SEREVENT DISKUS Inhalation powder Ref.[10690] Active ingredients: Salmeterol

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

The active component of SEREVENT DISKUS is salmeterol xinafoate, a beta2-adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-Îą1[[[6(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure:

Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4â€ĒC11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water.

SEREVENT DISKUS is a teal green plastic inhaler containing a foil blister strip. Each blister on the strip contains a white powder mix of micronized salmeterol xinafoate salt (72.5 mcg, equivalent to 50 mcg of salmeterol base) in 12.5 mg of formulation containing lactose monohydrate (which contains milk proteins). After the inhaler is activated, the powder is dispersed into the airstream created by the patient inhaling through the mouthpiece.

Under standardized in vitro test conditions, SEREVENT DISKUS delivers 47 mcg of salmeterol base per blister when tested at a flow rate of 60 L/min for 2 seconds.

In adult subjects with obstructive lung disease and severely compromised lung function (mean FEV1 20% to 30% of predicted), mean peak inspiratory flow (PIF) through the DISKUS inhaler was 82.4 L/min (range: 46.1 to 115.3 L/min).

The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.

Dosage Forms and Strengths

Inhalation powder: Inhaler containing a foil blister strip of powder formulation for oral inhalation. The strip contains salmeterol 50 mcg per blister.

How Supplied

SEREVENT DISKUS is supplied as a disposable teal green plastic inhaler containing a foil blister strip with 60 blisters. The inhaler is packaged in a plastic-coated, moisture-protective foil pouch (NDC 0173-0521-00).

SEREVENT DISKUS is also supplied in an institutional pack containing 28 blisters (NDC 0173-0520-00).

Drugs

Drug Countries
SEREVENT Austria, Australia, Brazil, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Turkey, United Kingdom, United States, South Africa

ÂĐ All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.