Advair

Video Overview: ADVAIR

FDA Black Box Warning

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• Long-acting beta2-adrenergic agonists (LABAs), such as salmeterol, one of the active ingredients in ADVAIR DISKUS, increase the risk of asthma-related death. A US study showed an increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 patients treated for 28 weeks on salmeterol versus 3 out of 13,179 patients on placebo). Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABAs. Available data from controlled clinical trials suggest that LABAs increase the risk of asthma-related hospitalization in pediatric and adolescent patients. 
• When treating patients with asthma, only prescribe ADVAIR DISKUS for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue ADVAIR DISKUS) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use ADVAIR DISKUS for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.

Get emergency medical care if:

• breathing problems worsen quickly and
• you use your rescue inhaler medicine, but it does not relieve your breathing problems.

1. ADVAIR DISKUS 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 inhaled corticosteroids.

2. When your asthma is well controlled, your healthcare provider may tell you to stop taking ADVAIR DISKUS. Your healthcare provider will decide if you can stop ADVAIR DISKUS without loss of asthma control. Your healthcare provider may prescribe a different asthma control medicine for you, such as an inhaled corticosteroid.

3. Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems. People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as salmeterol (one of the medicines in ADVAIR DISKUS), have an increased risk of death from asthma problems. It is not known whether fluticasone propionate, the other medicine in ADVAIR DISKUS, reduces the risk of death from asthma problems seen with salmeterol.

Who should not use ADVAIR DISKUS?

Do not use ADVAIR DISKUS:

• to treat sudden, severe symptoms of asthma or COPD and
• if you have a severe allergy to milk proteins. Ask your doctor if you are not sure.

What should I tell my healthcare provider before using ADVAIR DISKUS?

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

• have heart problems
• have high blood pressure
• have seizures
• have thyroid problems
• have diabetes
• have liver problems
• have osteoporosis
• have an immune system problem
• are pregnant or planning to become pregnant. It is not known if ADVAIR DISKUS may harm your unborn baby.
• are breastfeeding. It is not known if ADVAIR DISKUS passes into your milk and if it can harm your baby.
• are allergic to any of the ingredients in ADVAIR DISKUS, any other medicines, or food products. See the end of this Medication Guide for a complete list of the ingredients in ADVAIR DISKUS.
• are exposed to chickenpox or measles

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. ADVAIR DISKUS and certain other medicines may interact with each other. This may cause serious side effects. Especially, tell your healthcare provider if you take ritonavir. The anti-HIV medicines NORVIR® (ritonavir capsules) Soft Gelatin, NORVIR (ritonavir oral solution), and KALETRA® (lopinavir/ritonavir) Tablets contain ritonavir.

How do I use ADVAIR DISKUS?

• Children should use ADVAIR DISKUS with an adult’s help, as instructed by the child’s healthcare provider.
• Use ADVAIR DISKUS exactly as prescribed. Do not use ADVAIR DISKUS more often than prescribed. ADVAIR DISKUS comes in 3 strengths. Your healthcare provider has prescribed the one that is best for your condition.
• The usual dosage of ADVAIR DISKUS is 1 inhalation 2 times each day (morning and evening). The 2 doses should be about 12 hours apart. 
• Rinse your mouth with water after using ADVAIR DISKUS. This will prevent you from getting an oral/throat yeast infection known as thrush.
• If you take more ADVAIR DISKUS than your doctor has prescribed, get medical help right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.
• If you miss a dose of ADVAIR DISKUS, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at one time. Do not use a spacer device with ADVAIR DISKUS.
• Do not breathe into ADVAIR DISKUS.
• While you are using ADVAIR DISKUS 2 times each day, do not use other medicines that contain a LABA for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.
• Do not stop using ADVAIR DISKUS or other asthma medicines unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.
• ADVAIR DISKUS does not relieve sudden symptoms. Always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have an inhaled, short-acting bronchodilator, call your healthcare provider to have one prescribed for you.

Call your healthcare provider or get medical care right away if:

• your breathing problems worsen with ADVAIR DISKUS
• you need to use your rescue inhaler medicine more often than usual
• your rescue inhaler medicine does not work as well for you at relieving symptoms
• you need to use 4 or more inhalations of your rescue inhaler medicine for 2 or more days in a row
• you use 1 whole canister of your rescue inhaler medicine in 8 weeks’ time
• your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.
• you have asthma and your symptoms do not improve after using ADVAIR DISKUS regularly for 1 week

What are the possible side effects with ADVAIR DISKUS?

ADVAIR DISKUS can cause serious side effects, including:

1. 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
2. effects on heart:
   • increased blood pressure
   • a fast and irregular heartbeat
   • chest pain
3. effects on nervous system
   • tremor
   • nervousness
4. reduced adrenal function (may result in loss of energy)
5. changes in blood (sugar, potassium, certain types of white blood cells)
6. weakened immune system and a higher chance of infections
7. lower bone mineral density. This may be a problem for people who already have a higher chance of low bone density (osteoporosis).
8. eye problems including glaucoma and cataracts. You should have regular eye exams while using ADVAIR DISKUS.
9. slowed growth in children. A child’s growth should be checked often.
10. pneumonia. People with COPD have a higher chance of getting pneumonia. ADVAIR DISKUS may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of the following symptoms:

• increase in mucus (sputum) production
• change in mucus color
• fever
• chills
• increased cough
• increased breathing problems

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

How do I store ADVAIR DISKUS?

• Store ADVAIR DISKUS at room temperature between 68°F to 77°F (20°C to 25°C). Keep in a dry place away from heat and sunlight.
• Safely discard ADVAIR DISKUS 1 month after you remove it from the foil pouch, or after the dose indicator reads “0”, whichever comes first.
• Keep ADVAIR DISKUS and all medicines out of the reach of children.

What are the ingredients in ADVAIR DISKUS?

Active ingredients: fluticasone propionate, salmeterol xinafoate
Inactive ingredient: lactose (contains milk proteins)

Reviewed by:	Review Date:
Joseph V. Madia, MD	Friday, June 17, 2011

Source: FDA