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What is DULERA (mometasone furoate and formoterol fumarate dihydrate)?

DULERA is a prescription medicine used to control symptoms of asthma and prevent symptoms such as wheezing in people 12 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 adolescents 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 adolescents with asthma who need both an ICS and long-acting beta2-adrenergic agonist (LABA) medicine.

 

 
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 and electrocardiogram (ECG) changes. 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.
    • Thrush (yeast infection) in the mouth and 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.
    • 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, and headache.
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.
 

What is DULERA (mometasone furoate and formoterol fumarate dihydrate)?
 

DULERA is a prescription medicine used to control symptoms of asthma and prevent symptoms such as wheezing in people 12 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 adolescents 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 adolescents with asthma who need both an ICS and long-acting beta2-adrenergic agonist (LABA) medicine.

 
 
 
 
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 and electrocardiogram (ECG) changes. 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.
    • Thrush (yeast infection) in the mouth and 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.
    • 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, and headache.
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.