LABETALOL HYDROCHLORIDE tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

American Health Packaging

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 cardio selectivity, should not be used in patients with a history of obstructive airway disease, including asthma.

Resumen del producto:

Labetalol Hydrochloride Tablets, USP for oral administration are available as: Labetalol Hydrochloride Tablets USP, 100 mg are yellow colored, round, biconvex, film-coated tablets debossed with "7" and "98" on either side of score line on one side and plain on other side and are supplied as: Unit dose packages of 100 (10 x 10) NDC 60687-439-01 Labetalol Hydrochloride Tablets USP, 200 mg are white to off white colored, round, biconvex, film-coated tablets debossed with "7" and "99" on either side of score line on one side and plain on other side and are supplied as: Unit dose packages of 100 (10 x 10) NDC 60687-450-01 Labetalol Hydrochloride Tablets USP, 300 mg are light green colored, round, biconvex, beveled edge, film-coated tablets debossed with "800" on one side and plain on other side and are supplied as: Unit dose packages of 100 (10 x 10) NDC 60687-461-01 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 Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. This product's package insert may have been updated. For current package insert, call American Health Packaging at 1-800-707-4621. American Health Packaging unit dose blisters (see HOW SUPPLIED section) contain drug product from BluePoint Laboratories as follows: (100 mg / 100UD) NDC 60687-439-01 packaged from NDC 68001-381 (200 mg / 100UD) NDC 60687-450-01 packaged from NDC 68001-382 (300 mg / 100UD) NDC 60687-461-01 packaged from NDC 68001-383 Distributed by: American Health Packaging Columbus, OH 43217 8443901/0119

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

LABETALOL HYDROCHLORIDE- LABETALOL HYDROCHLORIDE TABLET, FILM COATED
AMERICAN HEALTH PACKAGING
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LABETALOL HYDROCHLORIDE TABLETS, USP
8443901/0119
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 (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 hydrochloride 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 almost white powder. It is
sparingly soluble in
water and in ethanol (96%), practically insoluble in ether and in
methylene chloride.
Labetalol hydrochloride tablet, 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, sodium starch glycolate (botanical
source: potato) and
titanium dioxide. Additionally, 100 mg tablets contain D&C yellow #10
Aluminum lake,
iron oxide yellow, iron oxide red and talc. 300 mg tablets contain
FD&C blue #1
Aluminum lake, iron oxide yellow and talc.
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