Labetalol (Labetalol Hydrochloride) - Description

Rx only

DESCRIPTION

Labetalol HCl is an adrenergic receptor blocking agent that has both selective alpha₁- and nonselective beta-adrenergic receptor blocking actions in a single substance.

Labetalol HCl is a racemate, chemically designated as 5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl] salicylamide monohydrochloride, and has the following structure:

Labetalol HCl has the molecular formula C₁₉H₂₄N₂O₃•HCl and a molecular weight of 364.87. 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.

Each tablet, for oral administration contains 100 mg, 200 mg, or 300 mg of labetalol HCl.

In addition, each 100 mg tablet has the following inactive ingredients: anhydrous lactose, carnauba wax, pregelatinized starch (corn), hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, polysorbate 80, synthetic yellow iron oxide, synthetic red iron oxide, titanium dioxide.

In addition, each 200 mg tablet has the following inactive ingredients: anhydrous lactose, carnauba wax, pregelatinized starch (corn), hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, polydextrose, titanium dioxide, triacetin.

In addition, each 300 mg tablet has the following inactive ingredients: anhydrous lactose, carnauba wax, pregelatinized starch (corn), hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, polysorbate 80, titanium dioxide, FD&C Blue #2 aluminum lake.