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-agonist (LABA) medicine.
DULERA combines an inhaled corticosteroid medicine (ICS), mometasone furoate, and a long-acting beta2-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.
Mometasone furoate and formoterol fumarate dihydrate are both powders. When you “puff” (inhale) a dose of DULERA, the medicine enters your lungs as a spray. 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, including:
- Thrush in the mouth and throat. You may develop thrush, a yeast infection (Candida albicans), in your mouth or throat. After each dose of DULERA (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.
- Immune system effects and a higher chance for infections. Signs of infection may include:
- fever
- nausea
- chills
- feeling tired
- body aches
- pain
- vomiting
- Adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines and start inhaled corticosteroid medicines.
- Increased wheezing right after taking DULERA. Always have a rescue inhaler with you to treat sudden wheezing.
- Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
- rash
- swelling, including swelling of the face, mouth, and tongue
- hives
- breathing problems
- Using too much of a LABA medicine may cause:
- chest pain
- a fast and irregular heartbeat
- tremor
- dizziness
- seizures
- increased or decreased blood pressure
- headache
- nervousness
- weakness
- electrocardiogram (ECG) changes
- 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. A child’s growth should be checked often.
- Eye problems including glaucoma, cataracts, and blurred vision. You should have regular eye exams while using DULERA.
- Decreases in blood potassium levels (hypokalemia).
- Increases in blood sugar levels (hyperglycemia).
The most common side effects reported while using DULERA include:
- inflammation of the nose and throat (nasopharyngitis)
- inflammation of the sinuses (sinusitis)
- headache
- flu
- upper respiratory infection
Tell your healthcare provider about any side effect that bothers you or that does not go away.
These are not all the side effects of 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 Organon LLC., a subsidiary of Organon & Co., at 1-844-674-3200.
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.