LABETALOL HYDROCHLORIDE injection

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Alvogen Inc.

Начин на приложение:

INTRAVENOUS

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Labetalol hydrochloride injection is indicated for control of blood pressure in severe hypertension. Labetalol hydrochloride injection 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.

Каталог на резюме:

Labetalol hydrochloride injection, 5 mg/mL, is supplied in: NDC 47781-586-29, 100 mg/20 mL Multiple Dose Vial, Carton of 1. NDC 47781-586-56, 200 mg/40 mL Multiple Dose Vial, Carton of 1. Store at 20°C to 25ºC (68°F to 77°F). See USP Controlled Room Temperature. Protect from freezing and light. Product of Italy Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA The brands listed are the registered trademarks of their respective owners and are not trademarks of Alvogen, Inc. Rev. 03/2017 PI586-00

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

LABETALOL HYDROCHLORIDE- LABETALOL HYDROCHLORIDE INJECTION
ALVOGEN INC.
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LABETALOL HYDROCHLORIDE INJECTION, USP
RX ONLY
DESCRIPTION
Labetalol hydrochloride injection is 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 HCl has the empirical formula C1 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 injection is a clear, colorless to light yellow,
aqueous, sterile, isotonic
solution for intravenous (IV) injection. It has a pH range of 3.0 to
4.5. Each mL contains
5 mg labetalol hydrochloride USP, 45 mg anhydrous dextrose, 0.10 mg
edetate
disodium; 0.80 mg of methylparaben and 0.10 mg of propylparaben as
preservatives;
and citric acid monohydrate and sodium hydroxide, as necessary, to
bring the solution
into the pH range.
CLINICAL PHARMACOLOGY
Labetalol HCl combines both selective, competitive, alpha -adrenergic
blocking and
nonselective, competitive, beta-adrenergic blocking activity in a
single substance. In
1
9
24
2
3
1
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