Lidocaine Hydrochloride: Package Insert and Label Information (Page 2 of 2)

DOSAGE AND ADMINISTRATION

Adults:

Single Direct Intravenous Injection (bolus): ONLY THE 5 mL, 50 MG or 100 MG DOSAGE SIZES should be used for direct intravenous injection. The usual dose is 50 to 100 mg of lidocaine hydrochloride (0.70 to 1.4 mg/kg; 0.32 to 0.63 mg/lb) administered intravenously under ECG monitoring. This dose may be administered at the rate of approximately 25 to 50 mg/min (0.35 to 0.70 mg/kg/min; 0.16 to 0.32 mg/lb/min). Sufficient time should be allowed to enable a slow circulation to carry the drug to the site of action. If the initial injection of 50 to 100 mg does not produce a desired response, a second dose may be injected after five minutes. NO MORE THAN 200 TO 300 MG OF LIDOCAINE HYDROCHLORIDE SHOULD BE ADMINISTERED DURING A ONE HOUR PERIOD.

Continuous Intravenous Infusion: Following bolus administration, intravenous infusions of lidocaine hydrochloride may be initiated at the rate of 1 to 4 mg/min of lidocaine hydrochloride (0.014 to 0.057 mg/kg/min; 0.006 to 0.026 mg/lb/min). The rate of intravenous infusions should be reassessed as soon as the patient’s basic cardiac rhythm appears to be stable or at the earliest signs of toxicity. It should rarely be necessary to continue intravenous infusions of lidocaine for prolonged periods.

When administering lidocaine hydrochloride (or any potent medication) by continuous intravenous infusion, it is advisable to use a precision volume control I.V. set.

Pediatric: Controlled clinical studies in the pediatric population to establish dosing schedules have not been conducted. The American Heart Association’s Standards and Guidelines recommends a bolus dose of 1 mg/kg, and an infusion rate of between 20-50 mcg/kg/min for prolonged therapy. When drug clearance is reduced, as in patients with shock, congestive heart failure or cardiac arrest, the infusion rate should not exceed 20 mcg/kg/min.

NOTE: Regarding Prolonged Infusions: There are data that indicate the half-life may be 3 hours or longer following infusions of greater than 24 hours in duration. Do not use if solution is discolored or cloudy.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

To prevent needle-stick injuries, needles should not be recapped, purposely bent or broken by hand.

HOW SUPPLIED

Lidocaine Hydrochloride Injection, USP is supplied as follows:

Unit of Sale and Product DescriptionStrength(Concentration)NDC
Bundle of 105 mL Single-Dose Ansyr® Plastic Syringe2%(100 mg/5 mL)(20 mg/mL)0409-1323-05
Bundle of 105 mL Single-Dose Ansyr® Plastic Syringe1%(50 mg/5 mL)(10 mg/mL)0409-9137-05
Bundle of 105 mL Single-Dose LifeShield® Abboject® Syringe with Male Luer Lock Adapter (20-Gauge protected needle)2%(100 mg/5 mL)(20 mg/mL)0409-4903-34
Bundle of 105 mL Single-Dose LifeShield® Abboject® Syringe with Male Luer Lock Adapter (20-Gauge protected needle)1%(50 mg/5 mL)(10 mg/mL)0409-4904-34
Bundle of 105 mL Single-Dose Abboject® Syringe with Male Luer Lock Adapter2%(100 mg/5 mL)(20 mg/mL)0409-4903-10
Bundle of 105 mL Single-Dose Abboject® Syringe with Male Luer Lock Adapter1%(50 mg/5 mL)(10 mg/mL)0409-4904-10

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

Logo

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

Abboject® is a trademark of Abbott Laboratories.

LifeShield® is the trademark of ICU Medical, Inc. and is used under license.

LAB-1021-4.0

Revised: 06/2021

PRINCIPAL DISPLAY PANEL — 20 mg/mL Syringe Label

5 mL Single-dose

NDC 0409-4903-11
Rx only

2% Lidocaine HCl
Inj., USP 100 mg/5 mL (20 mg/mL)

Contains no preservatives. See insert for dosage.
Sterile, nonpyrogenic. I.V. for cardiac arrhythmias.

