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Foradil Certihaler

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Foradil Certihaler

INDICATIONS

FORADIL CERTIHALER (formoterol fumarate inhalation powder) 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 airway disease. Long-acting beta2-adrenergic agonists (LABA), such as formoterol, the active ingredient in FORADIL CERTIHALER (formoterol fumarate inhalation powder) , increase the risk of asthma-related death (see WARNINGS). Use of FORADIL CERTIHALER for the treatment of asthma without concomitant use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated (see CONTRAINDICATIONS). Use FORADIL CERTIHALER (formoterol fumarate inhalation powder) 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 CERTIHALER (formoterol fumarate inhalation powder) ) 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 CERTIHALER (formoterol fumarate inhalation powder) for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

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 (see WARNINGS). 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.

DOSAGE AND ADMINISTRATION

FORADIL CERTIHALER (formoterol fumarate inhalation powder) should be administered only by the oral inhalation route (see the accompanying Medication Guide).

Treatment of Asthma

Long-acting beta2-adrenergic agonists, such as formoterol, the active ingredient in FORADIL CERTIHALER (formoterol fumarate inhalation powder) , increase the risk of asthma-related death. Because of this risk, use of FORADIL CERTIHALER (formoterol fumarate inhalation powder) for the treatment of asthma without concomitant use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated. Use FORADIL CERTIHALER (formoterol fumarate inhalation powder) 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 CERTIHALER) 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 CERTIHALER (formoterol fumarate inhalation powder) for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

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 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.

For adults and children 5 years of age and older, the usual dosage is one 10 mcg inhalation from the FORADIL CERTIHALER (formoterol fumarate inhalation powder) every 12 hours. The patient must not exhale into the device. The total daily dose of FORADIL CERTIHALER (formoterol fumarate inhalation powder) should not exceed one inhalation twice daily (20 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 beta2agonist 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 re-evaluated.

HOW SUPPLIED

FORADIL CERTIHALER (formoterol fumarate inhalation powder) consists of a number of assembled plastic components, the main parts being the mouthpiece, dosing mechanism, reservoir, body, valve socket, and counter. The body of the inhaler is light blue; the mouthpiece is white, and the protective cap is dark blue. The target net content (fill weight) is approximately 560 mg of formoterol powder blend. FORADIL CERTIHALER delivers 8.5 mcg of formoterol fumarate per dose, with 60 doses contained within the inhaler. The inhaler device will lock closed after the final dose is administered.

FORADIL CERTIHALER (formoterol fumarate inhalation powder) contains: one CERTIHALER Inhaler and Instructions for Using FORADIL CERTIHALER (formoterol fumarate inhalation powder) (NDC XXXX_XXXX_XX).

Unit Dose

Box of 1 CERTIHALER Inhaler (60 doses) NDC xxxx-xxxx-xx

Store at 25°C (77°F). Excursions permitted to 15°C–30°C (59°F–86°F) [see USP Controlled Room Temperature]. Protect from heat and moisture.

Keep out of the reach of children.

Manufactured by: SkyePharma Production SAS, Saint Quentin-Fallavier, France. Distributed by: Novartis Pharmaceuticals Corp., East Hanover, NJ 07936. May 2010.

Last reviewed on RxList: 6/29/2010
This monograph has been modified to include the generic and brand name in many instances.

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