Advair Diskus

Fluticasone/salmeterol

For COPD

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Track record

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Long (approved in 2003)

Special FDA warning?

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Yes - FDA requires black box warning

Bottom line

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COPD

What is COPD?

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COPD, or chronic obstructive pulmonary disease, is a progressive disease that makes it hard to breathe. Cigarette smoking is the leading cause of COPD. Medication can help open the airways and make it easier to breathe.

Other treatments for COPD

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Non-drug

Over-the-counter

Prescription

TABLE OF CONTENTS

Overview

FDA-approved use

To treat symptoms of COPD such as persistent cough and breathlessness and to prevent flare-ups (worsening of symptoms for several days).

Advair Diskus is NOT approved to treat attacks of wheezing

Who might consider taking it?

Adults with COPD (chronic lung diseases including chronic bronchitis and emphysema)

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 originally approved by FDA for asthma in 2000 and approved for COPD in 2003. Since Advair Diskus has now been used by large numbers of people over a long time‚ the emergence of important 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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