Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)
Hospira, Inc.
INFILTRATION
PRESCRIPTION DRUG
Lidocaine HCl injection is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and 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.
2% Lidocaine Hydrochloride Injection, USP: NDC 0409-2066-05 Carton of 10 Single-dose Vials 2% 100 mg/5 mL (20 mg/mL) Discard unused portion after initial use. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
Abbreviated New Drug Application
LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION HOSPIRA, INC. ---------- 2% LIDOCAINE HYDROCHLORIDE INJECTION, USP FOR INFILTRATION AND NERVE BLOCK Rx only DESCRIPTION Lidocaine hydrochloride has the chemical name of acetamide, 2-(diethylamino)-N-(2,6- dimethylphenyl)-,monohydrochloride and has the molecular weight of 270.8. Lidocaine HCl (C H N O • HCl) has the following structural formula: Each single-dose vial contains Lidocaine Hydrochloride Injection, USP, which is a sterile nonpyrogenic aqueous solution intended for parenteral administration as a local anesthetic agent. See INDICATIONS AND USAGE for special uses. Each mL contains 20 mg lidocaine hydrochloride and 6 mg sodium chloride, in Water for Injection. Sodium hydroxide and/or hydrochloric acid may be used to adjust pH between 5.0 and 7.0. 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 14 22 2 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 presence or absence of a vasoconstrictor agent. Except for intravascular administration, the highest blood levels are obtained following intercostal nerve block and the low Aqra d-dokument sħiħ