dentsply pharmaceutical - Medication Listings

ARTICADENT (articaine hydrochloride and epinephrine injection), for intraoral submucosal infiltration use, is a sterile, aqueous solution that contains articaine HCl 4% (40 mg/mL) and epinephrine bitartrate in an epinephrine 1:200,000 or epinephrine 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 with a concentration of 1:200,000 or 1:100,000 (expressed as free base). It has a molecular weight of 333.3 and the following structural formula: ARTICADENT contains the following inactive ingredients: sodium chloride (1.6 mg/mL), and sodium metabisulfite (0.5 mg/mL). The product is formulated with a 15% overage of epinephrine. The pH is adjusted with sodium hydroxide. Chemical Structure Chemical Structure

Mepivacaine Hydrochloride, a tertiary amine used as a local anesthetic, is 1-methyl-2,' 6' - pipecoloxylidide monohydrochloride with the following structural formula: It is a white, crystalline, odorless powder soluble in water, but very resistant to both acid and alkaline hydrolysis. Levonordefrin, a sympathomimetic amine used as a vasoconstrictor in local anesthetic solution, is (-)-α-(1-Aminoethyl)-3, 4-dihydroxybenzyl alcohol with the following structural formula: It is a white or buff-colored crystalline solid, freely soluble in aqueous solutions of mineral acids, but practically insoluble in water. DENTAL CARTRIDGES MAY NOT BE AUTOCLAVED. 3% (30 mg/mL) Polocaine ® DENTAL (mepivacaine hydrochloride injection 3% (30 mg/mL)) and 2% (20 mg/mL) Polocaine ® DENTAL with Levonordefrin 1:20,000 (mepivacaine hydrochloride 2% (20 mg/mL) with levonordefrin 1:20,000 injection) are sterile solutions for injection. COMPOSITION: CARTRIDGE The pH of the 2% cartridge solution is adjusted between 3.3 and 5.5 with NaOH. The pH of the 3% cartridge solution is adjusted between 4.5 and 6.8 with NaOH. Each mL contains: 2% 3% Mepivacaine Hydrochloride 20 mg 30 mg Levonordefrin 0.05 mg - Sodium Chloride 4 mg 6 mg Potassium metabisulfite 1.2 mg - Edetate disodium 0.25 mg - Sodium Hydroxide q.s. ad pH; Hydrochloric Acid 0.5 mg - Water For Injection, qs. ad. 1 mL 1 mL Chemical Structure Chemical Structure

2% Xylocaine DENTAL with Epinephrine 1:50,000 and 2% Xylocaine DENTAL with Epinephrine 1:100,000 are sterile isotonic solutions containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, Epinephrine (as bitartrate) and are administered parenterally by injection. Both solutions are available in single dose cartridges of 1.7 mL (See INDICATIONS AND USAGE for specific uses). 2% Xylocaine DENTAL solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula: C 14 H 22 N 2 O • HCI • H 2 O M.W. 288.8 Epinephrine is (-)-3,4-Dihydroxy-α-[(Methylamino) methyl] benzyl alcohol and has the following structural formula: C 9 H 13 NO 3 M.W. 183.21 The pH of the 2% Xylocaine DENTAL solutions are adjusted to USP limits with sodium hydroxide. COMPOSITION OF THE 2% Xylocaine DENTAL INJECTIONS BRAND NAME PRODUCT IDENTIFICATION FORMULA SINGLE DOSE CARTRIDGE Lidocaine hydrochloride Epinephrine (as the bitartrate) Sodium Chloride Potassium metabisulfite Edetate Disodium Concentration % Dilution (mg/mL) (mg/mL) (mg/mL) 2% Xylocaine Dental with Epinephrine 1:50,000 2 1:50,000 6.5 1.2 0.25 2% Xylocaine Dental with Epinephrine 1:100,000 2 1:100,000 6.5 1.2 0.25 The pH of the 2% Xylocaine DENTAL solutions are adjusted to USP limits with sodium hydroxide. Lidocaine Hydrochloride Epinephrine