Dulera
Dulera (mometasone / formoterol) is an inhaler that's used for the maintenance treatment of asthma in adults and children. It's a combination medication containing an inhaled corticosteroid (ICS) and a long-acting beta agonist (LABA) that work together to help make breathing easier. Dulera (mometasone / formoterol) is inhaled through the mouth twice per day. But the specific dosage depends on how old you are and how severe your asthma symptoms are. Side effects include common cold symptoms and headache. This medication isn't available as a lower-cost generic yet.
What is Dulera (mometasone / formoterol)?
What is Dulera (mometasone / formoterol) used for?
- Maintenance treatment of asthma in people ages 5 years and older
How Dulera (mometasone / formoterol) works
Dulera (mometasone / formoterol) is a combination of two medications that work together to help treat asthma symptoms.
- Mometasone is an inhaled corticosteroid (ICS). It's thought to work directly in your lungs to lessen inflammation and swelling in your airways. This helps make it easier for you to breathe.
- Formoterol is a long-acting beta agonist (LABA). It works by relaxing the muscles in your lungs. This opens up your airways so that you can breathe more easily.
Drug facts
More on Dulera (mometasone / formoterol) essentials
Side effects of Dulera (mometasone / formoterol)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Sore throat, stuffy nose, and other symptoms of the common cold (5%)
- Headache (up to 5%)
- Pressure in the sinuses and other symptoms of a sinus infection (up to 3%)
Less Common Side Effects
- Chest pain
- Blurry vision
Dulera (mometasone / formoterol) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious allergic reaction: hives; rash; itchy skin; flushed skin; swelling of the face, lips, or tongue; difficulty breathing
- Sudden narrowing of your airways: difficulty breathing, wheezing, chest pain or tightness, cough
- Changes to stress hormone levels: weight gain around your gut, puffiness of the face, muscle weakness in arms or legs, easy bruising, stretch marks around the belly, tiredness, mood changes, nausea, vomiting
- Heart problems: dizziness, fatigue, weakness, rapid heartbeat
More on Dulera (mometasone / formoterol) side effects
The following Dulera (mometasone / formoterol) side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
headache
muscle aches
pain or tenderness around the eyes and cheekbones
stuffy or runny nose
tightness of the chest
troubled breathing
unusual tiredness or weakness
Rare
Sore mouth or tongue
white patches in the mouth or on the tongue
Incidence not known
Blindness
blurred vision
cough or hoarseness
creamy white, curd-like patches in the mouth or throat
darkening of the skin
decreased vision
dizziness
fainting
fever or chills
loss of appetite
lower back or side pain
mental depression
nausea or vomiting
pain when eating or swallowing
painful or difficult urination
skin rash
tearing
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
Voice changes
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Pros and cons of Dulera (mometasone / formoterol)
Pros
- Works well to improve lung function and lessen asthma symptoms
- Combines two different asthma medications into a single inhaler for convenience
- Can use with a spacer if you have trouble using the inhaler
Cons
- Doesn't replace your rescue inhaler
- Need to inhale 2 puffs twice daily for it to work well
- Can raise your risk for infections
Pharmacist tips for Dulera (mometasone / formoterol)
- Use Dulera (mometasone / formoterol) twice daily at the same times every day. This medication works best if it's taken regularly every day.
- Use a rescue inhaler such as albuterol (Ventolin) if you have sudden trouble breathing during an asthma attack. Dulera (mometasone / formoterol) won't treat an asthma attack as it's happening.
- Call your prescriber if your breathing or peak flow meter results worsen. Also contact your care team if you need to use your rescue inhaler more often than usual. These could be signs that you need some treatment changes to help manage your asthma better.
- Don't use Dulera (mometasone / formoterol) more often than recommended. Otherwise, your risk is higher for side effects like nervousness, headache, a racing heart, tremor (shakiness), dizziness, and trouble sleeping.
How to use the Dulera (mometasone / formoterol) inhaler:
- Dulera (mometasone / formoterol) inhalers are color coded based on dosage strength. The 50 mcg/5 mcg inhaler is blue, the 100 mcg/5 mcg inhaler is yellow, and the 200 mcg/5 mcg inhaler is purple. Be sure you know which strength you have and what your dose is. Your dose might change or you might get prescribed a new inhaler with a different strength depending on how well your asthma is improving.
