Lidocaine Hydrochloride and Dextrose (Page 4 of 4)

Surgical anesthesia

The dosage recommended for abdominal anesthesia is 1.5 to 2 mL (75 to 100 mg).

Pediatric Patients

The dosage recommendations in healthy adolescents, 16 years of age and older, is the same as for normal healthy adults. There is insufficient data in pediatric patients below the age of 16 years to make dosage recommendations (see PRECAUTIONS).

Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. Solutions that are discolored and/or contain particulate matter should not be used.

Unused portions of solutions should be discarded following initial use.

5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP may be autoclaved once at 15 pounds pressure, 121°C (250°F) for 15 minutes. Since this preparation contains dextrose, carmelization may occur under prolonged heating and, in some instances, prolonged storage. Therefore this preparation should not be autoclaved more than once, according to the above instructions, and should not be permitted to remain in the autoclave any longer than necessary. Do not administer any solution which is discolored or contains particulate matter.

HOW SUPPLIED

5% Lidocaine Hydrochloride and 7.5% Dextrose Injection, USP, is supplied in the following:

Unit of Sale Concentration Clamcell Each
NDC 0409-4712-01 5 clamcells per Bundle 5%100 mg/2 mL (50 mg/mL) NDC 0409-4712-255 ampuls per Clamcell NDC 0409-4712-11Single-dose Glass Ampul

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

  1. Lambert DH and Hurley RJ: Cauda Equina syndrome and continuous spinal anesthesia. Anesth and Analg 72:817–9, 1991.
  2. Ready, LB, et al: Neurotoxicity of local anesthetics in rabbits. Anesthesiology 63:364–70, 1985.

Logo

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

LAB-1211-3.0

Revised: 11/2018

PRINCIPAL DISPLAY PANEL — 2 mL Ampul Label

2 mL
NDC 0409-4712-11

5% Lidocaine HCl
and 7.5% Dextrose
Injection, USP
For spinal anesthesia.

RL–7548

Hospira

Distributed by
Hospira, Inc.
Lake Forest, IL
60045 USA

##–###–AADMMMYYYY

Principal Display Panel -- 2 mL Ampul Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 2 mL Ampul Cello Pack Label

2 mL
Single-dose
5 Ampuls

Rx only
NDC 0409-4712-25
Contains 5 of NDC 0409-4712-11

5% Lidocaine HCl
100 mg/2 mL (50 mg/mL)
and 7.5% Dextrose
Injection, USP

Sterile, hyperbaric solution for spinal anesthesia. Each mL
contains lidocaine hydrochloride, anhydrous 50 mg; dextrose
hydrous 75 mg. May contain sodium hydroxide and/or
hydrochloric acid for pH adjustment. pH 6.5 (6.0 to 7.0).
0.75 mOsmol/mL (calc.). Usual dosage: See insert. For
spinal anesthesia. Store at 20 to 25°C (68 to 77°F).
[See USP Controlled Room Temperature.]

Hospira

Distributed by Hospira, Inc.,Lake Forest, IL 60045 USA

LOT ##-###-AA

EXP DMMMYYYY

RL–7903

Principal Display Panel -- 2 mL Ampul Cello Pack Label
(click image for full-size original)
LIDOCAINE HYDROCHLORIDE AND DEXTROSE lidocaine hydrochloride and dextrose injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-4712
Route of Administration INTRASPINAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 50 mg in 1 mL
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 75 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-4712-01 5 CELLO PACK in 1 PACKAGE contains a CELLO PACK (0409-4712-25)
1 NDC:0409-4712-25 5 AMPULE in 1 CELLO PACK This package is contained within the PACKAGE (0409-4712-01) and contains a AMPULE (0409-4712-11)
1 NDC:0409-4712-11 2 mL in 1 AMPULE This package is contained within a CELLO PACK (0409-4712-25) and a PACKAGE (0409-4712-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA083914 06/22/2005
Labeler — Hospira, Inc. (141588017)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 093132819 ANALYSIS (0409-4712), MANUFACTURE (0409-4712), PACK (0409-4712), LABEL (0409-4712)
Establishment
Name Address ID/FEI Operations
Hospira Worldwide, LLC 963711309 ANALYSIS (0409-4712)

Revised: 01/2022 Hospira, Inc.

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