LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE injection, solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987), Epinephrine (UNII: YKH834O4BH) (Epinephrine - UNII:YKH834O4BH)

Disponibil de la:

General Injectables & Vaccines, Inc

INN (nume internaţional):

Lidocaine Hydrochloride Anhydrous

Compoziție:

Lidocaine Hydrochloride Anhydrous 5 mg in 1 mL

Calea de administrare:

INFILTRATION

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Lidocaine Hydrochloride and Epinephrine Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, 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.

Rezumat produs:

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1298-1.0 Revised: 04/2018

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE- LIDOCAINE HYDROCHLORIDE AND
EPINEPHRINE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
----------
LIDOCAINE HCL 0.5% AND EPINEPHRINE 1:200,000 INJECTION, USP 50 ML
MULTI
DOSE VIAL
SPL UNCLASSIFIED
For Infiltration and Nerve Block
Ampul
Fliptop Vial
Multiple-dose Fliptop Vial
Protect from light.
Hospira
Rx only
DESCRIPTION
Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile,
nonpyrogenic
solution of lidocaine hydrochloride and epinephrine in water for
injection for parenteral
administration in various concentrations with characteristics as
follows:
Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL
added as
stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and
3183 are nitrogen
gassed. May contain sodium hydroxide and/or hydrochloric acid to
adjust pH; pH is 4.5
(3.3 to 5.5). See HOW SUPPLIED section for various sizes and
strengths.
Multiple-dose vials contain methylparaben 1 mg/mL added as
preservative.
Single-dose ampuls and vials contain no bacteriostat or antimicrobial
agent. Discard
unused portion.
Lidocaine is a local anesthetic of the amide type.
Lidocaine Hydrochloride, USP is chemically designated
2-(diethyl-amino)-2',6'-
acetoxylidide monohydrochloride monohydrate, a white powder freely
soluble in water. It
has the following structural formula:
Epinephrine, USP is a sympathomimetic (adrenergic) agent designated
chemically as 4-
[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white,
microcrystalline powder. It
has the following structural formula:
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 effe