国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987)
Cardinal Health
INFILTRATION
PRESCRIPTION DRUG
Xylocaine (lidocaine HCl) Injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. Lidocaine HCl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.
HOW SUPPLIED Xylocaine – 1% (10 mg/mL) Lidocaine HCl Injection, USP is available overbagged with 1 x 50 mL Multiple Dose Vial, NDC #55154-9572-8. Xylocaine® -1% (10 mg/mL) Lidocaine HCl and Epinephrine Injection, USP with Epinephrine 1:100,000 is available overbagged with 1 x 10 mL Multiple Dose Vial, NDC 55154-9566-8. Xylocaine – 1% 500 mg/50 mL (10 mg/mL) Lidocaine HCl and Epinephrine Injection, USP with Epinephrine 1:100,000 is available overbagged with 1 x 50 mL Multiple Dose Vial, NDC 55154-9565-8. Xylocaine 2% - 400 mg/ 20 mL (20 mg/mL) Lidocaine HCl Injection, USP is available overbagged with 5 x 20 mL Multiple Dose Vials, NDC #55154-9569-5 Xylocaine®- 2% (20 mg/mL) Lidocaine HCl Injection, USP is available overbagged with 1 Multiple Dose vial, 20 mL, NDC 55154-9569-8. Xylocaine® - 2% (20 mg/mL) Lidocaine HCl Injection, USP is available overbagged with 1 x 50 mL Multiple Dose Vial, NDC 55154-9563-8. Xylocaine – 2% MPF 40 mg/2 mL (20 mg/mL) Lidocaine HCl Injection, USP is available overbagged with 1 Single Dose Vial, 2mL, NDC 55154-9388-8. Xylocaine®- 2% (20 mg/mL) Lidocaine HCl and Epinephrine Injection, USP with Epinephrine 1:100,000 is available overbagged with 1 x 50 mL Multiple Dose Vial, NDC# 55154-9567-8. Xylocaine –MPF -2% 400 mg/20mL (20 mg/mL) Lidocaine HCl and Epinephrine Injection, USP with Epinephrine 1:200,000 is available overbagged with 1 x 20 mL Single Dose Vial, NDC 55154-9568-8. All solutions should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. All trademarks are the property of Fresenius Kabi USA, LLC. 451175D Revised: November 2014 Repackaged by Cardinal Health Zanesville, OH 43701 IA69501215
New Drug Application
XYLOCAINE MPF- LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION XYLOCAINE- LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION XYLOCAINE- LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE INJECTION, SOLUTION XYLOCAINE MPF- LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE INJECTION, SOLUTION CARDINAL HEALTH ---------- XYLOCAINE For Infiltration and Nerve Block Rx only DESCRIPTION Xylocaine (lidocaine HCl) Injections are sterile, nonpyrogenic, aqueous solutions that contain a local anesthetic agent with or without epinephrine and are administered parenterally by injection. See INDICATIONS for specific uses. Xylocaine solutions contain lidocaine HCl, which is chemically designated as acetamide, 2- (diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8. Lidocaine HCl (C H N O • HCl) has the following structural formula: Epinephrine is (-) -3, 4-Dihydroxy-α-[(methylamino) methyl] benzyl alcohol and has the molecular wt. 183.21. Epinephrine (C H NO ) has the following structural formula: Dosage forms listed as Xylocaine-MPF indicate single dose solutions that are Methyl Paraben Free (MPF). Xylocaine MPF is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. Xylocaine in multiple dose vials: Each mL also contains 1 mg methyl paraben as antiseptic preservative. The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid. Xylocaine MPF with Epinephrine is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. Each mL contains lidocaine hydrochloride and epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a stabilizer. Xylocaine with Epinephrine in multiple dose vials: Each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to approximately 4.5 (3.3 to 5.5) with sodium hydroxide and/or hydrochloric acid. Filled under nitrogen. 14 22 2 9 13 3 CLINICAL PHARMACOLOGY MECHANISM OF ACTION Lidocaine HCl stabilizes the neuronal mem 阅读完整的文件