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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (S's) » Salmeterol Xinafoate



DESCRIPTION

Serevent Diskus inhalation powder and Serevent inhalation aerosol contain 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-adrenergic bronchodilator. The chemical name of salmeterol xinafoate is 4-hydroxy-a1-[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1 -hydroxy-2-naphthalenecarboxylate.

The molecular weight of salmeterol xinafoate is 603.8, and the empirical formula is C25H37NO4C11H8O3. Salmeterol xinafoate is a white to off-white powder. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water.

Serevent Diskus Inhalation Powder

Serevent Diskus is a specially designed plastic device containing a double-foil blister strip of a powder formulation of salmeterol xinafoate intended for oral inhalation only. Each blister on the double-foil strip within the device contains 50 mcg of salmeterol administered as the salmeterol xinafoate salt in 12.5 mg of formulation containing lactose. When a blister containing medication is opened by activating the device, the medication is dispersed into the air stream created when the patient inhales through the mouthpiece.

The amount of drug delivered to the lung will depend on patient factors such as inspiratory flow. Under standardized in vitro testing, salmeterol xinafoate delivers 47 mcg when tested at 60 L/min wflow rate for 3 seconds. In adult patients with obstructive lung disease and severely compromised lung function (mean forced expiratory volume in 1 second [FEV1] 0.65 L [range, 0.35 to 0.92 L], 20% to 30% predicted FEV1), mean peak inspiratory flow (PIF) through salmeterol xinafoate was 82.4 L/min (range, 46.1 to 115.3 L/min). The emitted dose of salmeterol xinafoate determined in an in vitro experiment modeling these patient-generated flow rates was 46 mcg (range, 45 to 51 mcg).

Salmeterol Xinafoate Inhalation Aerosol

Serevent inhalation aerosol is a pressurized, metered-dose aerosol unit for oral inhalation. It contains a microcrystalline suspension of salmeterol xinafoate in a mixture of two chlorofluorocarbon propellants (trichlorofluoromethane and dichlorodifluoromethane) with lecithin. 36.25 mcg of salmeterol xinafoate is equivalent to 25 mcg of salmeterol base. Each actuation delivers 25 mcg of salmeterol base (as salmeterol xinafoate) from the valve and 21 mcg of salmeterol base (as salmeterol xinafoate) from the actuator. Each 6.5-g canister provides 60 inhalations and each 13-g canister provides 120 inhalations.

CATEGORIES, BRAND NAMES

CATEGORIES: Asthma; FDA Class 1P ("Priority Review"); FDA Approved 1994 Feb; Pregnancy Category C; Top 200 Drugs

FDA Drug Classes: Broncodilators

BRAND NAMES:

BRAND NAMES: Aeromax; Salmeter; Serevent; Serevent Inhaler and Disks; Serobid; Servent; Zamitrel
(Foreign Brand names outside U.S. in italics)

FOREIGN BRAND AVAILABILITY:
Aeromax (Germany)
Salmeter (India)
Serevent Inhaler and Disks (Australia)
Serobid (Bahrain; Cyprus; Egypt; India; Iran; Iraq; Jordan; Kuwait; Lebanon; Libya; Oman; Qatar; Republic-of-Yemen; Saudi-Arabia; Syria; United-Arab-Emirates)
Zamitrel (Mexico)





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