Bupivacaine Hydrochloride With Dextrose Side Effects

6 ADVERSE REACTIONS The following clinically significant adverse reactions have been reported and described in other sections of the labeling: Allergic-Type Reactions [see Contraindications (4) ] Dose-Related Toxicity [see Warnings and Precautions (5.3) ] Systemic Toxicities with Unintended Intravascular Injection [see Warnings and Precautions (5.4) ] Methemoglobinemia [see Warnings and Precautions (5.5) ] Cardiac Arrest in Obstetrical Anesthesia [see Warnings and Precautions (5.6) ] Chondrolysis with Intra-Articular Infusion [see Warnings and Precautions (5.7) ] Cardiac Arrest with Intravenous Regional Anesthesia Use [see Contraindications (4) , Warnings and Precautions (5.8) ] 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 in Dextrose Injection are characteristic of those associated with other amide-type local anesthetics.

A major cause of adverse reactions to Bupivacaine Hydrochloride in Dextrose Injection is due to cephalad extension of the motor level of anesthesia and/or 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 following the administration of spinal anesthesia were hypotension due to loss of sympathetic tone and respiratory paralysis or underventilation due to cephalad extension of the motor level of anesthesia.

These have led to cardiac arrest if untreated.

In addition, dose-related convulsions and cardiovascular collapse have resulted from diminished tolerance, rapid absorption from the injection site, or from unintentional intravascular injection of a local anesthetic solution.

Respiratory System : Respiratory paralysis or underventilation have been noted as a result of cephalad spread of spinal anesthesia and has led to secondary hypoxic cardiac arrest when untreated.

Preanesthetic medication, intraoperative anesthetics, analgesics, and sedatives, as well as surgical manipulation, may contribute to underventilation.

This has usually been noted within minutes of the injection of spinal anesthetic solution, but because of differing maximal onset times, differing intercurrent drug usage, and differing surgical manipulation, it may occur at any time during surgery or the immediate recovery period.