Dulera® (as a combination product containing Formoterol, Mometasone)
WHY is this medicine prescribed?
Mometasone oral inhalation is used to prevent difficulty breathing, chest tightness, wheezing, and coughing caused by asthma. Mometasone oral inhalation (Asmanex® HFA) is used in adults and children 12 years of age and older. Mometasone powder for oral inhalation (Asmanex® Twisthaler) is used in adults and children 4 years of age and older. It is in a class of medications called corticosteroids. Mometasone works by decreasing swelling and irritation in the airways to allow for easier breathing.
HOW should this medicine be used?
Mometasone inhalation comes as a powder to inhale by mouth and as an aerosol to inhale by mouth using an inhaler. Mometasone oral inhalation is usually inhaled twice daily. Mometasone powder for oral inhalation is usually inhaled once a day in the evening or twice daily. Use mometasone inhalation at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use mometasone inhalation exactly as directed. Do not inhale more or less of it or inhale it more often than prescribed by your doctor.
Talk to your doctor about how you should use your other oral and inhaled medications for asthma during your treatment with mometasone inhalation. If you were taking an oral steroid such as dexamethasone, methylprednisolone (Medrol), or prednisone (Rayos), your doctor may want to gradually decrease your steroid dose starting at least 1 week after you begin to use mometasone inhalation.
Mometasone inhalation helps to prevent asthma attacks but will not stop an asthma attack that has already started. Do not use mometasone inhalation during an asthma attack. Your doctor will prescribe a short-acting inhaler to use during asthma attacks.
Your doctor will probably start you on an average dose of mometasone inhalation. Your doctor may decrease your dose if your symptoms are controlled or gradually increase your dose if your symptoms have not improved after 2 weeks.
Mometasone inhalation controls asthma but does not cure it. It may take 1 to 2 weeks or longer before you feel the full benefit of the medication. Continue to use mometasone inhalation even if you feel well. Do not stop using mometasone inhalation without talking to your doctor.
Tell your doctor if your asthma worsens during your treatment. Call your doctor immediately if you have an asthma attack that does not stop when you use your fast-acting asthma medication, or if you need to use more of your fast-acting medication than usual.
Before you use your mometasone oral inhaler the first time, read the written instructions that come with it. Look at the diagrams carefully and be sure that you recognize all the parts of the inhaler. Ask your doctor, pharmacist, or respiratory therapist to show you how to use it. Practice using the inhaler while he or she watches.
The dose counter on the base of your mometasone inhaler tells you how many doses of medication are left in your inhaler. Read the numbers on the dose counter from top to bottom. The number on the dose counter decreases every time you lift the cap to load a dose of medication. Do not use the inhaler if the numbers on the dose counter do not change after you load a dose. Call your pharmacist if your inhaler is not working properly.
To use the aerosol inhaler, follow these steps:
Remove the cap from the mouthpiece.
If you are using the inhaler for the first time or if you have not used the inhaler in more than 5 days, prime it by releasing 4 test sprays into the air, away from your face. Be careful not to spray the medication into your eyes or face. Shake the inhaler prior to each inhalation.
Breathe out through your mouth.
Hold the inhaler facing you with the mouthpiece on the bottom. Place your thumb under the mouthpiece and your index finger on the center of the dose indicator at the top of the canister. Place the mouthpiece in your mouth and close your lips around it.
Breathe in deeply and slowly through your mouth. At the same time, press down firmly on the center of the dose indicator at the top of the canister with your index finger. Remove your index finger as soon as the spray is released.
When you have breathed in fully, remove the inhaler from your mouth and close your mouth.
Try to hold your breath for about 30 seconds, then breathe out gently.
If your doctor has told you to take more than one puffs per treatment, repeat steps 3 through 7.
Put the cap back on the mouthpiece.
Rinse your mouth with water and spit the water out. Do not swallow the water.
Clean your aerosol inhaler once a week. To clean your inhaler, use a clean, dry tissue or cloth. Do not wash or put any part of your inhaler in water.
To use the powder using the inhaler, follow these steps:
If you are using a new inhaler for the first time, remove it from the foil pouch. Write the date that you opened the inhaler in the space provided on the cap label.
Hold the inhaler straight up with the colored base on the bottom. Twist the white cap counterclockwise and remove it. This loads the correct amount of medication in the base of the inhaler, so it is important to twist the cap and not twist the base with your hand. As you lift the cap off, the dose counter on the base will count down by one to show the number of doses left after this use.
Breathe out fully.
Hold the inhaler on its side with the mouthpiece facing you. Be sure that you are not covering the ventilation holes on the sides of the inhaler. Place the mouthpiece of the inhaler in your mouth and close your lips firmly around it.
Breathe in a fast, deep breath. You will receive your medication as a very fine powder, so you may not be able to smell, feel, or taste it as you inhale.
Remove the inhaler from your mouth and hold your breath for 10 seconds or as long as you comfortably can. Do not breathe out into the inhaler.
