Prescription Drug Name:

Lidocaine HCl Injection, USP

ID:

bfcc485c-32bc-48ae-a44a-135a89e77436

Code:

34391-3

DESCRIPTION


id: 4dfc3b4f-e845-4d7c-b981-b9161b81ec84
displayName: Description Section
FDA Article Code: 34089-3

Lidocaine hydrochloride injection, USP is sterile, nonpyrogenic, aqueous solution that contains a local anesthetic agent and is administered parenterally by injection. See  INDICATIONS for
specific uses
.
 
Lidocaine hydrochloride injection, USP contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular weight 270.8. Lidocaine hydrochloride (C14H22N2O • HCl) has the following structural formula:

Lidocaine hydrochloride injection, USP is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. The pH of the solution is adjusted to approximately 6.5 (5.0−7.0) with sodium hydroxide and/or hydrochloric acid.

INDICATIONS AND USAGE


id: 24f61278-2d91-41f1-9232-b192cfc699b6
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: 0ac9eae1-083d-4d77-9b14-a4e32d7a33c6
displayName: Contraindications Section
FDA Article Code: 34070-3

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

WARNINGS


id: 9bea7fd7-04f9-46ef-a11d-d6cfe096280b
displayName: Warnings Section
FDA Article Code: 34071-1

LIDOCAINE HYDROCHLORIDE INJECTION, USP 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 postmarketing 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.

OVERDOSAGE


id: 9736731f-d1e7-45a4-9091-68f06be54098
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: fa8f4dc4-61ce-4327-a1d8-f1300495d4e7
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 hydrochloride injection, USP 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 the 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, USP 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, USP may result in a more profound fall in blood pressure when used in epidural anesthesia. Although the incidence of side effects with lidocaine hydrochloride 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.

MAXIMUM RECOMMENDED DOSAGES


id: a060a080-2d2f-45e1-b1d5-a59191174cc3
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

NOTE: The products accompanying this insert do not contain epinephrine.
 

STERILIZATION, STORAGE AND TECHNICAL PROCEDURES


id: 16e58003-6269-4843-95c1-eded08a3cb25
displayName: SPL UNCLASSIFIED SECTION
FDA Article Code: 42229-5

Disinfecting agents containing heavy metals, which cause release of respective ions (mercury, zinc, copper, etc.) should not be used for skin or mucous membrane disinfection as they have been related to incidents of swelling and edema.

HOW SUPPLIED


id: c3ee1e95-1564-4136-9478-18631ef8e4f7
displayName: How Supplied Section
FDA Article Code: 34069-5

Product: 50090-2496 NDC: 50090-2496-1 5 mL in a VIAL, SINGLE-DOSE / 10 in a CARTON

Lidocaine Hydrochloride


id: 99e2dda4-9bd8-4d16-9d8e-d67b0ad76462
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4