LABETALOL HCL- labetalol hydrochloride tablet, film coated

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Par Pharmaceutical, Inc.

ІПН (Міжнародна Ім'я):

LABETALOL HYDROCHLORIDE

Склад:

LABETALOL HYDROCHLORIDE 100 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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.  

Огляд продуктів:

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 49884-122-01) and 500 (NDC 49884-122-05). Labetalol hydrochloride tablets, USP 200 mg, white, round, film-coated tablets with bisect, debossed “N” on top and “T” on bottom of the bisect on one side and "042" on the other side of the tablet, bottles of 100 (NDC 49884-123-01) and 500 (NDC 49884-123-05). Labetalol hydrochloride tablets, USP 300 mg, white, round, film-coated tablets with bisect, debossed “N” on top and “T” on bottom of the bisect on one side and "043" on the other side of the tablet, bottles of 100 (NDC 49884-124-01) and 500 (NDC 49884-124-05). Labetalol hydrochloride tablets, USP should be stored at 20° to 25°C (68° to 77°F)[ See USP Controlled Room Temperature].   Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Formulations Private Limited, 9/215, Pudupakkam, Kelambakkam - 603 103. Made in India. Mfg. Lic. No.: TN00002121 OS122-01-74-01 Revised: 03/2017

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

LABETALOL HCL- LABETALOL HYDROCHLORIDE TABLET, FILM COATED
PAR PHARMACEUTICAL, INC.
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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 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 response