Serevent Aerosol

[salmeterol xinafoate]

Drug Description
DESCRIPTION

SEREVENT (salmeterol xinafoate) Inhalation Aerosol 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-adrenergic bronchodilator. The chemical name of salmeterol xinafoate is 4-hydroxy-1 -[[[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 C25H37NO4
C11H8O3. 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 Inhalation Aerosol is a pressurized, metered-dose aerosol unit for oral inhalation.

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It contains a microcrystalline suspension of salmeterol xinafoate in a mixture of 2 chlorofluorocarbon propellants (trichlorofluoromethane and dichlorodifluoromethane) with soya 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.