LABETALOL HYDROCHLORIDE tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Bryant Ranch Prepack

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Labetalol HCl tablets are indicated in the management of hypertension. Labetalol HCl tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics. Labetalol HCl 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.

leaflet_short:

Labetalol Hydrochloride Tablets, USP 200 mg are available as white to off-white, round biconvex tablets, debossed “AC 371” on one side and bisected on other side, packaged in bottles of 500 tablets. Bottles of 500: NDC 63629-8901-1 Labetalol Hydrochloride Tablets, USP should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

LABETALOL HYDROCHLORIDE- LABETALOL HYDROCHLORIDE TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
LABETALOL HYDROCHLORIDE TABLETS USP
RX ONLY
DESCRIPTION
Labetalol Hydrochloride Tablets, USP are adrenergic receptor blocking
agents that have
both selective alpha -adrenergic and non-selective
beta-adrenergic receptor blocking actions in a single substance.
Labetalol hydrochloride (HCl), USP 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 structural
formula:
Labetalol HCl, USP 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, USP is a white to off-white crystalline powder, soluble
in water.
Each tablet, for oral administration, contains 100 mg, 200 mg, or 300
mg of labetalol
hydrochloride, USP. In addition, each tablet contains the following
inactive ingredients:
corn starch, hypromellose, lactose monohydrate, magnesium stearate,
polyethylene
glycol, polysorbate 80, sodium starch glycolate and titanium dioxide.
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 and
1:7 following oral and intravenous 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
1
1
2
1
pressor response caused by immersing the hand in ice-cold water
(“cold-pres