Wipe the mouthpiece dry. Put the cap back onto the inhaler so that the indented arrow is in line with the dose counter. Gently press down and turn clockwise until you hear a click.
Rinse your mouth with water and spit. Do not swallow the water.
If your inhaler needs to be cleaned, gently wipe it with a dry cloth. Do not wash the inhaler. Keep the inhaler away from water or other liquids.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before using mometasone oral inhalation,
tell your doctor and pharmacist if you are allergic to mometasone, any other medications, or any of the ingredients in mometasone inhalation powder or aerosol inhaler. If you will be using the inhalation powder, also tell your doctor if you are allergic to lactose or milk proteins. Ask your pharmacist for a list of the ingredients.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or have recently taken. Be sure to mention any of the following: antifungals such as itraconazole (Onmel, Sporanox) and ketoconazole ; clarithromycin (Biaxin, in Prevpac); cobicistat (Tybost, in Evotaz, in Genvoya, others); HIV protease inhibitors such as atazanavir (Reyataz, in Evotaz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra, in Viekira Pak, others), and saquinavir (Invirase); medications for seizures, nefazodone; oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); and telithromycin (Ketek). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with mometasone oral inhalation, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
do not use mometasone during an asthma attack. Your doctor will prescribe a short-acting inhaler to use during asthma attacks. Call your doctor if you have an asthma attack that does not stop when using the fast-acting asthma medication, or if you need to use more of the fast-acting medication than usual.
tell your doctor if you or anyone in your family has or has ever had osteoporosis (a condition in which the bones become thin and weak and break easily) and if you have or have ever had tuberculosis (TB; a type of lung infection) in your lungs, cataracts (clouding of the lens of the eye), glaucoma (an eye disease) or high pressure in the eye, or liver disease. Also tell your doctor if you have any type of untreated infection anywhere in your body or a herpes eye infection (a type of infection that causes a sore on the eyelid or eye surface), or if you are on bedrest or unable to move around.
tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using mometasone inhalation, call your doctor.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are using mometasone inhalation.
if you have any other medical conditions, such as asthma, arthritis, or eczema (a skin disease), they may worsen when your oral steroid dose is decreased. Tell your doctor if this happens or if you experience any of the following symptoms during this time: extreme tiredness, muscle weakness or pain; sudden pain in stomach, lower body or legs; loss of appetite; weight loss; upset stomach; vomiting; diarrhea; dizziness; fainting; depression; irritability; and darkening of skin. Your body may be less able to cope with stress such as surgery, illness, severe asthma attack, or injury during this time. Call your doctor right away if you get sick and be sure that all healthcare providers who treat you know that you recently replaced your oral steroid with mometasone inhalation. Carry a card or wear a medical identification bracelet to let emergency personnel know that you may need to be treated with steroids in an emergency.
tell your doctor if you have never had chickenpox or measles and you have not been vaccinated against these infections. Stay away from people who are sick, especially people who have chickenpox or measles. If you are exposed to one of these infections or if you develop symptoms of one of these infections, call your doctor right away. You may need treatment to protect you from these infections.
you should know that mometasone inhalation sometimes causes wheezing and difficulty breathing immediately after it is inhaled. If this happens, use your fast-acting (rescue) asthma medication right away and call your doctor. Do not use mometasone inhalation again unless your doctor tells you that you should.
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
Skip the missed dose and continue your regular dosing schedule. Do not inhale a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Mometasone inhalation may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
stuffy or runny nose
swelling of nose, throat, and sinuses
bone, muscle, joint, or back pain
nose irritation or nosebleed
painful white patches in the mouth or throat
painful menstrual periods
Some side effects can be serious. If you experience any of the following symptoms or those in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:
swelling of the eyes, face, tongue, throat, arms, hands, feet, ankles, or lower legs
difficulty breathing or swallowing
Mometasone inhalation may cause slowed growth in children. Your child's doctor will monitor your child's growth carefully while he or she is using mometasone inhalation. Talk to your doctor about the risks of giving this medication to your child.
People who use mometasone for a long time may develop glaucoma or cataracts. Talk to your doctor about the risks of using mometasone and how often you should have your eyes examined during your treatment.
Mometasone inhalation may cause a decrease in your bone mineral density (bone strength and thickness) and may increase your risk of developing osteoporosis. Talk to your doctor about the risks of using mometasone inhalation.
Mometasone inhalation may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( Web Site ) or by phone (1-800-332-1088).
What should I know about STORAGE and DISPOSAL of this medication?
Store your mometasone inhaler out of reach of children, at room temperature, and away from excess heat and moisture (not in the bathroom). Do not store the inhaler near a heat source or an open flame. Protect the inhaler from freezing and direct sunlight. Do not puncture the aerosol container and do not throw it away in an incinerator or fire. Dispose of your mometasone oral inhalation powder inhaler 45 days after you open the package and any medication that is outdated or no longer needed.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. Web Site
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( Web Site) for more information if you do not have access to a take-back program.
What OTHER INFORMATION should I know?
Keep all appointments with your doctor.
Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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