FORADIL^® and Asthma

Asthma is a chronic condition of the airways in the lungs. In asthma, the bronchial tubes become narrowed and inflamed, making it difficult to move air into and out of the lungs. Symptoms include coughing, wheezing, shortness of breath, chest tightness, and overproduction of mucus.

Asthma is found in 3 to 5% of adults and 7 to 10% of children. Half of the people with asthma develop it before age 10, and most develop it before age 30. Asthma symptoms can decrease over time, especially in children. If you have asthma, or provide care for someone who does, browse the Asthma Relief and Interactive Tools sections for more information about asthma and how FORADIL^® can help.

FORADIL^® is a long-acting bronchodilator that can help with the treatment of asthma in patients who required additional controller medication. FORADIL^® acts to help keep the airways open, which may make it easier to breathe, and may reduce asthma symptoms.

FORADIL^® helps prevent asthma attacks and is for the maintenance treatment of asthma in patients age 5 and up when taken on a long-term, twice-daily basis.

FORADIL^® AEROLIZER^® 12 mcg is also indicated for the acute prevention of exercise-induced bronchospasm in patients age 5 and up when administered on an occasional, as-needed basis at least 15 minutes before exercise.

FORADIL^® AEROLIZER^® is not for patients whose asthma can be managed by occasional use of inhaled, fast-acting rescue inhalers or for those whose asthma can be successfully managed by an inhaled corticosteroid or by other controller medications.

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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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.