DOPAMINE HYDROCHLORIDE- dopamine hydrochloride injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Dopamine Hydrochloride Injection, USP is supplied as follows (40 mg/mL and 80 mg/mL): 5 mL Fliptop Vial (200 mg) List No. 5820 10 mL Fliptop Vial (400 mg) List No. 9104 10 mL Fliptop Vial (800 mg) List No. 4265 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.] Revised: 3/2014 EN-3462 Hospira, Inc., Lake Forest, IL 60045 USA Cardinal Health Zanesville, OH 43701 IA61600413

Authorization status:

New Drug Application

Summary of Product characteristics

DOPAMINE HYDROCHLORIDE- DOPAMINE HYDROCHLORIDE INJECTION, SOLUTION,
CONCENTRATE
CARDINAL HEALTH
----------
DOPAMINE
HYDROCHLORIDE
Injection, USP
FLIPTOP VIAL
PINTOP VIAL
_MUST BE DILUTED PRIOR TO ADMINISTRATION_
Rx only
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 C H NO •
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 the 80 mg/mL preparation contains 80 mg of dopamine
hydrochloride (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 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.
8
11
2
Dopamine produces positive chronotropic and inotropic effects on