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

Hospira

RL-7738

PRINCIPAL DISPLAY PANEL -- 20 mg/mL Syringe Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mg/mL Syringe Carton — LIFESHIELD

5 mL

NDC 0409-4903-11

Intravenous For
Cardiac Arrhythmias

2%
Lidocaine
HCl
Inj., USP

100 mg/5 mL
(20 mg/mL)

LIFESHIELD®

Glass
ABBOJECT®
Unit of Use Syringe

with male luer lock
adapter and 20-Gauge
protected needle

100 mg
TOTAL

LOT ##-###-AA EXP DMMMYYYY

Rx only

Hospira

◀ PRESS AND PULL TO OPEN

PRINCIPAL DISPLAY PANEL -- 20 mg/mL Syringe Carton -- LIFESHIELD
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mg/mL Syringe Label — RL-7722S

5 mL Single-Dose Syringe

NDC 0409-4903-05
Rx only

2% Lidocaine HCl
Injection, USP
100 mg/5 mL (20 mg/mL)

Contains no preservatives. See insert for dosage. Sterile,
nonpyrogenic. Intravenous for cardiac arrhythmias.

Distributed by
Hospira, Inc.,
Lake Forest, IL60045 USA

Hospira

RL-7722S

PRINCIPAL DISPLAY PANEL -- 20 mg/mL Syringe Label -- RL-7722S
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mg/mL Syringe Carton — CA-7359S

▬ PRESS AND PULL TO OPEN ▶

5 mL

NDC 0409-4903-05
Rx only

Intravenous For
Cardiac Arrhythmias

2%
Lidocaine
HCl
Injection, USP

100 mg/5 mL
(20 mg/mL)

Glass
ABBOJECT®
Single-Dose Syringe

with male luer lock adapter

100 mg
TOTAL

LOT ##-###-AAEXP DMMMYYYY

Hospira

PRINCIPAL DISPLAY PANEL -- 20 mg/mL Syringe Carton -- CA-7359S
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mg/mL Syringe Label — LIFESHIELD

5 mL Single-dose
NDC 0409-4904-11
Rx only

1% Lidocaine
HCl Injection, USP
50 mg/5 mL (10 mg/mL)

Contains no preservatives. See insert for dosage.
Sterile, nonpyrogenic. I.V. for cardiac arrhythmias.

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

Hospira

RL-7649

PRINCIPAL DISPLAY PANEL -- 10 mg/mL Syringe Label -- LIFESHIELD
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mg/mL Syringe Carton — LIFESHIELD

5 mL

NDC 0409-4904-11

Intravenous For
Cardiac Arrhythmias

Lidocaine
HCl
Injection, USP
1%

50 mg/5 mL
(10 mg/mL)

LIFESHIELD®

Glass
ABBOJECT®
Unit of Use Syringe

with male luer lock adapter
and 20-Gauge protected needle

50 mg
TOTAL

Rx only

LOT ##-###-AA EXP DMMMYYYY

Hospira

◀ PRESS AND PULL TO OPEN

PRINCIPAL DISPLAY PANEL -- 10 mg/mL Syringe Carton -- LIFESHIELD
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mg/mL Syringe Label — RL-7721S

5 mL Single-Dose Syringe

NDC 0409-4904-05
Rx only

1% Lidocaine HCl
Injection, USP
50 mg/5 mL (10 mg/mL)

Contains no preservatives. See insert for dosage. Sterile,
nonpyrogenic. Intravenous for cardiac arrhythmias.

Distributed by
Hospira, Inc.,
Lake Forest, IL60045 USA

Hospira

RL-7721S

PRINCIPAL DISPLAY PANEL -- 10 mg/mL Syringe Label -- RL-7721S
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mg/mL Syringe Carton — CA-7358S

▬ PRESS AND PULL TO OPEN ▶

5 mL

NDC 0409-4904-05
Rx only

Intravenous For
Cardiac Arrhythmias

1%
Lidocaine
HCl
Injection, USP

50 mg/5 mL
(10 mg/mL)

Glass
ABBOJECT®
Single-Dose Syringe
with male luer lock adapter

50 mg
TOTAL

LOT ##-###-AAEXP DMMMYYYY

Hospira

PRINCIPAL DISPLAY PANEL -- 10 mg/mL Syringe Carton -- CA-7358S
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mg/mL Syringe Label

5 mL Single-dose syringe
NDC 0409-1323-15

2% Lidocaine HCl Injection, USP
100 mg/5 mL (20 mg/mL)
Rx only

Intravenous use for Ventricular Arrhythmias.
pH ( 5.0 to 7.0 ).

