Dulera is a brand-name prescription medication. It’s used to treat asthma in adults as well as children ages 5 years and older. Asthma is a disease in which your airways swell and tighten, making it hard to breathe. Dulera isn’t approved to treat asthma symptoms that suddenly get worse. These are commonly known as asthma attacks.

Dulera contains two drugs. The first is mometasone, which belongs to a class of drugs called inhaled corticosteroids. (A class of drugs is a group of medications that work in a similar way.) Inhaled corticosteroids help reduce swelling in the lungs.

The second drug is formoterol. It’s a type of drug known as a long-acting beta agonist (LABA), and it relaxes muscles in the airways.

Dulera comes in a metered dose inhaler. You’ll inhale the medication twice a day.

Effectiveness

Clinical studies looked at people with asthma who took either Dulera or a placebo (treatment with no active drug). Researchers measured the people’s forced expiratory volume (FEV1). This is how much air a person can exhale during a forced breath in 1 second. A trough FEV1 is a measurement taken 24 hours after a person last uses a drug.

People who took Dulera had an average increase of 0.13 L in their trough FEV1. This was compared with people who took a placebo, who had an average decrease of 0.05 L in their trough FEV1.

In the same study, asthma got worse over time for 30% of people who took Dulera, compared with 56% of people who took a placebo.

Dulera is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. The generic is considered to be just as safe and effective as the original drug. Generics also tend to cost less than brand-name drugs.

Dulera contains two active drug ingredients: mometasone and formoterol. This means that mometasone and formoterol are the ingredients that make Dulera work.

Dulera can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Dulera. These lists don’t include all possible side effects.

For more information on the possible side effects of Dulera, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to report to the FDA a side effect you’ve had with Dulera, you can do so through MedWatch.

More common side effects

The more common side effects of Dulera can include:

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Dulera aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • Mouth and throat infections, such as oral thrush. Symptoms can include:
    • loss of taste
    • pain while eating or swallowing
    • redness or soreness in your mouth or throat
    • white patches on your inner cheeks, on the roof of your mouth, on your tongue, or in your throat
  • Paradoxical bronchospasm (a sudden tightening of the airways that makes it hard to breathe). Symptoms can include:
    • coughing
    • shortness of breath
  • Glaucoma (a type of eye disease), cataracts (cloudy spots in the lens of the eye), or both. Symptoms can include:
    • blurred or cloudy vision
    • trouble seeing at night
    • eye redness
    • seeing “halos” around lights
    • sensitivity to light
  • Hyperglycemia (high blood sugar). Symptoms can include:
    • fatigue (lack of energy)
    • frequent urination
    • headache
    • increased thirst
    • trouble concentrating
  • Hypokalemia (low level of potassium). Symptoms can include:
    • muscle weakness
    • muscle cramps
    • muscle twitching
    • low blood pressure
    • irregular heartbeat
    • frequent urination
    • increased thirst
  • Adrenal suppression (low levels of a hormone called cortisol). Symptoms can include:
    • belly pain
    • chronic (long-lasting) fatigue
    • depression
    • hypotension (low blood pressure)
    • feeling irritable
    • joint pain
    • muscle weakness
    • weight loss
  • Decrease in bone density, which can lead to osteoporosis. Symptoms can include:
    • back pain
    • loss of height over time
    • stooped posture
  • Increased risk of infection, such as chickenpox or measles

Other serious side effects, explained in more detail below in “Side effect details,” include:

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on several of the side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Dulera. To date, there are no statistics on how many people have an allergic reaction to Dulera. So although a mild allergic reaction is highly unlikely to occur, it’s still important to know the symptoms, which can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • trouble breathing
  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • hives (itchy welts on your skin)

Call your doctor right away if you have a severe allergic reaction to Dulera. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Withdrawal symptoms

Withdrawal symptoms aren’t likely to occur when treatment with Dulera is ended.

People who take steroids (such as prednisone) by mouth sometimes have withdrawal symptoms when they stop treatment. But this problem hasn’t been seen with inhaled corticosteroids such as mometasone (one of the active ingredients in Dulera). That’s because inhaling a steroid medication leads to a lower level of the drug in your blood than when you take a steroid medication in pill form.

To date, Dulera hasn’t been linked to withdrawal symptoms in any studies. However, if you have joint or muscle pain, feel depressed, or have low energy after you stop taking Dulera, talk with your doctor right away.

