Mometasone/Formoterol, Inhalation Aerosol moh-MET-a-sone for-MOH-ter-ol

What are other names for this medicine?

Type of medicine: corticosteroid; long-acting beta agonist; bronchodilator

Generic and brand names: mometasone/formoterol, inhalation aerosol; Dulera

What is this medicine used for?

This is a combination of two medicines. Mometasone is a steroid that reduces inflammation in the lungs. Formoterol is a long-acting medicine that helps open up the airways. This medicine is inhaled to prevent asthma attacks. (It does not stop asthma attacks that have already started.)

This medicine is used only when your asthma is not controlled with another long-term asthma medicine, such as an inhaled steroid.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine or to milk products
• a weakened immune system from diseases such as HIV/AIDS or from cancer chemotherapy, radiation therapy, or steroid medicine
• adrenal or thyroid gland problems
• diabetes
• eye problems such as glaucoma or cataracts
• heart disease, heart failure, or heart rhythm problems
• high blood pressure
• long QT syndrome (problems with electrical activity in the heart muscle)
• liver problems
• osteoporosis
• problems with low levels of potassium in your blood
• seizures
• tuberculosis

Tell your healthcare provider about all other medicines you are taking or using for your breathing problem.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without discussing with your healthcare provider.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Read the information sheet that comes in the medicine package. Ask your healthcare provider or pharmacist about anything you do not understand.

Use this medicine exactly as your healthcare provider prescribes. Do NOT take more of this medicine than prescribed. Do not stop using this medicine or any other medicine without your healthcare provider's approval.

Do not spray this medicine in your eyes. If you get some medicine in your eyes, flush them with cool water and contact your healthcare provider if redness or irritation continues.

There are 2 main parts to your 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 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. You should not remove the canister from the actuator because reinsertion may cause the counter to count down by 1 and discharge a puff. The counter will count down each time you release a puff of medicine (either when priming or when taking the medicine). It is important that you pay attention to the number of inhalations (puffs) left in your inhaler by reading the counter.

Wash your hands before using this medicine. Prime the inhaler before you use it for the first time and when you have not used it for more than 5 days. Prime the inhaler by shaking it well for 5 seconds and then releasing a test spray into the air (away from your face). Repeat for a total of 4 test sprays. Your inhaler is now primed and ready for use.

To use the inhaler without a spacer:

1. Shake the inhaler well for 5 seconds right before each use. Remove the mouthpiece cover.
2. Breathe out fully (exhale). Raise the inhaler up to your mouth. Place the mouthpiece fully into your mouth and close your lips around it. Make sure that the inhaler is upright and that the opening of the mouthpiece is pointing towards the back of your throat.
3. Breathe in deeply and slowly through your mouth and press down firmly and fully on the top of the inhaler to release the medicine.
4. Hold your breath for 5 to 10 seconds, or for as long as is comfortable. Before breathing out, release your finger from the top and remove the inhaler from your mouth. Keep the inhaler upright.
5. Wait at least 30 seconds to take your second puff of this medicine. Shake the inhaler again for 5 seconds and repeat steps 2 through 5. Take the number of puffs prescribed by your healthcare provider.
6. Replace the mouthpiece cover after use.

Your provider may suggest that you use a spacer. The spacer helps you get the right amount of medicine.

To use the inhaler with a spacer:

1. Shake the inhaler well for 5 seconds right before each use. Remove the mouthpiece cover.
2. Hold the inhaler upright so the mouthpiece is at the bottom.
3. Insert the mouthpiece of the inhaler into the rubber-sealed end of the spacer.
4. Place the spacer into your mouth. Breathe slowly in and out of the spacer several times.
5. Press the inhaler down once so it releases a spray of medicine into the spacer while you breathe in deeply through your mouth. Each time you press down, a metered (measured) dose is delivered. (One spray is called a puff.)
6. Hold your breath for 5 to 10 seconds and then breathe out slowly. If you are unable to hold your breath, another method is to breathe in and out slowly for 3 to 5 breaths.
7. If your provider prescribes more than 1 puff, wait at least 30 seconds, and then repeat steps 1 through 5. Take the number of puffs prescribed by your healthcare provider.

If you do not understand how to use the inhaler, ask your healthcare provider or pharmacist to demonstrate. Rinse your mouth with water without swallowing after each use to help prevent thrush (a fungal infection that shows up as white spots on your tongue and in your mouth).

Use a clean, dry cloth to wipe the mouthpiece opening after every 7 days of use. Do not put the inhaler into water.

What if I miss a dose?

