Advair Diskus

Fluticasone/salmeterol

For Asthma

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Track record

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Long (approved in 2000)

Special FDA warning?

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Yes - FDA requires black box warning

Bottom line

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Asthma

What is Asthma?

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Asthma is a chronic disease that causes inflammation or narrowing of the airways that carry the air you breathe in and out of your lungs.

Other treatments for Asthma

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Non-drug

Over-the-counter

Prescription

TABLE OF CONTENTS

Overview

FDA-approved use

To treat asthma symptoms not adequately controlled on long-term asthma medicines such as steroid inhalers in adults and children age 4 and older

Advair Diskus is NOT approved to treat asthma attacks including severe prolonged attacks (status asthmaticus) or if asthma is rapidly worsening (for example, you need increasing doses of your short acting inhaler). Do not use Advair Diskus if asthma is well controlled on long-term asthma medicines such as steroid inhalers. Once asthma is controlled, Advair Diskus should be reduced and discontinued if possible due to the chance of asthma-related death from salmeterol, a long-acting beta agonist (LABA) which is a component of Advair Diskus.

Who might consider taking it?

Adults and children age 4 and older with severe asthma not adequately controlled with long-term medicines such as steroid inhalers

Only use Advair Diskus for asthma that is severe and persistent enough to need treatment with both an inhaled steroid and a long-acting beta agonist.

What is not known

No specific issues

Track record

LONG TRACK RECORD

Long track record means that new‚ unexpected side effects are unlikely. Advair Diskus was approved by FDA in 2000. Since Advair Diskus has now been used by large numbers of people over a long time‚ the emergence of rare but serious side effects is less likely than with new drugs.

Open questions

No FDA-required studies at approval

Do not take if you...

Do not use Advair Diskus to treat asthma attacks including severe prolonged attacks (status asthmaticus) or if your asthma is getting rapidly worse (for example, you need increasing doses of your rescue inhaler)

Are allergic to milk proteins

Are allergic to Advair diskus or its ingredients

Take other medicines containing long-acting beta agonists (LABA)

Due to chance of overdose

Safe if pregnant or breastfeeding?

Pregnant

Only take if potential benefits outweigh potential harm to baby (FDA Category C)

Breastfeeding

Be cautious about breastfeeding - unknown if Advair Diskus gets into breast milk

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