Headache

Headaches may occur while taking Dulera. In clinical trials, up to 4.5% of people who took Dulera had headaches, compared with 3.6% of people who took a placebo (treatment with no active drug). This side effect may go away on its own as you continue to use Dulera.

If you’re taking Dulera and develop headaches that don’t go away or become severe, talk with your doctor. They can suggest treatments to help you feel more comfortable or suggest a different medication.

Thrush

Oral thrush may occur with the use of Dulera. Thrush is an infection caused by the fungus Candida, commonly known as yeast. In clinical studies, up to 0.8% of people who took Dulera had Candida infections in their mouth or throat, compared with 0.5% of people who took a placebo.

The good news is that you can take steps to help prevent oral thrush. After using Dulera, rinse your mouth with water and spit it out without swallowing. Do this every time you take a dose.

If you do develop oral thrush while taking Dulera, tell your doctor. They can prescribe medications to treat the infection.

Side effects in children

In one study of children ages 5 to 11 years, Dulera was compared with mometasone (one of the active ingredients in Dulera). Of the children who took Dulera, 5.49% had the flu, and 2.2% had symptoms of the common cold. Of those who took only mometasone, 3.33% had the flu and 8.89% had symptoms of the common cold.

The side effects in children ages 12 to 17 years were the same as those seen in adults. Of the people ages 12 and over who took Dulera in clinical studies, 4.7% had common cold symptoms, compared with 3.6% of people who took a placebo.

Medications that contain inhaled corticosteroids, like Dulera, may slow how quickly children grow. A review of 23 clinical studies looked at children with asthma who took inhaled corticosteroids for a year or longer. When these children grew up, they were about 1 cm shorter than people who hadn’t taken inhaled corticosteroids. (One cm is about 0.39 inches.)

If you’re concerned how Dulera may affect your child’s growth, talk with your child’s doctor. They can monitor your child’s height to see if Dulera is affecting your child.

The Dulera dosage your doctor prescribes will depend on several factors. These include:

  • the type and severity of the condition you’re using Dulera to treat
  • your age
  • other medical conditions you may have

Typically, your doctor will start you on a low dosage. Then they’ll adjust it over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Dulera comes as a metered dose inhaler, which is blue in color and disposable. Each inhaler is made up of a canister and an actuator. The canister contains the two active ingredients in Dulera: mometasone and formoterol. The actuator holds the canister in place and releases the medication in premeasured inhalations (puffs).

Dulera is available in three strengths:

  • 50 mcg mometasone/5 mcg formoterol
  • 100 mcg mometasone/5 mcg formoterol
  • 200 mcg mometasone/5 mcg formoterol

The canisters contain either 60 or 120 puffs. Two puffs equal one dose. So there are 30 or 60 doses in a canister.

Dosage for asthma

The two Dulera strengths used for asthma in adults are:

  • 100 mcg mometasone/5 mcg formoterol
  • 200 mcg mometasone/5 mcg formoterol

You’ll inhale two puffs of Dulera through your mouth twice a day. Wait at least 30 seconds in between each puff.

The maximum dose is two puffs of Dulera (200 mcg/5 mcg strength) twice a day.

Dulera isn’t approved for the immediate relief of asthma symptoms. If you have symptoms of asthma between Dulera doses, your doctor will likely want you to use a rescue inhaler, such as a short-acting beta2-agonist (SABA).

Pediatric dosage

The strength of Dulera for children ages 5 to 11 years is 50 mcg/5 mcg. The recommended dose is two puffs twice a day.

Children ages 12 years and older can take the same doses as adults.

What if I miss a dose?

If you miss a dose of Dulera, skip that dose. Then take your next dose at your regular time. Don’t double up on doses because this can increase your risk for serious side effects. (For more about side effects, see the “Dulera side effects” section above.)

To help make sure that you don’t miss a dose, try using a medication reminder.

Will I need to use this drug long term?

Dulera is meant to be used as a long-term treatment. If you and your doctor determine that Dulera is safe and effective for you, you’ll likely take it long term.

