Lidocaine Hydrochloride, Injection, USP

/Lidocaine Hydrochloride, Injection, USP
Lidocaine Hydrochloride, Injection, USP2018-09-06T09:12:40+00:00

Prescription Drug Name:

Lidocaine Hydrochloride, Injection, USP

ID:

6bdd64a8-b90f-57d4-e053-2a91aa0a3911

Code:

34391-3

DESCRIPTION


id: 6bdd6f42-5d37-8d8f-e053-2991aa0a77a1
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride in water for injection for parenteral administration in various concentrations with characteristics as follows:

Concentration 0.5% 1% 1.5% 2%
mg/mL lidocaine HCl (anhyd.) 5 10 15 20
mg/mL sodium chloride 8 7 6.5 6
Multiple-dose vials contain 0.1% of methylparaben added as preservative. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH is 6.5 (5.0 to 7.0). See
HOW SUPPLIED section for various sizes and strengths.
Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethylamino)-N-(2,6-dimethylphenyl)-acetamide monohydrochloride monohydrate, a white powder freely soluble in water. The molecular weight is 288.82. It has the following structural formula: The semi-rigid vial used for the plastic vials is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.

INDICATIONS AND USAGE


id: 6bdd6f42-5d3c-8d8f-e053-2991aa0a77a1
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia 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.

CONTRAINDICATIONS


id: 6bdd6f42-5d3d-8d8f-e053-2991aa0a77a1
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

WARNINGS


id: 6bdd6f42-5d3e-8d8f-e053-2991aa0a77a1
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

LIDOCAINE HYDROCHLORIDE INJECTION, FOR INFILTRATION AND NERVE BLOCK, SHOULD BE EMPLOYED ONLY BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE EMERGENCIES THAT MIGHT ARISE FROM THE BLOCK TO BE EMPLOYED AND THEN ONLY AFTER ENSURING THE
IMMEDIATE AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY EQUIPMENT, AND THE PERSONNEL NEEDED FOR PROPER MANAGEMENT OF TOXIC REACTIONS AND RELATED EMERGENCIES (see also
ADVERSE REACTIONS and
PRECAUTIONS ). DELAY IN PROPER MANAGEMENT OF DOSE-RELATED TOXICITY, UNDERVENTILATION FROM ANY CAUSE AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF ACIDOSIS, CARDIAC ARREST AND, POSSIBLY, DEATH.
Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions. The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humeral chondrolysis have been described in pediatric and adult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods are not associated with these findings. The time of onset of symptoms, such as joint pain, stiffness and loss of motion can be variable, but may begin as early as the 2nd month after surgery. Currently, there is no effective treatment for chondrolysis; patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement. To avoid intravascular injection, aspiration should be performed before the local anesthetic solution is injected. The needle must be repositioned until no return of blood can be elicited by aspiration. Note, however, that the absence of blood in the syringe does not guarantee that intravascular injection has been avoided. Local anesthetic solutions containing antimicrobial preservatives (e.g., methylparaben) should not be used for epidural or spinal anesthesia because the safety of these agents has not been established with regard to intrathecal injection, either intentional or accidental.

OVERDOSAGE


id: 6bdd6f42-5d51-8d8f-e053-2991aa0a77a1
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics or to unintended subarachnoid injection of local anesthetic solution (see
ADVERSE REACTIONS ,
WARNINGS and
PRECAUTIONS ).

DOSAGE AND ADMINISTRATION


id: 6bdd6f42-5d53-8d8f-e053-2991aa0a77a1
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Lidocaine Hydrochloride Injection, USP for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrine-free solutions. When larger volumes are required only solutions containing epinephrine should be used, except in those cases where vasopressor drugs may be contraindicated. There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. Lidocaine is not approved for this use (see
WARNINGS and
DOSAGE AND ADMINISTRATION ).
These recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes and concentrations to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia and degree of muscular relaxation required, duration of anesthesia required, and the physical condition of the patient. In all cases the lowest concentration and smallest dose that will produce the desired result should be given. Dosages should be reduced for children and for elderly and debilitated patients and patients with cardiac and/or liver disease. The onset of anesthesia, the duration of anesthesia and the degree of muscular relaxation are proportional to the volume and concentration (i.e., total dose) of local anesthetic used. Thus, an increase in volume and concentration of Lidocaine Hydrochloride Injection will decrease the onset of anesthesia, prolong the duration of anesthesia, provide a greater degree of muscular relaxation and increase the segmental spread of anesthesia. However, increasing the volume and concentration of Lidocaine Hydrochloride Injection may result in a more profound fall in blood pressure when used in epidural anesthesia. Although the incidence of side effects with lidocaine is quite low, caution should be exercised when employing large volumes and concentrations, since the incidence of side effects is directly proportional to the total dose of local anesthetic agent injected. For intravenous regional anesthesia, only the 50 mL single-dose vial containing 0.5% Lidocaine Hydrochloride Injection, USP should be used.

