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Foradil Certihaler

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Foradil Certihaler

FORADIL® CERTIHALER®
(formoterol fumarate) Inhalation Powder

WARNING

ASTHMA RELATED DEATH

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. Data from a large placebo-controlled US study that compared the safety of another LABA (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including formoterol (see WARNINGS). 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.

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 (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. 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.

DRUG DESCRIPTION

FORADIL® CERTIHALER® (formoterol fumarate inhalation powder) is a breath-actuated multi-dose dry powder inhaler, which contains a powder formulation of formoterol fumarate intended for oral inhalation only. Each actuation of FORADIL CERTIHALER delivers approximately 8.5 mcg of formoterol fumarate from the mouthpiece (based on in vitro testing at 60 L/min for 2 sec), corresponding to a metered dose of 10 mcg of formoterol fumarate. The weight of the formulation metered is approximately 5.6 mg. Ten mcg of formoterol fumarate metered is equivalent to 8.2 mcg of formoterol base. The delivered inhalation powder also contains lactose monohydrate (which contains trace levels of milk proteins) and magnesium stearate.

The active component of FORADIL is formoterol fumarate, a racemate. Formoterol fumarate is a selective beta2-adrenergic bronchodilator. Its chemical name is (±)-2-hydroxy-5-[(1RS)-1-hydroxy-2-[[(1RS)-2-(4-methoxyphenyl)-1methylethyl]-amino]ethyl]formanilide fumarate dihydrate; its structural formula is

FORADIL®CERTIHALER® (formoterol fumarate) Structural Formula Illustration

Formoterol fumarate has a molecular weight of 840.9, and its empirical formula is (C19H24N2O4)2•C4H4O4•2H2O. Formoterol fumarate is a white to yellowish crystalline powder, which is freely soluble in glacial acetic acid, soluble in methanol, sparingly soluble in ethanol and isopropanol, slightly soluble in water, and practically insoluble in acetone, ethyl acetate, and diethyl ether.

The CERTIHALER Inhaler is a plastic device used for inhaling FORADIL and contains 60 doses. The amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow rate and inspiratory time, which may vary for different patient populations. Under standardized in vitro testing at a fixed flow rate of 60 L/min for 2 seconds, the FORADIL CERTIHALER delivered 8.5 mcg of formoterol fumarate from the mouthpiece. In 38 adult and 17 adolescent patients with asthma, mean peak inspiratory flow rates (PIF) through the CERTIHALER Inhaler were 63 (45-80) L/min and 70 (56-95) L/min, respectively. Similar results [mean PIF 63 (44-79) L/min] were obtained in 27 asthmatic children (aged 5 to 12 years).

Patients should be carefully instructed on the correct use of this drug product to assure optimal dose delivery (please refer to the accompanying Medication Guide).

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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