Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987), DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)
Hospira, Inc.
LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE ANHYDROUS 50 mg in 1 mL
INTRASPINAL
PRESCRIPTION DRUG
5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP is indicated for the production of spinal anesthesia when the accepted procedures for this technique as described in standard textbooks are observed. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. The following conditions preclude the use of spinal anesthesia: - Severe hemorrhage, shock or heart block - Local infection at the site of proposed puncture - Septicemia - Known sensitivity to the local anesthetic agent.
5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP, is supplied in the following: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
Abbreviated New Drug Application
LIDOCAINE HYDROCHLORIDE AND DEXTROSE- LIDOCAINE HYDROCHLORIDE AND DEXTROSE INJECTION, SOLUTION HOSPIRA, INC. ---------- 5% LIDOCAINE HYDROCHLORIDE AND 7.5% DEXTROSE INJECTION, USP AMPUL SINGLE-DOSE CONTAINER Rx only DESCRIPTION 5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP is a sterile, nonpyrogenic, hyperbaric solution for use in spinal anesthesia. 5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP contains lidocaine HCl, which is chemically designated as 2-(diethylamino)-N-(2,6-dimethylphenyl)-acetamide monohydrochloride, monohydrate and Dextrose (D-Glucose monohydrate) which have the following structural formulas: Lidocaine Hydrochloride (monohydrate) Dextrose (hydrous) 5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP contains 50 mg/mL of lidocaine hydrochloride, anhydrous with 75 mg/mL of dextrose, hydrous in water for injection. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH 6.5 (6.0 to 7.0). The osmolar concentration is 0.75 mOsmol/mL (calc.). The specific gravity is 1.030 to 1.035. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Lidocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. ONSET AND DURATION OF ANESTHESIA The onset of action is rapid. The duration of perineal anesthesia provided by 1 mL (50 mg) 5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP averages 100 minutes, with analgesia continuing for an additional 40 minutes. The duration of surgical anesthesia provided by 1.5 to 2 mL (75 to 100 mg) of this agent is approximately two hours. 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, or a direct depressant effect of the local anesthetic agent on various components of the cardiovascular system. The net effect is normally a modest hypotension when Lire le document complet