- Prime the Dulera (mometasone / formoterol) inhaler before you use a new inhaler for the first time or before you use your inhaler when you haven't used it in more than 5 days. To prime the inhaler, hold it upright and and spray 4 times into the air away from your face. Shake the inhaler well between each test spray.
- Shake the Dulera (mometasone / formoterol) inhaler well before every puff. Breathe out through your mouth as much as you can before you place your lips firmly around the mouthpiece. Then, take a slow and deep breath through your mouth as you push the button on the top of the canister to get the medication out. Try to hold your breath for up to 10 seconds or for as long as you comfortably can. This allows time for the medication to reach deep into your lungs.
- Wait at least 30 seconds between each puff of Dulera (mometasone / formoterol).
- Rinse your mouth with water and then spit after you take your 2 puffs of Dulera (mometasone / formoterol) for each dose. This helps lower the risk for thrush (fungal infection) in the mouth and throat.
- There's a dose counter on the Dulera (mometasone / formoterol) inhaler. Use this counter to keep track of when you need to get a refill.
- How to clean Dulera (mometasone / formoterol): Wipe the mouthpiece of the inhaler with a clean, dry tissue at least once a week. Don't use water to clean any part of the inhaler.
- How to store Dulera (mometasone / formoterol): Keep Dulera (mometasone / formoterol) at room temperature. The inhaler either contains 60 or 120 puffs (actuations). Keep the 60-actuation inhaler with the mouthpiece down or sideways. You can place the 120-actuation inhaler in any position.
Common questions about Dulera
No. Dulera is still available by prescription from a healthcare professional.
Yes. Dulera is a combination medication that contains an inhaled steroid called mometasone as one of its ingredients. Mometasone helps you breathe better by lessening swelling and inflammation in your lungs. The other ingredient in Dulera is formoterol, a long-acting beta-agonist (LABA) that relaxes the muscles of your airways to open up your lungs. Mometasone and formoterol work together to control symptoms of asthma to help you breathe better.
Dulera is a maintenance inhaler that's taken twice per day every day. It works over time to lessen inflammation and swelling in your lungs and open your airways. Rescue inhalers typically refer to short-acting inhalers, like albuterol (Ventolin), because they're used to relieve asthma attacks quickly. There's new research suggesting that low-dose Dulera can be used as both a maintenance inhaler and a rescue inhaler for certain people, a concept called single maintenance and reliever therapy (SMART). But SMART is still a new idea that isn't FDA approved yet. Don't use Dulera as a rescue inhaler unless your prescriber specifically instructs you to do so.
Yes. You should take Dulera every day to improve your asthma and your lung function in the long run. At the same time, you can use albuterol (Ventolin) whenever you need to treat an asthma attack (sudden trouble breathing). You can take albuterol (Ventolin) at any time; it doesn't matter when you last used your Dulera inhaler.
Dulera contains mometasone and formoterol. It can take about 5 days for most of mometasone and about 2 days for most of formoterol to leave your body after an inhalation of Dulera. This time frame is estimated based on the half-life of each medication in Dulera. But keep in mind that you need to take Dulera twice per day every day for it to work well for your asthma.
There isn't an exact date yet for when a generic version of Dulera will be available. Speak with your prescriber if you need resources to help cover the cost of this medication. Your prescriber can also discuss lower-cost alternatives, such as the generic version of Symbicort (budesonide / formoterol) or Advair (fluticasone / salmeterol).
Each new Dulera inhaler contains 120 puffs. This means one inhaler will last for 30 days. There's a smaller version of the inhaler typically used as a sample that contains 60 puffs, which lasts for 15 days. Look for the dose counter on the back of the inhaler. This dose counter helps you keep track of how many puffs you have left with the inhaler. Make sure to request a refill in a timely manner before your inhaler runs out so you don't miss any doses.