HOW SUPPLIED


id: 6bdd6f42-5d5a-8d8f-e053-2991aa0a77a1
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Lidocaine Hydrochloride Injection, USP is supplied as follows:

Unit of Sale Concentration Each
Single-dose
NDC 0409-4278-01

Tray of 25

0.5%

250 mg/50 mL

(5 mg/mL)

NDC 0409-4278-16

Glass Teartop Vial

NDC 0409-4713-62

Case of 800

1%

20 mg/2 mL

(10 mg/mL)

NDC 0409-4713-72

Glass Ampul

NDC 0409-4713-65

Case of 800

1%

50 mg/5 mL

(10 mg/mL)

NDC 0409-4713-75

Glass Ampul

NDC 0409-4279-02

Carton of 25

1%

300 mg/30 mL

(10 mg/mL)

NDC 0409-4279-16

Glass Teartop Vial

NDC 0409-4270-01

Case of 25

1%

300 mg/30 mL

(10 mg/mL)

NDC 0409-4270-11

Glass Teartop Vial

NDC 0409-4776-01

Carton of 25

1.5%

300 mg/20 mL

(15 mg/mL)

NDC 0409-4776-10

Glass Ampul

NDC 0409-4056-01

Carton of 5

1.5%

300 mg/20 mL

(15 mg/mL)

NDC 0409-4056-11

Glass Ampul

NDC 0409-4282-02

Carton of 25

2%

200 mg/10 mL

(20 mg/mL)

NDC 0409-4282-12

Glass Ampul

Unit of Sale Concentration Clam cell Each
Single-dose
NDC 0409-4713-02

5 clamcells per Carton

1%

50 mg/5 mL

(10 mg/mL)

NDC 0409-4713-26

5 ampuls per Clamcell

NDC 0409-4713-12

Glass Ampul

NDC 0409-4713-32

5 clamcells per Carton

1%

20 mg/2 mL

(10 mg/mL)

NDC 0409-4713-25

10 ampuls per Clamcell

NDC 0409-4713-42

Glass Ampul

NDC 0409-4282-01

5 clamcells per Bundle

2%

40 mg/2 mL

(20mg/mL)

NDC 0409-4282-25

5 ampuls per Clamcell

NDC 0409-4282-11

Glass Ampul

Unit of Sale Concentration Each
Multiple-dose:
NDC 0409-4275-01

Tray of 25

0.5%

250 mg/50 mL

(5 mg/mL)

NDC 0409-4275-16

Plastic Fliptop Vial

NDC 0409-4276-01

Tray of 25

1%

200 mg/20 mL

(10 mg/mL)

NDC 0409-4276-16

Plastic Fliptop Vial

NDC 0409-4276-02

Tray of 25

1%

500 mg/50 mL

(10 mg/mL)

NDC 0409-4276-17

Plastic Fliptop Vial

NDC 0409-4277-01

Tray of 25

2%

400 mg/20 mL

(20 mg/mL)

NDC 0409-4277-16

Plastic Fliptop bottle

NDC 0409-4277-02

Tray of 25

2%

1000 mg/50 mL

(20 mg/mL)

NDC 0409-4277-17

Plastic Fliptop Vial

Single-dose products are preservative-free.

PRINCIPAL DISPLAY PANEL – OUTER PACKAGE LABEL


id: 6bde2184-563d-3ec6-e053-2991aa0a115f
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

1 – 20 mL Multiple-dose Fliptop Vial 1%

Lidocaine HCl

Injection, USP 200 mg/20 mL

(10 mg/mL) Rx only NDC 71872-7137-1 FOR INFILTRATION AND

NERVE BLOCK.
Not for epidural and caudal use.

Contains preservative.