DOPAMINE HYDROCHLORIDE injection

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

DOPAMINE HYDROCHLORIDE (UNII: 7L3E358N9L) (DOPAMINE - UNII:VTD58H1Z2X)

Предлага се от:

Hikma Pharmaceuticals USA Inc.

INN (Международно Name):

DOPAMINE HYDROCHLORIDE

Композиция:

DOPAMINE HYDROCHLORIDE 40 mg in 1 mL

Начин на приложение:

INTRAVENOUS

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Dopamine Hydrochloride, USP is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarction, trauma, endotoxic septicemia, open-heart surgery, renal failure, and chronic cardiac decompensation as in congestive failure. Patients most likely to respond adequately to Dopamine Hydrochloride, USP are those in whom physiological parameters, such as urine flow, myocardial function, and blood pressure, have not undergone profound deterioration. Multiclinic trials indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with blood volume correction and Dopamine Hydrochloride, USP, the better the prognosis. Where appropriate, blood volume restoration with a suitable plasma expander or whole blood should be accomplished prior to administration of Dopamine Hydrochloride, USP. Poor Perfusion of Vital Organs – Urine flow appears to be one of the better diagnostic signs by which adequacy of vital organ perfusion can be mo

Каталог на резюме:

Dopamine Hydrochloride Injection, USP is a clear, colorless to slightly yellow aqueous solution supplied as follows: Strength Packaged NDC No. 200 mg/5 mL (40 mg/mL) Carton of 25 vials 0143-9252-25 400 mg/5 mL (80 mg/mL) Carton of 25 vials 0143-9253-25 400 mg/10 mL (40 mg/mL) Carton of 25 vials 0143-9254-25 800 mg/10 mL (80 mg/mL) Carton of 25 vials 0143-9255-25 Avoid contact with alkalies (including sodium bicarbonate), oxidizing agents or iron salts. Do not use the injection if it is darker than slightly yellow or discolored in any other way. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, nº 8, 8A e 8B – Fervença, 2705 – 906 Terrugem SNT PORTUGAL Distributed by: Hikma Pharmaceuticals USA Inc.  Berkeley Heights, NJ 07922 Revised: August 2020 PIN491-WES/2

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

DOPAMINE HYDROCHLORIDE- DOPAMINE HYDROCHLORIDE INJECTION
HIKMA PHARMACEUTICALS USA INC.
----------
DOPAMINE
HYDROCHLORIDE
INJECTION, USP
_MUST BE DILUTED PRIOR TO ADMINISTRATION _
RX ONLY
DESCRIPTION
Dopamine Hydrochloride, USP a sympathomimetic amine vasopressor, is
the naturally
occurring immediate precursor of norepinephrine. Dopamine
Hydrochloride, USP is a
white to off-white crystalline powder, which may have a slight odor of
hydrochloric acid.
It is freely soluble in water and soluble in alcohol. Dopamine
Hydrochloride, USP is
sensitive to alkalies, iron salts, and oxidizing agents. Chemically it
is designated as 4-(2-
aminoethyl) pyrocatechol hydrochloride, and its molecular formula is C
H
NO • HCl.
The structural formula is:
and the molecular weight is 189.64.
Dopamine Hydrochloride Injection, USP is a clear, practically
colorless, sterile, pyrogen-
free, aqueous solution of Dopamine Hydrochloride, USP for intravenous
infusion after
dilution. Each milliliter of the 40 mg/mL preparation contains 40 mg
of Dopamine
Hydrochloride, USP (equivalent to 32.31 mg of dopamine base). Each
milliliter of the 80
mg/mL preparation contains 80 mg of Dopamine Hydrochloride, USP
(equivalent to
64.62 mg of dopamine base). Each milliliter of both preparations
contains the following:
Sodium metabisulfite 9 mg added as an antioxidant; citric acid,
anhydrous 10 mg; and
sodium citrate, dihydrate 5 mg added as a buffer. May contain
additional citric acid
and/or sodium citrate for pH adjustment. pH is 3.3 (2.5 to 5.0).
Dopamine Hydrochloride Injection, USP must be diluted in an
appropriate sterile
parenteral solution before intravenous administration. (See DOSAGE AND
ADMINISTRATION)
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11
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CLINICAL PHARMACOLOGY
Dopamine is a natural catecholamine formed by the decarboxylation of
3,4-
dihydroxyphenylalanine (DOPA). It is a precursor to norepinephrine in
noradrenergic
nerves and is also a neurotransmitter in certain areas of the central
nervous system,
especially in the nigrostriatal tract, and in a few peripheral
sympathetic nerv