LABETALOL HYDROCHLORIDE injection

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

West-Ward Pharmaceuticals Corp

Tuyến hành chính:

INTRAVENOUS

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Labetalol HCl Injection, USP 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.

Tóm tắt sản phẩm:

Labetalol HCl Injection, USP, 5 mg/mL, is supplied in 20 mL (100 mg) multidose vials, individually-boxed (NDC 0143-9320-01 ). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not freeze. Protect from light. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689. PREMIER ProRx®   Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: West-Ward Pharmaceuticals Eatontown, NJ 07724 USA PREMIERProRx® is a registered trademark of Premier Healthcare Alliance, L.P., used under license. Revised June 2018 PIN492-PRE/1

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

LABETALOL HYDROCHLORIDE- LABETALOL HYDROCHLORIDE INJECTION
WEST-WARD PHARMACEUTICALS CORP
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LABETALOL HYDROCHLORIDE INJECTION, USP
RX ONLY
PREMIERProRx®
DESCRIPTION
Labetalol Hydrochloride Injection, USP 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
5-[1-Hydroxy-2-[(1-methyl-3-
phenylpropyl)amino]ethyl]-salicylamide monohydrochloride and it has
the following structural formula:
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 HCl Injection, USP is a clear, colorless to light yellow,
aqueous, sterile, isotonic solution
for intravenous injection. It has a pH range of 3 to 4. Each
milliliter contains 5 mg of labetalol HCl, 45
mg of anhydrous dextrose, 0.1 mg of edetate disodium; 0.8 mg of
methylparaben and 0.1 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 combines both selective, competitive, alpha -adrenergic
blocking and nonselective,
1
19
24
2
3
1
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 r