If you miss a dose, skip the missed dose and use the next one as directed. Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: chest pain, fast or irregular heartbeat, muscle cramps, dry mouth, nausea, nervousness, headache, seizures, severe dizziness, tremors.

What should I watch out for?

In people with asthma, long-acting beta2-adrenergic agonists increase the risk of asthma-related death. Talk with your healthcare provider about this. If you have any of these signs of worsening asthma, call your healthcare provider right away:

• You need to use more puffs than usual of your short-acting inhaler or use it more often.
• You have severe breathing trouble that does not improve, such as persistent wheezing, coughing, or shortness of breath.
• You have a bluish color in your lips or fingernails or cannot speak.
• You have any asthma symptoms that are getting worse.

Do not use this medicine for sudden breathing problems. Your healthcare provider may also prescribe a short-acting inhaled medicine to use when you have a sudden breathing problem. Use all medicines as directed by your healthcare provider.

This combination medicine is used only when your asthma is not well controlled with a long-term asthma control medicine, such as an inhaled corticosteroid. After your asthma is well controlled, your healthcare provider will decide if you can stop using this medicine. At that time, your provider may prescribe a different long-term asthma-control medicine for you.

Talk with your healthcare provider about this.

Your healthcare provider will want to see you regularly to see how this medicine is affecting you and may adjust your medicine. Keep all appointments for checkups and eye exams.

If you have switched from steroid tablets taken by mouth to this medicine, you may need extra doses of steroid tablets during periods of stress such as injury, surgery, infection, or severe asthma attacks. Talk with your healthcare provider about this.

This medicine may increase your heart rate or blood pressure. Talk with your healthcare provider about this.

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert.

This medicine may affect growth in children. Talk to your healthcare provider about this.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. If you are exposed to an infectious disease or have any signs of infection, contact your healthcare provider right away. Chickenpox or measles may be more serious than usual while you are using this medicine. Also, do not have any vaccines without getting your healthcare provider's approval first.

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you are unable to reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives, itching, rash, swelling of your tongue or throat, tightness in your chest, increased trouble breathing).

Serious (report these to your healthcare provider right away): Chest pain, fast or irregular heartbeat, seizures, tremor, nervousness, fever, chills, cough, sore throat, runny nose, white patches in or around your mouth, muscle aches and pains, infection, unexplained tiredness, vision changes.

Other: Nausea, dizziness, trouble sleeping, headache, muscle cramps, hoarseness, stuffy or runny nose.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (Ery-Tabs, E.E.S.), isoniazid, metronidazole (Flagyl), norfloxacin (Noroxin), rifampin (Rifadin), and telithromycin (Ketek)
• antifungal medicines such as clotrimazole, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Monistat, Micatin), posaconazole (Noxafil), and voriconazole (VFEND)
• anti-HIV medicines such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• antipsychotic medicines such as chlorpromazine, haloperidol (Haldol), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon) arsenic trioxide (Trisenox)
• beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), pindolol, propranolol (Inderal LA), and sotalol (Betapace)
• diuretics such as bumetanide, chlorthalidone (Thalitone), chlorothiazide (Diuril), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide), methyclothiazide, and torsemide (Demadex)
• heart medicines such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), flecainide (Tambocor), propafenone (Rythmol), procainamide, quinidine, and sotalol (Betapace)
• MAO inhibitor antidepressants such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• medicines to treat breathing or lung problems such as arformoterol (Brovana), aminophylline, fluticasone/salmeterol (Advair), formoterol fumarate (Foradil), salmeterol (Serevent, Advair), and theophylline
• nefazodone
• St. John's wort
• stimulants such as caffeine, dextroamphetamine (Dexedrine), methamphetamine (Desoxyn), and pseudoephedrine (Sudafed)
• tricyclic antidepressants such as amitriptyline, desipramine (Norpramin), doxepin, imipramine (Tofranil), and nortriptyline (Pamelor)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store the medicine at room temperature. Do not wash the inhaler. The contents of the canister are under pressure. Do not puncture. Keep it away from heat and moisture. Discard the inhaler after you have used all of the doses.

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This advisory includes selected information only and may not include all side effects of this medicine or drug interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.

Developed by RelayHealth.
Medication Advisor 2012.1 published by RelayHealth.
Last modified: 2011-04-18
Last reviewed: 2010-12-21
This content is reviewed periodically and is subject to change as new health information becomes available. The information is intended to inform and educate and is not a replacement for medical evaluation, advice, diagnosis or treatment by a healthcare professional.
© 2012 RelayHealth and/or its affiliates. All rights reserved.