LIDOCAINE HYDROCHLORIDE injection, solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)

Disponibil de la:

Eugia US LLC

INN (nume internaţional):

LIDOCAINE HYDROCHLORIDE

Compoziție:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL

Calea de administrare:

INFILTRATION

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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. 

Rezumat produs:

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

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

LIDOCAINE HYDROCHLORIDE - LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION
EUGIA US LLC
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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