Dopamine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic, prediluted solution of dopamine hydrochloride in 5% dextrose injection. It is administered by intravenous infusion.
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 (mol. wt. 189.64). The structural formula is:
Dopamine hydrochloride injection is a clear, practically colorless, sterile, pyrogen-free, aqueous solution of dopamine HCl for intravenous infusion after dilution.
Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6 • H2O)
mol. wt. 198.17, a hexose sugar freely soluble in water. It has the following structural formula:
Water for Injection, USP is chemically designated H2O.
Each 100 mL contains dopamine hydrochloride 80 mg (equivalent to 64.6 mg dopamine base), 160 mg (equivalent to 129.2 mg dopamine base) or 320 mg (equivalent to 258.4 mg dopamine base) and dextrose, hydrous 5 g in water for injection, with sodium metabisulfite 50 mg added as an antioxidant; osmolar concentration, respectively 269, 277 or 294 mOsmol/liter (calc.). pH 3.6 (2.5 to 4.5). May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Dopamine Hydrochloride and 5% Dextrose Injection, USP is oxygen sensitive. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment), and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded.