Bupivacaine Hydrochloride Injection, Solution Side Effects

6 ADVERSE REACTIONS The following clinically significant adverse reactions have been reported and described in the Warnings and Precautions section of the labeling: Cardiac Arrest in Obstetrical Anesthesia [see WARNINGS AND PRECAUTIONS ] Dose-Related Toxicity [see WARNINGS AND PRECAUTIONS ] Methemoglobinemia [see WARNINGS AND PRECAUTIONS ] Chondrolysis with Intra-Articular Infusion [see WARNINGS AND PRECAUTIONS ] Cardiac Arrest with Intravenous Regional Anesthesia Use [see CONTRAINDICATIONS , WARNINGS AND PRECAUTIONS ] Systemic Toxicities with Unintended Intravascular or Intrathecal Injection [see WARNINGS AND PRECAUTIONS ] Respiratory Arrest Following Retrobulbar Block [see WARNINGS AND PRECAUTIONS ] The following adverse reactions from voluntary reports or clinical studies have been reported with bupivacaine.

Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Adverse reactions to bupivacaine hydrochloride are characteristic of those associated with other amide-type local anesthetics.

A major cause of adverse reactions to this group of drugs is excessive plasma levels, which may be due to overdosage, unintentional intravascular injection, or slow metabolic degradation.

The most commonly encountered acute adverse reactions that demand immediate counter-measures were related to the CNS and the cardiovascular system.

These adverse reactions were generally dose-related and due to high plasma levels which may have resulted from overdosage, rapid absorption from the injection site, diminished tolerance, or from unintentional intravascular injection of the local anesthetic solution.

In addition to systemic dose-related toxicity, unintentional intrathecal injection of drug during the intended performance of caudal or lumbar epidural block or nerve blocks near the vertebral column (especially in the head and neck region) has resulted in underventilation or apnea ("Total or High Spinal").

Also, hypotension due to loss of sympathetic tone and respiratory paralysis or underventilation due to cephalad extension of the motor level of anesthesia have occurred.

This has led to secondary cardiac arrest when untreated.

Nervous System Disorders: Adverse reactions were characterized by excitation and/or depression of the central nervous system and included restlessness, anxiety, dizziness, tinnitus, blurred vision, tremors, convulsions, drowsiness, unconsciousness, respiratory arrest, nausea, vomiting, chills, pupillary constriction.