LIDOCAINE HYDROCHLORIDE injection

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987)

Disponible desde:

Afaxys Pharma 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 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, 1% is provided as a clear colourless solution filled in 20 mL clear moulded glass vial USP Type I with 20 mm Chlorobutyl rubber stopper and 20 mm aluminium violet flip-off seal. LIDOCAINE HYDROCHLORIDE INJECTION USP, 1 % is supplied as follows: Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from light. To report SUSPECTED ADVERSE REACTIONS, contact Afaxys at 1-855-888-2467 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Manufactured for Afaxys Pharma, LLC Charleston, SC 29403 www.afaxys.com Revised: June 2022

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE INJECTION
AFAXYS PHARMA LLC
----------
Revised: June 2022
LIDOCAINE HYDROCHLORIDE INJECTION, USP
For Infiltration and Nerve Block
Rx only
DESCRIPTION:
Lidocaine Hydrochloride Injection is a sterile, nonpyrogenic, aqueous
solution that
contains a local anesthetic agent which produces 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. See
INDICATIONS AND USAGE section for specific uses.
Lidocaine Hydrochloride Injection 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 (C
H
N O •HCl) has the following structural
formula:
Lidocaine Hydrochloride Injection in multiple dose vials: Each mL also
contains 1 mg
methylparaben as antiseptic preservative and 7 mg of sodium chloride
as tonicity
adjuster. 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-
14
22
2
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, concentra