LIDOCAINE HYDROCHLORIDE- lidocaine hydrochloride injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

International Medication Systems, Limited

INN (International Name):

LIDOCAINE HYDROCHLORIDE

Composition:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL

Administration route:

INTRAVENOUS

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

Product summary:

Lidocaine Hydrochloride Injection, USP For Direct Intravenous Injection In unit-use packages containing a Luer-Jet™ Luer-Lock Prefilled Syringe. Ten cartons per package. Concentration          Stock No.          NDC No.                   Size        2%                     3390           76329-3390-1       5 mL (100 mg) Syringe Assembly Directions: USE ASEPTIC TECHNIQUE Do not assemble until ready to use. *CAUTION: IMPROPER ENGAGING MAY CAUSE GLASS BREAKAGE AND SUBSEQUENT INJURY. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. Protect from light. INTERNATIONAL MEDICATION SYSTEMS, LIMITED                      REV. 10-19 SO. EL MONTE, CA 91733, U.S.A. An Amphastar Pharmaceuticals Company 6933900C

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE - LIDOCAINE HYDROCHLORIDE INJECTION
INTERNATIONAL MEDICATION SYSTEMS, LIMITED
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LIDOCAINE HYDROCHLORIDE INJECTION, USP
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 USAGE section 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 (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 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.
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 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