Lidocaine Hydrochloride Injection, USP, 1%, 5 mL Single-Dose Ampules (box of 25)

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NDC: 65282-1605-1

*USP Type I Glass Ampules hermetically sealed, compatible with EtO sterilization.Glass is impermeable to EtO per ANSI/AAMI ST41:1999 Standard

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IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

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.

IMPORTANT SAFETY INFORMATION

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

WARNINGS AND PRECAUTIONS

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 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.

• 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.

• In the case of severe reaction, discontinue the use of the drug.
• The safety and effectiveness of lidocaine HCl depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies.
• Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use.
• Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their age and physical condition. Lidocaine HCl should also be used with caution in patients with severe shock or heart block.
• Use with caution in patients with hepatic disease.
• Use with caution in patients with impaired cardiovascular function since they may be less able to compensate for functional changes associated with the prolongation of A-V conduction produced by these drugs. • The intramuscular injection of lidocaine HCl may result in an increase in creatine phosphokinase levels