Other drugs are available that can treat asthma. Some may be a better fit for you than others. If you’re interested in finding an alternative to Dulera, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Alternatives for asthma

Examples of other drugs that may be used to treat asthma include:

  • Short-acting beta2-agonists (SABAs), such as:
    • albuterol (ProAir HFA, Proventil HFA, Ventolin HFA)
    • levalbuterol (Xopenex, Xopenex HFA)
  • Short-acting anticholinergics, such as:
    • ipratropium bromide (Atrovent HFA)
  • Inhaled corticosteroids, such as:
    • beclomethasone dipropionate (Qvar RediHaler)
    • budesonide (Pulmicort Flexhaler)
    • fluticasone furoate (Arnuity Ellipta)
    • fluticasone propionate (Flovent Diskus, Flovent HFA)
    • mometasone furoate (Asmanex HFA, Asmanex Twisthaler)
  • Long-acting beta2-agonists (LABAs) with an inhaled corticosteroid, such as:
  • Mast cell stabilizers, such as:
    • cromolyn sodium
  • Leukotriene modifiers, such as:
    • montelukast (Singulair)
    • zafirlukast (Accolate)
    • zileuton (Zyflo)
  • Xanthine derivatives, such as:
  • Biologic therapies, such as:

You may wonder how Dulera compares to other medications that are prescribed for similar uses. Here we look at how Dulera and Symbicort are alike and different.

Ingredients

Dulera contains the active drugs mometasone and formoterol. Symbicort contains the active drugs budesonide and formoterol.

Mometasone and budesonide are types of inhaled corticosteroids. Formoterol is a type of long-acting beta2-agonist (LABA).

Uses

Dulera and Symbicort are both approved to treat asthma in adults. Dulera is also approved for use in children ages 5 years and older, while Symbicort is also approved for use in children ages 6 years and older.

In addition, Symbicort is approved to treat chronic obstructive pulmonary disease (COPD).

Drug forms and administration

Dulera and Symbicort both come as a metered dose inhaler. Both drugs are inhaled twice a day.

Side effects and risks

Dulera and Symbicort both contain the drug formoterol. Therefore, these medications can cause some similar side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Dulera, with Symbicort, or with both drugs (when taken individually).

Serious side effects

These lists contain examples of serious side effects that can occur with Dulera, with Symbicort, or with both drugs (when taken individually).

  • Can occur with Dulera:
    • few unique serious side effects
  • Can occur with Symbicort:
    • increased risk of pneumonia (a type of lung infection) in people with COPD
  • Can occur with both Dulera and Symbicort:

Effectiveness

Dulera and Symbicort have different FDA-approved uses, but they’re both used to treat asthma.

These drugs haven’t been directly compared in clinical studies, but studies have found both Dulera and Symbicort to be effective for treating asthma.

Costs

Dulera and Symbicort are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

Dulera and Symbicort generally cost about the same. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Like Symbicort (above), the drug Advair has uses similar to those of Dulera. Here’s a comparison of how Dulera and Advair are alike and different.

Ingredients

Dulera contains the active drugs mometasone and formoterol. Advair contains the active drugs fluticasone propionate and salmeterol.

Mometasone and fluticasone propionate are types of inhaled corticosteroids. Formoterol and salmeterol are types of long-acting beta2-agonists (LABAs).

Uses

Dulera is approved to treat asthma in adults as well as children ages 5 years and older.

Advair is available in two forms: Advair Diskus and Advair HFA. Both forms are approved to treat asthma in adults. Advair Diskus is also approved to treat asthma in children ages 4 years and older, while Advair HFA is approved to treat asthma in children ages 12 years and older.

In addition, Advair Diskus is also approved to treat chronic obstructive pulmonary disease (COPD).

Drug forms and administration

Dulera comes as a metered dose inhaler. You’ll inhale the drug twice a day.

Advair is available in two forms: Advair Diskus and Advair HFA. Advair Diskus is a dry powder inhaler. Advair HFA is a metered dose inhaler. Both drugs are inhaled twice a day.

Side effects and risks

Dulera and Advair contain different drugs. Therefore, some of the side effects caused by these medications are similar and some are different. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Dulera, with Advair, or with both drugs (when taken individually).

  • Can occur with Dulera:
    • few unique common side effects
  • Can occur with Advair:
    • hoarseness
    • muscle pain
    • nausea
    • vomiting
    • sore throat
    • dizziness
  • Can occur with both Dulera and Advair:

Serious side effects

These lists contain examples of serious side effects that can occur with Dulera, with Advair, or with both drugs (when taken individually).

