FORADIL AEROLIZER is indicated for long-term, twice-daily (morning and evening) administration in the maintenance treatment of asthma and in the prevention of bronchospasm in adults and children 5 years of age and older with reversible obstructive airways disease, including patients with symptoms of nocturnal asthma.

Long-acting beta₂-adrenergic agonists may increase the risk of asthma-related death (see WARNINGS). Therefore, when treating patients with asthma, FORADIL AEROLIZER should only be used as additional therapy for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies, including FORADIL AEROLIZER. It is not indicated for patients whose asthma can be managed by occasional use of inhaled, short-acting, beta₂-agonists or for patients whose asthma can be successfully managed by inhaled corticosteroids or other controller medications along with occasional use of inhaled, short-acting beta₂-agonists.

FORADIL AEROLIZER is also indicated for the acute prevention of exercise-induced bronchospasm (EIB) in adults and children 5 years of age and older, when administered on an occasional, as-needed basis.

FORADIL AEROLIZER is indicated 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 capsules should be administered only by the oral inhalation route and only using the AEROLIZER Inhaler (see the accompanying Medication Guide). FORADIL capsules should not be ingested (i.e., swallowed) orally. FORADIL capsules should always be stored in the blister, and only removed IMMEDIATELY BEFORE USE.

Long-acting beta₂-adrenergic agonists may increase the risk of asthma-related death (see WARNINGS). Therefore, when treating patients with asthma, FORADIL AEROLIZER should only be used as additional therapy for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies, including FORADIL AEROLIZER. It is not indicated for patients whose asthma can be managed by occasional use of inhaled, short-acting, beta₂-agonists or for patients whose asthma can be successfully managed by inhaled corticosteroids or other controller medications along with occasional use of inhaled short-acting beta₂-agonists.

For adults and children 5 years of age and older, the usual dosage is the inhalation of the contents of one 12-mcg FORADIL capsule every 12 hours using the AEROLIZER Inhaler. The patient must not exhale into the device. The total daily dose of FORADIL should not exceed one capsule twice daily (24 mcg total daily dose). More frequent administration or administration of a larger number of inhalations is not recommended. If symptoms arise between doses, an inhaled short-acting beta₂-agonist should be taken for immediate relief.

If a previously effective dosage regimen fails to provide the usual response, medical advice should be sought immediately as this is often a sign of destabilization of asthma. Under these circumstances, the therapeutic regimen should be reevaluated.

For adults and children 5 years of age or older, the usual dosage is the inhalation of the contents of one 12-mcg FORADIL capsule at least 15 minutes before exercise administered on an occasional as needed basis. When used intermittently as needed for prevention, protection may last up to 12 hours.

Additional doses of FORADIL AEROLIZER should not be used for 12 hours after the administration of this drug. Regular, twice-daily dosing has not been studied in preventing EIB. Patients who are receiving FORADIL AEROLIZER twice daily for maintenance treatment of their asthma should not use additional doses for prevention of EIB and may require a short-acting bronchodilator.

The usual dosage is the inhalation of the contents of one 12 mcg FORADIL capsule every 12 hours using the AEROLIZER inhaler.

A total daily dose of greater than 24 mcg is not recommended.

If a previously effective dosage regimen fails to provide the usual response, medical advice should be sought immediately as this is often a sign of destabilization of COPD. Under these circumstances, the therapeutic regimen should be reevaluated and additional therapeutic options should be considered.

FORADIL AEROLIZER contains: aluminum blister-packaged 12-mcg FORADIL (formoterol fumarate) clear gelatin capsules with "CG" printed on one end and "FXF" printed on the opposite end; one AEROLIZER Inhaler; and Medication Guide.

Unit Dose (blister pack)

Box of 12 (strips of 6). . . . . . . . . . . . . . . . . . . . . . . . . . NDC 0085-1402-01

Unit Dose (blister pack)

Box of 60 (strips of 6). . . . . . . . . . . . . . . . . . . . . . . . . . NDC 0085-1401-01

FORADIL capsules should be used with the AEROLIZER Inhaler only. The AEROLIZER Inhaler should not be used with any other capsules.

Prior to dispensing: Store in a refrigerator, 2°C-8°C (36°F-46°F)

After dispensing to patient: Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from heat and moisture. CAPSULES SHOULD ALWAYS BE STORED IN THE BLISTER AND ONLY REMOVED FROM THE BLISTER IMMEDIATELY BEFORE USE.

Always discard the FORADIL capsules and AEROLIZER Inhaler by the "Use by" date and always use the new AEROLIZER Inhaler provided with each new prescription.

Keep out of the reach of children.

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