DOPAMINE HYDROCHLORIDE injection, solution, concentrate

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

Dopamine Hydrochloride (UNII: 7L3E358N9L) (Dopamine - UNII:VTD58H1Z2X)

Dostopno od:

General Injectables & Vaccines, Inc

INN (mednarodno ime):

Dopamine Hydrochloride

Sestava:

Dopamine Hydrochloride 40 mg in 1 mL

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Dopamine HCl 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 HCl 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 HCl, 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 HCl. 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 monitored. Nevertheless, the physician should also observe the

Povzetek izdelek:

Dopamine Hydrochloride Injection, USP is supplied as follows (40 mg/mL): 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.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1154-3.0 Revised: 02/2019

Status dovoljenje:

New Drug Application

Lastnosti izdelka

DOPAMINE HYDROCHLORIDE- DOPAMINE HYDROCHLORIDE INJECTION, SOLUTION,
CONCENTRATE
GENERAL INJECTABLES & VACCINES, INC
----------
DOPAMINE HYDROCHLORIDE INJECTION, USP
RX ONLY
FLIPTOP VIAL
MUST BE DILUTED PRIOR TO ADMINISTRATION
DESCRIPTION
Dopamine, a sympathomimetic amine vasopressor, is the naturally
occurring immediate
precursor of norepinephrine. Dopamine hydrochloride 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 HCl is sensitive to alkalies, iron
salts, and oxidizing
agents. Chemically it is designated as 4-(2-aminoethyl) pyrocatechol
hydrochloride, and
its molecular formula is C8H11NO2 • HCl.
The structural formula is:
and the molecular weight is 189.64.
Dopamine hydrochloride injection is a clear, practically colorless,
sterile, pyrogen-free,
aqueous solution of dopamine HCl for intravenous infusion after
dilution. Each milliliter of
the 40 mg/mL preparation contains 40 mg of dopamine hydrochloride
(equivalent to
32.31 mg of dopamine base). Each milliliter of preparation 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 must be diluted in an appropriate sterile parenteral solution
before
intravenous administration. (See DOSAGE AND ADMINISTRATION)
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 nerves.
Dopamine produces positive chronotropic and inotropic effects on the
myocardium,
resulting in increased heart rate and cardiac contractility. This is
accomplished directly by
exerting an agonist a