LABETALOL HYDROCHLORIDE injection, solution

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

labetalol hydrochloride (UNII: 1GEV3BAW9J) (labetalol - UNII:R5H8897N95)

থেকে পাওয়া:

Sagent Pharmaceuticals

প্রশাসন রুট:

INTRAVENOUS

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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.

পণ্য সারাংশ:

Labetalol Hydrochloride Injection, USP, is a clear colorless to light yellow aqueous solution supplied as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not freeze. Protect from light. Retain in carton until time of use. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex. Brands listed are the trademarks of their respective owners. SAGENT® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in India ©2021 Sagent Pharmaceuticals, Inc. September 2021 SAGENT Pharmaceuticals ®

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

LABETALOL HYDROCHLORIDE- LABETALOL HYDROCHLORIDE INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
----------
LABETALOL HYDROCHLORIDE INJECTION, USP
(FOR INTRAVENOUS USE)
SAGENT
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 hydrochloride (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, USP 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
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
®
1
19
24
2
3
1
2
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-receptor