Articaine Hydrochloride And Epinephrine
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Uses
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.
History
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Other Information
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.
Sources
Articaine Hydrochloride And Epinephrine Manufacturers
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Hospira, Inc.
![Articaine Hydrochloride And Epinephrine (Articaine Hydrochloride And Epinephrine Bitartrate) Injection, Solution [Hospira, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Articaine Hydrochloride And Epinephrine | Hospira, Inc.
2.1 General Dosing InformationTable 1 (below) summarizes the recommended volumes and concentrations of articaine hydrochloride and epinephrine injection, USP for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults, administered by submucosal infiltration or nerve block.
Table 1: Recommended DosagesProcedure
Articaine hydrochloride and epinephrine injection, USP
Volume (mL)
Total dose of articaine HCl (mg)
Infiltration
0.5 – 2.5
20 – 100
Nerve block
0.5 – 3.4
20 – 136
Oral surgery
1.0 – 5.1
40 – 204
The recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia, degree of muscular relaxation, and condition of the patient. In all cases, the smallest dose that will produce the desired result should be given.
The onset of anesthesia and the duration of anesthesia are proportional to the volume and concentration (i.e., total dose) of local anesthetic used. Caution should be exercised when employing large volumes because the incidence of side effects may be dose-related.
For most routine dental procedures, articaine hydrochloride and epinephrine injection containing epinephrine 1:200,000 is preferred. However, when more pronounced hemostasis or improved visualization of the surgical field are required, Articaine hydrochloride and epinephrine injection containing epinephrine 1:100,000 may be used.
2.2 Maximum Recommended Dosages • Adults: For normal healthy adults, the maximum dose of articaine HCl administered by submucosal infiltration or nerve block should not exceed 7 mg/kg (0.175 mL/kg). • Pediatric Patients Ages 4 to 16 Years: The quantity of articaine HCl in children ages 4 to 16 years of age to be injected should be determined by the age and weight of the child and the magnitude of the operation. The maximum dose of articaine HCl should not exceed 7 mg/kg (0.175 mL/kg) [ see Use in Specific Populations (8.4)]. • Safety and effectiveness of artcaine HCl in pediatric patients below the age of 4 years have not been established. 2.3 Dosing in Special PopulationsDose reduction may be required in debilitated patients, acutely ill patients, elderly patients, and pediatric patients commensurate with their age and physical condition. No studies have been performed in patients with renal or liver dysfunction. Caution should be used in patients with severe liver disease [see Warnings and Precautions (5.2), Use in Specific Populations (8.4, 8.5, and 8.6)].
2.1 General Dosing InformationTable 1 (below) summarizes the recommended volumes and concentrations of articaine hydrochloride and epinephrine injection, USP for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults, administered by submucosal infiltration or nerve block.
Table 1: Recommended DosagesProcedure
Articaine hydrochloride and epinephrine injection, USP
Volume (mL)
Total dose of articaine HCl (mg)
Infiltration
0.5 – 2.5
20 – 100
Nerve block
0.5 – 3.4
20 – 136
Oral surgery
1.0 – 5.1
40 – 204
The recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia, degree of muscular relaxation, and condition of the patient. In all cases, the smallest dose that will produce the desired result should be given.
The onset of anesthesia and the duration of anesthesia are proportional to the volume and concentration (i.e., total dose) of local anesthetic used. Caution should be exercised when employing large volumes because the incidence of side effects may be dose-related.
For most routine dental procedures, articaine hydrochloride and epinephrine injection containing epinephrine 1:200,000 is preferred. However, when more pronounced hemostasis or improved visualization of the surgical field are required, Articaine hydrochloride and epinephrine injection containing epinephrine 1:100,000 may be used.
2.2 Maximum Recommended Dosages • Adults: For normal healthy adults, the maximum dose of articaine HCl administered by submucosal infiltration or nerve block should not exceed 7 mg/kg (0.175 mL/kg). • Pediatric Patients Ages 4 to 16 Years: The quantity of articaine HCl in children ages 4 to 16 years of age to be injected should be determined by the age and weight of the child and the magnitude of the operation. The maximum dose of articaine HCl should not exceed 7 mg/kg (0.175 mL/kg) [ see Use in Specific Populations (8.4)]. • Safety and effectiveness of artcaine HCl in pediatric patients below the age of 4 years have not been established. 2.3 Dosing in Special PopulationsDose reduction may be required in debilitated patients, acutely ill patients, elderly patients, and pediatric patients commensurate with their age and physical condition. No studies have been performed in patients with renal or liver dysfunction. Caution should be used in patients with severe liver disease [see Warnings and Precautions (5.2), Use in Specific Populations (8.4, 8.5, and 8.6)].
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