  • Can occur with Dulera:
    • few unique serious side effects
  • Can occur with Advair:
    • increased risk of pneumonia (a type of lung infection) in people with COPD
  • Can occur with both Dulera and Advair:

Effectiveness

Dulera and Advair have different FDA-approved uses, but they’re both used to treat asthma in adults and children.

These drugs haven’t been directly compared in clinical studies, but studies have found Dulera, Advair HFA, and Advair Diskus to be effective for treating asthma.

Costs

Dulera and Advair are both brand-name drugs. Advair Diskus is available as a generic called Wixela Inhub. Brand-name medications usually cost more than generics.

Dulera costs significantly less than Advair HFA and Advair Diskus. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

The Food and Drug Administration (FDA) approves prescription drugs such as Dulera to treat certain conditions. Dulera may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Dulera for asthma

Asthma is a disease that causes swelling in your airways and lungs and makes it harder to breathe. People with asthma may struggle with physical activity.

When you breathe, air enters through your nose or mouth and travels through your airways down to your lungs. Your lungs remove oxygen from the air so it can enter your bloodstream, where it can move throughout your body.

People with asthma have trouble breathing because their airways swell. The muscles around the airways tighten, and mucus fills this tightened space, which means even less air can pass through.

Dulera is approved to treat asthma in adults as well as children ages 5 years and older. The drug works to control symptoms of asthma, such as wheezing, by keeping your airways open over time.

Effectiveness

Clinical studies looked at people with asthma who took either Dulera or a placebo (treatment with no active drug). Researchers measured the people’s forced expiratory volume (FEV1). This is how much air a person can exhale during a forced breath in 1 second. A trough FEV1 is a measurement taken 24 hours after a person last uses a drug.

People who took Dulera had an average increase of 0.13 L in their trough FEV1. This was compared with people who took a placebo, who had an average decrease of 0.05 L in their trough FEV1.

In the same study, asthma got worse over time for 30% of people who took Dulera, compared with 56% of people who took a placebo.

Dulera for off-label uses

In addition to the use listed above, Dulera may be used off-label. Off-label drug use is when a drug that’s approved for one use is used for a different one that’s not approved. And you may wonder if Dulera is used for certain other conditions.

Dulera for COPD

Chronic obstructive pulmonary disease (COPD) is a group of lung conditions that includes chronic bronchitis and emphysema. The FDA hasn’t approved Dulera for use in people with COPD. However, in some situations, your doctor may prescribe Dulera off-label for COPD.

Two clinical trials have found Dulera to be both safe and effective for improving breathing in people with COPD.

One study measured forced expiratory volume (FEV1) in people with COPD. FEV1 is how much air a person can exhale during a forced breath in 1 second. After 26 weeks, people who took Dulera had an average increase of 9.3% to 13.2% in their FEV1 results. People who took a placebo had an average decrease of 0.2% in their FEV1 results. This shows that people who took Dulera were able to breathe easier than people who took a placebo.

People who took Dulera also reported that their symptoms eased more, and COPD had less of a negative impact on their daily lives. This was compared with people who took a placebo.

A second study found that people with COPD who took Dulera had improvements in their FEV1 and fewer COPD flare-ups compared with people who took a placebo. A flare-up is when your COPD symptoms suddenly get worse. In the Dulera group, 32.3% to 37.6% of people had a COPD flare-up, compared with 45.7% in the placebo group.

Dulera for sudden breathing problems

Dulera isn’t approved to treat asthma symptoms that suddenly get worse. These are commonly known as asthma attacks. However, in some situations, your doctor may prescribe Dulera off-label for sudden breathing problems.

Treatment guidelines now recommend that people ages 12 years and older use an inhaler that includes an inhaled corticosteroid (ICS) and formoterol when they have an asthma attack. Dulera contains an ICS (mometasone) and formoterol. That means that your doctor may prescribe Dulera as your rescue inhaler.

Dulera and children

Dulera has been found to be safe and effective in children ages 5 years and older.

In clinical trials, children ages 12 to 17 years with asthma were treated with the same doses of Dulera as adults. The drug’s rates of effectiveness and safety were similar for both children and adults.

Researchers looked at people’s trough FEV1, which is FEV1 measured 24 hours after a person last uses a drug. People with asthma (including children ages 12 to 17 years) who took Dulera saw an average increase of 0.13 L in their trough FEV1. In comparison, people with asthma (including children ages 12 to 17 years) who took a placebo had an average decrease of 0.05 L in their trough FEV1. So children who took Dulera were able to breathe easier compared with children who took a placebo.

