/* mobile /* end mobile MEDDESKTOP: FDA staff Memo: Asthma drug, SEREVENT DISKUS,safety review recommended

Saturday, November 24, 2007

FDA staff Memo: Asthma drug, SEREVENT DISKUS,safety review recommended

FDA WARNING
Long-acting beta2-adrenergic agonists, such as salmeterol, the active ingredient in SEREVENT DISKUS, may increase the risk of asthma-related death. Therefore, when treating patients with asthma, SEREVENT DISKUS should only be used as additional therapy for patients not adequately controlled on other asthma-controller medications (e.g.,low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies, including SEREVENT DISKUS. Data from a large placebo-controlled us study that compared the safety of salmeterol (SEREVENT® Inhalation Aerosol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 patients treated for 28 weeks on salmeterol versus 3 deaths out of 13,179 patients on placebo) (see WARNINGS and CLINICAL TRIALS: Asthma: Salmeterol Multi-center Asthma Research Trial).

DESCRIPTION
SEREVENT DISKUS (salmeterol xinafoate inhalation powder) contains salmeterol xinafoate as the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. The active component of the formulation is salmeterol base, a highly selective beta2- drenergic bronchodilator. The chemical name of salmeterol xinafoate is 4-hydroxy-a1-[[[6-(4-phenylbutoxy) hexyl]amino] methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate.
Salmeterol xinafoate has the following chemical structure:
Salmeterol xinafoate is a white to off-white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4•C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water.
SEREVENT DISKUS is a specially designed plastic inhalation delivery system containing a double-foil blister strip of a powder formulation of salmeterol xinafoate intended for oral inhalation only. The DISKUS®, which is the delivery component, is an integral part of the drug product. Each blister on the double-foil strip within the unit contains 50 mcg of salmeterol administered as the salmeterol xinafoate salt in 12.5 mg of formulation containing lactose (which contains milk proteins). After a blister containing medication is opened by activating the DISKUS, the medication is dispersed into the airstream created by the patient inhaling through the mouthpiece.
Under standardized in vitro test conditions, SEREVENT DISKUS delivers 47 mcg when tested at a flow rate of 60 L/min for 2 seconds. In adult patients with obstructive lung disease and severely compromised lung function (mean forced expiratory volume in 1 second [FEV1] 20% to 30% of predicted), mean peak inspiratory flow (PIF) through a DISKUS 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.



[PDF] Serevent Diskus Label
Page 1. Effective Date: 03/31/2006 SEREVENT® DISKUS® (salmeterol xinafoate
inhalation powder) For Oral Inhalation Only WARNING ...

www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4325b_03_08_Salmeterol%20Label.pdf - 11-23-2007

[PDF] DIVISION DIRECTOR MEMORANDUM
... These are salmeterol xinafoate, marketed as a single ingredient product under the
trade name Serevent and as a combination product with fluticasone propionate ...

www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4325b_03_01_Salmeterol%20BPCA%20Summary.pdf - 11-23-2007


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