LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE- lidocaine hydrochloride anhydrous and epinephrine injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987), EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)

Available from:

US MedSource, LLC

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 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: NDC No. Container Size Drug Concentration Lidocaine HCl Epinephrine Single-dose 0409-3181-01 Fliptop Vial  30 mL 1.5% 1:200,000 0409-3183-01 Fliptop Vial  20 mL 2% 1:200,000 Epidural Test Dose (single-dose) 0409-1209-01 Ampul  5 mL 1.5% 1:200,000 0409-1209-05 Ampul  5 mL 1.5% 1:200,000 0409-1209-65 Ampul  5 mL 1.5% 1:200,000 Multiple-dose 0409-3177-01 Fliptop Vial  50 mL 0.5% 1:200,000 0409-3178-01 Fliptop Vial  20 mL 1% 1:100,000 0409-3178-02 Fliptop Vial  30 mL 1% 1:100,000 0409-3178-03 Fliptop Vial  50 mL 1% 1:100,000 0409-3182-01 Fliptop Vial  20 mL 2% 1:100,000 0409-3182-02 Fliptop Vial  30 mL 2% 1:100,000 0409-3182-03 Fliptop Vial  50 mL 2% 1:100,000 Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]  Protect from light. Revised: March, 2010 Printed in USA                            EN-2440 Hospira, Inc., Lake Forest, IL 60045 USA

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE- LIDOCAINE HYDROCHLORIDE
ANHYDROUS
AND EPINEPHRINE INJECTION, SOLUTION
US MEDSOURCE, LLC
----------
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, USP
For Infiltration and Nerve Block.
AMPUL
FLIPTOP VIAL
MULTIPLE-DOSE FLIPTOP VIAL
PROTECT FROM LIGHT.
Rx only
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:
CONCENTRATION
LIDOCAINE HCLEPINEPHRINE
LIDOCAINE HCL
(ANHYD.) MG/ML
EPINEPHRINE
MCG/ML
SODIUM CHLORIDE
MG/ML
0.5%
1:200,000
5
5
8
1%
1:200,000
10
5
7
1.5%
1:200,000
15
5
6.5
2%
1:200,000
20
5
6
1%
1:100,000
10
10
7
2%
1:100,000
20
10
6
Sodium metabisulfite 0.5 mg/mL and citric acid, anhydrous 0.2 mg/mL
added as stabilizers. The
headspace of Lists 1209, and 3179 are carbon dioxide gassed and Lists
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 stabilizes the neuronal membrane by
inhibiting the ionic fluxes
required for the initiation and conduction of impulses, thereby
effecting local anesthetic action.
HEMODYNAMICS: Excessive