Formoterol Fumarate (for-MOE-ter-ol FUE-ma-rate), Mometasone Furoate (moe-MET-a-sone FURE-oh-ate)

Prevents asthma attacks. This medicine contains a steroid.

Brand Name(s):

Dulera

When This Medicine Should Not Be Used:

How to Use This Medicine:

Powder Under Pressure

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• You will use this medicine with a device called a metered-dose inhaler. The inhaler fits on the medicine canister and turns the medicine into a fine spray that you breathe in through your mouth and to your lungs. You may be told to use a spacer, which is a tube that is placed between the inhaler and your mouth. Your caregiver will show you how to use your inhaler and the spacer (if needed).
• Do not remove the canister from the actuator.
• Remove the cap and look at the mouthpiece to make sure it is clean.
• Prime the inhaler: Before you use an inhaler for the first time, prime it by pointing it away from your face and spraying into the air 4 times. If the inhaler has not been used for 5 days or longer, prime it again.
• Always shake the inhaler right before you spray it, every time.
• To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece just in front of your mouth with the canister upright.
• Open your mouth and breathe in slowly and deeply (like yawning), and at the same time firmly press down on the top of the canister once.
• Hold your breath for about 5 to 10 seconds, and then breathe out slowly.
• If you are supposed to use more than one puff, wait 1 to 2 minutes before inhaling the second puff. Repeat these steps for the next puff, starting with shaking the inhaler.
• When you have finished all your inhalations, rinse your mouth out with water. Do not swallow the water.
• Clean the inhaler mouthpiece daily with warm water.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty. Store the inhaler that has 60 doses with the mouthpiece down or sideways.
• Dispose of the inhaler when the counter reads "0" even if it feels like it still has medicine in it.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• This medicine should not be used with arformoterol, budesonide/formoterol, formoterol, or salmeterol inhalers.
• Some medicines can affect how mometasone or formoterol works. Tell your doctor if you are using atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, a steroid medicine (such as dexamethasone, methylprednisolone, prednisolone, prednisone), a diuretic (water pill), or a beta-blocker blood pressure medicine.
• Make sure your doctor knows if you have used medicine for depression, an antibiotic, or an MAO inhibitor within the past 2 weeks.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, heart or blood vessel disease (including aneurysm), heart rhythm problems, high blood pressure, or seizures. Tell your doctor if you have adrenal gland problems, bone problems (including osteoporosis), cataracts, diabetes, glaucoma, thyroid problems, tuberculosis, or any type of infection.
• This should not be the first and only medicine you use for asthma. This medicine will not stop an asthma attack that has already started. Your doctor may prescribe another medicine for you to use in case of an acute asthma attack.
• This medicine may cause the following problems:
  • Changes in blood sugar levels
  • Decrease in bone mineral density, which can lead to weak bones
  • Glaucoma or cataracts
  • Higher risk of infection (tell your doctor if you are exposed to chickenpox or measles)
  • Hypokalemia (low potassium levels in the blood)
  • Fungus infections in the mouth or throat
  • Problems with the adrenal gland
  • Slow growth in children
• This medicine helps prevent asthma attacks for most people, but some people may have more severe asthma attacks when they use it. Talk to your doctor about what you should do if this happens.
• If any of your asthma medicines do not seem to be working as well as usual, call your doctor right away. Do not change your doses or stop using your medicines without asking your doctor.
• Make sure any doctor or dentist who treats you knows that you are using this medicine.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Breathing problems get worse
• Dark freckles, skin color changes, coldness, weakness, tiredness, nausea, vomiting, weight loss
• Dry mouth, increased thirst, muscle cramps, nausea or vomiting, uneven heartbeat
• Eye pain or trouble seeing
• Fast, pounding, or uneven heartbeat, chest pain
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches
• Tremors or nervousness
• White patches inside your mouth or throat, pain when eating or swallowing

If you notice these less serious side effects, talk with your doctor:

• Headache
• Hoarseness or voice changes

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088