DESCRIPTION
Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations with characteristics as follows:
Concentration Lidocaine HCl | Epinephrine | Lidocaine HCl (anhyd.) mg/mL | Epinephrine mcg/mL | Sodium Chloride mg/mL |
0.5% | 1:200,000 | 5 | 5 | 8 |
1% | 1:200,000 | 10 | 5 | 7 |
1.5% | 1:200,000 | 15 | 5 | 6.5 |
2% | 1:200,000 | 20 | 5 | 6 |
1% | 1:100,000 | 10 | 10 | 7 |
2% | 1:100,000 | 20 | 10 | 6 |
Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL added as stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and 3183 are nitrogen gassed. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). See HOW SUPPLIED section for various sizes and strengths.
Multiple-dose vials contain methylparaben 1 mg/mL added as preservative.
Single-dose ampuls and vials contain no bacteriostat or antimicrobial agent. Discard unused portion.
Lidocaine is a local anesthetic of the amide type.
Lidocaine Hydrochloride, USP is chemically designated 2-(diethyl-amino)-2',6'-acetoxylidide monohydrochloride monohydrate, a white powder freely soluble in water. It has the following structural formula:
Epinephrine, USP is a sympathomimetic (adrenergic) agent designated chemically as 4-[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white, microcrystalline powder. It has the following structural formula:
