How to use your

DULERA inhaler

 
 

Instructions on using DULERA

 

For complete instructions for using your DULERA Inhaler, please read the Patient Information.

Read this important information for details about using the DULERA inhaler.

If you doctor decides DULERA is right for you, take DULERA every day–2 puffs in the morning, 2 puffs at night.

 
 

Using Your DULERA Inhaler

 
DULERA® (mometasone furoate and formoterol fumarate dihydrate) Has a Built-in Counter to Show Remaining Doses

DULERA has a built-in counter that shows remaining doses. With every puff the counter counts backward automatically. If you can’t remember if you’ve taken your daily doses, check the counter.

Refill DULERA® (mometasone furoate and formoterol fumarate dihydrate) When Counter Reads The Number '20'

When the counter reads the number ’20’, you should refill your prescription or ask your healthcare provider if you need a new prescription for DULERA.

Before Using Your DULERA Inhaler

 
Remove the Cap From the Mouthpiece of the Actuator Before Using DULERA® (mometasone furoate and formoterol fumarate dihydrate)

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.

Do Not Remove the Canister From the Actuator Before Using DULERA® (mometasone furoate and formoterol fumarate dihydrate)
  • You should not remove the canister from the actuator because:

  • •  You may not receive the correct amount of medication.
  • •  The dose counter may not function properly.
 
 

Follow these steps each time you use your DULERA inhaler

 
PRIME
 
Before you use DULERA for the first time, you must prime the inhaler.
Step 1: 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.

Step 2: Shake the Inhaler

Shake the inhaler well before each of the priming actuations. The dose counter will initially show the number ‘64’ or ‘124’. After priming 4 times, the dose counter should read either ‘60’ or ‘120’.

Step 3: Prime the Inhaler Again if Not Used for More Than 5 Days

If you do not use your DULERA for more than 5 days, you will need to prime it again before use.

SHAKE
 
Step 4: Remove the Cap

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.

Step 5: Shake the Inhaler Well Before Each Use

Shake the inhaler well before each use.

INHALE
 
Step 6: Breathe Out Fully

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.

Step 7: Take a Deep Breath In

Take a deep breath in (inhale) slowly through your mouth. While doing this, press down firmly and fully on the top of the canister until it stops moving in the actuator. Take your finger off the canister.

Step 8: Remove the Inhaler From Your Mouth and Breathe Out Through Your Nose

When you have finished breathing in, hold your breath as long as you comfortably can, up to 10 seconds. Then remove the inhaler from your mouth and breathe out through your nose, while keeping your lips closed.

REPEAT
 
Step 9: Wait 30 Seconds to Take Second Puff

Wait at least 30 seconds to take your second puff of DULERA.

Step 10: Shake the Inhaler Well Again

Shake the inhaler well again and repeat the steps under “Inhale” to take your second puff of DULERA.

Step 11: Replace the Cap Over the Mouthpiece

Replace the cap over the mouthpiece right away after use.

Step 12: Rinse Your Mouth With Water

After you finish taking DULERA (2 puffs), rinse your mouth with water. Spit out the water. Do not swallow it.

STORE
 
Step 13: Store Properly

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.

 

Possible Side Effects of DULERA

*Not all patients are eligible. Terms and conditions apply.
 

 
What is DULERA (mometasone furoate and formoterol fumarate dihydrate)?

DULERA is a prescription medicine used to control symptoms of asthma and prevent symptoms such as wheezing in people 12 years of age and older.

DULERA is not used to relieve sudden breathing problems and will not replace a rescue inhaler.

DULERA is not for adults and adolescents with asthma who are well controlled with an asthma control medicine, such as a low to medium dose inhaled corticosteroid (ICS) medicine. DULERA is for adults and adolescents with asthma who need both an ICS and long-acting beta2-adrenergic agonist (LABA) medicine.

