Articaine Hydrochloride And Epinephrine Recall
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FDA Labeling Changes
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Articaine hydrochloride and epinephrine injection, USP, an amide local anesthetic containing a vasoconstrictor, is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures.
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Articaine hydrochloride and epinephrine injection, USP is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in 1:100,000 strength. Articaine HCl is an amino amide local anesthetic, chemically designated as 4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene‑carboxylic acid, methyl ester hydrochloride and is a racemic mixture. Articaine HCl has a molecular weight of 320.84 and the following structural formula:
Articaine HCl has a partition coefficient in n-octanol/Soerensen buffer (pH: 7.35) of 17 and a pKa of 7.8.
Epinephrine bitartrate, (-)-1-(3,4-Dihydroxyphenyl)-2-methylamino-ethanol (+) tartrate (1:1) salt, is a vasoconstrictor that is added to articaine HCl in a concentration of 1:100,000 (express as free base). It has a molecular weight of 333.3 and the following structural formula:
Articaine hydrochloride and epinephrine injection, USP contains articaine HCl (40 mg/mL), epinephrine as bitartrate (1:100,000) sodium chloride (1.6 mg/mL), and sodium metabisulfite (0.5 mg/mL) in water for injection. The product is formulated with a 10% overage of epinephrine. The pH is adjusted with sodium hydroxide.