LABETALOL HYDROCHLORIDE injection, solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Hospira, Inc.

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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.

Περίληψη προϊόντος:

Labetalol hydrochloride injection, USP 5 mg/mL, is supplied in: NDC 0409-2267-20 Carton containing 1 Multiple-dose Vial 100 mg/20 mL (5 mg/mL) NDC 0409-2267-54 Carton containing 1 Multiple-dose Vial 200 mg/40 mL (5 mg/mL) NDC 0409-0125-25 Tray containing 25 Multiple-dose Vials 100 mg/20 mL (5 mg/mL) Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing and light. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA                                                                             LAB-1224-4.0 Revised: 11/2022

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

LABETALOL HYDROCHLORIDE- LABETALOL HYDROCHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
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LABETALOL HYDROCHLORIDE
Injection, USP
Rx only
DESCRIPTION
Labetalol hydrochloride is an adrenergic receptor blocking agent that
has both selective
alpha - and nonselective 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 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 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 4.5. Each mL
contains 5 mg labetalol hydrochloride, USP, 45 mg anhydrous dextrose,
0.1 mg edetate
disodium; 0.8 mg methylparaben and 0.1 mg propylparaben as
preservatives; citric acid
monohydrate and sodium hydroxide, as necessary, to bring the solution
into the pH
range.
CLINICAL PHARMACOLOGY
1
19
24
2
3
Labetalol combines both selective, competitive alpha1-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.
PHARMACODYNAMICS
The capacity of labetalol to block alpha-receptors in man has been
demonstrated by
attenuation of the presser effec