DOPAMINE HYDROCHLORIDE AND DEXTROSE- dopamine hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Baxter Healthcare Corporation

INN (International Name):

DOPAMINE HYDROCHLORIDE

Composition:

DOPAMINE HYDROCHLORIDE 80 mg in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dopamine hydrochloride is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarctions, trauma, endotoxic septicemia, open heart surgery, renal failure and chronic cardiac decompensation as in congestive failure. Where appropriate, restoration of blood volume with a suitable plasma expander or whole blood should be instituted or completed prior to administration of dopamine hydrochloride. Patients most likely to respond adequately to dopamine hydrochloride are those in whom physiological parameters, such as urine flow, myocardial function and blood pressure have not undergone profound deterioration. Reports indicate that the shorter the time interval between onset of signs and symptoms and initiation of therapy with volume correction and dopamine hydrochloride, the better the prognosis. 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:

Code Size (mL) mcg/mL NDC 2B0832 250 800 0338-1005-02 2B0842 250 1600 0338-1007-02 2B0833 500 800 0338-1005-03 2B0846 250 3200 0338-1009-02 2B0843 500 1600 0338-1007-03 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product. Avoid contact with alkalies (including sodium bicarbonate), oxidizing agents or iron salts. NOTE - Do not use the injection if it is darker than slightly yellow or discolored in any other way.

Authorization status:

New Drug Application

Summary of Product characteristics

DOPAMINE HYDROCHLORIDE AND DEXTROSE- DOPAMINE HYDROCHLORIDE INJECTION,
SOLUTION
BAXTER HEALTHCARE CORPORATION
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DOPAMINE HYDROCHLORIDE AND 5% DEXTROSE INJECTION, USP
IN PLASTIC CONTAINER
VIAFLEX PLUS CONTAINER
DESCRIPTION
Dopamine Hydrochloride and 5% Dextrose Injection, USP is a sterile,
nonpyrogenic solution of
Dopamine Hydrochloride, USP and Dextrose, USP in Water for Injection.
Structural formulas are
shown below:
Dopamine Hydrochloride and 5% Dextrose Injection, USP is intended for
intravenous use only. It
contains no antimicrobial agents. The pH is adjusted with hydrochloric
acid and is 3.5 (2.5 to 4.5).
Approximately 5 mEq/L sodium bisulfite is added as a stabilizer. The
solution provides a caloric
content of 170 kcal/L. The solution is intended for single use only.
When smaller doses are required,
the unused portion should be discarded. Composition and osmolarity are
given below:
800 MCG/ML DOPAMINE HYDROCHLORIDE AND 5% DEXTROSE INJECTION, USP
provides 800 mcg/mL
Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an
osmolarity of 261
mOsmol/L (calc).
1600 MCG/ML DOPAMINE HYDROCHLORIDE AND 5% DEXTROSE INJECTION, USP
provides 1600 mcg/mL
Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an
osmolarity of 269
mOsmol/L (calc).
3200 MCG/ML DOPAMINE HYDROCHLORIDE AND 5% DEXTROSE INJECTION, USP
provides 3200 mcg/mL
Dopamine Hydrochloride, USP and 50 g/L Dextrose Hydrous, USP with an
osmolarity of 286
mOsmol/L (calc).
Dopamine administered intravenously is a myocardial inotropic agent
which also may increase
mesenteric and renal blood flow plus urinary output.
Dopamine hydrochloride is designated chemically as
3,4-dihydroxyphenethylamine hydrochloride, a
white crystalline powder freely soluble in water. Dopamine (also
referred to as 3-hydroxytyramine) is a
naturally occurring biochemical catecholamine precursor of
norepinephrine.
This VIAFLEX Plus plastic container is fabricated from a specially
formulated polyvinyl chloride (PL
2207 Plastic). VIAFLEX containers, including V