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Approved Uses for ADVAIR for Asthma

ADVAIR DISKUS is for the treatment of asthma in patients 4 years and older. ADVAIR® HFA (fluticasone propionate and salmeterol) Inhalation Aerosol is for the treatment of asthma in patients
12 years and older.

ADVAIR should be used only if your healthcare provider decides that your asthma is not well controlled with a long-term asthma control medicine, such as an inhaled corticosteroid.

ADVAIR is not for, and should not be used to treat, sudden, severe symptoms of asthma. ADVAIR won’t replace a rescue inhaler.

ADVAIR HFA is not approved for the treatment of COPD.

Approved Uses for ADVAIR DISKUS 250/50 for COPD

ADVAIR DISKUS 250/50 is approved for adults with COPD, including chronic bronchitis, emphysema, or both.

ADVAIR DISKUS is not for, and should not be used to treat, sudden, severe symptoms of COPD. ADVAIR won't replace a rescue inhaler.

You should only take 1 inhalation of ADVAIR twice a day. Higher doses will not provide additional benefits.















 

























The brands listed, with the exceptions of ADVAIR DISKUS, ADVAIR HFA, FLOVENT DISKUS, FLOVENT HFA, and VENTOLIN HFA, are trademarks of their respective owners and are not trademarks of the GlaxoSmithKline group of companies. The makers of these brands are not affiliated with and do not endorse GlaxoSmithKline or its products.











The brands listed are trademarks of their respective owners and are not trademarks of the GlaxoSmithKline group of companies. The makers of these brands are not affiliated with and do not endorse GlaxoSmithKline or its products.










Important Safety Information About ADVAIR DISKUS® (fluticasone propionate and salmeterol inhalation powder) and ADVAIR® HFA (fluticasone propionate and salmeterol) Inhalation Aerosol

  • People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as salmeterol (one of the medicines in ADVAIR), have an increased risk of death from asthma problems. It is not known whether fluticasone propionate, the other medicine in ADVAIR, reduces the risk of death from asthma problems seen with salmeterol.
    • Call your healthcare provider if breathing problems worsen over time while using ADVAIR. You may need different treatment.
    • Get emergency medical care if:
      • breathing problems worsen quickly and
      • you use your rescue inhaler medicine, but it does not relieve your breathing problems.
  • ADVAIR should be used only if your healthcare provider decides that your asthma is not well controlled with a long-term asthma control medicine, such as an inhaled corticosteroid.
  • When your asthma is well controlled, your healthcare provider may tell you to stop taking ADVAIR. Your healthcare provider will decide if you can stop ADVAIR without loss of asthma control. Your healthcare provider may prescribe a different asthma control medicine for you, such as an inhaled corticosteroid.
  • Children and adolescents with asthma who take LABA medicines may have an increased risk of hospitalization for asthma problems.
  • Do not use ADVAIR to treat sudden, severe symptoms of asthma or COPD. Always have a rescue inhaler medicine with you to treat sudden symptoms.
  • Do not use ADVAIR if you are allergic to any of the ingredients in ADVAIR. Do not use ADVAIR DISKUS if you have severe allergy to milk proteins. Ask your doctor if you are not sure.
  • Do not use ADVAIR more often than prescribed. Do not take ADVAIR with other medicines that contain a LABA for any reason. Tell your doctor about medicines you take and about all of your medical conditions.
  • ADVAIR DISKUS can cause serious side effects, including:
    • 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 the face, mouth, and tongue
      • breathing problems
    • sudden breathing problems immediately after inhaling your medicine
    • effects on heart
      • increased blood pressure
      • a fast and irregular heartbeat
      • chest pain
    • effects on nervous system
      • tremor
      • nervousness
    • reduced adrenal function (may result in loss of energy)
    • changes in blood (sugar, potassium, certain types of white blood cells)
    • weakened immune system and a higher chance of infections. You should avoid exposure to chickenpox and measles, and, if exposed, consult your healthcare provider without delay. Worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex may occur.
    • lower bone mineral density. This may be a problem for people who already have a higher chance of low bone density (osteoporosis).
    • eye problems including glaucoma and cataracts. You should have regular eye exams while using ADVAIR.
    • slowed growth in children. A child’s growth should be checked often.
    • pneumonia. People with COPD have a higher chance of getting pneumonia. ADVAIR may increase the chance of getting pneumonia. Call your doctor if you notice any of the following symptoms:
      • increase in mucus (sputum) production
      • change in mucus color
      • fever
      • chills
      • increased cough
      • increased breathing problems
    • ADVAIR HFA can cause throat tightness.
  • Common side effects of ADVAIR DISKUS for asthma include:
    • upper respiratory tract infection
    • throat irritation
    • hoarseness and voice changes
    • thrush in the mouth and throat
    • bronchitis
    • cough
    • headache
    • nausea and vomiting

In children with asthma, infections in the ear, nose, and throat are common.

