Using the AEROLIZER®

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Indications
FORADIL® AEROLIZER® is for the long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema. FORADIL® AEROLIZER® is for the maintenance treatment of asthma in those 5 years and older when taken on a long-term, twice-daily basis. FORADIL® AEROLIZER® should only be used as additional therapy for patients not adequately controlled on other asthma controller medications.

FORADIL® AEROLIZER® is not indicated for patients whose asthma can be managed by occasional use of fast-acting rescue inhalers.

FORADIL® AEROLIZER® is also for the acute prevention of exercise-induced bronchospasm (EIB) in those 5 years of age and older when administered on an occasional, as-needed basis at least 15 minutes before exercise.

Important Safety Information on FORADIL®
FORADIL® belongs to a class of medications known as long-acting beta2-adrenergic agonists or LABAs. In patients with asthma, LABAs may increase the chance of asthma related death. Therefore, FORADIL® should only be used as additional therapy for patients not adequately controlled on other asthma controller medications.

In COPD clinical trials, the most common adverse events reported with FORADIL® AEROLIZER® were upper respiratory infection, back pain, and sore throat.

In asthma clinical trials, the most common adverse events reported with FORADIL® AEROLIZER® were viral infection, bronchitis, and chest infection.

FORADIL® capsules should only be inhaled orally using the AEROLIZER® inhaler. The capsules should not be swallowed.

FORADIL® AEROLIZER® should not be used to treat acute symptoms. Acute symptoms should be treated with fast-acting rescue inhalers. Do not use more than one capsule twice daily. FORADIL® AEROLIZER® should be used with caution in patients with cardiovascular disorders. FORADIL® AEROLIZER® is not a substitute for inhaled or oral corticosteroids and, in the treatment of asthma, they should not be stopped or reduced at the time FORADIL® AEROLIZER® is initiated.

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 see additional important product information.

Patients who are having difficulty affording Schering-Plough medications can call the Schering-Plough Cares Patient Assistance Program at 1-800-656-9485 to see if they qualify for assistance. Or visit www.pparx.org for additional information.

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