Frequently Asked Questions (FAQs) About DULERA® (mometasone furoate and formoterol fumarate dihydrate)Frequently Asked Questions (FAQs) About DULERA® (mometasone furoate and formoterol fumarate dihydrate)

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 healthcare provider.

DULERA (mometasone furoate and formoterol fumarate dihydrate) is a prescription medicine that may help control symptoms of asthma and prevent symptoms such as wheezing in people 5 years of age and older.

DULERA is not used to relieve sudden breathing problems and will not replace a rescue inhaler.

DULERA is not for adults and children with asthma who are well controlled with an asthma control medicine, such as a low to medium dose inhaled corticosteroid (ICS) medicine. DULERA is for adults and children with asthma who need both an ICS and long-acting beta2-adrenergic agonist (LABA) medicine.

DULERA combines an inhaled corticosteroid medicine (ICS), mometasone furoate, and a long-acting beta2-adrenergic agonist medicine (LABA), formoterol.

ICS medicines such as mometasone furoate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.

LABA medicines such as formoterol help the muscles around the airways in your lungs stay relaxed to prevent asthma symptoms, such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten, making it hard to breathe.

DULERA is taken twice daily every day. DULERA should be taken every day as 2 puffs in the morning and 2 puffs in the evening.

  • Mometasone furoate is an inhaled corticosteroid—ICS for short. Inhaled corticosteroids help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.
  • Formoterol fumarate is a long-acting beta2-agonist—LABA for short. LABA medicines help the muscles around the airways in your lungs stay relaxed to prevent asthma symptoms, such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe.

DULERA contains formoterol. LABA medicines such as formoterol when used alone increase the risk of hospitalizations and death from asthma problems. DULERA contains an ICS and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.

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 (2 puffs), rinse your mouth with water. Spit out the water. Do not swallow it.

DULERA is a prescription medicine that may help control symptoms of asthma and prevent symptoms such as wheezing in people 5 years of age and older. DULERA is not for adults and children with asthma who are well controlled with an asthma control medicine, such as a low to medium dose ICS medicine. DULERA is for adults and children with asthma who need both an ICS and LABA medicine.

Do not use DULERA to treat sudden severe symptoms of asthma, as a rescue inhaler, or if you are allergic to any of the ingredients in DULERA. See the end of the Patient Information for a list of ingredients in DULERA.

Yes. DULERA is available in 3 dosage strengths. DULERA 50 mcg/5 mcg is available for children aged 5 to less than 12 years. DULERA 100 mcg/5 mcg or DULERA 200 mcg/5 mcg are available for adults and adolescents 12 years of age and older. Your healthcare provider will decide which dosage strength is right for you.

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

DULERA may cause serious side effects. To learn more, please see Possible Side Effects.

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

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

Do not use DULERA unless your healthcare provider has taught you and you understand how to use it. 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 3 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.

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.

Do not change or stop using DULERA or other asthma medicines used to control or treat your breathing problems unless told to do so by your healthcare provider. Your healthcare provider will change your medicines as needed.

DULERA is a prescription medicine that may help control symptoms of asthma and prevent symptoms such as wheezing in people 5 years of age and older. DULERA is for adults and children with asthma who need both an ICS and LABA medicine. Only your healthcare provider can decide if DULERA is right for you.

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 68°F to 77°F (20°C to 25°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.

It contains 120 actuations (puffs), 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.

Yes. Rinse your mouth with water after each dose (2 puffs) of DULERA. Spit out the water. Do not swallow it. This will help to lessen the chance of getting a yeast infection (thrush) in the mouth and throat.


Selected Important Safety Information about DULERA

DULERA contains formoterol. LABA medicines such as formoterol when used alone increase the risk of hospitalizations and death from asthma problems. DULERA contains an ICS and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.

  • 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.

Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.

DULERA does not replace rescue inhalers for sudden asthma symptoms. Always have a rescue inhaler medicine with you to treat sudden symptoms.

Do not use DULERA more often than prescribed. Do not take DULERA with other medicines that contain a LABA for any reason, as using too much LABA may cause chest pain, increase or decrease in blood pressure, fast and irregular heartbeat, headache, tremor, nervousness, dizziness, weakness, seizures, electrocardiogram (ECG) changes, or death. Tell your doctor about medicines you take and about all of your medical conditions.

People taking DULERA may experience

  • Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of these symptoms of a serious allergic reaction: rash, hives, swelling, including swelling of the face, mouth and tongue, or breathing problems.
  • Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of these symptoms of a serious allergic reaction: rash, hives, swelling, including swelling of the face, mouth and tongue, or breathing problems.
  • Thrush (yeast infection) in the mouth and throat. After each dose (2 puffs), rinse your mouth with water. Spit out the water. Do not swallow it. This will help to prevent thrush in your mouth or throat.
  • A higher chance of infection. Avoid exposure to chickenpox or measles. If exposed, or if you have any signs of infection, tell your healthcare provider immediately. Worsening of existing tuberculosis, fungal, bacterial, viral or parasitic infections, or ocular herpes simplex may occur.
  • A higher chance of infection. Avoid exposure to chickenpox or measles. If exposed, or if you have any signs of infection, tell your healthcare provider immediately. Worsening of existing tuberculosis, fungal, bacterial, viral or parasitic infections, or ocular herpes simplex may occur.
  • Reduced adrenal function (may result in loss of energy). This can happen when you stop taking oral corticosteroid medicines and start inhaled corticosteroid medicines.
  • Increase in wheezing right after taking DULERA.
  • Lower bone mineral density. This may be a problem for people who already have a higher chance for low bone density (osteoporosis).
  • Slowed growth in children.
  • Eye problems including glaucoma, cataracts, and blurred vision. You should have regular eye exams while using DULERA.
  • Decrease in blood potassium and increase in blood sugar levels.

If you are switching to DULERA from an oral corticosteroid, follow your healthcare provider’s instructions to avoid serious health risks when you stop using oral corticosteroids.

The most common side effects of DULERA include inflammation of the nose and throat, inflammation of the sinuses, headache, flu, and upper respiratory infection.

You are encouraged to report the negative side effects of prescription drugs to the FDA.Visit www.fda.gov/medwatch or call 1.800.FDA.1088.

Please read the Patient Information for DULERA and discuss it with your doctor. The physician Prescribing Information also is available.


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