LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987), Epinephrine (UNII: YKH834O4BH) (Epinephrine - UNII:YKH834O4BH)

Available from:

General Injectables & Vaccines

INN (International Name):

Lidocaine Hydrochloride

Composition:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL

Administration route:

INFILTRATION

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lidocaine Hydrochloride and Epinephrine Injection, USP 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.

Product summary:

Lidocaine Hydrochloride and Epinephrine Injection, USP is supplied in single-dose and multiple-dose containers as shown below: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light . Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1298-1.0 Revised: 08/2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE- LIDOCAINE HYDROCHLORIDE AND
EPINEPHRINE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES
----------
LIDOCAINE HYDROCHLORIDE
AND EPINEPHRINE
INJECTION, USP
FOR INFILTRATION AND NERVE BLOCK AMPUL
FLIPTOP VIAL
MULTIPLE-DOSE FLIPTOP VIAL
PROTECT FROM LIGHT. RX ONLY
EN-5828
DESCRIPTION
Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile,
nonpyrogenic
solution of lidocaine hydrochloride and epinephrine in water for
injection for parenteral
administration in various concentrations with characteristics as
follows:
Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL
added as
stabilizers. The headspace of Lists 1209, 3177, 3178, 3181, 3182 and
3183 are nitrogen
gassed. May contain sodium hydroxide and/or hydrochloric acid to
adjust pH; pH is 4.5
(3.3 to 5.5). See HOW SUPPLIED section for various sizes and
strengths.
Multiple-dose vials contain methylparaben 1 mg/mL added as
preservative.
Single-dose ampuls and vials contain no bacteriostat or antimicrobial
agent.
Discard unused portion.
Lidocaine is a local anesthetic of the amide type.
Lidocaine Hydrochloride, USP is chemically designated
2-(diethyl-amino)-2',6'-
acetoxylidide monohydrochloride monohydrate, a white powder freely
soluble in water. It
has the following structural formula:
Epinephrine, USP is a sympathomimetic (adrenergic) agent designated
chemically as 4-
[1-hydroxy-2 (methylamino) ethyl]-1,2 benzenediol, a white,
microcrystalline powder. It
has the following structural formula:
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 compo