NA- lidocaine hydrochloride injection, solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987)

Disponible desde:

Sintetica US LLC

Vía de administración:

INFILTRATION

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Lidocaine Hydrochloride Injection 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.

Resumen del producto:

Lidocaine Hydrochloride Injection, USP is supplied as sterile, clear colorless solution free from visible particles as follows: Lidocaine Hydrochloride Injection, 1% (10 mg per mL) Unit of sale Strength Each NDC 83090-001-10         Unit of 10 1% (20 mg per 2 mL )          (10 mg per mL) 2 mL Single-Dose Ampule NDC 83090-002-10 Unit of 10 1% (50 mg per 5 mL ) (10 mg per mL) 5 mL Single-Dose Ampule NDC 83090-003-10 Unit of 10 1% (100 mg per 10 mL ) (10 mg/mL) 10 mL Single Dose Ampule Lidocaine Hydrochloride Injection, 2% (20 mg per mL) Unit of sale Strength Each NDC 83090-004-10 Unit of 10 2% (40 mg per 2 mL )          (20 mg per mL) 2 mL Single-Dose Ampule NDC 83090-005-10       Unit of 10 2% (100 mg per 5 mL )   (20 mg per mL) 5 mL Single-Dose Ampule NDC 83090-006-10 Unit of 10 2% (200 mg per 10 mL ) (20 mg per mL) 10 mL Single Dose Ampule Sterile, Nonpyrogenic Discard unused portion Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured by: Sintetica S.A. Mendrisio Switzerland Manufactured for: Sintetica US LLC 301 Carnegie Center Suite 101 Princeton, New Jersey 08540 USA Revised: 11/2022

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

NA- LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION
SINTETICA US LLC
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LIDOCAINE HYDROCHLORIDE INJECTION, USP 1%
LIDOCAINE HYDROCHLORIDE INJECTION, USP 2%
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 AND USAGEsection for specific uses.Lidocaine Hydrochloride
Injection,
USP 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 solution is for single dose
usage, and is Methyl
Paraben Free (Preservative-Free).Lidocaine Hydrochloride Injection,
USP solution 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 exa