ASMANEX® HFA (mometasone furoate) Inhalation Aerosol  
 

Important Safety Information about ASMANEX HFA

Do not use ASMANEX HFA to treat sudden, severe symptoms of asthma. ASMANEX HFA is not a rescue inhaler and should not be used to provide relief from a sudden asthma attack. Serious side effects of ASMANEX HFA may include worsening asthma or sudden asthma symptoms. Use a rescue inhaler (an inhaled short-acting bronchodilator, such as albuterol) to relieve symptoms of a sudden asthma attack.

ASMANEX HFA is not for patients who have a hypersensitivity (including allergic reactions) to mometasone.

ASMANEX HFA can cause serious allergic reactions. Call your health care provider or get emergency medical care if you develop any symptoms of a serious allergic reaction, including rash, swelling of the face, mouth and tongue, or breathing problems.

Patients who use inhaled steroid medicines for asthma may develop a fungal infection of the mouth and throat. Rinse your mouth after using ASMANEX HFA.

Avoid coming in contact with measles, chickenpox virus, tuberculosis, or any other infections before or while using ASMANEX HFA. Contact your health care provider immediately if you or your child has been exposed.

If you or your child took steroids by mouth and are having them decreased or are being switched to ASMANEX HFA, you should be followed closely by your health care provider, and the oral steroids should be reduced slowly. Deaths due to adrenal insufficiency have occurred during and after switching from oral steroids to inhaled steroids. Tell your health care provider right away about any symptoms such as feeling tired or exhausted, weakness, nausea, vomiting, or symptoms of low blood pressure (such as dizziness or faintness). If you or your child is under stress, such as with surgery, after surgery, or trauma, you may need steroids by mouth again.

It is possible that hypercorticism (an excess level of steroids in your body) or adrenal insufficiency (your adrenal glands cannot produce enough steroids) may appear in a small number of patients, particularly when ASMANEX HFA is administered at higher than recommended doses over prolonged periods of time. If such effects occur, consult your health care provider, as the dosage of ASMANEX HFA should be reduced slowly.

Patients who use inhaled steroids, including ASMANEX HFA, for a long time may have an increased risk of decreased bone mass, which can affect bone strength. Patients who are at increased risk of decreased bone mass should be monitored.

Inhaled steroids, including ASMANEX HFA, may cause a reduction in growth velocity when administered to pediatric patients. The long-term effect on final adult height is unknown. Health care providers should closely follow the growth of children and adolescents taking corticosteroids by any route, and reduce each patient’s dose to the lowest dose that effectively controls his/her symptoms.

ASMANEX HFA may increase the risk of some eye problems such as glaucoma and cataracts. Patients should have regular eye exams while using ASMANEX HFA.

The most common side effects of ASMANEX HFA include: inflammation of the nose and throat, headache, inflammation of the sinuses, bronchitis, and flu infection.

Use ASMANEX HFA as directed by your health care provider. If your asthma symptoms do not improve after using ASMANEX HFA regularly for 1 to 2 weeks, contact your health care provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read the accompanying Patient Information for ASMANEX® HFA (mometasone furoate) Inhalation Aerosol and discuss it with your doctor. The physician Prescribing Information also is available.

This site is intended only for residents of the United States, its territories, and Puerto Rico.

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