LIDOCAINE HYDROCHLORIDE solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Brookfield Pharmaceuticals, LLC.

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Lidocaine Hydrochloride Injection, USP 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 HCl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Resumen del producto:

Lidocaine Hydrochloride Injection, USP is supplied as follows: Single Dose Vial (Box of 10) Single Dose Vial (Box of 25) SIngle Dose Vial (Box of 10) Single Dose Vial (Box of 25) Discard unused portion. All solutions should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Distributed By: Brookfield Pharmaceuticals, LLC Brookfield, WI 53005 Revised: 06/2023

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE SOLUTION
BROOKFIELD PHARMACEUTICALS, LLC.
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LIDOCAINE HYDROCHLORIDE INJECTION USP
FOR INFILTRATION AND NERVE BLOCK
RX ONLY
DESCRIPTION:
Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic,
aqueous solution that
contains a local anesthetic agent and is administered parenterally by
injection. See
INDICATIONS for specific uses.
The solution contains lidocaine HCl, which is chemically designated as
acetamide, 2-
(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the
molecular wt.
270.8. Lidocaine HCl (C14H22N2O • HCl) has the following structural
formula:
Lidocaine Hydrochloride Injection, USP single dose solutions are
methylparaben free.
Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic,
isotonic solution
containing sodium chloride. The pH of this 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 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 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.
E