Indicated for:

Treatment of Asthma:

• For the treatment of asthma and in the prevention of bronchospasm only as concomitant therapy with a long-term asthma control medication, such as an inhaled corticosteroid, in adults and children 5 years of age and older with reversible obstructive airways disease, including patients with symptoms of nocturnal asthma.

Prevention of Exercise-Induced Bronchospasm:

• For the acute prevention of exercise-induced bronchospasm in adults and children 5 years of age and older, when administered on an occasional, as-needed basis. Use of FORADIL AEROLIZER as a single agent for the prevention of exercise induced bronchospasm may be clinically indicated in patients who do not have persistent asthma. In patients with persistent asthma, use of FORADIL AEROLIZER for the prevention of exercise induced bronchospasm may be clinically indicated, but the treatment of asthma should include a long-term asthma control medication, such as an inhaled corticosteroid.

Maintenance Treatment of Chronic Obstructive Pulmonary Disease:

• For the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with Chronic Obstructive Pulmonary Disease including chronic bronchitis and emphysema.

FORADIL AEROLIZER is not indicated for the relief of acute bronchospasm. Foradil should not be used as first-line therapy or to treat acute symptoms. Foradil should not be initiated in patients with significantly worsening or acutely deteriorating asthma.

Long-acting beta2-adrenergic agonists (LABA), such as formoterol the active ingredient in FORADIL, increase the risk of asthma-related death. A large placebo-controlled study with another LABA (salmeterol) showed an increase in asthma-related deaths in patients receiving salmeterol. Because of this risk, use of FORADIL AEROLIZER for the treatment of asthma without concomitant use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated.

Use FORADIL AEROLIZER only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue FORADIL AEROLIZER) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid.

Do not use FORADIL AEROLIZER for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. For pediatric and adolescent patients with asthma who require addition of a LABA to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and LABA should ordinarily be considered to ensure adherence with both drugs. In cases where use of a separate long-term asthma control medication (e.g., inhaled corticosteroid) and LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components. If adherence cannot be assured, a fixed dose combination product containing both an inhaled corticosteroid and LABA is recommended.

There are no data demonstrating that FORADIL has any clinical anti-inflammatory effect and therefore it cannot be expected to take the place of corticosteroids. Corticosteroids should not be stopped or reduced at the time FORADIL AEROLIZER is initiated. Patients who already require oral or inhaled corticosteroids for treatment of asthma should be continued on this type of treatment even if they feel better as a result of initiating FORADIL AEROLIZER. Any change in corticosteroid dosage, in particular a reduction, should be made ONLY after clinical evaluation.

FORADIL AEROLIZER should not be used more often or at doses higher than recommended, or in conjunction with other medications containing LABA, as an overdose may result. Patients using FORADIL AEROLIZER should not use an additional LABA (e.g., salmeterol xinafoate, arformoterol tartrate) for any reason.

As with other inhaled beta2-agonists, formoterol can produce paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs, FORADIL AEROLIZER should be discontinued immediately and alternative therapy instituted.

Excessive beta-adrenergic stimulation has been associated with seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.

Formoterol fumarate, like other beta2-agonists, can produce a clinically significant cardiovascular effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of FORADIL AEROLIZER at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, formoterol fumarate, like other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Immediate hypersensitivity reactions may occur after administration of FORADIL AEROLIZER, as demonstrated by cases of anaphylactic reactions, urticaria, angioedema, rash, and bronchospasm.

Beta-agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation.

Concomitant treatment with xanthine derivatives or systemic corticosteroids may potentiate any hypokalemic effect of adrenergic agonists.

The ECG changes or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded.

Formoterol, as with other beta2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, macrolides or drugs known to prolong the QTc interval because the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Drugs that are known to prolong the QTc interval have an increased risk of ventricular arrhythmias.

Beta-adrenergic receptor antagonists (beta-blockers) and formoterol may inhibit the effect of each other when administered concurrently. Beta-blockers not only block the therapeutic effects of beta2-agonists, such as formoterol, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta blockers in patients with asthma. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

There are no adequate and well-controlled studies in pregnant women. Animal studies: teratogenicity as well as other developmental toxic effects.

In reproductive studies in rats, formoterol was excreted in the milk. It is not known whether formoterol is excreted in human milk.

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• Use in patients with asthma who are well controlled with other asthma-controller medicines. GoToSource 

• Maintenance treatment of asthma in patients with reversible obstructive airways disease, including patients with symptoms of nocturnal asthma, who are using optimal corticosteroid treatment. GoToSource

• Stuttering. GoToSource

• Enhance performance and lung function in athletes. GoToSource

Severe exacerbation of asthma symptoms, leading to hospitalizations and death and growth suppression. GoToSource

New onset diabetes mellitus. GoToSource

Tremor and palpitation. GoToSource

Monotherapy associated with increased risk of asthma-related death. GoToSource

Tachycardia (fast heart rate), heart failure, cardiomyopathy, decreased serum potassium level and respiratory infection. GoToSource

Arrhythmias. GoToSource

Lawsuits filed for death, heart attacks, arrhythmia, hyperglycemia and worsening asthma symptoms.