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Frequently Asked Questions (FAQs) About DULERA

Here are some answers to frequently asked questions.

If you need more information about DULERA, here are some answers to frequently asked questions. However, this does not replace talking to your doctor.

Q. What is DULERA?
Q. What does DULERA do?
Q. What are the 2 medicines in DULERA?
Q. Is the medicine inside a DULERA inhaler a powder or a spray?
Q. Who should use DULERA?
Q. Who should not use DULERA?
Q. Does DULERA come in different dose strengths?
Q. Will DULERA replace my rescue inhaler?
Q. What are the side effects of DULERA?
Q. How should I use DULERA?
Q. What do I do if I miss a dose?
Q. How long do I keep taking DULERA?
Q. How can I find out if DULERA is right for me?
Q. How do I store DULERA?
Q. How often do I have to refill DULERA?
Q. Do I need to rinse my mouth after using DULERA?

Q. What is DULERA?

A. DULERA is an inhaled medicine used to control and prevent asthma symptoms such as wheezing in people 12 and older.
DULERA is not a rescue inhaler and should not be used as a treatment for sudden asthma symptoms.
DULERA is not for people who are well controlled on a long-term asthma control medicine like a low to medium dose of an inhaled corticosteroid medicine, or who only need a rescue inhaler once in a while.

Q. What does DULERA do?

A. DULERA is an FDA-approved inhaler for people 12 and older that you use every day to help control and prevent asthma symptoms. It is NOT a rescue inhaler.

In a research study of asthma patients 12 years of age and older, those using DULERA experienced a significant improvement in lung function. This was demonstrated over a 6-month clinical study. Over the 6-month clinical research study, 70% of the people taking DULERA 100 mcg/5 mcg did not have an asthma flare-up*—compared to 66% taking mometasone furoate 100 mcg, 46% taking formoterol 5 mcg alone and 44% of patients using an inhaler containing only placebo (the placebo inhaler did not contain medicine).

*Flare-up defined as an important reduction in lung function that may last 2 or more consecutive days, emergency treatment, hospitalization, or treatment with certain additional asthma medications.

Q. What are the 2 medicines in DULERA?

A. DULERA is an FDA-approved inhaler that combines 2 medicines that treat asthma. DULERA contains an inhaled corticosteroid called mometasone furoate and a long-acting beta2-agonist medicine (LABA) called formoterol fumarate dihydrate.

Q. Is the medicine inside a DULERA inhaler a powder or a spray?

A. When you "puff" (inhale) a dose of DULERA, the medicine enters your lungs as a spray. It is not a powder. After you finish taking a dose of DULERA, always rinse your mouth with water.

Q. Who should use DULERA?

A. You and your doctor can decide on the right daily "controller" medicine for you. DULERA is for people aged 12 years and older whose asthma is not well controlled by another asthma control medicine. DULERA is NOT a rescue inhaler. If your asthma is under control and you need a rescue inhaler only once in a while, DULERA is not right for you.

Q. Who should not use DULERA?

A. Do not use DULERA to treat sudden severe symptoms of asthma or if you are allergic to any of the ingredients in DULERA. See the end of the Medication Guide for a list of ingredients in DULERA.

Q. Does DULERA come in different dose strengths?

A. Yes. DULERA is available in 2 dose strengths. Your doctor will decide which dose strength is right for you.

Q. Will DULERA replace my rescue inhaler?

A. No, DULERA is not a rescue inhaler and should not be used to treat sudden asthma symptoms.

Q. What are the side effects of DULERA?

A. DULERA can cause serious side effects. To learn more please see Possible Side Effects.
Get emergency care if breathing problems worsen and you use your rescue inhaler medicine, but it does not relieve your breathing problems.

Q. How should I use DULERA?

A. Do not use DULERA unless your healthcare provider has taught you how to use it properly. Ask your healthcare provider or pharmacist if you have any questions.

Use DULERA exactly as prescribed. Do not use DULERA more often than prescribed. DULERA comes in 2 strengths. Your healthcare provider has prescribed the strength that is best for you. Note the differences between DULERA and your other inhaled medications, including the differences in prescribed use and physical appearance. DULERA should be taken every day as 2 puffs in the morning and 2 puffs in the evening. For a step-by-step guide see Using Your DULERA Inhaler.

Q. What do I do if I miss a dose?

A. If you miss a dose of DULERA, skip your missed dose and take your next dose at your regular time. Do not take DULERA more often or use more puffs than you have been prescribed.

Q. How long do I keep taking DULERA?

A. DULERA is not an inhaler you start and stop. To be effective, you need to use it regularly. Don't change or stop using DULERA except as directed by your doctor. If your asthma is well controlled your doctor may tell you to stop taking DULERA and may prescribe a different long-term asthma control medicine like an inhaled corticosteroid.

Q. How can I find out if DULERA is right for me?

A. Only your doctor can decide if DULERA is right for you. Completing the My 6-Month Asthma Story is a great way to give your doctor a detailed picture of your asthma symptoms over the past 6 months to help determine which prescription medicines are right for you.

Q. How do I store DULERA?

A. The 120-actuation inhaler can be stored in any position. For the 60-actuation inhaler, after priming, store the inhaler with the mouthpiece down or sideways. Store DULERA at room temperature between 59°F to 86°F (15°C to 30°C). The contents of your DULERA are under pressure. Do not puncture. Do not use or store near heat or open flame. Storage above 120°F may cause the canister to burst. Do not throw container into fire or incinerator. Keep DULERA and all medicines out of the reach of children.

Q. How often do I have to refill DULERA (120-puff inhaler)?

A. Your DULERA inhaler will last about 1 month of regular use. It contains 120 doses, enough for 2 puffs in the morning and 2 puffs at night for 30 days. When the counter reads 20, you should refill your prescription or ask your doctor if you need a new prescription for DULERA. Throw away DULERA after the counter reaches 0, indicating that you have used the number of actuations on the product label and box. Your inhaler may not feel empty and it may continue to operate, but you will not get the right amount of medicine if you keep using it.

Q. Do I need to rinse my mouth after using DULERA?

A. Yes. Rinse your mouth with water after each dose (2 puffs) of DULERA. This will help to lessen the chance of getting a yeast infection (thrush) in the mouth and throat.