LABETALOL HCL- labetalol hcl tablet, film coated

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

American Health Packaging

INN:

LABETALOL HYDROCHLORIDE

composition:

LABETALOL HYDROCHLORIDE 100 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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 is 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, for oral administration, are available as 100 mg Round, white, film-coated tablets, debossed “ E” over “ 10” on one side and bisected on the other side and supplied as: Unit dose packages of 100 (10 x 10) NDC 60687-114-01 200 mg Round, white, film-coated tablets, debossed “ E” over “ 117” on one side and bisected on the other side and supplied as: Unit dose packages of 100 (10 x 10) NDC 60687-125-01 300 mg Round, white, film-coated tablets, debossed “ E” over “ 118” on one side and plain on the other side and supplied as: Unit dose packages of 100 (10 x 10) NDC 60687-136-01 Labetalol Hydrochloride Tablets, USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. PACKAGING INFORMATION American Health Packaging unit dose blisters (see How Supplied section) contain drug product from BluePoint Laboratories as follows: (100 mg / 100 UD) NDC 60687-114-01 packaged from NDC 68001-205 (200 mg / 100 UD) NDC 60687-125-01 packaged from NDC 68001-204 (300 mg / 100 UD) NDC 60687-136-01 packaged from NDC 68001-206 Distributed by: American Health Packaging Columbus, OH 43217 8411401/0117OS

authorization_status:

Abbreviated New Drug Application

SPC

LABETALOL HCL- LABETALOL HCL TABLET, FILM COATED
AMERICAN HEALTH PACKAGING
----------
LABETALOL HYDROCHLORIDE TABLETS, USP
8411401/0117OS
RX ONLY
DESCRIPTION
Labetalol hydrochloride tablets, USP are an adrenergic receptor
blocking agent that has both selective
alpha
-adrenergic and nonselective beta-adrenergic receptor blocking actions
in a single substance.
Labetalol hydrochloride 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 hydrochloride, USP has the molecular formula C
H
N
O
•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 hydrochloride, USP is a white or off-white crystalline
powder, soluble in water.
Labetalol hydrochloride tablets USP, for oral administration, contain
100 mg, 200 mg or 300 mg
labetalol hydrochloride USP.
In addition, each tablet contains the following inactive ingredients:
corn starch, hypromellose, lactose
monohydrate, magnesium stearate, polyethylene glycol, polysorbate,
sodium starch glycolate (potato)
and titanium dioxide.
CLINICAL PHARMACOLOGY
Labetalol hydrochloride 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 (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 hydrochloride to block alpha receptors in
man has been demonstrated by
attenuation of the pressor effect of phen