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Foradil

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Foradil Aerolizer

Indications
Dosage
How Supplied

INDICATIONS

Treatment of Asthma

FORADIL AEROLIZER is indicated 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.

Long acting beta2-adrenergic agonists (LABA), such as formoterol, the active ingredient in FORADIL AEROLIZER, increase the risk of asthma-related death. 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 [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

Pediatric and Adolescent Patients

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 used 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 [see WARNINGS AND PRECAUTIONS].

Important Limitation of Use

FORADIL AEROLIZER is NOT indicated for the relief of acute bronchospasm.

Prevention of Exercise-Induced Bronchospasm

FORADIL AEROLIZER is also indicated 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

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.

Important Limitation of Use

FORADIL AEROLIZER is NOT indicated for the relief of acute bronchospasm.

DOSAGE AND ADMINISTRATION

FORADILcapsules 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 swallowed. FORADIL capsules should always be stored in the blister, and only removed IMMEDIATELY BEFORE USE.

Asthma

Long-acting beta2-adrenergic agonists (LABA), such as formoterol, the active ingredient in FORADIL AEROLIZER, increase the risk of asthma-related death [see WARNINGS AND PRECAUTIONS]. 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.

Pediatric and Adolescent Patients

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.

Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. For patients with asthma less than 18 years of age 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 used 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.

Exercise-Induced Bronchospasm (EIB)

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. 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 treatment of their asthma should not use additional doses for prevention of EIB and may require a short-acting bronchodilator.

Chronic Obstructive Pulmonary Disease (COPD)

For maintenance treatment of bronchoconstriction in patients with COPD (including chronic bronchitis and emphysema) 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.

HOW SUPPLIED

Dosage Forms And Strengths

FORADIL AEROLIZER consists of FORADIL capsules and an AEROLIZER inhaler. FORADIL capsules contain 12 mcg dry powder formulation of formoterol fumarate in a clear, hard gelatin capsule for inhalation use with the AEROLIZER inhaler only.

FORADIL AEROLIZER contains: aluminum blister-packaged 12-mcg FORADIL (formoterol fumarate) clear gelatin capsules with &lduqo;CG&rduqo; printed on one end and &lduqo;FXF&rduqo; 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

Storage and Handling

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

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

Always discard the FORADIL capsules and AEROLIZERInhaler by the &lduqo;Use by&rduqo; date and always use the new

AEROLIZER Inhaler provided with each new prescription.

Keep out of the reach of children.

Manufactured by: Novartis Pharma AG, Basle, Switzerland. Distributed by: Schering Corporation, a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA. Revised: 03/2012

Last reviewed on RxList: 4/2/2012
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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