LIDOCAINE HYDROCHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Medical Purchasing Solutions, LLC

Administration route:

INFILTRATION

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 hydrochloride is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. 

Product summary:

Lidocaine Hydrochloride Injection USP, is supplied as follows: Lidocaine Hydrochloride Injection USP, 1% (10 mg/mL)    2 mL Single Dose Vials in a Carton of 10                                   NDC 55150-161-02    5 mL Single Dose Vials in a Carton of 10                                   NDC 55150-162-05    30 mL Single Dose Vials in a Carton of 1                                   NDC 55150-163-30 Lidocaine Hydrochloride Injection USP, 2% (20 mg/mL)    2 mL Single Dose Vials in a Carton of 10                                   NDC 55150-164-02    5 mL Single Dose Vials in a Carton of 10                                   NDC 55150-165-05 The vial stopper is not made with natural rubber latex. Sterile, Nonpyrogenic Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad - 500038 India Revised: March 2017

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE- LIDOCAINE HYDROCHLORIDE INJECTION, SOLUTION
MEDICAL PURCHASING SOLUTIONS, LLC
----------
LIDOCAINE HCL INJECTION, USP
For Infiltration and Nerve Block Including Caudal and Epidural Use.
Preservative-Free
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 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 weight 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. The pH of the solution is adjusted to
approximately 6.5
(5.0−7.0) with sodium hydroxide and/or hydrochloric acid.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Lidocaine hydrochloride stabilizes the neuronal membrane by inhibiting
the ionic fluxes
14
22
2
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