July 30, 2016
Recommended Topic Related To:

Flovent HFA

"The U.S. Food and Drug Administration will complete its phase-out of all inhaler medical products containing chlorofluorocarbons (CFCs) by Dec. 31, 2013. This effort is to comply with an international treaty to protect the ozone layer by phasing "...

A A A

Flovent HFA




PATIENT INFORMATION

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

FLOVENT® HFA 110 mcg
(fluticas one propionate 110 mcg) Inhalation Aerosol

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

Read the Patient Information that comes with FLOVENT HFA Inhalation Aerosol before you start using it and each time you get a refill. There may be new information. This Patient Information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is FLOVENT HFA?

FLOVENT HFA is a prescription inhaled corticosteroid (ICS) medicine for the long-term treatment of asthma in people aged 4 years and older.

  • ICS medicines such as fluticasone propionate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.
  • FLOVENT HFA is not used to relieve sudden breathing problems.
  • It is not known if FLOVENT HFA is safe and effective in children younger than 4 years of age.

Who should not use FLOVENT HFA?

Do not use FLOVENT HFA:

  • to relieve sudden breathing problems
  • if you are allergic to fluticasone propionate or any of the ingredients in FLOVENT HFA. See “What are the ingredients in FLOVENT HFA?” below for a complete list of ingredients.

What should I tell my healthcare provider before using FLOVENT HFA?

Tell your healthcare provider about all of your health conditions , including if you:

  • have liver problems.
  • have weak bones (osteoporosis).
  • have an immune system problem.
  • have eye problems such as glaucoma or cataracts.
  • are allergic to any of the ingredients in FLOVENT HFA or any other medicines. See “What are
  • the ingredients in FLOVENT HFA?” below for a complete list of ingredients.
  • have any type of viral, bacterial, or fungal infection.
  • are exposed to chickenpox or measles.
  • have any other medical conditions.
  • are pregnant or planning to become pregnant. It is not known if FLOVENT HFA may harm your
  • unborn baby.
  • are breastfeeding. It is not known if the medicine in FLOVENT HFA passes into your milk and if it
  • can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-thecounter medicines, vitamins, and herbal supplements. FLOVENT HFA and certain other medicines may interact with each other. This may cause serious side effects. Especially, tell your healthcare provider if you take antifungal or anti-HIV medicines.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use FLOVENT HFA?

Read the step-by-step instructions for using FLOVENT HFA at the end of this Patient Information.

  • Do not use FLOVENT HFA unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
  • Children should use FLOVENT HFA with an adult's help, as instructed by the child's healthcare provider.
  • FLOVENT HFA comes in 3 different strengths. Your healthcare provider has prescribed the strength that is best for you.
  • Use FLOVENT HFA exactly as your healthcare provider tells you to use it. Do not use FLOVENT HFA more often than prescribed.
  • It may take 1 to 2 weeks or longer after you start FLOVENT HFA for your asthma symptoms to get better. You must use FLOVENT HFA regularly.
  • Do not stop using FLOVENT HFA, even if you are feeling better, unless your healthcare provider tells you to.
  • Talk to your healthcare provider right away if you stop using FLOVENT HFA.
  • If you miss a dose of FLOVENT HFA, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at 1 time.
  • FLOVENT HFA does not relieve sudden symptoms . Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
  • Call your healthcare provider or get medical care right away if:
    • your breathing problems get worse.
    • you need to use your rescue inhaler more often than usual.
    • your rescue inhaler does not work as well to relieve your symptoms.
    • you need to use 4 or more inhalations of your rescue inhaler in 24 hours for 2 or more days in a row.
    • you use 1 whole canister of your rescue inhaler in 8 weeks.
    • your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.

What are the possible side effects with FLOVENT HFA?

FLOVENT HFA can cause serious side effects, including:

  • fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using FLOVENT HFA to help reduce your chance of getting thrush.
  • weakened immune system and increased chance of getting infections (immunosuppression).
  • reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an inhaled steroid (such as FLOVENT HFA). When your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse and may cause death.
    Symptoms of adrenal insufficiency include:
  • serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
    • rash
    • hives
    • swelling of your face, mouth, and tongue
    • breathing problems
  • bone thinning or weakness (osteoporosis).
  • slowed growth in children. A child's growth should be checked often.
  • eye problems including glaucoma and cataracts . You should have regular eye exams while using FLOVENT HFA.
  • increased wheezing (bronchospasm). Increased wheezing can happen right away after using FLOVENT HFA. Always have a rescue inhaler with you to treat sudden wheezing.

Common side effects of FLOVENT HFA include:

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

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the side effects with FLOVENT HFA. Ask your healthcare provider or pharmacist for more information.

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

How should I store FLOVENT HFA?

  • Store FLOVENT HFA at room temperature between 68°F and 77°F (20°C and 25°C) with the mouthpiece down.
  • The contents of your FLOVENT HFA inhaler are under pres sure. Do not puncture. Do not use or store near heat or open flame. Temperatures above 120°F may cause the canister to burst.
  • Do not throw into fire or an incinerator.
  • Safely throw away FLOVENT HFA in the trash when the counter reads 000.
  • Keep FLOVENT HFA and all medicines out of the reach of children.

