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:

Hospira, Inc.

INN (International Name):

LIDOCAINE HYDROCHLORIDE

Composition:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 15 mg in 1 mL

Administration route:

EPIDURAL

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 a clear, colorless to slightly yellow solution supplied in single-dose and multiple-dose containers as shown below: Single-Dose NDC 0409-3181-01 Carton of 5 Fliptop Vials Lidocaine HCl 1.5% (450 mg/30 mL) (15 mg/mL) and Epinephrine 1:200,000 NDC 0409-3183-01 Carton of 5 Fliptop Vials Lidocaine HCl 2% (400 mg/20 mL) (20 mg/mL) and Epinephrine 1:200,000 Epidural Test Dose (single-dose) NDC 0409-1209-01 Tray of 10 Ampuls Lidocaine HCl 1.5% (75 mg/5 mL) (15 mg/mL) and Epinephrine 1:200,000 NDC 0409-1209-05 Case of 400 Ampuls Lidocaine HCl 1.5% (75 mg/5 mL) (15 mg/mL) and Epinephrine 1:200,000 NDC 0409-1209-65 Case of 800 Ampuls Lidocaine HCl 1.5% (75 mg/5 mL) (15 mg/mL) and Epinephrine 1:200,000 (Kit Packer) Multiple-Dose NDC 0409-3177-01 Tray of 25 Fliptop Vials Lidocaine HCl 0.5% (250 mg/50 mL) (5 mg/mL) and Epinephrine 1:200,000 NDC 0409-3178-01 Tray of 25 Fliptop Vials Lidocaine HCl 1% (200 mg/20 mL) (10 mg/mL) and Epinephrine 1:100,000 NDC 0409-3178-02 Tray of 25 Fliptop Vials Lidocaine HCl 1% (300 mg/30 mL) (10 mg/mL) and Epinephrine 1:100,000 NDC 0409-3178-03 Tray of 25 Fliptop Vials Lidocaine HCl 1% (500 mg/50 mL) (10 mg/mL) and Epinephrine 1:100,000 NDC 0409-3182-01 Tray of 25 Fliptop Vials Lidocaine HCl 2% (400 mg/20 mL) (20 mg/mL) and Epinephrine 1:100,000 NDC 0409-3182-02 Tray of 25 Fliptop Vials Lidocaine HCl 2% (600 mg/30 mL) (20 mg/mL) and Epinephrine 1:100,000 NDC 0409-3182-03 Tray of 25 Fliptop Vials Lidocaine HCl 2% (1000 mg/50 mL) (20 mg/mL) and Epinephrine 1:100,000 Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light. For single-dose vials and ampules: Discard unused portion.    Distributed by Hospira, Inc., Lake Forest, IL 60045 USA                                                                              LAB-1298-5.0 Revised: 08/2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE- LIDOCAINE HYDROCHLORIDE AND
EPINEPHRINE INJECTION, SOLUTION
HOSPIRA, INC.
----------
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 HCL
EPINEPHRINE
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, 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
perip