LABETALOL HYDROCHLORIDE- labetalol hydrochloride tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LABETALOL (UNII: R5H8897N95) (LABETALOL - UNII:R5H8897N95)

Available from:

AMICI PHARMACEUTICALS LLC

INN (International Name):

LABETALOL

Composition:

LABETALOL 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Labetalol hydrochloride tablets are indicated in the management of hypertension. Labetalol hydrochloride tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics. Labetalol hydrochloride tablets are contraindicated in bronchial asthma, overt cardiac failure, greater-than-first-degree heart block, cardiogenic shock, severe bradycardia, other conditions associated with severe and prolonged hypotension, and in patients with a history of hypersensitivity to any component of the product (see WARNINGS). Beta-blockers, even those with apparent cardioselectivity, should not be used in patients with a history of obstructive airway disease, including asthma.

Product summary:

Labetalol hydrochloride tablets, USP are available as follows: Labetalol hydrochloride tablets, 100 mg, beige, film coated, round, scored, debossed MP 277 Bottles of 100 CRC                NDC 69292-501-10 Bottles of 500                       NDC 69292-501-50 Labetalol hydrochloride tablets, 200 mg, white, film coated, round, scored, debossed MP 271 Bottles of 100 CRC                NDC 69292-502-10 Bottles of 500                       NDC 69292-502-50 Labetalol hydrochloride tablets, 300 mg, blue, film coated, round, unscored, debossed MP 272 Bottles of 100 CRC                NDC 69292-503-10 Bottles of 500                       NDC 69292-503-50 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER. TOXI-LAB is a registered trademark of Varian, Inc. EMIT and EMIT-d.a.u. are registered trademarks of Siemens Healthcare Diagnostics, Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LABETALOL HYDROCHLORIDE- LABETALOL HYDROCHLORIDE TABLET, COATED
AMICI PHARMACEUTICALS LLC
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LABETALOL HYDROCHLORIDE TABLETS USP
RX ONLY
DESCRIPTION:
Labetalol hydrochloride 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.
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,
hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80,
pregelatinized starch (corn),
synthetic red iron oxide, synthetic yellow iron oxide, and titanium
dioxide.
In addition, each 200 mg tablet has the following inactive
ingredients: anhydrous lactose, carnauba wax,
hypromellose, magnesium stearate, polydextrose, polyethylene glycol,
pregelatinized starch (corn),
titanium dioxide, and triacetin.
In addition, each 300 mg tablet has the following inactive
ingredients: anhydrous lactose, carnauba wax,
FD&C Blue #2 aluminum lake, hypromellose, magnesium stearate,
polyethylene glycol, polysorbate 80,
pregelatinized starch (corn), and titanium dioxide.
CLINICAL PHARMACOLOGY:
Labetalol HCl combines both selective, competitive, alpha1-adrenergic
blocking and nonselective,
competitive, beta-adrenergic blocking activity in a single substance.
In man, the ratios of alpha- to beta-
blockade have been estimated to be approximately 1:3 and 1: