Dulera Information and Uses

Dulera

Dulera (generic: mometasone/formoterol) is a prescription medication used as a maintenance treatment for asthma in people over 12 years old. It is not intended for use after an asthma attack has started.

This medication contains two drugs. Mometasone belongs to a group of drugs called corticosteroids, which decrease inflammation in the lungs. Formoterol belongs to a group of drugs called long-acting beta agonists (LABA), which relax and open airways in the lungs.

This medication comes in an inhaler. The usual dose is 2 inhalations twice each day.

Common side effects of Dulera include inflammation of the nose, throat, and sinuses and headaches.

Uses of Dulera

Dulera is a prescription medication used to control symptoms of asthma and prevent symptoms such as wheezing in people 12 years of age and older. Dulera should not be used as a rescue inhaler.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Side Effects of Dulera

Dulera can cause serious side effects, including:

See "Drug Precautions".
Thrush in the mouth and throat. You may develop a yeast infection (Candida albicans) in your mouth or throat. Rinse your mouth with water after using Dulera to help prevent an infection in your mouth or throat.
Immune system effects and a higher chance for infections.
Tell your healthcare provider about any signs of infection such as:
- fever
- feeling tired
- pain
- nausea
- body aches
- vomiting
- chills

Adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines and start inhaled corticosteroid medicines.
Increased wheezing right after taking Dulera. Always have a rescue inhaler with you to treat sudden wheezing.
Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
- rash
- hives
- swelling, including swelling of the face, mouth, and tongue
- breathing problems
Using too much of a LABA medicine may cause:
- chest pain
- increased or decreased blood pressure
- a fast and irregular heartbeat
- headache
- tremor
- nervousness
- dizziness
- weakness
- seizures
Lower bone mineral density. This may be a problem for people who already have a higher chance for low bone density (osteoporosis).
Slowed growth in children. A child's growth should be checked often.
Eye problems including glaucoma and cataracts. You should have regular eye exams while using Dulera.
Decreases in blood potassium levels (hypokalemia)
Increases in blood sugar levels (hyperglycemia)

The most common side effects of Dulera include:

inflammation of the nose and throat (nasopharyngitis)
inflammation of the sinuses (sinusitis)
headache

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the side effects with Dulera. Ask your healthcare provider or pharmacist for more information.

Dulera Interactions

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Dulera and certain other medicines may interact with each other. This may cause serious side effects.

Especially, tell your healthcare provider if you take antifungal medicines, such as ketoconazole, or anti-HIV medicines, such as ritonavir. The anti-HIV medicines Norvir (ritonavir capsules) Soft Gelatin, Norvir (ritonavir oral solution), and Kaletra (lopinavir/ritonavir) Tablets contain ritonavir.

Know the medicines you take. Keep a list and show it to your healthcare provider and pharmacist each time you get a new medicine.

Dulera Precautions

Dulera can cause serious side effects, including:

Do not use Dulera:

to treat sudden severe symptoms of asthma
if you are allergic to any of the ingredients in Dulera.

1. People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines such as formoterol (one of the medicines in Dulera), have an increased risk of death from asthma problems. It is not known whether mometasone furoate, the other medicine in Dulera, reduces the risk of death from asthma problems seen with formoterol.

Call your healthcare provider if breathing problems worsen over time while using Dulera. You may need different treatment.
Get emergency medical care if:
- breathing problems worsen quickly, and
- you use your rescue inhaler medicine, but it does not relieve your breathing problems.

2. Dulera should be used only if your healthcare provider decides that your asthma is not well controlled with a long-term asthma control medicine, such as an inhaled corticosteroid.

3. When your asthma is well controlled, your healthcare provider may tell you to stop taking Dulera. Your healthcare provider will decide if you can stop Dulera without loss of asthma control. Your healthcare provider may prescribe a different long-term asthma-control medicine for you, such as an inhaled corticosteroid.

4. Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.

Dulera Food Interactions

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Dulera there are no specific foods that you must exclude from your diet when receiving Dulera.

Inform MD

Tell your healthcare provider about all of your health conditions, including if you:

have heart problems
have high blood pressure
have seizures
have thyroid problems
have diabetes
have liver problems
have osteoporosis
have an immune system problem
have eye problems such as increased pressure in the eye, glaucoma, or cataracts
are allergic to any medicines
are exposed to chickenpox or measles
have any other medical problems
are pregnant or planning to become pregnant. It is not known if Dulera may harm your unborn baby.
are breastfeeding. It is not known if Dulera passes into your milk and if it can harm your baby. You and your healthcare provider should decide if you will take Dulera while breastfeeding.

Dulera and Pregnancy

Tell your doctor if you are pregnant or planning to become pregnant. It is not known if Dulera may harm your unborn baby.

Dulera and Lactation

Tell your doctor if you are breastfeeding. It is not known if Dulera passes into your milk and if it can harm your baby. You and your healthcare provider should decide if you will take Dulera while breastfeeding.