  • Common side effects of ADVAIR DISKUS 250/50 for COPD include:
    • thrush in the mouth and throat
    • throat irritation
    • hoarseness and voice changes
    • viral respiratory infections
    • headache
    • muscle and bone pain
  • Common side effects of ADVAIR HFA for asthma include:
    • upper respiratory tract infection
    • throat irritation
    • hoarseness and voice changes
    • headache
    • dizziness
    • nausea and vomiting

Complete Prescribing Information and Medication Guide for ADVAIR DISKUS


Complete Prescribing Information and Medication Guide for ADVAIR HFA

Approved Uses for FLOVENT® DISKUS® 50 mcg (fluticasone propionate inhalation powder, 50 mcg) and FLOVENT® HFA 44 mcg (fluticasone propionate 44 mcg) Inhalation Aerosol

Prescription FLOVENT is for patients with asthma 4 years of age and older. FLOVENT is not for, and should not be used to treat, sudden symptoms of asthma. FLOVENT won't replace a rescue inhaler.

Important Safety Information About FLOVENT

  • Do not use FLOVENT:
    • to treat sudden symptoms of asthma. FLOVENT is not a rescue inhaler and should not be used to give you fast relief from your asthma attack. Always use a rescue inhaler, such as albuterol, during a sudden asthma attack.
    • if you are allergic to any of the ingredients in FLOVENT or other inhaled corticosteroids. Do not use FLOVENT DISKUS if you have severe allergy to milk proteins or fluticasone propionate. Ask your doctor if you are not sure.
  • Tell your doctor about the medicines you take and about all of your medical conditions. Do not stop taking FLOVENT, even if you are feeling better, unless your doctor tells you to. If you miss a dose, just take your next scheduled dose when it is due. Do not take 2 doses at the same time unless your doctor tells you to. If you are not sure about your dosing, call your doctor.
  • If you have not had or have not been vaccinated against chickenpox, measles, or active tuberculosis, you should stay away from people who are infected. You should avoid exposure to chickenpox, measles, and tuberculosis. If exposed, consult your healthcare provider without delay.
  • FLOVENT 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.
    • 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 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 should be checked regularly.
    • eye problems including glaucoma and cataracts. Tell your doctor about any vision changes while using FLOVENT. Your doctor may tell you to have your eyes checked.
    • increased wheezing (bronchospasm). Increased wheezing can happen right away after using FLOVENT. Always have a rescue inhaler with you to treat sudden wheezing.
  • The most common side effects of FLOVENT DISKUS include:
    • a cold or upper respiratory tract infection
    • throat irritation
    • nausea and vomiting
    • fever
    • headache
  • The most common side effects of FLOVENT HFA include:
    • a cold or upper respiratory tract infection
    • throat irritation
    • headache
    • fever
    • diarrhea
    • ear infection


Approved Uses for VENTOLIN® HFA (albuterol sulfate) Inhalation Aerosol 90 mcg

VENTOLIN HFA is a prescription medicine used to treat or prevent bronchospasm in people 4 years of age and older with reversible obstructive airway disease. VENTOLIN HFA is also used to prevent exercise-induced bronchospasm (EIB) in patients 4 years of age and older. It is not known if VENTOLIN HFA is safe and effective in children under 4 years of age.

Important Safety Information About VENTOLIN HFA

  • Do not use VENTOLIN HFA if you are allergic to albuterol sulfate or any of the ingredients in VENTOLIN HFA. If you have any questions or are not sure, you should ask your healthcare provider.
  • Tell your healthcare provider about the medicines you take and about all of your medical conditions.
  • Use VENTOLIN HFA exactly as your healthcare provider tells you to use it.
  • Do not increase your dose or take extra doses of VENTOLIN HFA without first talking to your healthcare provider.
  • Get medical help right away if VENTOLIN HFA no longer helps your symptoms (like wheezing and trouble breathing), if your symptoms get worse, or if you need to use your inhaler more often.
  • While you are using VENTOLIN HFA, use other inhaled medicines and asthma medicines only as directed by your healthcare provider.
  • VENTOLIN HFA may cause serious side effects, including:
    • worsening trouble breathing, coughing, and wheezing (paradoxical bronchospasm). If this happens, stop using VENTOLIN HFA and call your healthcare provider or get emergency help right away. This is more likely to happen with your first use of a new canister of medicine.
    • heart problems, including faster heart rate and higher blood pressure.
    • possible death in people with asthma who use too much VENTOLIN HFA.
    • allergic reactions. Call your healthcare provider right away if you have any of the following symptoms of an allergic reaction:
      • itchy skin
      • swelling beneath your skin or in your throat
      • rash
      • worsening trouble breathing
    • low potassium levels in your blood.
    • worsening of other medical problems in people who also use VENTOLIN HFA, including increases in blood sugar.
  • Common side effects of VENTOLIN HFA include:
    • your heart feels like it is pounding or racing (palpitations)
    • chest pain
    • fast heart rate
    • shakiness
    • nervousness
    • headache
    • pain
    • dizziness
    • sore throat
    • runny nose

Complete Prescribing Information and Patient Information for VENTOLIN HFA