1 What is Dulera?

Brand: Dulera

Generic: Mometasone and Formoterol

Brand name:


Mometasone and Formoterol is a combination of two medicines that are used to treat asthma and improve lung function. It is best used when the management of asthma has not been done by use of other drug. It is also used when the patient’s condition is so severe and that more than one medicine is required for use every day as result of the severity of the medical condition. It is also used when the medicine that is used may not be used to relieve the asthma attack that has already started and that may be difficult to manage.

Mometasone is corticosteroids (cortisone-like medicines). It’s main mechanism of action is by reducing inflammation (swelling) in the lungs and other associated areas that promote the aggravation of asthma attack.

On the other hand, Formoterol belongs to adrenergic bronchodilators. These drugs are breathed in through the mouth so that the bronchial tubes can open the air passages in the lungs.

They are effective in the management of the symptoms of asthma such as:

This medicine is only used after a doctor’s prescriptions.

2 What to Know Before Using

Before one can use this medicine, one need to consider the risk of the medicine and weighed against the good the medicine can confer to the patient. This is the decision that you and your doctor will be required to reach. There are other factors that need to be considered such as allergies. Inform your medical doctor of any form of allergies or allergic reaction for this medicine or any form of allergies to any other medicine. Moreover, let your doctor know of any other form of allergies such as reaction to foods, dyes, preservatives or animals. In case one is using the non-prescription drugs, they are required to read the label or package ingredients carefully before they can use them.

Findings about the effects of Mometasone and Formoterol on the pediatrics have not indicated pediatrics problems that limit the use of Mometasone and Formoterol in the children. The safety and efficacy for use of the medicine has also not been determined in children that are younger than 12 years of age.

Moreover, geriatric specific problems which limit the usefulness of a combination of Mometasone and Formoterol in the elderly patients have not been established. However, it has been shown that the elderly patients that have heart problems may require special caution when using or receiving a combined dose of Mometasone and Formoterol.

In pregnancy, Studies on use of a combination of Mometasone and Formoterol inhalation have shown an adverse effect and there are no adequate studies in pregnant women or animal studies conducted. Similarly, there are no adequate studies that have been made in pregnant women. In breastfeeding, no adequate studies have been made to determine the risk of the infants when using this medication during breastfeeding. It is important to weigh the potential benefits of using this medicine before one can make a decision on using this medicine while breastfeeding.

Drug interactions may also occur when used together with other medicines. However, other medicines may be used together even with the possibility of a potential interaction. In these case, your medical doctor may want to change the dose of other precautions may be applied as necessary. When using this medicine, It is important that your healthcare professional know what medicine you are using and if they are listed below.

The interactions with these medicines are listed on the basis of potential interactions and significance and are not necessarily all inclusive. The use of these medicines with a combination of Mometasone and Formoterol is not recommended.

Your medical doctor will decide to treat you with the medicines or change some of the medicines that will be administered to you.

They include:

  • Amifampridine
  • Bepridil
  • Cisapride
  • Dronedarone
  • Mesoridazine
  • Pimozide
  • Piperaquine
  • Saquinavir
  • Sparfloxacin
  • Terfenadine
  • Thioridazine and
  • Ziprasidone

Use of these medicines with any of the following medicines may not be allowed. It may be permitted sometimes. However, when both of the medicines are prescribed at the same time, the doctor may make a decision of changing the dose or how often one can use the dose of one or more of the medicines. This include:

  • Amiodarone
  • Anagrelide
  • Aripiprazole
  • Buserelin
  • Dabrafenib
  • Degarelix
  • Delamanid
  • Deslorelin
  • Domperidone
  • Donepezil
  • Escitalopram
  • Fluoxetine
  • Gonadorelin
  • Goserelin
  • Histrelin
  • Hydroxychloroquine
  • Ivabradine
  • Leuprolide
  • Levofloxacin
  • Metronidazole
  • Nafarelin
  • Panobinostat
  • Pasireotide
  • Pixantrone
  • Tacrolimus
  • Triptorelin
  • Vemurafenib
  • Vinflunine

It is also known that using some of these medicines with the following medicines may cause an increased risk of certain side effects. However, the use of these medicines may be the best treatment when prescribed together. Your doctor may however alter the dose or how often you use one or both of the medicines such as Ketoconazole.

Other interactions may occur when used with certain medicines especially when used at the time of eating or eating certain types of foods since interactions can occur. It is important that the use of alcohol or tobacco with certain medicines may cause some form of interactions. Always discuss the use of medicines, foods, tobacco or alcohol with your doctor. The presence of other medical problems may present which may affect the use of the medicine.

Always inform your medical doctor if you have other medical problems such as:

Using these drugs may make these conditions worse. A combination of Mometasone and Formoterol must never be used in people with the following conditions:

These conditions can reduce the ability of the body to fight off infections. Diabetes or Hyperglycemia (high glucose in the blood) or Ketoacidosis (high ketones in the blood) makes the blood sugar levels to increase together with the number of infection or Stress or Surgery or Trauma.

Use of oral corticosteroids may be needed during these periods. Always check with your personal doctor. In case of a liver disease, use this drug with caution. Since the effects of the drug may be increased because of the slow removal of the medicine from the body.