Results from another study

In a different clinical study, children ages 5 to 12 years with asthma were treated with either Dulera or mometasone (one of the drugs in Dulera). Both the Dulera and mometasone groups took the standard dose of the medication twice a day. The Dulera dose was 50 mcg/5 mcg, and the mometasone dose was 50 mcg.

Children who took Dulera had a higher increase in FEV1 (about 9%) compared with the children who took only mometasone furoate (about 4%). This means that children who took Dulera were able to breathe easier than children who took only mometasone.

Dulera hasn’t been studied in children younger than age 5 years, so the drug isn’t approved for use in this age group.

Dulera is meant to be used as a long-term treatment. You should take Dulera every day, no matter how good or bad your breathing feels.

Dulera isn’t approved for the immediate relief of sudden breathing problems, which are known as asthma attacks. If you have symptoms of asthma between Dulera doses, your doctor will likely want you to use a rescue inhaler.

Here are answers to some frequently asked questions about Dulera.

Is Dulera similar to Breo?

Yes, Dulera and the medication called fluticasone furoate/vilanterol trifenatate (Breo) are similar. The Food and Drug Administration (FDA) has approved both Dulera and Breo to treat asthma in adults. Dulera is also approved to treat asthma in children ages 5 and older.

Both drugs contain an inhaled corticosteroid (ICS) and a long-acting beta2-agonist (LABA). Dulera contains mometasone (an ICS) and formoterol (a LABA). Breo contains fluticasone furoate (an ICS) and vilanterol trifenatate (a LABA).

Both Dulera and Breo come as inhalers. Dulera is a metered dose inhaler, which dispenses the drug as a spray. Breo is a dry powder inhaler, which dispenses the drug as a fine powder.

If you have questions about Dulera, Breo, or other asthma medications, talk with your doctor.

Can Dulera cause weight loss or weight gain?

In clinical studies, Dulera didn’t cause weight loss or weight gain. But there’s a small chance that Dulera can affect the function of your adrenal glands. The adrenal glands make hormones that play a role in maintaining weight. So changes in the levels of the hormones could potentially cause weight gain.

Talk with your doctor if you’re concerned about Dulera affecting your weight.

Is Dulera a bronchodilator?

Dulera works as a bronchodilator, which is drug that relaxes muscles in your airways to make it easier for you to breathe. Formoterol, which is one of the two ingredients in Dulera, is a long-acting bronchodilator. This means that formoterol works to widen your airways so more air can pass in and out of your lungs, and keeps working for several hours.

Mometasone (the other ingredient in Dulera) isn’t a bronchodilator. But it can reduce inflammation (swelling) in your airways, which makes it easier for you to breath.

Can I use Dulera as a rescue inhaler for sudden breathing problems?

Maybe. Dulera isn’t approved to treat sudden breathing problems. But treatment guidelines now recommend that people ages 12 years and older use an inhaler that includes an inhaled corticosteroid (ICS) and formoterol when they have an asthma attack. Dulera contains an ICS (mometasone) and formoterol. This means that your doctor may prescribe Dulera as your rescue inhaler. (This is considered off-label use.)

Your doctor may want you to use a separate rescue inhaler when you have an asthma attack. This could depend on what other asthma medications you’re already taking. Children ages 6 to 11 years may also need a separate rescue inhaler.

If you have questions about rescue inhalers and how to treat sudden breathing problems while taking Dulera, talk with your doctor.

Should I rinse out my mouth after inhaling my dose of Dulera?

Yes, you should rinse your mouth after inhaling a dose of Dulera. Doing so will help prevent mouth and throat infections, such as oral thrush.

After each dose of Dulera, rinse your mouth with water, then spit out the water. Don’t swallow it.

Can Dulera slow my child’s growth?

Possibly. An ingredient in Dulera, mometasone, is type of drug called an inhaled corticosteroid (ICS). ICSs may slightly slow growth in children. If your child needs to take Dulera, their doctor will prescribe the lowest dose needed to treat your child’s asthma. This helps reduce the risk of slowing your child’s growth. During your child’s treatment with Dulera, their doctor will monitor their height closely.

For more about Dulera and children’s growth, see “Side effects in children” in the “Dulera side effects” section above.

