LABETALOL HCL- labetalol hydrochloride tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

LABETALOL HYDROCHLORIDE (UNII: 1GEV3BAW9J) (LABETALOL - UNII:R5H8897N95)

제공처:

Bryant Ranch Prepack

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP 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.

제품 요약:

Labetalol hydrochloride tablets, USP 100 mg, white, round, film-coated tablets with bisect, debossed “N” on top and “T” on bottom of the bisect on one side and "041" on the other side of the tablet, bottles of 100 (NDC 63629-2212-1). Labetalol hydrochloride tablets, USP should be stored at 20° to 25°C (68° to 77°F)[ See USP Controlled Room Temperature].

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

LABETALOL HCL- LABETALOL HYDROCHLORIDE TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
LABETALOL HYDROCHLORIDE TABLETS, USP 100 MG, 200 MG AND 300 MG
RX ONLY
DESCRIPTION
Labetalol hydrochloride tablets, USP are adrenergic receptor blocking
agents that have
both selective alpha
-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 molecular formula C
H
N
O
•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.
Labetalol hydrochloride tablets contain 100, 200, or 300 mg of
labetalol HCl and are
taken orally. The tablets also contain the inactive ingredients
lactose monohydrate, corn
starch, crospovidone, colloidal silicon dioxide, magnesium stearate,
polyvinyl alcohol,
polyethylene glycol, titanium dioxide and talc.
CLINICAL PHARMACOLOGY
Labetalol HCl combines both selective, competitive, alpha
-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
1
19
24
2
3
1
and 1:7 following oral and intravenous (IV) administration,
respectively. Beta
-agonist
activity has been demonstrated in animals with minimal beta
-agonist (ISA) activity
detected. In animals, at doses greater than those required for alpha-
or beta-adrenergic
blockade, a membrane stabilizing effect has been demonstrated.
PHARMACODYNAMICS:The capacity of labetalol HCl to block alpha
receptors in man has
been demonstrated by attenuation of the pressor effect of
phenylephrine and by a
significant reduction of the pressor re