Dulera
No generic available
Prevents asthma attacks in adults and children 5 years and older
Off-label may be used to control COPD symptoms in adults
Inhaled corticosteroid (ICS)/long-acting beta-agonist (LABA)
Metered dose inhaler (MDI)
Inhaled through the mouth into the lungs
Dulera is an inhaler that can be used to treat asthma in adults and children 5 years of age and older. Dulera contains two ingredients:
Mometasone furoate is an inhaled corticosteroid (ICS). It works by decreasing inflammation in the lungs.
Formoterol fumarate is a long-acting beta-agonist (LABA) or bronchodilator. It works by relaxing and opening up the airways in the lungs, making it easier to breathe. LABA medicines used alone can increase the risk of hospitalizations and deaths due to asthma, but by combining a LABA with a steroid, as in Dulera, there is not a significant increased risk of hospitalizations and deaths due to asthma.
Off-label prescribing is when a healthcare provider prescribes a medication for a use that is not FDA-approved. Dulera is sometimes prescribed off-label for breathing problems due to chronic obstructive pulmonary disease (COPD) in adults.
Dulera is a prescription medication used to treat asthma in adults and children 5 years and older. It is sometimes used off-label in adults to control COPD symptoms. However, Dulera is not a rescue inhaler and will not help if you are having an asthma attack or exacerbation.
Dulera contains two ingredients: mometasone, a steroid, and formoterol, a long-acting bronchodilator. Together they help decrease inflammation in the lungs and relax the airways, making it easier to breathe.
Make sure your healthcare provider is aware of all your medical conditions, allergies to medications, and the medications you take, before taking Dulera.
Always rinse your mouth with water (and then spit; do not swallow) after using Dulera. This helps prevent fungal infections of the mouth and throat.
Be sure you understand how to properly prime, use, and store your Dulera inhaler. Ask your healthcare provider or pharmacist if you have any questions or concerns.
Inhaler
50-5 micrograms (mcg)/actuation (act)
100-5 mcg/act
200-5 mcg/act
Adults and adolescents 12 years and older:
Dulera 100 mcg/5 mcg or 200 mcg/5 mcg (starting dose will depend on the severity of symptoms): 2 puffs by mouth twice a day
Children age 5 years old to less than 12 years old:
Dulera 50 mcg/5 mcg: 2 puffs by mouth twice a day
Dulera
13gm of 100-5mcg/act inhaler
Dulera
13gm of 200-5mcg/act inhaler
Dulera
13gm of 50-5mcg/act inhaler
Dulera
8.8gm of 100-5mcg/act inhaler
Dulera
8.8gm of 200-5mcg/act inhaler
Take your medicine as directed. Your dose may need to be changed by your healthcare provider to find what works best for you. Follow your healthcare provider’s instructions carefully.
Before using Dulera, read the patient information leaflet that comes with your prescription and ask your healthcare provider or pharmacist if you have any questions.
Remove the cap from the mouthpiece of the inhaler.
Before you use this inhaler for the first time, shake the inhaler well and prime it by pointing it away from your face and spraying it into the air 4 times. If the inhaler has not been used for 5 days or longer, prime it again.
Inhalation route:
This device is called a metered-dose inhaler. The inhaler fits on the medicine canister and turns the medicine into a fine spray that you breathe in through your mouth and to your lungs. You may be told to use a spacer, which is a tube that is placed between the inhaler and your mouth. Your healthcare provider will show you how to use your inhaler and the spacer (if needed).
Store Dulera at room temperature, away from heat, direct light, and moisture. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.
If your inhaler contains 120 inhalations, you can store it in any orientation. However, for the 60-inhalation inhaler, store it with the mouthpiece down or in a horizontal position.
To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece just in front of your mouth with the canister upright.
Open your mouth and breathe in slowly and deeply, and at the same time, firmly press down on the top of the canister once.
Hold your breath for about 5 to 10 seconds, and then breathe out slowly through your nose, keeping the lips closed.
Wait at least 30 seconds before inhaling the second puff.
When you have finished, rinse your mouth out with water and spit. Do not swallow the water. This helps prevent a yeast infection of the mouth and throat.
Clean the inhaler with a dry wipe once a week.
Dispose of the inhaler when the counter reads "0", even if it feels like it still has medicine in it.
Do not remove the canister from the actuator.
Always shake the inhaler right before you spray it.
If you miss a dose, take the next dose at the regularly scheduled time. Do not take extra medicine to make up for a missed dose.
This medicine is not right for everyone. Do not use this medicine if you have had an allergic reaction to mometasone or formoterol. Do not use this medicine if your asthma attack has already started, or if you are in status asthmaticus.
Tell your doctor if you are pregnant or breastfeeding, or if you have any medical conditions, including liver disease, heart or blood vessel disease (including aneurysm), heart rhythm problems, high blood pressure, or seizures. Tell your doctor if you have diabetes, adrenal gland problems, bone problems (including osteoporosis), cataracts, glaucoma, thyroid problems, tuberculosis, immune system problems, or any type of infection.
This should not be the first and only medicine you use for asthma. This medicine will not stop an asthma attack that has already started. Your doctor will prescribe another medicine for you to use in case of an acute asthma attack (a rescue inhaler such as albuterol).
This medicine may cause the following problems:
Increased blood sugar levels
Decrease in bone mineral density, which can lead to weak bones
Glaucoma or cataracts
Higher risk of infection due to immune suppression (tell your doctor if you are exposed to chickenpox or measles)
Hypokalemia (low potassium levels in the blood)
Fungus infections in the mouth or throat (rinse and spit with water after each use to help prevent infections; do not swallow the water after rinsing)
Problems with the adrenal gland
Slowed growth in children (children who use steroid medication will be closely monitored for growth)
This medicine helps prevent asthma attacks for most people, but some people may have worsening symptoms when they use it. Talk to your doctor about what you should do if this happens.
If any of your asthma medicines do not seem to be working as well as usual, call your doctor right away. Do not change your doses or stop using your medicines without asking your doctor.
Make sure any doctor or dentist who treats you knows that you are using this medicine.
Keep all medicine out of the reach of children. Never share your medicine with anyone, even if they have the same symptoms.
Always tell your healthcare provider about all the medications you take, including prescription and OTC drugs, vitamins, and supplements. While taking Dulera, do not start any new medication unless approved by your healthcare provider.
This medicine should not be used with arformoterol, budesonide/formoterol, formoterol, or salmeterol inhalers.
Some medicines can affect how mometasone or formoterol works. Consult your doctor for medical advice if you are using atazanavir, clarithromycin, itraconazole, ketoconazole, nelfinavir, ritonavir, saquinavir, oral corticosteroid medicines (such as dexamethasone, methylprednisolone, prednisolone, or prednisone), a diuretic (water pill), or a beta-blocker blood pressure medicine.
Make sure your doctor knows if you have used an MAO inhibitor—or a tricyclic antidepressant, such as amitriptyline, within the past 2 weeks.
Some of the most common side effects of Dulera include:
Headache
Sinus infection
Symptoms of a cold or flu
Hoarse voice
Fungal infections of the mouth and throat may occur. Rinse and spit with water (do not swallow) after each use of Dulera to help prevent these infections.
Serious side effects
Serious allergic reactions are rare. Symptoms such as hives, difficulty breathing or swallowing, or swelling of the face, lips, tongue, or throat, require emergency medical care.
Other rare but serious side effects may include, but are not limited to:
Paradoxical bronchospasm (worsening of asthma symptoms)
High blood pressure
Chest pain
Irregular heartbeat
High blood sugar
Low potassium levels in the blood
Some serious side effects, which are rare, are more likely to occur with long-term use of Dulera, such as:
Adrenal gland problems
Immune system suppression
Cataracts (clouding of the lens of the eye)
Glaucoma (increased pressure in the eye)
Osteoporosis
Growth problems in children
Consult your healthcare professional for more information about the potential side effects of Dulera.
Dulera, National Library of Medicine DailyMed (2023)
Dulera, Prescribers’ Digital Reference
COPD Control Drugs, National Library of Medicine MedlinePlus (2022)
Dulera, Medical Professionals Reference (2023)
Mometasone inhaled/formoterol (Rx), Medscape
Mometasone; formoterol metered dose inhaler (MDI), Cleveland Clinic (2023)
After receiving her doctorate from the University of Pittsburgh School of Pharmacy, Karen Berger, Pharm.D., has worked in both chain and independent community pharmacies. She currently works at an independent pharmacy in New Jersey. Dr. Berger enjoys helping patients understand medical conditions and medications—both in person as a pharmacist, and online as a medical writer and reviewer.
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