Dulera Usage

Use Dulera exactly as prescribed. Do not use Dulera more often than prescribed. Dulera comes in 2 strengths. Your healthcare provider has prescribed the strength that is best for you. Note the differences between Dulera and your other inhaled medications, including the differences in prescribed use and physical appearance.
Dulera should be taken every day as 2 puffs in the morning and 2 puffs in the evening.
If you miss a dose of Dulera, skip your missed dose and take your next dose at your regular time. Do not take Dulera more often or use more puffs than you have been prescribed.
While you are using Dulera 2 times each day, do not use other medicines that contain a long-acting beta2-agonist (LABA) for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.
If you take more Dulera than your healthcare provider has prescribed, get medical help right away if you have any unusual symptoms, such as problems breathing, palpitations, chest pain, increased heart rate, nervousness or shakiness.
Do not change or stop using Dulera or other asthma medicines used to control or treat your breathing problems unless told to do so by your healthcare provider. Your healthcare provider will change your medicines as needed.
Dulera does not relieve sudden asthma symptoms. Always have a rescue inhaler with you to treat sudden symptoms. Use your rescue inhaler if you have breathing problems between doses of Dulera. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
Rinse your mouth with water after each dose (2 puffs) of Dulera. This will help to lessen the chance of getting a yeast infection (thrush) in the mouth and throat.
Do not spray Dulera in your eyes. If you accidentally get Dulera in your eyes, rinse your eyes with water and if redness or irritation continues, call your healthcare provider.
Call your healthcare provider or get medical care right away if:
- your breathing problems worsen with Dulera
- you need to use your rescue inhaler more often than usual
- your rescue inhaler does not work as well for you at relieving symptoms
- you need to use 4 or more inhalations of your rescue inhaler for 2 or more days in a row
- you use 1 whole canister of your rescue inhaler in 8 weeks' time
- your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.
- you have asthma and your symptoms do not improve after using Dulera regularly for 1 to 2 weeks

Before using your Dulera, read the complete instructions and use only as directed.

There are 2 main parts to your Dulera inhaler – the metal canister that holds the medicine and the blue plastic actuator that sprays the medicine from the canister. The inhaler also has a cap that covers the mouthpiece of the actuator. The inhaler contains 60 or 120 actuations (puffs).

The inhaler comes with dose counter located on the plastic actuator. The counter display will show the number of actuations (puffs) of medicine remaining. The dose counter will initially display "64" or "124" actuations remaining. Each time you press the canister, a puff of medicine is released and the counter will count down by 1. The counter will stop counting at 0.

You should not remove the canister from the actuator because reinsertion may cause the counter to count down by 1 and discharge a puff.
Use the Dulera canister only with the actuator supplied with the product. Do not use parts of the Dulera inhaler with parts from any other inhalation medicine.

Before using your Dulera remove the cap from the mouthpiece of the actuator. Check the mouthpiece for objects before use. Make sure the canister is fully inserted into the actuator.

Before you use Dulera for the first time, you must prime the inhaler.

To prime the inhaler, hold it in the upright position and release 4 actuations (puffs) into the air, away from your face.
Shake the inhaler well before each of the priming actuations. After priming 4 times, the dose counter should read either "60" or "120".
If you do not use your Dulera for more than 5 days, you will need to prime it again before use.

Using your Dulera

Remove the cap from the mouthpiece of the actuator. Check the mouthpiece for objects before use. Make sure the canister is fully inserted into the actuator.
Shake the inhaler well before each use.
Breathe out as fully as you comfortably can through your mouth. Push out as much air from your lungs as possible. Hold the inhaler in the upright position and place the mouthpiece into your mouth. Close your lips around the mouthpiece.

When to replace your Dulera:

It is important that you pay attention to the number of inhalations (puffs) left in your Dulera inhaler by reading the counter.
When the counter reads 20, you should refill your prescription or ask your healthcare provider if you need a new prescription for Dulera.
Throw away Dulera after the counter reaches 0, indicating that you have used the number of actuations on the product label and box. Your inhaler may not feel empty and it may continue to operate, but you will not get the right amount of medicine if you keep using it.
Never try to change the numbers on the counter or remove the counter from the actuator.
Do not use the inhaler after the expiration date.

Dulera Dosage

Take Dulera exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Dulera should be administered as two puffs twice daily every day (morning and evening) by the orally inhaled route. Shake well prior to each inhalation.

The recommended starting dosages for Dulera treatment are based on prior asthma therapy. The maximum daily recommended dose is two inhalations of Dulera 200 mcg/5 mcg twice daily.

Dulera Overdose

If you take too much Dulera, call your local Poison Control Center or seek emergency medical attention right away.

Forms of Dulera

Dulera 100 mcg/5 mcg delivers 100 mcg of mometasone furoate and 5 mcg of formoterol fumarate dihydrate per actuation.

Dulera 200 mcg/5 mcg delivers 200 mcg of mometasone furoate and 5 mcg of formoterol fumarate dihydrate per actuation.

Active ingredients: mometasone furoate and formoterol fumarate dihydrate

Inactive ingredients: hydrofluoroalkane (HFA-227), anhydrous alcohol and oleic acid

Other Requirements

Store Dulera at room temperature between 59°F to 86°F (15°C to 30°C).
The 120-actuation inhaler can be stored in any position. For the 60-actuation inhaler, after priming, store the inhaler with the mouthpiece down or sideways.
The contents of your Dulera are under pressure. Do not puncture. Do not use or store near heat or open flame. Storage above 120°F may cause the canister to burst.
Do not throw container into fire or incinerator.
Keep Dulera and all medicines out of the reach of children.

How to clean your Dulera:

The mouthpiece should be cleaned using a dry wipe after every 7 days of use.

Routine cleaning instructions:

Remove the cap off the mouthpiece. Wipe the inside and outside surfaces of the actuator mouthpiece with a clean, dry, lint-free tissue or cloth. Put the cap back on the mouthpiece after cleaning.
Do not attempt to unblock the actuator with a sharp object, such as a pin.
Do not wash or put any parts of your inhaler in water.

Dulera FDA Warning

WARNING: ASTHMA-RELATED DEATH

Long-acting beta2-adrenergic agonists (LABA), such as formoterol, one of the active ingredients in Dulera, increase the risk of asthma-related death. Data from a large placebo-controlled U.S. study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of the LABA, including formoterol. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Therefore, when treating patients with asthma, Dulera should only be used for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue Dulera) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use Dulera for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.