swallow it.

7. Put the cap back on the mouthpiece after each time you use the inhaler. Make sure it snaps firmly into place.

Cleaning your FLOVENT HFA

Clean the inhaler at least once a week after your evening dose. It is important to keep the canister and plastic actuator clean so the medicine will not build-up and block the spray.

1. Take the cap off the mouthpiece. The strap on the cap will stay attached to the actuator. Do not take the canister out of the plastic actuator.

2. Use a clean cotton swab dampened with water to clean the small circular opening where the medicine sprays out of the canister. Gently twist the swab in a circular motion to take off any medicine (see Figure 4). Repeat with a new swab dampened with water to take off any medicine still at the opening.

Figure 4

3. Wipe the inside of the mouthpiece with a clean tissue dampened with water. Let the actuator air-dry overnight.

4. Put the cap back on the mouthpiece after the actuator has dried.

Replacing your FLOVENT HFA

• When the counter reads 020, you should refill your prescription or ask your doctor if you need a refill of your prescription.
• When the counter reads 000, throw the inhaler away. You should not keep using the inhaler because you will not receive the right amount of medicine.
• Do not use the inhaler after the expiration date, which is on the packaging it comes in.

Last reviewed on RxList: 9/6/2011
This monograph has been modified to include the generic and brand name in many instances.