Foradil Certihaler

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&reg (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).



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