Dulera dosage, forms, and strengths

Dulera (formoterol/ mometasone) is a prescription inhaler used for maintenance treatment of asthma in adults and children aged 5 years and older. It is also used off-label for maintenance treatment of chronic obstructive pulmonary disease (COPD), though it has not been approved by the Food and Drug Administration for this purpose. 

Dulera is available in a few different strengths and is intended to be used by taking two puffs (inhalations) by mouth twice daily.  Dulera is a prescription medicine that contains two active ingredients to help control the symptoms of asthma: a combination of formoterol and mometasone. Formoterol is a long-acting beta2-agonist (LABA) drug whose mechanism helps dilate the airways and open them up. Mometasone is an inhaled corticosteroid (ICS) drug that works to decrease tissue inflammation in the airways. 

Dulera is a long-term asthma control medication that is to be used everyday for maintenance treatment and should not be used as a rescue medication for an asthma attack or acute bronchospasm and breathing problems. People who suffer from severe symptoms of asthma should also maintain access to a separate, fast-acting rescue inhaler and have a plan of care for asthma attacks. A common rescue medication is an inhaled short-acting beta2-agonist such as albuterol.

Dulera forms and strengths

Dulera is available as a metered dose inhaler (MDI) in three strengths:

• Inhaler: 50 / 5 mcg/actuation

• Inhaler: 100 / 5 mcg/actuation

• Inhaler: 200 / 5 mcg/actuation

Dulera dosage for adults

Dulera is a prescription asthma control medicine approved as a maintenance treatment for asthma in adults and children ages 5 years and older. Dulera is also commonly prescribed off-label for COPD in adults. The appropriate dose for a patient depends on their age, diagnosis, and previous asthma therapy regimen. Dulera should not be used in children or adults to treat asthmaticus or acute bronchospasm, and you should seek medical help immediately if this occurs.

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Dulera dosage for children

Dulera is only approved for use in children ages 5 and older for the maintenance treatment of asthma. Dose is determined by age, with children ages 5 to 11 years using the lowest recommended dose, and children 12 and older utilizing a higher recommended dose.

Dulera dosage restrictions

The maximum recommended dosage of Dulera in adults is 800 mcg of mometasone and 20 mcg of formoterol. This is also true for adolescents aged 12 years and older, as well as for the geriatric population. 

The maximum dosage for children aged 5 to 11 is 200 mcg of mometasone and 20 mcg of formoterol. The recommended starting dosage and max dosage are the same. Safety and efficacy in children younger than 5 have not been established.While there are no dose recommendations for other specific diseases or patient types, there are a few other considerations when considering Dulera for asthma control. You should tell your healthcare provider if you have any of the following medical conditions:

• History of heart disease or high blood pressure

• Irregular heartbeat

• History of seizures or epilepsy diagnosis

• Weakened immune system

• Liver or hepatic disease

• Osteoporosis or lower bone mineral density

• History of glaucoma, cataracts, or other vision or eye problems

• Diabetes

• Tumor of the adrenal glands (pheochromocytoma)

• Thyroid disorder

• Aneurysm

People with an allergy to Dulera or any of its ingredients should not take Dulera. If you have suffered from serious allergic reactions to similar medications, please inform our doctor before taking Dulera.

Those who take Dulera should get regular eye exams. Providers should also monitor for adrenal insufficiency, changes in bone density, and other important health markers.

How to take Dulera

Dulera is a combination prescription medication that should be inhaled through your mouth. You should not use more than four inhalations of Dulera daily. You should follow the manufacturer’s detailed instructions for use and take according to your healthcare provider’s instructions. The manufacturer, Organon, makes important safety information available on its website.

• 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 performing 4 test sprays into the air. 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 into your lungs. You may be told to use a spacer, which is a tube 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. 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.

Dulera dosage FAQs

How long does it take Dulera to work?

Dulera does not typically work right away. It may take 1 to 2 weeks to see an improvement in asthma problems or symptoms. Do not use Dulera for an acute bronchospasm or asthma attack. Do not abruptly stop Dulera without speaking to your prescriber first.

Remember: an asthma attack or acute bronchospasm is an emergency, and you should use a rescue medication and seek medical care immediately.

What happens if I miss a dose of Dulera?

If you realize you have missed a dose of Dulera, just take your normal dose at the next scheduled time and skip the missed dose. Do not double up doses. Use an alarm or other tool to help you remember your dose as serious adverse effects can occur from missing doses of Dulera regularly.

How long can you take Dulera?

Dulera is intended for long-term use to control asthma symptoms. If you have persistent asthma, you may have to take Dulera for a long period of time. If your asthma becomes well-controlled and you have fewer exacerbations, your doctor may consider lowering your dose or stopping Dulera altogether. You should not make any changes to how you take Dulera without visiting with your healthcare provider first. Uncontrolled asthma carries a significantly increased risk of hospitalizations and need for medical care.

How do I stop taking Dulera?

Do not stop Dulera without first speaking to your provider. If your asthma has been well-controlled for an extended period of time, you may be eligible to decrease your dose and work towards stopping Dulera altogether. While there may be different specific approaches to titrating the dose down, your prescriber will likely decrease your total dose by 25 to 50% at a time. When your asthma symptoms remain stable at the lower dose for a month or other time preferred by your provider, they will step down the dose again. It is preferred to find the lowest maintenance dose of Dulera possible to minimize the possibility of side effects without inducing withdrawal symptoms until a patient can stop it altogether.

What is the maximum dosage for Dulera?

The maximum prescribed strength of Dulera is age-dependent. The maximum recommended dosage of Dulera in adults, geriatrics, and children and adolescents 12 years of age and older is 800 mcg of mometasone and 20 mcg of formoterol. In children aged 5 to 11 years, the maximum dosage is 200 mcg of mometasone and 20 mcg of formoterol.

Can you overdose on Dulera?

It is possible to take too much Dulera. Taking too much of LABA medicines such as formoterol can lead to serious side effects such as increased heart rate, chest pain, and a higher chance of hospitalization. A high dose of inhaled corticosteroids such as mometasone can lead to an increased risk of infection. The potential risk of systemic corticosteroid effects is higher in patients who may be taking oral corticosteroid medicines as well. Too much systemic corticosteroids can leave a patient at a higher chance of infections, some of which can be very serious. High steroid intake can lead to fungal infections such as candidiasis as well as parasitic infections. It is important that you monitor for signs of infection while taking Dulera and seek medical attention immediately if you suspect you have an infection.

What interacts with Dulera?

Taking Dulera with cisapride, a chemotherapeutic drug, is contraindicated. This is due to the risk of a specific type of arrhythmia known as QT prolongation, which can be fatal.

Dulera should also be avoided in combination with desmopressin as there is a serious risk of low sodium levels.

Is it safe to take Dulera during pregnancy?

There are no well-controlled studies of Dulera in pregnant patients, and there is no recommended dose. Use of Dulera should be limited to cases where the benefit to the mother far outweighs the unknown risk to the fetus.

Sources

• DULERA- mometasone furoate and formoterol fumarate dihydrate aerosol, NIH, DailyMed (2023)

• Dosing - US, Organon Pro (2024)

• FAQs for DULERA®, Dulera (2024)

• How to step down asthma preventer treatment in patients with well-controlled asthma – more is not always better, Australian Prescriber (2022)