TRANDATE®
(labetalol hydrochloride)
Tablets
DESCRIPTION
TRANDATE Tablets are adrenergic receptor blocking agents that have both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance.
Labetalol hydrochloride (HCl) is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]benzamide monohydrochloride, and it has the following structure:
Labetalol HCl has the empirical formula C19H24N2O3•HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R´ stereoisomer, makes up 25% of racemic labetalol.
Labetalol HCl is a white or off-white crystalline powder, soluble in water.
TRANDATE Tablets contain 100, 200, or 300 mg of labetalol HCl and are taken orally. The tablets also contain the inactive ingredients corn starch, FD&C Yellow No. 6 (100- and 300-mg tablets only), hydroxypropyl methylcellulose, lactose, magnesium stearate, pregelatinized corn starch, sodium benzoate (200-mg tablet only), talc (100-mg tablet only), and titanium dioxide.
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