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Schering-Plough Announces U.S. Filing of Mometasone Furoate/Formoterol Fumarate Combination for the Maintenance Treatment of Asthma
Date:7/22/2009

nformation for ASMANEX TWISTHALER

ASMANEX TWISTHALER is not a rescue inhaler and should not be used to treat sudden asthma symptoms. Use a rescue inhaler to relieve sudden asthma symptoms.

ASMANEX should not be used to treat acute asthma episodes (including status asthmaticus) where extra measures are required.

ASMANEX is not for patients who have a hypersensitivity (including allergic reactions) to mometasone or any of the ingredients in ASMANEX. There have been cases of hypersensitivity, allergic reactions, facial swelling, hives, and throat tightness reported.

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

It is possible that hypercorticism (an excess level of steroids in your body) or adrenal insufficiency (your adrenal gland cannot produce enough steroids) may appear in a small number of patients, particularly when ASMANEX 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 should be reduced slowly.

If you or your child took steroids by mouth and are having them decreased or are being switched to ASMANEX, 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.

Avoid coming in contact with measles, chicken pox virus, tuberculosis, o
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SOURCE Schering-Plough Corporation
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