LIDOCAINE HYDROCHLORIDE- lidocaine hydrochloride injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Camber Pharmaceuticals, Inc.

Administreringsrute:

INFILTRATION

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Lidocaine hydrochloride injection is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and by peripheral nerve block techniques such as brachial plexus and intercostal, 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.

Produkt oppsummering:

Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic, clear, colorless, isotonic solution and is supplied as follows: Lidocaine Hydrochloride Injection USP, 1% (10 mg/mL): 10x 20 mL Multiple-Dose Vials                  NDC 31722-116-32 25x 20 mL Multiple-Dose Vials                   NDC 31722-116-31 10x 50 mL Multiple-Dose Vials                  NDC 31722-116-34 25 x 50 mL Multiple-Dose Vials                 NDC 31722-116-33 Lidocaine Hydrochloride Injection USP, 2% (20 mg/mL): 25 x 20 mL Multiple-Dose Vials                 NDC 31722-217-31 10 x 50 mL Multiple-Dose Vials                 NDC 31722-217-33 25 x 50 mL Multiple-Dose Vials                 NDC 31722-217-32 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854 Manufactured by: Aspiro Pharma Limited Survey No. 321, Biotech Park, Phase – III Karkapatla Village, Markook (Mandal) Siddipet, Telangana-502281, India.                              Revised: 02/2024

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

LIDOCAINE HYDROCHLORIDE - LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION
CAMBER PHARMACEUTICALS, INC.
----------
FOR INFILTRATION AND NERVE BLOCK
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 USAGEsection 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 wt. 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. Each mL also contains 1 mg methylparaben
as antiseptic
preservative. 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
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 presence or absen