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FDA Approves ASMANEX (R) TWISTHALER(R) (Mometasone Furoate Inhalation Powder) for the Once Daily Maintenance Treatment of Asthma in Children Ages 4-11
Date:2/4/2008

lant, thus eliminating the need for hand-breath coordination, and it provides patients with a numeric dose counter that provides a visual indication of the remaining doses.

ASMANEX is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older. ASMANEX is not indicated for the relief of acute bronchospasm or in children less than 4 years of age.

ASMANEX TWISTHALER therapy should not be used to treat sudden asthma attacks. A fast acting inhaler is still needed to relieve sudden asthma symptoms.

Patients should be careful while adjusting to a switch from an oral steroid to the inhaled steroid ASMANEX. Patients should be followed closely by their doctor. Death can occur. Patients should tell their doctor 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 a patient is under stress, such as with surgery, after surgery or trauma, they may need steroids by mouth again.

Inhaled steroids including ASMANEX TWISTHALER may cause a reduction in growth velocity when administered to pediatric patients. The long-term effect on final adult height is unknown. Physicians should closely follow the growth of children and adolescents taking corticosteroids by any route.

Patients who use inhaled steroid medicines for asthma may develop a fungal infection of the mouth. Patients should rinse their mouth after using ASMANEX.

Patients should contact their health care provider if they have or had tuberculosis, are exposed to chickenpox or measles, or about any other infections they had before or while using ASMANEX.

If a patient is at an increased risk for decreased bone mineral density, the use of corticosteroids may increase their risk. The health care provider should monitor their condition and, if needed, provide treatment.

Long-term use of inhaled corticosteroids, such as
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SOURCE Schering-Plough Corporation
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