3 Proper Usage

This medicine is administered by the use of a special inhaler. The medicine comes with a patient direction or a medication guide. It is recommended that the medication guide need to be read carefully before the drug can be used. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor or pharmacist to show you what to do.

Use this medicine only as directed. Never use more or less of the recommended dose of the medicine as instructed by your medical doctor. Moreover, never stop using this medicine without informing your medical doctor. This may only increase the chance of the side effects. When one has used an inhaler for the first time, or if you have not used it for more than 5 days or longer, it may not be able to deliver the right amount of medicine with the first puff. Therefore, even before one can use an inhaler, prime it by spraying the medicine four times into the air away from the face, and shaking it well before each spray.

On how to use this medicine:

  • Take the inhaler out of the carton before you use it for the first time.
  • Do not use the inhaler for this medicine with any other medicine.
  • Remove the cap from the mouthpiece of the actuator.
  • Do not remove the canister from the actuator.
  • Prime the inhaler before use by shaking the inhaler well and then releasing 4 test sprays.
  • To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible.
  • Put the mouthpiece fully into your mouth and close your lips around it.
  • Do not block the mouthpiece with your teeth or tongue.
  • While pressing down firmly and fully on the blue top of the inhaler, breathe in through your mouth as deeply as you can until you have taken a full deep breath.
  • Repeat these steps for the next puff, starting with shaking the inhaler.
  • Replace the mouthpiece cover after using the medicine.
  • Gargle and rinse your mouth with water after each dose. This will help prevent hoarseness, throat irritation, and infection in the mouth.
  • Do not swallow the water after rinsing.

Dosing for this medicine varies from patient to patient. It is advisable that you follow your doctor’s orders or directions on the label. The information provided here are only average doses for this medicine. If your dose is different, never change the dose of the medicine unless instructed by your medical doctor.

Similarly, the amount of medicine that is taken varies and relies on the strength of the medicine, numbers of doses you are required to take every day and the length of time you are to take the medicine. As an inhalation in the form of an aerosol for prevention of asthma in adults and children 12 years and above.

Two puffs of the medicine needs to be taken in the morning and another two Puffs in the evening. Each puff contains 100 or 200 micrograms (mcg) of mometasone and 5 mcg of formoterol.

For children younger than 12 years of age, the dose of the medicine must be determined by your child's doctor. In case of a missed dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. The drugs need to be stored and kept out of the reach of children. Dispose outdated medicine or medicine no longer needed. Consult your medical doctor on how best the medicine can be disposed.

Keep the medicine at room temperature and away from any source of direct heat and light. Never freeze the canister or keep them inside a car where it can be exposed to extreme heat or cold. Never pole holes in the canister or throw it into the fire even when it is out of use. When storing the inhaler, always ensures that the mouthpiece of the inhaler is down.

4 Precautions to Take

It is very important that your doctor check the progress of you or your child at regular visits, to make sure that this medicine is working properly and to check for any unwanted effects that may be caused by this medicine. You may need to have your eyes checked at regular visits. Be sure to keep all appointments. Although this medicine decreases the number of asthma episodes, it may increase the chances of a severe asthma episode when they do occur.

Talk to your doctor or pharmacist about any questions or concerns that you have. You or your child should not use this medicine if your asthma attack has already started or if you already have a severe asthma attack. Your doctor may prescribe another medicine (eg, a short-acting inhaler) for you to use in case of an acute asthma attack. Call your doctor immediately for instructions.

Do not use any other asthma medicine or medicine for breathing problems without talking to your doctor. This medicine should not be used with:

  • Arformoterol (Brovana)
  • Budesonide/formoterol (Symbicort)
  • Formoterol (Foradil, Perforomist)
  • or Salmeterol (Serevent) inhalers

Talk to your doctor or get medical care right away if:

  • Your or your child's symptoms do not improve after using this medicine for 1 week or if they become worse.
  • Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often (eg, you use 1 whole canister of your short-acting inhaler in 8 weeks’ time, or you need to use 4 or more inhalations of your short-acting inhaler for 2 or more days in a row).
  • You or your child has a significant decrease in your peak flow when measured as directed by your doctor.
  • Your doctor may want you to carry a medical identification card stating that you or your child are using this medicine and that you may need additional medicine during times of emergency, a severe asthma attack or other illness, or unusual stress.
  • You may get infections more easily while using this medicine.

Tell your doctor right away if you or your child has been exposed to someone with chickenpox or measles. This medicine may cause fungus infection of the mouth or throat (thrush). Tell your doctor right away if you have white patches in the mouth or throat, or pain when eating or swallowing. Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems.

Talk to your doctor if you or your child have more than one of these symptoms while you are using this medicine:

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor. This medicine may cause children to grow more slowly than usual. Talk to your child's doctor if you have any concerns. Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

5 Potential Side 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 side effects present as:

Rare side effects include:

  • Sore mouth or tongue
  • White patches in the mouth or on the tongue

Some of the incidences are not known such as:

  • Blindness
  • Blurred vision
  • Cough or hoarseness
  • Creamy white, curd-like patches in the mouth or throat darkening of the skin
  • Decreased vision
  • Diarrhea
  • Dizziness
  • Eye pain
  • Fainting
  • Fever or chills loss of appetite lower back
  • Side pain mental depression nausea
  • Vomiting pain when eating
  • Swallowing painful
  • 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 side effects come as a change in the voice. 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.

6 Related Clinical Trials