Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)
Afaxys Pharma LLC
INFILTRATION
PRESCRIPTION DRUG
Lidocaine Hydrochloride Injection is 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.
Lidocaine Hydrochloride Injection USP, 1% is provided as a clear colourless solution filled in 20 mL clear moulded glass vial USP Type I with 20 mm Chlorobutyl rubber stopper and 20 mm aluminium violet flip-off seal. LIDOCAINE HYDROCHLORIDE INJECTION USP, 1 % is supplied as follows: Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from light. To report SUSPECTED ADVERSE REACTIONS, contact Afaxys at 1-855-888-2467 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Manufactured for Afaxys Pharma, LLC Charleston, SC 29403 www.afaxys.com Revised: June 2022
Abbreviated New Drug Application
LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE INJECTION AFAXYS PHARMA LLC ---------- Revised: June 2022 LIDOCAINE HYDROCHLORIDE INJECTION, USP For Infiltration and Nerve Block Rx only DESCRIPTION: Lidocaine Hydrochloride Injection is a sterile, nonpyrogenic, aqueous solution that contains a local anesthetic agent which produces 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. See INDICATIONS AND USAGE section for specific uses. Lidocaine Hydrochloride Injection 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 (C H N O •HCl) has the following structural formula: Lidocaine Hydrochloride Injection in multiple dose vials: Each mL also contains 1 mg methylparaben as antiseptic preservative and 7 mg of sodium chloride as tonicity adjuster. 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- 14 22 2 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, concentra Belgenin tamamını okuyun