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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Asthma & Your Lungs
Airway constriction and inflammation are the two main causes of asthma symptoms. Both make your airways narrow and can make it harder to breathe.
- Airway constriction (which you may feel as shortness of breath or hear as wheezing) is the tightening of the muscles around the airways of your lungs.
- Airway inflammation (which you may not feel) is the swelling of the airways.
Patients with asthma are more sensitive to triggers, like pet dander or cigarette smoke. When exposed to these triggers, their lungs react by getting narrower, or constricting. Airway constriction means less air is getting to the lungs. It can feel like breathing through a straw. This can lead to asthma symptoms like wheezing or shortness of breath.
Is there more you can do to help manage asthma symptoms? If you are 12 years of age or older, the ASTHMA CONTROL TEST™* will provide a score that you should share with your healthcare provider to help assess your treatment plan.
*ASTHMA CONTROL TEST is a trademark of QualityMetric Incorporated.
Approved Uses for ADVAIR DISKUS
ADVAIR DISKUS is for the treatment of asthma in patients 4 years and older. ADVAIR is available by prescription only.
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.
Important Safety Information About ADVAIR DISKUS® (fluticasone propionate and salmeterol inhalation powder)
- 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 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.
- 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 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.
Next: Asthma Symptoms
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