If you’re concerned about Dulera slowing your child’s growth, talk with their doctor.

You should take Dulera according to your doctor’s or healthcare provider’s instructions.

Dulera comes as a metered dose inhaler, which dispenses the drug as a spray. Each inhaler is made up of a canister and an actuator. The canister contains the drug. The actuator holds the canister in place and releases the medication in premeasured inhalations (puffs).

You’ll use the Dulera inhaler to breathe in the medication. For a video and instructions how to use the inhaler, visit the Dulera website.

You should always rinse your mouth after each dose of Dulera. Once you’ve taken your puffs, rinse your mouth with water and spit it out right away. Don’t swallow the water. This rinsing process helps reduce your risk for mouth and throat infections, such as oral thrush.

When to take

You’ll take Dulera twice a day. You should take your dose of Dulera every 12 hours.

Two puffs count as one dose. So you’ll take a total of four puffs each day.

To help make sure that you don’t miss a dose, try using a medication reminder.

Using more than the recommended dosage of Dulera can lead to serious side effects.

Overdose symptoms

Symptoms of an overdose can include:

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

To date, there’s no known interaction between Dulera and alcohol.

But there are studies that show long-term alcohol use can damage the cilia in your airways. Cilia are tiny hair-like structures in the lungs that help trap and remove germs each time you take a breath. If your cilia are damaged, your body will have a tougher time removing germs from your airways. This can increase your risk for infection, which can sometimes make it harder to breathe.

If you drink alcohol, talk with your doctor about how much you may safely drink during your Dulera treatment.

Dulera can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

Dulera and other medications

Below is a list of medications that can interact with Dulera. This list doesn’t contain all drugs that may interact with Dulera.

Before taking Dulera, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Dulera and certain HIV drugs

Taking Dulera along with certain medications to treat HIV may increase the level of Dulera in your body. This is because certain HIV medications prevent your body from breaking down Dulera. Having a higher level of Dulera in your system can increase your risk for serious side effects. (For more about side effects, see the “Dulera side effects” section above.)

Examples of these HIV medications include:

  • atazanavir (Reyataz)
  • indinavir (Crixivan)
  • nelfinavir (Viracept)
  • ritonavir (Norvir)
  • saquinavir (Invirase)

If you’re taking one of these medications for HIV, your doctor may prescribe a different asthma medication.

Dulera and certain antibiotic or antifungal medications

Using Dulera with certain antibiotic or antifungal drugs may increase the level of Dulera in your system. This occurs because certain antibiotic and antifungal drugs prevent Dulera from breaking down in your body. The result can be a higher-than-normal level of Dulera, which can lead to serious side effects. (For more about side effects, see the “Dulera side effects” section above.)

Examples of these antibiotic drugs include:

  • clarithromycin (Biaxin)
  • telithromycin (Ketek)

Examples of these antifungal drugs include:

  • ketoconazole (Ketozole, Nizoral, Xolegel)
  • itraconazole (Onmel, Sporanox, Tolsura)

Using these medications while taking Dulera isn’t usually recommended. But if you do need to be treated with one of these drugs while taking Dulera, your doctor will closely monitor you for side effects.

Dulera and certain diuretics

Taking certain diuretics (water pills) with Dulera may increase your risk of developing hypokalemia (low potassium levels). It may also increase your risk for serious heart problems such as abnormal heart rhythms.

Examples of these diuretics include:

If you need to take one of these diuretics while using Dulera, your doctor will closely monitor you for changes in your heart rhythm and low potassium.

Dulera and certain antidepressants

Using Dulera with certain antidepressants may increase your risk for serious side effects, including abnormal heart rhythms. You shouldn’t take Dulera within 2 weeks of using these antidepressants.

Examples of these antidepressants include:

If you’re taking one of these antidepressants, your doctor may prescribe a different asthma medication. Be sure to let your doctor know if you’re using an antidepressant before taking Dulera.

Dulera and certain heart rate and blood pressure medications

Taking certain heart rate and blood pressure drugs with Dulera may increase your risk for serious breathing problems. These problems include bronchospasm (a sudden tightening of the muscles lining the walls of your lungs). This is because these medications may keep Dulera from working properly to treat your asthma.

Examples of these heart rate and blood pressure medications include:

These medications should be taken with Dulera only in the event of an emergency, such as a heart attack, or if other drugs aren’t right for you. If you need to take one of these medications with Dulera, your doctor will monitor you for any serious breathing problems.

