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Asmanex Twisthaler

Drug Description
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ASMANEX® TWISTHALER® 220 mcg
(mometasone furoate) Inhalation Powder

ASMANEX® TWISTHALER® 110 mcg
(mometasone furoate) Inhalation powder

FOR ORAL INHALATION ONLY

DRUG DESCRIPTION

Mometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene- 3,20-dione 17-(2-furoate) and the following chemical structure:

ASMANEX (Mometasone furoate) structural formula illustration

Mometasone furoate is a white powder with an empirical formula of C27H30Cl2O6, and molecular weight of 521.44 Daltons.

The ASMANEX TWISTHALER 110 mcg and 220 mcg products are cap-activated, inhalation-driven, multi-dose dry powder inhalers containing mometasone furoate and anhydrous lactose (which contains milk proteins).

Each actuation of the ASMANEX TWISTHALER 110 mcg or 220 mcg inhaler provides a measured dose of approximately 0.75 or 1.5 mg mometasone furoate inhalation powder, containing 110 or 220 mcg of mometasone furoate, respectively. This results in delivery of 100 or 200 mcg mometasone furoate from the mouthpiece, respectively, based on in vitro testing at flow rates of 30 L/min and 60 L/min with constant volume of 2 L. The amount of mometasone furoate emitted from the inhaler in vitro does not differ significantly for flow rates ranging from 28.3 L/min to 70 L/min at a constant volume of 2 L. However, the amount of drug delivered to the lung will depend on patient factors such as inspiratory flow and peak inspiratory flow through the device. In adult and adolescent patients (aged ≥ 12 years) with varied asthma severity, mean peak inspiratory flow rate through the device was 69 L/min (range 54-77 L/min). In pediatric patients (ages 5-12 years) diagnosed with asthma, mean peak inspiratory flow rate in the 5- to 8-year old subgroup was > 50 L/min (minimum of 46 L/min) and for the 9- to 12-year old subgroup was > 60 L/min (minimum of 48 L/min).

Brand Name: Asmanex Twisthaler
Generic Name: Mometasone Furoate

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