Dulera isn't FDA approved to treat chronic obstructive pulmonary disease (COPD). There are other combination inhalers approved for COPD that contain an inhaled corticosteroid (ICS) and a long-acting beta agonist (LABA), just like Dulera. Keep in mind that ICS/LABA combination inhalers aren't typically recommended for COPD because there are other COPD inhalers that studies show improve asthma better. Speak with your healthcare team about possible COPD treatments for you.
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Risks and warnings for Dulera (mometasone / formoterol)
Dulera (mometasone / formoterol) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Not for use for asthma attack or worsening breathing
Don't use Dulera (mometasone / formoterol) if you're having an asthma attack because this medication won't provide relief right away. Use a rescue inhaler, such as albuterol (Ventolin), if you're having trouble breathing.
Let your prescriber know if you're using your rescue inhaler more often than usual because this could mean that your asthma is getting worse. Don't use more doses of Dulera (mometasone / formoterol) than recommended because it won't improve your breathing. Rather, it can raise your risk for side effects, such as heart problems, tremors, and dizziness.
Fungal infection in the mouth (oral thrush)
- Risk factors: Not rinsing and spitting after using Dulera (mometasone / formoterol) | Weakened immune system from medical conditions or medications
Dulera contains mometasone, a steroid medication. When inhaled through the mouth, steroids can cause a fungal infection in the mouth and throat called thrush. Rinse your mouth with water and spit after each time you use Dulera (mometasone / formoterol) to lower your risk for thrush.
Tell your prescriber if you notice symptoms of thrush, like white patches in your mouth, cotton-like feeling in your mouth, pain while eating or swallowing, or loss of taste. You might need to take medication to treat thrush. Sometimes, you might need to temporarily stop Dulera (mometasone / formoterol) until the thrush goes away.
Sudden narrowing of your airways (bronchospasm)
Inhaled medications, including Dulera (mometasone / formoterol), can sometimes cause a muscle spasm in your lungs (bronchospasm). This can lead to difficulty breathing, wheezing, cough, and chest discomfort right away you inhale the medication. These breathing problems can be life-threatening. Use your rescue inhaler and get medical help right away if you have a hard time breathing right after you inhale Dulera (mometasone / formoterol).
Higher risk of infections
Like all corticosteroid-containing medications, Dulera (mometasone / formoterol) can weaken your immune system. As a result, it can raise your risk for infections, including upper respiratory infections and pneumonia. Your risk for infections is higher if you're taking other medications that also weaken the immune system.
Let your prescriber know if you're currently being treated for a serious infection, such as tuberculosis (TB). Your prescriber might need to consider a different medication for your asthma until you get better. Let your prescriber or primary care provider know right away if you have symptoms of an infection, such as fever, chills, or body aches.
Caution when switching from oral to inhaled steroids
- Risk factors: Long-term use of oral steroids | Suddenly stopping prednisone 20 mg or equivalent dose of steroid
Some people might switch from an oral steroid (taking a steroid medication by mouth) to an inhaled steroid like Dulera (mometasone / formoterol). Switching from an oral steroid to an inhaled steroid can cause the levels of the stress hormone called cortisol to drop suddenly in the body. This can lead to withdrawal symptoms, like nausea, tiredness, weakness, or muscle and joint pain. Low cortisol levels can also affect how well the body responds to stressful situations, such as trauma, surgery, and infection.
Your prescriber will slowly transition you from the oral steroid to Dulera (mometasone / formoterol) to lower the risk for withdrawal and other effects of low cortisol levels. They might also perform tests to check your lung function and breathing during this transition period. Don't switch between steroids without proper guidance from your prescriber. Let your prescriber know if you develop any withdrawal symptoms, such as tiredness, weakness, dizziness, loss of energy, or stomach upset.
If you've taken oral steroids for long periods of time in the past, it's important to carry a medical identification card with you that states that you might need additional steroid pills during an asthma attack. In these cases, a rescue inhaler alone might not be enough to treat this medical emergency.
Changes in stress hormone levels
- Risk factors: Using Dulera (mometasone / formoterol) for a long time | Using too much Dulera (mometasone / formoterol)
Take Dulera (mometasone / formoterol) only as directed. Don't take more than the maximum recommended number of inhalations each day. Otherwise, more of the steroid in Dulera (mometasone) can get absorbed into the body. This can raise your risk for side effects related to having too much cortisol (stress hormone) in the body, such as weight gain in the upper body, muscle weakness, higher blood sugar, or higher blood pressure.
