Bupivacaine Hydrochloride With Dextrose

1 INDICATIONS AND USAGE Bupivacaine Hydrochloride in Dextrose Injection, USP is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia). Bupivacaine Hydrochloride in Dextrose Injection, USP is an amide-local anesthetic indicated in adults for subarachnoid injection for the production of subarachnoid block (spinal anesthesia).

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.

8.1 Pregnancy Risk Summary The available data on the use of Bupivacaine Hydrochloride in Dextrose Injection in pregnant women do not establish the presence or absence of developmental toxicity related to the use of Bupivacaine Hydrochloride in Dextrose Injection. In animal studies, embryo-fetal lethality was noted when bupivacaine was administered subcutaneously to pregnant rabbits during organogenesis and decreased pup survival was observed in a rat pre- and post-natal developmental study (dosing from implantation through weaning).

5 WARNINGS AND PRECAUTIONS Use of Spinal Anesthetics During Uterine Contractions: Spinal anesthetics, including Bupivacaine Hydrochloride in Dextrose Injection, should not be injected during uterine contractions because cerebrospinal fluid current may carry the drug further cephalad than desired, resulting in a high motor block. (5.1) Patients with Hypertension: Sympathetic blockade due to spinal anesthesia may result in peripheral vasodilation and hypotension. Monitor blood pressure frequently. Hypotension may be controlled by administration of vasoconstrictor agents in titrated dosages depending on the severity of hypotension and response to treatment. Monitor the onset of adequate spinal anesthesia frequently. 4 CONTRAINDICATIONS Bupivacaine Hydrochloride in Dextrose Injection is contraindicated in: intravenous regional anesthesia (Bier Block) [see Warnings and Precautions (5.8) ] . patients with septicemia. patients with severe hemorrhage, severe hypotension or shock, due to a reduced cardiac output.