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:

Baxter Healthcare Corporation

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, 5 mg/mL, is supplied as below: AIN code Fill Volume Strength NDC NUMBER AIN02969 4 mL Single-dose vial 20 mg/4 mL 36000-320-10 (Pack of 10) AIN02970 20 mL Multi-dose vial 100 mg/20 mL 36000-322-02 (Pack of 01) AIN02971 40 mL Multi-dose vial 200 mg/40 mL 36000-324-02 (Pack of 01) Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Protect from freezing and light. Retain in carton until time of use. Manufactured by: Caplin Steriles Limited Gummidipoondi - 601 201, India Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA 2020-07-24 22200114 07-19-00-5391

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

LABETALOL HYDROCHLORIDE- LABETALOL HYDROCHLORIDE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
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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 hydrochloride is a racemate, chemically designated as
5-[1-hydroxy-2-[(1-
methyl-3-phenylpropyl) amino] ethyl] salicylamide monohydrochloride,
and has the
following structure:
Labetalol hydrochloride 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 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
USP, 0.1 mg
edetate disodium USP; 0.8 mg methylparaben NF and 0.1 mg propylparaben
NF as
preservatives; citric acid anhydrous USP and/or sodium hydroxide NF 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
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.
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19
24
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3
1
2
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PHARMACODYNAMICS:
The capacity of labetalol to block alpha-receptors in man has been