On the other hand, you might have symptoms of low cortisol if you stop taking Dulera (mometasone / formoterol) suddenly after long-term use. Having low cortisol levels can also happen if you're transitioning from taking steroids by mouth to using the Dulera (mometasone / formoterol) inhaler. When you need to stop your medication or transition to Dulera (mometasone / formoterol), your prescriber will work with you to lower the dose of your steroid medication slowly over time to prevent these side effects. , such as stomach pain, loss of appetite, and nausea.
Heart problems
- Risk factors: High blood pressure | Heart failure | Heart rate or heart rhythm problems | Using more Dulera (mometasone / formoterol) than recommended
Dulera contains formoterol, which can cause changes to your blood pressure, heart rate, and heart rhythm. These side effects are typically unlikely to happen if you're taking the recommended dose of Dulera (mometasone / formoterol). Don't take this medication more often than recommended to lower the risk for side effects. Tell your prescriber if you feel dizzy or weak or have a fast heartbeat after you take Dulera (mometasone / formoterol).
Note that people who have high blood pressure or other heart problems might be at risk for changes in blood pressure, heart rate, and heart rhythm while they're taking Dulera (mometasone / formoterol). Let your care team know about your medical history so they know to follow up with you more closely. Your care team might suggest that you regularly check your blood pressure and heart rate at home.
Delayed growth in children
Children who use inhaled steroids, like Dulera (mometasone / formoterol), might experience a delay in growth. To lower the risk of growth problems, the healthcare professional will only prescribe the lowest dose that your child needs to help with their asthma.
Let your child's primary care provider or pediatrician know that your child is taking Dulera (mometasone / formoterol). This makes sure the care team knows to check your child's growth regularly while they're taking this medication. Discuss with your child's prescriber to see whether Dulera (mometasone / formoterol) is right for them if you're concerned about how this medication might affect your child's growth.
Eye and vision problems
- Risk factors: History of glaucoma or cataracts
Although rare, people who use inhaled steroids over a long period of time might develop higher pressure in the eyes, glaucoma, or cataracts. Talk to your optometrist before you start Dulera (mometasone / formoterol) if you have glaucoma or cataracts because they might recommend for you to come in more often for eye exams. Also speak with them if you notice any changes to your vision while you're using Dulera (mometasone / formoterol).
Low potassium levels in the blood
- Risk factors: Using Dulera (mometasone / formoterol) more than recommended
Dulera contains formoterol, a medication that can cause the potassium levels in your blood to drop too low. In most cases, this happens if you use more Dulera (mometasone / formoterol) than recommended. Drops in potassium levels are typically mild and your levels should go back to usual with time. Sometimes, low potassium can cause tiredness, weakness, muscle cramps, and a racing heart. Tell your prescriber if you have any symptoms of low potassium while you're using Dulera (mometasone / formoterol).
Dulera (mometasone / formoterol) dosage
Inhaler| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 120 doses of 100mcg/5mcg | 1 inhaler | $199.00 | $199.00 |
| 120 doses of 200mcg/5mcg | 1 inhaler | $199.00 | $199.00 |
| 120 doses of 50mcg/5mcg | 1 inhaler | $199.00 | $199.00 |
Typical dosage for Dulera (mometasone / formoterol)
Your prescriber will pick a starting dose based on how old you are, how severe your asthma symptoms are, and which other asthma medications you were taking before.
- Ages 12 years and older: The typical dose is to inhale 2 puffs of either Dulera 100 mcg/5 mcg (mometasone/formoterol) or Dulera 200 mcg/5 mcg (mometasone/formoterol) by mouth twice daily. Your dose might change depending on how well the medication is controlling your asthma symptoms and whether you're having side effects.
- Ages 5 to under 12 years: The typical dose is to inhale 2 puffs of Dulera 50 mcg/5 mcg (mometasone/formoterol) by mouth twice daily.
