Complete Prescribing Information and Medication Guide for ADVAIR DISKUS
Important Safety Information About ADVAIR DISKUS
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 (see Bolded Warning).
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ADVAIR helps prevent asthma symptoms from occurring in the first place. Results may vary. ADVAIR is not for, and should not be used to treat, sudden, severe symptoms of asthma. ADVAIR won't replace a rescue inhaler.
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ADVAIR DISKUS is for the treatment of asthma in patients 4 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 helps significantly improve lung function so you can breathe better.*
ADVAIR DISKUS is not for, and should not be used to treat, sudden, severe symptoms of COPD. ADVAIR won’t replace a rescue inhaler.
Get your first full prescription of ADVAIR free†
ADVAIR DISKUS 250/50 is approved for adults with COPD, including chronic bronchitis, emphysema, or both. You should only take 1 inhalation of ADVAIR twice a day. Higher doses will not provide additional benefits.
Important Safety Information About ADVAIR DISKUS
- 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. Always have a rescue inhaler medicine with you to treat sudden symptoms.
- 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
- 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:
- 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, and muscle and bone pain.
*Measured by a breathing test in people taking ADVAIR 250/50, compared with people taking fluticasone propionate 250 mcg or salmeterol 50 mcg. Your results may vary.
†Subject to eligibility. Restrictions apply.
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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