国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987)
Spectra Medical Devices, LLC
LIDOCAINE HYDROCHLORIDE ANHYDROUS
LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL
EPIDURAL
PRESCRIPTION DRUG
Lidocaine HCl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.
Lidocaine Hydrochloride Injection, USP is supplied as follows: Single Dose Ampule (box of 25) All solutions should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Manufactured for: Spectra Medical Devices, LLC. Wilmington, MA 01887 Manufactured by: Huons Co., Ltd., Seoul, S. Korea Product Code: 1605-1 Revised: 03/2018
Abbreviated New Drug Application
LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE ANHYDROUS INJECTION, SOLUTION SPECTRA MEDICAL DEVICES, LLC ---------- LIDOCAINE HYDROCHLORIDE INJECTION, USP SPL UNCLASSIFIED SECTION For Infiltration and Nerve Block Rx only DESCRIPTION Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic, aqueous solution that contains a local anesthetic agent and is administered parenterally by injection. See INDICATIONS for specific uses. The solution contains lidocaine HCl, which is chemically designated as acetamide, 2- (diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8. Lidocaine HCl (C14H22N2O • HCl) has the following structural formula: Lidocaine Hydrochloride Injection, USP single dose solutions are methylparaben free. Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. The pH of this solution is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid. CLINICAL PHARMACOLOGY: MECHANISM OF ACTION: Lidocaine HCl stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses thereby effecting local anesthetic action. HEMODYNAMICS: Excessive blood levels may cause changes in cardiac output, total peripheral resistance, and mean arterial pressure. With central neural blockade these changes may be attributable to block of autonomic fibers, a direct depressant effect of the local anesthetic agent on various components of the cardiovascular system, and/or the beta- adrenergic receptor stimulating action of epinephrine when present. The net effect is normally a modest hypotension when the recommended dosages are not exceeded. PHARMACOKINETICS AND METABOLISM: Information derived from diverse formulations, concentrations and usages reveals that lidocaine HCl is completely absorbed following parenteral administration, its rate of absorption depending, for example, upon various factors such as the site of administration and the presen 完全なドキュメントを読む