Country: United States
Language: English
Source: NLM (National Library of Medicine)
MEPIVACAINE HYDROCHLORIDE (UNII: 4VFX2L7EM5) (MEPIVACAINE - UNII:B6E06QE59J), LEVONORDEFRIN (UNII: V008L6478D) (LEVONORDEFRIN - UNII:V008L6478D)
Septodont, Inc.
MEPIVACAINE HYDROCHLORIDE
MEPIVACAINE HYDROCHLORIDE 20 mg in 1 mL
SUBCUTANEOUS
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. Manufactured for SEPTODONT, Inc., 205 Granite Run Dr., Suite 150, Lancaster, PA, USA 17601 by Novocol Pharmaceutical of Canada Inc., 25 Wolseley Court, Cambridge, Ontario, Canada N1R 6X3 Rev. March 2021 (2558-9)
Abbreviated New Drug Application
SCANDONEST 2% L- MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN 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: 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 q.s. 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 st Read the complete document