 

 
Selected Important Safety Information about DULERA
  • DULERA contains formoterol. LABA medicines such as formoterol when used alone increase the risk of hospitalizations and death from asthma problems. DULERA contains an ICS and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.
    • 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.
  • Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.
  • DULERA does not replace rescue inhalers for sudden asthma symptoms. Always have a rescue inhaler medicine with you to treat sudden symptoms.
  • Do not use DULERA more often than prescribed. Do not take DULERA with other medicines that contain a LABA for any reason, as using too much LABA may cause chest pain, increase or decrease in blood pressure, fast and irregular heartbeat, headache, tremor, nervousness, dizziness, weakness, seizures and electrocardiogram (ECG) changes. Tell your doctor about medicines you take and about all of your medical conditions.
  • People taking DULERA may experience
    • Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of these symptoms of a serious allergic reaction: rash, hives, swelling, including swelling of the face, mouth and tongue, or breathing problems.
    • Thrush (yeast infection) in the mouth and throat.
    • A higher chance of infection. Avoid exposure to chickenpox or measles. If exposed, or if you have any signs of infection, tell your healthcare provider immediately. Worsening of existing tuberculosis, fungal, bacterial, viral or parasitic infections, or ocular herpes simplex may occur.
    • Reduced adrenal function (may result in loss of energy). This can happen when you stop taking oral corticosteroid medicines and start inhaled corticosteroid medicines.
    • Increase in wheezing right after taking DULERA.
    • 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.
    • Eye problems including glaucoma, cataracts, and blurred vision. You should have regular eye exams while using DULERA.
    • Decrease in blood potassium and increase in blood sugar levels.
  • If you are switching to DULERA from an oral corticosteroid, follow your healthcare provider’s instructions to avoid serious health risks when you stop using oral corticosteroids.
  • The most common side effects of DULERA include inflammation of the nose and throat, inflammation of the sinuses, and headache.
You are encouraged to report the negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1.800.FDA.1088.
Please read the Patient Information for DULERA and discuss it with your doctor. The physician Prescribing Information also is available.
 

What is DULERA (mometasone furoate and formoterol fumarate dihydrate)?
 

DULERA is a prescription medicine used to control symptoms of asthma and prevent symptoms such as wheezing in people 12 years of age and older.

DULERA is not used to relieve sudden breathing problems and will not replace a rescue inhaler.

DULERA is not for adults and adolescents with asthma who are well controlled with an asthma control medicine, such as a low to medium dose inhaled corticosteroid (ICS) medicine. DULERA is for adults and adolescents with asthma who need both an ICS and long-acting beta2-adrenergic agonist (LABA) medicine.

 
 
 
 
Selected Important Safety Information about DULERA
 
  • DULERA contains formoterol. LABA medicines such as formoterol when used alone increase the risk of hospitalizations and death from asthma problems. DULERA contains an ICS and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.
    • 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.
  • Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.
  • DULERA does not replace rescue inhalers for sudden asthma symptoms. Always have a rescue inhaler medicine with you to treat sudden symptoms.
  • Do not use DULERA more often than prescribed. Do not take DULERA with other medicines that contain a LABA for any reason, as using too much LABA may cause chest pain, increase or decrease in blood pressure, fast and irregular heartbeat, headache, tremor, nervousness, dizziness, weakness, seizures and electrocardiogram (ECG) changes. Tell your doctor about medicines you take and about all of your medical conditions.
  • People taking DULERA may experience
    • Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of these symptoms of a serious allergic reaction: rash, hives, swelling, including swelling of the face, mouth and tongue, or breathing problems.
    • Thrush (yeast infection) in the mouth and throat.
    • A higher chance of infection. Avoid exposure to chickenpox or measles. If exposed, or if you have any signs of infection, tell your healthcare provider immediately. Worsening of existing tuberculosis, fungal, bacterial, viral or parasitic infections, or ocular herpes simplex may occur.
    • Reduced adrenal function (may result in loss of energy). This can happen when you stop taking oral corticosteroid medicines and start inhaled corticosteroid medicines.
    • Increase in wheezing right after taking DULERA.
    • 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.
    • Eye problems including glaucoma, cataracts, and blurred vision. You should have regular eye exams while using DULERA.
    • Decrease in blood potassium and increase in blood sugar levels.
  • If you are switching to DULERA from an oral corticosteroid, follow your healthcare provider’s instructions to avoid serious health risks when you stop using oral corticosteroids.
  • The most common side effects of DULERA include inflammation of the nose and throat, inflammation of the sinuses, and headache.
You are encouraged to report the negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1.800.FDA.1088.
Please read the Patient Information for DULERA and discuss it with your doctor. The physician Prescribing Information also is available.