Patients should be instructed to read the accompanying Medication Guide with each new prescription and refill. The complete text of the Medication Guide is reprinted at the end of this document. Patients should be given the following information:

  1. Patients should be informed that long-acting beta2-adrenergic agonists (LABA), including formoterol, the active ingredient in FORADIL AEROLIZER, increase the risk of asthma-related death and may increase the risk of asthma-related hospitalizations in pediatric and adolescent patients. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma- related death from LABA. Patients should be informed that FORADIL AEROLIZER should not be the only therapy for the treatment of asthma and must only be used as additional therapy when a long-term asthma control medication (e.g., inhaled corticosteroids) do not adequately control asthma symptoms. Patients should be informed that when FORADIL AEROLIZER is added to their treatment regimen they must continue to use their long-term asthma control medication.    

  2. FORADIL AEROLIZER is not indicated to relieve acute asthma symptoms and extra doses should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting, beta2-agonist (the health-care provider should prescribe the patient with such medication and instruct the patient in how it should be used). Patients should be instructed to seek medical attention if their symptoms worsen, if FORADIL AEROLIZER treatment becomes less effective, or if they need more inhalations of a short-acting beta2-agonist than usual. Patients should not inhale more than the contents of one capsule at any one time. The daily dosage of FORADIL AEROLIZER should not exceed one capsule twice daily (24 mcg total daily dose).  

  3. FORADIL AEROLIZER should not be used as a substitute for oral or inhaled corticosteroids. The dosage of these medications should not be changed and they should not be stopped without consulting the physician, even if the patient feels better after initiating treatment with FORADIL AEROLIZER.  

  4. The active ingredient of FORADIL (formoterol fumarate) is a long-acting, bronchodilator used for the treatment of asthma, including nocturnal asthma, and for the prevention of exercise-induced bronchospasm. FORADIL AEROLIZER provides bronchodilation for up to 12 hours. Patients should be advised not to increase the dose or frequency of FORADIL AEROLIZER without consulting the prescribing physician. Patients should be warned not to stop or reduce concomitant asthma therapy without medical advice.  

  5. When FORADIL AEROLIZER is used for the prevention of EIB, the contents of one capsule should be taken at least 15 minutes prior to exercise. Additional doses of FORADIL AEROLIZER should not be used for 12 hours. Prevention of EIB has not been studied in patients who are receiving chronic FORADIL AEROLIZER administration twice daily and these patients should not use additional FORADIL AEROLIZER for prevention of EIB.  

  6. Patients should be informed that treatment with beta2-agonists may lead to adverse events which include palpitations, chest pain, rapid heart rate, tremor or nervousness.   

  7. Patients should be informed never to use FORADIL AEROLIZER with a spacer and never to exhale into the device.  

  8. Patients should avoid exposing the FORADIL capsules to moisture and should handle the capsules with dry hands. The AEROLIZER Inhaler should never be washed and should be kept dry. The patient should always use the new AEROLIZER Inhaler that comes with each refill.  

  9. Women should be advised to contact their physician if they become pregnant or if they are nursing.  

  10. Patients should be told that in rare cases, the gelatin capsule might break into small pieces. These pieces should be retained by the screen built into the AEROLIZER Inhaler. However, it remains possible that rarely, tiny pieces of gelatin might reach the mouth or throat after inhalation. The capsule is less likely to shatter when pierced if: storage conditions are strictly followed, capsules are removed from the blister immediately before use, and the capsules are only pierced once.  

  11. It is important that patients understand how to use the AEROLIZER Inhaler appropriately and how it should be used in relation to other asthma medications they are taking (see the accompanying Medication Guide).