Hospira

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

RL-7647

PRINCIPAL DISPLAY PANEL -- 20 mg/mL Syringe Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mg/mL Syringe Carton

5 mL

NDC 0409-1323-15
Rx only

Intravenous use for
Ventricular Arrhythmias

2%
Lidocaine
HCl
Injection, USP

100 mg/5 mL
(20 mg/mL)

Ansyr™

Single-dose
syringe

100 mg
TOTAL

Preservative Free

LOT ##-###-AA EXP DMMMYYYY

Hospira

◀ PRESS AND PULL TO OPEN ▶

PRINCIPAL DISPLAY PANEL -- 20 mg/mL Syringe Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mg/mL Syringe Label

5 mL Single-dose syringe
NDC 0409-9137-11

1% Lidocaine HCl Injection, USP
50 mg/5 mL (10 mg/mL)
Rx only

Intravenous use for Ventricular Arrhythmias.
pH ( 5.0 to 7.0 ).

Hospira

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

RL-7650

PRINCIPAL DISPLAY PANEL -- 10 mg/mL Syringe Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mg/mL Syringe Carton

5 mL

NDC 0409-9137-11
Rx only

Intravenous use for
Ventricular Arrhythmias

1%
Lidocaine
HCl
Injection, USP

50 mg/5 mL
(10 mg/mL)

Ansyr™

Single-dose
syringe

50 mg
TOTAL

Preservative Free

LOT ##-###-AA EXP DMMMYYYY

Hospira

◀ PRESS AND PULL TO OPEN ▶

PRINCIPAL DISPLAY PANEL -- 10 mg/mL Syringe Carton
(click image for full-size original)
LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-4903
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-4903-34 10 CARTON in 1 CONTAINER contains a CARTON
1 1 SYRINGE in 1 CARTON This package is contained within the CONTAINER (0409-4903-34) and contains a SYRINGE (0409-4903-11)
1 NDC:0409-4903-11 5 mL in 1 SYRINGE This package is contained within a CARTON and a CONTAINER (0409-4903-34)
2 NDC:0409-4903-10 10 CARTON in 1 CONTAINER contains a CARTON
2 1 SYRINGE in 1 CARTON This package is contained within the CONTAINER (0409-4903-10) and contains a SYRINGE (0409-4903-05)
2 NDC:0409-4903-05 5 mL in 1 SYRINGE This package is contained within a CARTON and a CONTAINER (0409-4903-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA083158 12/01/2005
LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-4904
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-4904-34 10 CARTON in 1 CONTAINER contains a CARTON
1 1 SYRINGE in 1 CARTON This package is contained within the CONTAINER (0409-4904-34) and contains a SYRINGE (0409-4904-11)
1 NDC:0409-4904-11 5 mL in 1 SYRINGE This package is contained within a CARTON and a CONTAINER (0409-4904-34)
2 NDC:0409-4904-10 10 CARTON in 1 CONTAINER contains a CARTON
2 1 SYRINGE in 1 CARTON This package is contained within the CONTAINER (0409-4904-10) and contains a SYRINGE (0409-4904-05)
2 NDC:0409-4904-05 5 mL in 1 SYRINGE This package is contained within a CARTON and a CONTAINER (0409-4904-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA083158 08/30/2005
LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1323
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-1323-05 10 CARTON in 1 CONTAINER contains a CARTON
1 1 SYRINGE, PLASTIC in 1 CARTON This package is contained within the CONTAINER (0409-1323-05) and contains a SYRINGE, PLASTIC (0409-1323-15)
1 NDC:0409-1323-15 5 mL in 1 SYRINGE, PLASTIC This package is contained within a CARTON and a CONTAINER (0409-1323-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040302 12/09/2005
LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-9137
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
HYDROCHLORIC ACID
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-9137-05 10 CARTON in 1 CONTAINER contains a CARTON
1 1 SYRINGE, PLASTIC in 1 CARTON This package is contained within the CONTAINER (0409-9137-05) and contains a SYRINGE, PLASTIC (0409-9137-11)
1 NDC:0409-9137-11 5 mL in 1 SYRINGE, PLASTIC This package is contained within a CARTON and a CONTAINER (0409-9137-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040302 07/06/2005
Labeler — Hospira, Inc. (141588017)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 093132819 ANALYSIS (0409-1323), ANALYSIS (0409-4903), ANALYSIS (0409-4904), ANALYSIS (0409-9137), MANUFACTURE (0409-1323), MANUFACTURE (0409-4903), MANUFACTURE (0409-4904), MANUFACTURE (0409-9137), PACK (0409-1323), PACK (0409-4903), PACK (0409-4904), PACK (0409-9137), LABEL (0409-1323), LABEL (0409-4903), LABEL (0409-4904), LABEL (0409-9137)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 827731089 ANALYSIS (0409-1323), ANALYSIS (0409-4903), ANALYSIS (0409-4904), ANALYSIS (0409-9137)

Revised: 11/2021 Hospira, Inc.

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