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
Formoterol fumarate has a molecular weight of 840.9, and its empirical formula
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
Last reviewed on RxList: 6/29/2010
This monograph has been modified to include the generic and brand name in many instances.