Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
Mepivacaine hydrochloride (UNII: 4VFX2L7EM5) (Mepivacaine - UNII:B6E06QE59J)
Caresteam Health, Inc.
Mepivacaine hydrochloride
Mepivacaine hydrochloride 30 mg in 1 mL
SUBCUTANEOUS
PRESCRIPTION DRUG
CARBOCAINE is indicated for production of local anesthesia for dental procedures by infiltration or nerve block in adults and pediatric patients. CARBOCAINE is contraindicated in patients with a known hypersensitivity to amide-type local anesthetics.
CARBOCAINE 3% injection (mepivacaine hydrocholoride injection, USP) is available in cartons containing 5 blisters of 10 × 1.7 mL dental cartridges, 50 per carton (NDC 31382-753-05). CARBOCAINE 2% with NEO-COBEFRIN 1:20,000 injection, USP (mepivacaine hydrochloride and levonordefrin injection, USP) is available in cartons containing 5 blisters of 10 × 1.7 mL dental cartridges, 50 per carton (NDC 31382-931-05). Both solutions should be stored at controlled room temperature, below 25° C (77° F). Protect from light. Do not permit to freeze. For protection from light, retain in box until time of use. Once opened, the box should be reclosed by closing the flap. The mepivacaine 2% 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 CARBOCAINE products.
Abbreviated New Drug Application
CARBOCAINE- MEPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION CARBOCAINE WITH NEO-COBEFRIN- MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN INJECTION, SOLUTION CARESTEAM HEALTH, INC. ---------- CARBOCAINE 3% INJECTION (MEPIVACAINE HYDROCHLORIDE INJECTION, USP) CARBOCAINE 2% WITH NEO-COBEFRIN 1:20,000 INJECTION (MEPIVACAINE HYDROCHLORIDE AND LEVONORDEFRIN INJECTION, USP) RX ONLY THESE SOLUTIONS ARE INTENDED FOR DENTAL USE ONLY. DESCRIPTION CARBOCAINE (mepivacaine hydrochloride), a tertiary amine used as a local anesthetic, is 1-methyl-2', 6' - pipecoloxylidide monohydrochloride with the following structural formula: C H N 0.HCl M.W. 282.81 It is a white, crystalline, odorless powder soluble in water, but very resistant to both acid and alkaline hydrolysis. NEO-COBEFRIN, a sympathomimetic amine used as a vasoconstrictor in local anesthetic solution, is (- )- -(1-Aminoethyl)-3, 4-dihydroxybenzyl alcohol with the following structural formula: C H NO M.W. 183.21 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. CARBOCAINE 3% injection and CARBOCAINE 2% with NEO-COBEFRIN 1:20,000 injection are sterile solutions for injection. COMPOSITION: CARTRIDGE Each mL contains: 2% 3% Mepivacaine hydrochloride 20 mg 30 mg Levonordefrin 0.05mg - Sodium chloride 4 mg 6 mg Potassium metabisulfite 1.2 mg - ® ® ® 15 22 2 9 13 3 Potassium metabisulfite 1.2 mg - Edetate disodium 0.25mg - Sodium hydroxide q.s. ad pH Hydrochloric acid 0.5 mg - Water for injections 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 CARBOCAINE stabilizes the neuronal membrane and prevents the initiation and transmission of nerve impulses, thereby effecting local anesthesia. CARBOCAINE is rapidly metabolized, with only a small percentage of the anesthetic (5 to 10 percent) being excreted uncha Прочетете целия документ