LABETALOL HYDROCHLORIDE tablet, film coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

BluePoint Laboratories Inc.

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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.

Каталог на резюме:

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: NDC 68001-381-00 in bottle of 100 tablets NDC 68001-381-03 in bottle of 500 tablets 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: NDC 68001-382-00 in bottle of 100 tablets NDC 68001-382-03 in bottle of 500 tablets 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: NDC 68001-383-00 in bottle of 100 tablets NDC 68001-383-03 in bottle of 500 tablets 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. 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, please visit www.zydususa.com Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. For BluePoint Laboratories Rev 07/22 Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India For BluePoint Laboratories Rev.: 07/22

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

LABETALOL HYDROCHLORIDE- LABETALOL HYDROCHLORIDE TABLET, FILM COATED
BLUEPOINT LABORATORIES INC.
----------
LABETALOL HYDROCHLORIDE TABLETS, USP
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 mono hydrochloride and it has the
following
structure:
Labetalol hydrochloride has the molecular formula C19 H24 N2 O3 •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
1
1
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