General information about the safe and effective us e of FLOVENT HFA.

Medicines are sometimes prescribed for purposes not mentioned in a Patient Information leaflet. Do not use FLOVENT HFA for a condition for which it was not prescribed. Do not give your FLOVENT HFA to other people, even if they have the same condition that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about FLOVENT HFA. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information about FLOVENT HFA that was written for healthcare professionals.

For more information about FLOVENT HFA, call 1-888-825-5249 or visit our website at www.flovent.com.

What are the ingredients in FLOVENT HFA?

Active ingredient: fluticasone propionate

Inactive ingredient: propellant HFA-134a

Instructions for Use

For Oral Inhalation Only

Your FLOVENT HFA inhaler

  • The metal canister holds the medicine. See Figure A.

Figure A

FLOVENT HFA inhaler - Illustration

  • 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. See Figure B.

Figure B

Dose counter - Illustration

  • 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.
  • Do not 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 dark orange plastic actuator sprays the medicine from the canister. The actuator has a protective cap that covers the mouthpiece. See Figure A. Keep the protective cap on the mouthpiece when the canister is not in use. The strap keeps the cap attached to the actuator.
  • Do not use the actuator with a canister of medicine from any other inhaler.
  • Do not use a FLOVENT HFA canister with an actuator from any other inhaler.

Before using your FLOVENT HFA inhaler

  • The inhaler should be at room temperature before you use it.
  • 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 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.

Priming your FLOVENT HFA 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 1 time into the air away from your face. See Figure C. Avoid s praying in eyes.

Figure C

Spray the inhaler 1 time into the air - Illustration

  • Shake and spray the inhaler like this 3 more times to finish priming it. The counter should now read 120. See Figure D.

Figure D

Counter reading - Illustration

  • You must prime your 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.

How to us e your FLOVENT HFA inhaler

Follow these steps every time you use FLOVENT HFA.

Step 1. Make sure the canister fits firmly in the actuator. The counter should show through the window in the actuator.

Shake the inhaler well for 5 seconds before each spray.

Take the cap off the mouthpiece of the actuator. Look inside the mouthpiece for foreign objects, and take out any you see.

Step 2. Hold the inhaler with the mouthpiece down. See Figure E.

Figure E

Hold the inhaler with the mouthpiece down - Illustration

Step 3. 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. See Figure F.

Figure F

Put the mouthpiece in your mouth and close your lips around it - Illustration

Step 4. Push the top of the canister all the way down while you breathe in deeply and slowly through your mouth. See Figure F.

Step 5. 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.

Step 6. Hold your breath for about 10 s econds, or for as long as is comfortable. Breathe out s lowly as long as you can.

Wait about 30 seconds and shake the inhaler well for 5 seconds. Repeat steps 2 through 6.

Step 7. Rinse your mouth with water after breathing in the medicine. Spit out the water. Do not swallow it. See Figure G.

Figure G

Rinse your mouth - Illustration

Step 8. Put the cap back on the mouthpiece after every time you use the inhaler. Make sure it snaps firmly into place.

Cleaning your FLOVENT HFA inhaler

Clean your inhaler at least 1 time each week after your evening dose. You may not see any medicine build-up on the inhaler, but it is important to keep it clean so medicine build-up will not block the spray. See Figure H.

Figure H

FLOVENT HFA- fluticas one propionate aerosol Figure H Illustration

Step 9. 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.

Step 10. 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 I. Repeat with a new swab dampened with water to take off any medicine still at the opening.

Figure I

Clean the small circular opening - Illustration

Step 11. Wipe the inside of the mouthpiece with a clean tissue dampened with water. Let the actuator air-dry overnight.

Step 12. Put the cap back on the mouthpiece after the actuator has dried.

Replacing your FLOVENT HFA inhaler

  • When the counter reads 020, you should refill your prescription or ask your healthcare provider if you need another prescription for FLOVENT HFA.
  • When the counter reads 000, throw the inhaler away. You should not keep using the inhaler when the counter reads 000 because you may not receive the right amount of medicine.
  • Do not use the inhaler after the expiration date, which is on the packaging it comes in.

For correct us e of your FLOVENT HFA inhaler, remember:

  • The canister should always fit firmly in the actuator.
  • Breathe in deeply and slowly to make sure you get all the medicine.
  • Hold your breath for about 10 seconds after breathing in the medicine. Then breathe out fully.
  • After each dose, rinse your mouth with water and spit it out. Do not swallow the water.
  • Do not take the inhaler apart.
  • Always keep the protective cap on the mouthpiece when your inhaler is not in use.
  • Always store your inhaler with the mouthpiece pointing down.
  • Clean your inhaler at least 1 time each week.

If you have questions about FLOVENT HFA or how to use your inhaler, call GlaxoSmithKline (GSK) at 1-888-825-5249 or visit www.flovent.com.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 7/26/2016
This monograph has been modified to include the generic and brand name in many instances.

Flovent HFA - User Reviews

Flovent HFA User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Flovent HFA sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Allergies & Asthma

Improve treatments & prevent attacks.