LABETALOL HYDROCHLORIDE injection, solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

Labetalol Hydrochloride (UNII: 1GEV3BAW9J) (Labetalol - UNII:R5H8897N95)

Dostupné s:

Akorn

INN (Mezinárodní Name):

Labetalol Hydrochloride

Složení:

Labetalol Hydrochloride 5 mg in 1 mL

Podání:

INTRAVENOUS

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Labetalol HCl Injection is indicated for control of blood pressure in severe hypertension. Labetalol HCl 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.

Přehled produktů:

Labetalol HCl Injection, 5 mg/mL, is supplied in: 20 mL (100 mg) (NDC 17478-420-20) multi-dose vial, box of 1 40 mL (200 mg) (NDC 17478-420-40) multi-dose vial, box of 1 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. PROTECT FROM LIGHT.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

LABETALOL HYDROCHLORIDE- LABETALOL HYDROCHLORIDE INJECTION, SOLUTION
AKORN
----------
LABETALOL HYDROCHLORIDE
INJECTION, USP
RX ONLY
DESCRIPTION
Labetalol Hydrochloride is an adrenergic receptor blocking agent that
has both selective
alpha - and non-selective beta-adrenergic receptor blocking actions in
a single
substance.
Labetalol HCl is a racemate, chemically designated as
5-[1-hydroxy-2-[(1-methyl-3-
phenylpropyl) amino] ethyl]salicylamide monohydrochloride, and has the
following
structural formula:
Labetalol HCl 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 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 injection. It has a pH range of 3.0
to 4.0.
EACH ML CONTAINS:
ACTIVE: Labetalol Hydrochloride USP, 5 mg. PRESERVATIVES:
Methylparaben, 0.80 mg;
Propylparaben, 0.10 mg. INACTIVES: Anhydrous Dextrose, 45 mg; Edetate
Disodium
0.10 mg; Citric Acid Anhydrous and/or Sodium Hydroxide may be added to
adjust pH
(3.0 to 4.0), and Water for Injection.
CLINICAL PHARMACOLOGY
Labetalol 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 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.
1
19
24
2
3
1
2
1
PHARMACODYNAMICS
The capacity of labetalol to block alpha-receptors in man has been
demonstrated by
attenuation of the pres