FLOVENT® HFA 44 mcg (fluticasone propionate 44 mcg) Inhalation Aerosol

Important Safety Information for FLOVENT

FLOVENT does not relieve sudden symptoms of asthma. Always have a rescue inhaler with you to treat sudden symptoms.
See full Important Safety Information below

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FAQs

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

FLOVENT is not used to relieve sudden breathing problems. FLOVENT won’t replace a rescue inhaler.

Ask your healthcare provider if FLOVENT is right for you.

For RISKS & SIDE EFFECTS for FLOVENT, click here.



FLOVENT helps prevent asthma symptoms by reducing inflammation in the airways of the lungs. Your results may vary.

Asthma is a long-term, chronic disease of the airways of the lungs characterized by two main causes: airway constriction and inflammation. Together, they cause narrowing of the airways, which results in symptoms such as wheezing and shortness of breath. FLOVENT is not for, and should not be used to treat, sudden symptoms of asthma. FLOVENT won't replace a rescue inhaler. Always have a fast-acting bronchodilator medicine (rescue inhaler) with you to treat sudden symptoms.

FLOVENT is a long-term asthma control medicine for appropriate patients with asthma who are 4 years of age or older and whose symptoms are not well controlled on a rescue inhaler. Ask your doctor if FLOVENT is right for you.

Taken twice daily as directed, FLOVENT can help prevent symptoms before they start because it helps reduce airway inflammation, an underlying cause of asthma symptoms. Your results may vary. FLOVENT does not relieve sudden symptoms of asthma. Always have a fast-acting bronchodilator medicine (rescue inhaler) with you to treat sudden symptoms.

This is not all the safety information about FLOVENT. For more information, please see the complete Prescribing Information and Patient Information Leaflet for FLOVENT DISKUS and FLOVENT HFA, and ask your healthcare provider or pharmacist.

FLOVENT can cause serious side effects, including:

  • fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using FLOVENT to help reduce your chance of getting thrush.
  • weakened immune system and increased chance of getting infections (immunosuppression). You should avoid exposure to chickenpox and measles, and, if exposed, tell your healthcare provider right away. Worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or herpes infection of the eye (ocular herpes simplex) may occur.
  • reduced adrenal function. This can happen when you stop taking an oral corticosteroid (such as prednisone) and start taking a medicine containing an inhaled corticosteroid (such as FLOVENT). 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:
    • feeling tired
    • lack of energy
    • weakness
    • nausea and vomiting
    • low blood pressure
  • 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, throat, 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.
  • increased wheezing (bronchospasm). Increased wheezing can happen right away after using FLOVENT. Always have a rescue inhaler with you to treat sudden wheezing.

Common side effects of FLOVENT DISKUS include:

  • upper respiratory tract infection
  • throat irritation
  • nausea and vomiting
  • fever
  • headache

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 possible side effects with FLOVENT. Ask your healthcare provider or pharmacist for more information.

Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

If you have asthma, airway inflammation is always there whether you have symptoms or not. Take FLOVENT as prescribed by your healthcare provider. Do not stop using FLOVENT even if you are feeling better, unless your healthcare provider tells you to do so, because your symptoms might get worse. Your healthcare provider will change your medicines as needed.

FLOVENT DISKUS is a product that you inhale to help prevent your asthma symptoms from occurring in the first place. Take FLOVENT twice a day, every day, approximately 12 hours apart, as prescribed by your healthcare provider. Learn how to use FLOVENT DISKUS.

FLOVENT HFA is a product that you inhale to help prevent your asthma symptoms from occurring in the first place. Take FLOVENT twice a day, every day, approximately 12 hours apart, as prescribed by your healthcare provider. Learn how to use 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. Repeat with a new swab dampened with water to take off any medicine still at the opening.
  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.

No. FLOVENT is not for, and should not be used to treat, sudden symptoms of asthma. FLOVENT does not replace a rescue inhaler. Always have a fast-acting bronchodilator medicine (rescue inhaler) with you to treat sudden symptoms.

