Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)
Eugia US LLC
LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL
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 hydrochloride 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: Lidocaine Hydrochloride Injection USP, 1% (10 mg/mL) 2 mL Single-Dose Vials in a Carton of 10 NDC 55150-161-02 5 mL Single-Dose Vials in a Carton of 10 NDC 55150-162-05 30 mL Single-Dose Vials in a Carton of 1 NDC 55150-163-30 Lidocaine Hydrochloride Injection USP, 2% (20 mg/mL) 2 mL Single-Dose Vials in a Carton of 10 NDC 55150-164-02 5 mL Single-Dose Vials in a Carton of 10 NDC 55150-165-05 Sterile, Nonpyrogenic Discard unused portion. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The vial stopper is not made with natural rubber latex. Distributed by: Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India Revised: March 2023
Abbreviated New Drug Application
LIDOCAINE HYDROCHLORIDE - LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION EUGIA US LLC ---------- LIDOCAINE HCL INJECTION, USP For Infiltration and Nerve Block Including Caudal and Epidural Use. Preservative-Free RX ONLY DESCRIPTION Lidocaine hydrochloride injection, USP is sterile, nonpyrogenic, aqueous solution that contains a local anesthetic agent and is administered parenterally by injection. See INDICATIONS AND USAGE section for specific uses. Lidocaine hydrochloride injection, USP contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular weight 270.8. Lidocaine hydrochloride (C H N O • HCl) has the following structural formula: Lidocaine hydrochloride injection, USP is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. The pH of the 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 hydrochloride stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses thereby effecting local anesthetic 14 22 2 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 hydrochloride is completely absorbed following parenteral administration, its rate of absorption depending, for example, upon various factors such as the site of administration and the presenc Olvassa el a teljes dokumentumot