Dulera and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Dulera. However, you should still check with your doctor or pharmacist before using any of these products while taking Dulera.

It’s not known if Dulera is safe to use during pregnancy. No clinical studies have been conducted with Dulera in pregnant animals. But there have been animal studies of the two ingredients in Dulera: mometasone and formoterol. Babies had birth defects when mometasone or formoterol was given to their pregnant mothers. However, animal studies don’t always predict how the drugs will affect humans.

If your asthma isn’t well managed while you’re pregnant, both you and your baby may have health problems. Examples of these problems include low birth weight, premature birth, and preeclampsia (high blood pressure during pregnancy). Having your asthma well managed during pregnancy helps lower your risk for these problems.

Current asthma treatment guidelines suggest that the use of an inhaled corticosteroid and a long-acting beta2-agonist (such as Dulera) is safe for pregnant women with asthma.

If you have asthma and are pregnant or thinking about becoming pregnant, speak with your doctor. They can review the pros and cons of Dulera with you.

It’s not known if Dulera is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Dulera.

It’s not known if Dulera is safe to use while breastfeeding because researchers aren’t sure if Dulera passes into human breast milk. Drugs similar to mometasone (one of the ingredients in Dulera) have been found in human breast milk. And animal studies have shown that formoterol (another ingredient in Dulera) is present in breast milk, but animal studies don’t always predict what will happen in humans.

If you’re taking Dulera and are considering breastfeeding, talk with your doctor. Together, you can discuss the benefits and risks of Dulera and the best way to feed your child.

As with all medications, the cost of Dulera can vary.

The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Your insurance plan may require you to get prior authorization before approving coverage for Dulera. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the information and let you and your doctor know if your plan will cover Dulera.

If you’re not sure if you’ll need to get prior authorization for Dulera, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Dulera, help is available.

Merck & Co., Inc., the manufacturer of Dulera, offers a program that may provide one free oral inhaler of Dulera. They also offer a coupon that can help lower the cost of your prescription. For more information and to find out if you’re eligible for support, visit the program website.

Asthma is a disease in which inflammation causes swelling and extra mucus in your airways and lungs. This makes it harder for you to breathe.

It isn’t fully known why some people develop asthma and some people don’t. It’s thought that people with asthma have an overactive immune system, which causes inflammation. (The immune system is your body’s defense against infection.) This inflammation causes your airways to tighten and makes it harder for you to get the oxygen your body needs.

Dulera contains two drugs. One is mometasone, a corticosteroid. The other is formoterol, a long-acting beta2-agonist (LABA). Corticosteroids help reduce inflammation in the lungs and block further inflammation from making your breathing worse. Long-acting beta2-agonists act in the lungs to relax the muscles that line your airways. This widens the airways and allows more air to flow in when you take a breath.

Mometasone and formoterol work together to help you breathe easier and get more oxygen into your lungs.

How long does it take to work?

According to clinical studies, Dulera may help you breathe easier as soon as 5 minutes after taking a dose of the medication. These effects last for about 12 hours.

Even if Dulera helps ease your asthma symptoms quickly, it’s important to keep taking it every day as your doctor prescribed. This is because Dulera gradually improves the way your lungs work and helps prevent asthma attacks over time.

