DULERA- mometasone furoate and formoterol fumarate aerosol 
Merck Sharp & Dohme Corp.

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Medication Guide

DULERA® [dew-LAIR-ah] 100 mcg/5 mcg
(mometasone furoate 100 mcg and formoterol fumarate dihydrate 5 mcg) Inhalation Aerosol
DULERA® 200 mcg/5 mcg
(mometasone furoate 200 mcg and formoterol fumarate dihydrate 5 mcg) Inhalation Aerosol

Read the Medication Guide that comes with DULERA® before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about DULERA?

DULERA can cause serious side effects, including:

1.
People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines such as formoterol (one of the medicines in DULERA), have an increased risk of death from asthma problems. It is not known whether mometasone furoate, the other medicine in DULERA, reduces the risk of death from asthma problems seen with formoterol.
  • Call your healthcare provider if breathing problems worsen over time while using DULERA. 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.
2.
DULERA 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.
3.
When your asthma is well controlled, your healthcare provider may tell you to stop taking DULERA. Your healthcare provider will decide if you can stop DULERA without loss of asthma control. Your healthcare provider may prescribe a different long-term asthma-control medicine for you, such as an inhaled corticosteroid.
4.
Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.

What is DULERA?

DULERA combines an inhaled corticosteroid medicine, mometasone furoate (the same medicine found in ASMANEX TWISTHALER), and a long-acting beta2-agonist medicine (LABA), formoterol (the same medicine found in FORADIL® AEROLIZER®).

DULERA is used to control symptoms of asthma and prevent symptoms such as wheezing in people 12 years of age and older.

DULERA should not be used as a rescue inhaler.

DULERA contains formoterol (the same medicine found in FORADIL AEROLIZER). LABA medicines such as formoterol increase the risk of death from asthma problems.

DULERA is not for children and adults with asthma who:

It is not known if DULERA is safe and effective in children less than 12 years of age.

Who should not use DULERA?

Do not use DULERA:

What should I tell my healthcare provider before using DULERA?

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

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. DULERA and certain other medicines may interact with each other. This may cause serious side effects.

Especially, tell your healthcare provider if you take antifungal medicines, such as ketoconazole, or anti-HIV medicines, such as ritonavir. The anti-HIV medicines NORVIR® (ritonavir capsules) Soft Gelatin, NORVIR® (ritonavir oral solution), and KALETRA® (lopinavir/ritonavir) Tablets contain ritonavir.

Know the medicines you take. Keep a list and show it to your healthcare provider and pharmacist each time you get a new medicine.

How should I use DULERA?

See the step-by-step instructions for using DULERA at the end of this Medication Guide. Do not use DULERA unless your healthcare provider has taught you and you understand everything. Ask your healthcare provider or pharmacist if you have any questions.

What are the possible side effects of DULERA?

DULERA can cause serious side effects, including:

The most common side effects of DULERA include:

Other side effects:

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the side effects with DULERA. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231.

How do I store DULERA?

General Information about DULERA

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DULERA for a condition for which it was not prescribed. Do not give your DULERA to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about DULERA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about DULERA that was written for healthcare professionals. For more information about DULERA, go to www.DULERA.com or call 1-800-622-4477.

What are the ingredients in DULERA?

Active ingredients: mometasone furoate and formoterol fumarate dihydrate

Inactive ingredients: hydrofluoroalkane (HFA-227), anhydrous alcohol and oleic acid

Revised: 04/2014
 
Merck Sharp & Dohme Corp.