Country: United States
Language: English
Source: NLM (National Library of Medicine)
Mepivacaine Hydrochloride (UNII: 4VFX2L7EM5) (Mepivacaine - UNII:B6E06QE59J)
Septodont, Inc.
Mepivacaine Hydrochloride
Mepivacaine Hydrochloride 30 mg in 1 mL
SUBMUCOSAL
PRESCRIPTION DRUG
Mepivacaine is indicated for production of local anesthesia for dental procedures by infiltration or nerve block in adults and pediatric patients. SCANDONEST is contraindicated in patients with a known hypersensitivity to amide-type local anesthetics.
SCANDONEST 3% (30 mg/mL) Plain; (Mepivacaine Hydrocholoride Injection USP) (NDC 0362-1098-90) is available in cardboard boxes containing 5 blisters of 10 × 1.7 mL single-dose dental cartridges, 50 per carton. SCANDONEST 2% (20 mg/mL) L (Mepivacaine Hydrochloride and Levonordefrin Injection; USP) (NDC 0362-1097-80) is available in cardboard boxes containing 5 blisters of 10 × 1.7 mL single-dose dental cartridges, 50 per carton. Both solutions should be stored at controlled room temperature, below 25° C (77° F). Protect from light. Do not permit to freeze. BOXES: For protection from light, retain in box until time of use. Once opened, the box should be reclosed by closing the top flap. The SCANDONEST 2% (20 mg/mL) L solution should not be used if its color is pinkish or darker than slightly yellow or it contains a precipitate. Cartridge warmers should not be used with SCANDONEST products.
Abbreviated New Drug Application
SCANDONEST 3% PLAIN- MEPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION SEPTODONT, INC. ---------- SCANDONEST 3% (30 MG/ML) PLAIN (MEPIVACAINE HYDROCHLORIDE INJECTION, USP) SCANDONEST 2% (20 MG/ML) L (WITH LEVONORDEFRIN 1:20,000) (MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN INJECTION, USP) RX ONLY THESE SOLUTIONS ARE INTENDED FOR DENTAL USE ONLY. DESCRIPTION: 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 (-)- -(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. SCANDONEST 3% (30 mg/mL) Plain (mepivacaine hydrochloride injection 3% (30 mg/mL)) and SCANDONEST 2% (20 mg/mL) L (mepivacaine hydrochloride 2% (20 mg/mL) with levonordefrin 1:20,000 injection are sterile solutions for injection. COMPOSITION: COMPOSITION: CARTRIDGE 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 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. CLINICAL PHARMACOLOGY: SCANDONEST stabilizes the neuronal membrane and prevents the initiation and transmission of nerve impulses, thereby effecting local anesthesia. SCANDONEST is rapidly metabolized, with only a small percentage of the anesthetic (5 to 10 percent) being excreted unchanged in the urine. SCANDONEST because of its amide structure Read the complete document