Before taking Dulera, talk with your doctor about your health history. Dulera may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Certain hormone disorders. Mometasone, an active drug in Dulera, can cause an imbalance of cortisol (a hormone made in the adrenal glands). Formoterol, the other active drug in Dulera, can worsen symptoms of hyperthyroidism (high levels of the thyroid hormone). Either of these hormone disorders can lead to serious side effects such as muscle weakness and abnormal heartbeat. If you have a hormone disorder, talk with your doctor before taking Dulera. They may suggest a different asthma medication.
  • Diabetes. Dulera can increase blood sugar levels. If you have diabetes, Dulera may worsen your condition. Talk with your doctor before taking Dulera. They may monitor your blood sugar more closely during treatment.
  • High blood pressure and other heart problems. Formoterol, one of the drugs in Dulera, can worsen certain heart problems, including high blood pressure and abnormal heart rhythms. If you have high blood pressure or other heart problems, talk with your doctor to see if using Dulera is safe for you.
  • Allergic reaction. You shouldn’t use Dulera if you’ve had an allergic reaction to Dulera or any of its ingredients in the past. If you’re unsure of whether you’ve had an allergic reaction, speak with your doctor.
  • Rapidly worsening asthma. You shouldn’t start using Dulera if you have rapidly worsening asthma. Dulera shouldn’t be used in place of intense medical treatment or a hospital stay if your asthma becomes life threatening. If you’re not sure whether your asthma is stable enough to begin taking Dulera, talk with your doctor.
  • Seizures or other convulsive disorders. Formoterol, one of the drugs in Dulera, may worsen seizure disorders in some people. If you have a seizure disorder, talk with your doctor before starting to take Dulera. They may suggest a different asthma medication.
  • Serious infections. Dulera can make your body less able to fight infections. If you have a serious infection, such as tuberculosis (TB), you might not be able to take Dulera. So if you have a serious infection with symptoms, or have had one in the past, talk with your doctor before using Dulera.
  • Use of oral corticosteroids. In some situations, you may be using an oral corticosteroid such as prednisone and are switching to Dulera. Suddenly stopping the use of an oral corticosteroid may cause you to have withdrawal symptoms such as joint and muscle pain or depression. So your doctor may have you slowly taper off the corticosteroid. If you’re currently taking an oral corticosteroid, talk with your doctor before switching to Dulera.
  • Pregnancy. It’s not known if Dulera is safe to use during pregnancy. For more information, please see the “Dulera and pregnancy” section above.
  • Breastfeeding. It isn’t known if Dulera is safe to use while breastfeeding. For more information, please see the “Dulera and breastfeeding” section above.

Note: For more information about the potential negative effects of Dulera, see the “Dulera side effects” section above.

When you get Dulera from the pharmacy, the pharmacist will add an expiration date to the label on the box. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to use it.

You should throw your Dulera inhaler away once the dose counter reads “0.” To make sure you always have enough medication, refill your prescription when the dose counter reads “20.”

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

You should store your Dulera inhaler at room temperature (68°F to 77°F/20°C to 25°C) away from light. It’s fine to keep your inhaler at a temperature of 59°F to 86°F (15°C to 30°C) for a short time, if needed. Avoid keeping Dulera in areas where it could get damp or wet, such as in bathrooms. If you store the medication in areas where Dulera can get too hot, the canister could burst.

Disposal

If you no longer need to take Dulera and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

The following information is provided for clinicians and other healthcare professionals.

Indications

Dulera is approved by the Food and Drug Administration (FDA) to treat asthma in adults and children ages 5 years and older.

Mechanism of action

Dulera contains two active ingredients: mometasone furoate and formoterol fumarate dihydrate.

Mometasone furoate is a corticosteroid that improves asthma symptoms by reducing inflammation in the lungs. Mometasone binds to glucocorticoid receptors and reduces activation of inflammatory mediators such as cytokines, eicosanoids, and leukotrienes.

Formoterol fumarate dihydrate is a long-acting beta2-agonist that improves asthma symptoms by relaxing bronchial smooth muscle via increased cyclic AMP levels. Formoterol also inhibits the release of mast cell inflammatory mediators, including histamine and leukotrienes, from the lung.

Pharmacokinetics and metabolism

Following inhalation by asthma patients, peak concentrations are achieved within 1 to 2 hours for mometasone, and within 0.5 to 2 hours for formoterol. Systemic bioavailability of mometasone is insignificant (<1%).

Mometasone is 98% to 99% bound to plasma proteins. Formoterol is 61% to 64% bound to plasma proteins (31% to 38% to albumin). Both undergo extensive metabolism in the liver. Mometasone is primarily metabolized via CYP3A4, whereas formoterol is primarily metabolized by direct glucuronidation.

Mometasone is primarily excreted in the feces (74%). Less than 7% of inhaled formoterol is excreted through urine as unchanged drug. The elimination half-life for mometasone is 25 hours, and ranges from 9 to 11 hours for formoterol.

Contraindications

Dulera is contraindicated in patients with status asthmaticus or other acute asthmatic episodes that require intensive therapy.

Dulera is also contraindicated in patients with hypersensitivity to any component of Dulera.

Storage

Dulera should be stored at controlled room temperature between 68°F to 77°F (20°C to 25°C). Excursions are permitted from 59°F to 86°F (15°C to 30°C).

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.