LIDOCAINE- lidocaine hydrochloride injection, solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Fresenius Kabi USA, LLC

Vía de administración:

INFILTRATION

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Lidocaine Hydrochloride Injection, USP is indicated for the production of local anesthesia, by infiltration techniques, such as percutaneous injection, and by peripheral nerve block techniques, such as brachial plexus and inter-costal, 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 is preserved with 0.1% methylparaben and is available in the following concentrations: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

LIDOCAINE - LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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LIDOCAINE HYDROCHLORIDE INJECTION, USP
Rx only
LOCAL ANESTHETIC FOR INFILTRATION AND NERVE BLOCK
NOT FOR SPINAL OR EPIDURAL ANESTHESIA
DESCRIPTION
Lidocaine Hydrochloride Injection, USP is a local anesthetic which is
a sterile,
nonpyrogenic solution intended for parenteral injection. See
INDICATIONS AND
USAGE_ _for specific uses.
Lidocaine hydrochloride is chemically designated as
2-(Diethylamino)-2’, 6’-acetoxylidide
monohydrochloride and has the following structural formula:
C
H
N
O • HCL M.W. 288.82
Each mL contains: Lidocaine hydrochloride 10 or 20 mg; methylparaben
0.1%; sodium
chloride (7 mg and 6 mg of sodium chloride for 1% and 2% respectively)
to render it
isotonic; Water for Injection q.s. Hydrochloric acid and/or sodium
hydroxide may have
been added for pH adjustment (5.0 to 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
attributable to block of autonomic fibers, 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 the recommended dosages are not
exceeded.
14
22
2
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 lowest after subcutane