FLOVENT HFA is a metered-dose inhaler that comes in 3 strengths. Only the lowest strength is approved for use in children aged 4 to 11 years.

FLOVENT DISKUS is a dry powder inhaler that comes in 3 strengths. Only the 2 lowest strengths are approved for use in children aged 4 to 11 years.

FLOVENT is not approved for use in children younger than 4 years of age.

FLOVENT is available by prescription only.

Your healthcare provider will determine which strength is best for you or your child.

  • Store FLOVENT DISKUS at room temperature between 68°F and 77°F (20°C and 25°C). Keep in a dry place away from heat and sunlight.
  • Store FLOVENT DISKUS in the unopened foil pouch and only open when ready for use.
  • Safely throw away FLOVENT DISKUS 50 mcg in the trash 6 weeks after you open the foil pouch or when the counter reads 0, whichever comes first.
  • Safely throw away FLOVENT DISKUS 100 mcg and FLOVENT DISKUS 250 mcg in the trash 2 months after you open the foil pouch or when the counter reads 0, whichever comes first.
  • Keep FLOVENT DISKUS and all medicines out of the reach of children.

Store FLOVENT HFA at room temperature between 59°F and 86°F (15°C-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.

FLOVENT DISKUS contains lactose. Do not use FLOVENT DISKUS if you have severe allergy to milk proteins. Ask your healthcare provider if you are not sure.

FLOVENT HFA does NOT contain lactose.

Thrush is the overgrowth of candida, a fungus, in the mouth. It can occur when the normal balance of bacteria in your mouth is altered. Thrush is treatable, and there are things you can do to help prevent it. If you take FLOVENT, make sure to rinse your mouth with water after taking the medicine and spit the water out. Do not swallow it.

GSK offers multiple programs to help patients afford their medicine. To learn more about these programs, please go to www.GSKforYou.com.

Inhaled corticosteroids like FLOVENT can cause serious side effects, including slow growth in children. The growth of children using FLOVENT should be checked regularly.

Approved Uses for FLOVENT

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

FLOVENT is not used to relieve sudden breathing problems. FLOVENT won't replace a rescue inhaler.

Important Safety Information for FLOVENT

  • FLOVENT does not relieve sudden symptoms of asthma. Always have a rescue inhaler with you to treat sudden symptoms.
  • Do not use FLOVENT DISKUS if you have a severe allergy to milk proteins. Do not use FLOVENT DISKUS or FLOVENT HFA if you are allergic to fluticasone propionate or any of the ingredients in the products. Ask your healthcare provider if you are not sure.
  • Tell your healthcare provider about all the medicines you take and about all of your health conditions.
  • Do not use FLOVENT more often than prescribed.
  • Do not stop using FLOVENT, even if you are feeling better, unless your healthcare provider tells you to. If you miss a dose of FLOVENT, just take your next dose at your usual time. Do not take 2 doses at 1 time.
  • FLOVENT can cause serious side effects, including:
    • fungal infections in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using FLOVENT to help reduce your chance of getting thrush.
    • weakened immune system and increased chance of getting infections (immunosuppression). You should avoid exposure to chickenpox and measles, and, if exposed, tell your healthcare provider right away. Worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or herpes infection of the eye (ocular herpes simplex) may occur.
    • reduced adrenal function. This can happen when you stop taking an oral corticosteroid (such as prednisone) and start taking a medicine containing an inhaled corticosteroid (such as FLOVENT). 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:
      • feeling tired
      • lack of energy
      • weakness
      • nausea and vomiting
      • low blood pressure
    • 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, throat, 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.
    • increased wheezing (bronchospasm). Increased wheezing can happen right away after using FLOVENT. Always have a rescue inhaler with you to treat sudden wheezing.
  • Common side effects of FLOVENT DISKUS include:
    • upper respiratory tract infection
    • throat irritation
    • nausea and vomiting
    • fever
    • headache
  • Common side effects of FLOVENT HFA include:
    • a cold or upper respiratory tract infection
    • throat irritation
    • headache
    • fever
    • diarrhea
    • ear infection

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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