Asmanex contains mometasone furoate, a corticosteroid medicine. Mometasone furoate prevents the release of substances in the body that cause inflammation.

Asmanex is used to prevent asthma attacks.

Asmanex will not treat an asthma attack that has already begun.

Do not use Asmanex as a rescue medicine for asthma attacks. It will not work fast enough. Use only fast-acting inhalation medicine for an attack.

Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well. An increased need for medication could be an early sign of a serious asthma attack.

Use Asmanex exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Asmanex is not a rescue medicine for asthma attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Asmanex comes in a powder form that is preloaded in with a special inhaler device (twisthaler). The device will deliver a measured dose of mometasone as a fine spray of powder each time you use the inhaler.

You may or may not be able to feel or taste this powder in your mouth while using the inhaler. Do not use extra doses if you do not feel or taste the powder. Tell your doctor or pharmacist if you think your inhaler is not working properly.

It may take up to 2 weeks before your symptoms improve. Keep using the medication as directed and call your doctor if your symptoms do not improve after 1 week of treatment.

To help prevent thrush (a yeast infection in the mouth or throat), rinse your mouth with water without swallowing after each use of your inhaler.

Mometasone can weaken (suppress) your immune system, and you may get an infection more easily.

If you also use an oral steroid medication, you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose.

Your dose needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your medication dose or schedule without your doctor's advice.

If you switched to Asmanex from an oral (taken by mouth) steroid, you may need to restart the oral medicine if you are under stress or have an asthma attack or other medical emergency. Wear a medical alert tag or carry an ID card stating that you may need an oral steroid in an emergency.

Asthma is often treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Store Asmanex at room temperature away from moisture and heat. When you first open the foil pouch and remove the inhaler device, write the date on the device. Throw away the inhaler when the dose counter shows "00."

Keep the cap on your inhaler when not in use. Keep the inhalation aerosol canister away from open flame or high heat. The canister may explode if it gets too hot. Do not puncture or burn an empty inhaler canister.

Do not wash your inhaler device or allow it to get wet. Wipe the mouthpiece with a clean dry tissue or cloth.

Usual Adult Dose of Asmanex for Asthma -- Maintenance:

Inhalation Aerosol Powder:
Previous therapy with bronchodilators alone, or inhaled corticosteroids:
-Initial dose: 220 mcg inhaled orally in the evening
-Maximum dose: 440 mcg in divided doses of 220 mcg twice a day, or as 440 mcg once daily.

Previous therapy with oral corticosteroids:
-Initial dose: 440 mcg inhaled orally twice a day
-Maximum dose: 880 mcg

Inhalation Aerosol:
Previous therapy with inhaled medium-dose corticosteroids:
-2 inhalations of 100 mcg orally twice a day

Previous therapy with inhaled high-dose or oral corticosteroids:
-2 inhalations of 200 mcg orally twice a day
-Maximum dose: 800 mcg per day

For Patients Currently Receiving Chronic Oral Corticosteroid Therapy:
-Prednisone should be weaned slowly, beginning after at least 1 week of therapy with this drug.
-Monitor for signs of asthma instability, including serial objective measures of airflow, and for signs of adrenal insufficiency during steroid taper and following discontinuation of oral corticosteroid therapy.

Use: Maintenance treatment of asthma as prophylactic therapy

Usual Pediatric Dose of Asmanex for Asthma -- Maintenance:

Inhalation Aerosol Powder:
Less than 4 years: Not approved for this age.

4 to 11 years:
-110 mcg orally once a day, in the evening

12 years and older:
Previous therapy with bronchodilators alone or inhaled corticosteroids:
-Initial dose: 220 mcg inhaled orally in the evening
-Maximum dose: 440 mcg in divided doses of 220 mcg twice a day, or as 440 mcg once daily.
Previous therapy with oral corticosteroids:
-Initial dose: 440 mcg inhaled orally twice a day
-Maximum dose: 880 mcg

Inhalation Aerosol:
Less than 12 years: Not approved for this age.

12 years or older:
Previous therapy with inhaled medium-dose corticosteroids:
-2 inhalations of 100 mcg orally twice a day
Previous therapy with inhaled high-dose or oral corticosteroids:
-2 inhalations of 200 mcg orally twice a day
-Maximum dose: 800 mcg per day

For Patients Currently Receiving Chronic Oral Corticosteroid Therapy:
-Prednisone should be weaned slowly, beginning after at least 1 week of therapy with this drug.
-Monitor for signs of asthma instability, including serial objective measures of airflow, and for signs of adrenal insufficiency during steroid taper and following discontinuation of oral corticosteroid therapy.

You should not use Asmanex if you are allergic to mometasone, or to milk proteins.

To make sure Asmanex is safe for you, tell your doctor if you have ever had:

• liver disease;

• herpes infection of the eyes;

• glaucoma, cataracts, or other vision problems;

• low bone mineral density, osteoporosis; or

• any illness or infection, including tuberculosis.

Tell your doctor if you are pregnant. It is not known whether mometasone will harm an unborn baby. However, having untreated or uncontrolled asthma during pregnancy may cause complications such as low birth weight, premature birth, or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating asthma may outweigh any risks to the baby.

It may not be safe to breastfeed while using Asmanex. Ask your doctor about any risk.

Do not give Asmanex to a child younger than 4 years old. Asmanex HFA should not be given to a child younger than 5 years old.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk of osteoporosis.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using Asmanex.

Get emergency medical help if you have signs of an allergic reaction to Asmanex: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using this medication;

• blurred vision, tunnel vision, eye pain, or seeing halos around lights;

• worsening asthma symptoms;

• signs of infection - fever, feeling tired, body aches, pain, chills;

• signs of thrush (a fungal infection) - sores or white patches in your mouth or throat, trouble swallowing; or

• symptoms of low adrenal gland hormones - extreme tiredness or weakness, nausea, vomiting, a light-headed feeling (like you might pass out);

Mometasone can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using Asmanex.

Common Asmanex side effects may include:

• fungal infection;

• increased sinus allergy symptoms (runny nose, stuffy nose, sinus pain), sore throat, nosebleed;

• headache;

• muscle or bone pain, back pain;

• flu symptoms;

• indigestion, upset stomach;

• menstrual pain; or

• hoarseness or deepened voice.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially:

• nefazodone;

• an antibiotic - clarithromycin, telithromycin;

• antifungal medicine - itraconazole, ketoconazole;

• an antidepressant; or

• antiviral medicine to treat HIV/AIDS - atazanavir, cobicistat, indinavir, nelfinavir, ritonavir, saquinavir.

This list is not complete. Other drugs may interact with mometasone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.