Interactions between Dulera (mometasone / formoterol) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Cisapride
- Desmopressin
- Dronedarone
- Mesoridazine
- Pimozide
- Piperaquine
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acebutolol
- Alfuzosin
- Amiodarone
- Amisulpride
- Anagrelide
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arotinolol
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Atenolol
- Azithromycin
- Bedaquiline
- Befunolol
- Bemiparin
- Betaxolol
- Bevantolol
- Bisoprolol
- Bopindolol
- Bucindolol
- Bupranolol
- Buprenorphine
- Buserelin
- Carteolol
- Carvedilol
- Celiprolol
- Ceritinib
- Chloroquine
- Chlorpromazine
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clofazimine
- Clozapine
- Crizotinib
- Cyclobenzaprine
- Dabrafenib
- Dasatinib
- Degarelix
- Delamanid
- Deslorelin
- Deutetrabenazine
- Dilevalol
- Disopyramide
- Dofetilide
- Dolasetron
- Domperidone
- Donepezil
- Droperidol
- Ebastine
- Efavirenz
- Encorafenib
- Entrectinib
- Eribulin
- Erythromycin
- Escitalopram
- Esmolol
- Famotidine
- Felbamate
- Fingolimod
- Flecainide
- Fluconazole
- Fluoxetine
- Foscarnet
- Fosphenytoin
- Fostemsavir
- Galantamine
- Gatifloxacin
- Gemifloxacin
- Glasdegib
- Gonadorelin
- Goserelin
- Granisetron
- Halofantrine
- Haloperidol
- Histrelin
- Hydroquinidine
- Hydroxychloroquine
- Hydroxyzine
- Ibutilide
- Iloperidone
- Inotuzumab Ozogamicin
- Itraconazole
- Ivabradine
- Ivosidenib
- Ketoconazole
- Labetalol
- Landiolol
- Lapatinib
- Lefamulin
- Lenvatinib
- Leuprolide
- Levobunolol
- Levofloxacin
- Lofexidine
- Lumefantrine
- Lutetium Lu 177 Dotatate
- Macimorelin
- Mefloquine
- Mepindolol
- Methacholine
- Methadone
- Methotrimeprazine
- Metipranolol
- Metoprolol
- Metronidazole
- Mifepristone
- Mirtazapine
- Mizolastine
- Moricizine
- Moxifloxacin
- Nadolol
- Nadroparin
- Nafarelin
- Nebivolol
- Nelfinavir
- Nilotinib
- Norfloxacin
- Octreotide
- Ofloxacin
- Olanzapine
- Ondansetron
- Osilodrostat
- Osimertinib
- Oxaliplatin
- Oxprenolol
- Ozanimod
- Paliperidone
- Panobinostat
- Papaverine
- Paroxetine
- Pasireotide
- Pazopanib
- Penbutolol
- Pentamidine
- Perphenazine
- Pimavanserin
- Pindolol
- Pipamperone
- Pitolisant
- Ponesimod
- Posaconazole
- Practolol
- Probucol
- Procainamide
- Prochlorperazine
- Promethazine
- Propafenone
- Propranolol
- Quetiapine
- Quinidine
- Quinine
- Ranolazine
- Ribociclib
- Risperidone
- Ritonavir
- Sargramostim
- Selpercatinib
- Sertindole
- Sertraline
- Siponimod
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
- Solifenacin
- Sorafenib
- Sotalol
- Sulpiride
- Sultopride
- Sunitinib
- Tacrolimus
- Talinolol
- Tamoxifen
- Telaprevir
- Telavancin
- Telithromycin
- Tertatolol
- Tetrabenazine
- Timolol
- Tolterodine
- Toremifene
- Trazodone
- Triclabendazole
- Triptorelin
- Vandetanib
- Vardenafil
- Vemurafenib
- Venlafaxine
- Vilanterol
- Vinflunine
- Voclosporin
- Voriconazole
- Vorinostat
- Zotepine
- Zuclopenthixol
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Auranofin
- Ketoconazole
How much does Dulera (mometasone / formoterol) cost?
$199.00
Dulera (mometasone / formoterol) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Dulera (mometasone / formoterol) will not be safe for you to take.
- Currently having a sudden, severe asthma attack
- Allergy to mometasone or formoterol
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