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 Asthma Control Checklist 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.
Selected Important Safety Information About DULERA
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.
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.
Selected Important Safety Information About DULERA
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.
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.
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.
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
Selected Important Safety Information About DULERA
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.
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.
Selected Important Safety Information About DULERA
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.
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 and cataracts. You should have regular eye exams while using DULERA.
Decrease in blood potassium and increase in blood sugar levels.
Selected Important Safety Information About DULERA
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.
Selected Important Safety Information About DULERA
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.
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.
Selected Important Safety Information About DULERA
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.
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.
Selected Important Safety Information About DULERA
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 and cataracts. You should have regular eye exams while using DULERA.
Decrease in blood potassium and increase in blood sugar levels.
Selected Important Safety Information About DULERA
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.
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.
Selected Important Safety Information About DULERA
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.
Selected Important Safety Information About DULERA
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.
>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.
What is DULERA?
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.
Click here for additional Selected Important Safety Information About DULERA.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1.800.FDA.1088.
Please read the Medication Guide for DULERA, including the information about asthma-related death, and discuss it with your doctor. The physician Prescribing Information also is available.
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.
Please read the Medication Guide for DULERA, including the information about asthma-related death, and discuss it with your doctor. The physician Prescribing Information also is available.
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