Important Safety Information
Bupivacaine Hydrochloride in Dextrose Injection, USP, 0.75%/8.25%, 2 mL Single-Dose Ampules
Indications and Usage:
Bupivacaine Hydrochloride in Dextrose Injection, USP is indicated for the production of subarachnoid block (spinal anesthesia).
1. Severe hemorrhage, severe hypotension or shock and arrhythmias, such as complete heart block, which severely restrict cardiac output.
2. Local infection at the site of proposed lumbar puncture.
WARNINGS: Local anesthetics should only be employed by clinicians who are well versed in diagnosis and management of dose-related toxicity and other acute emergencies which might arise from the block to be employed, and then only after insuring the immediate availability of oxygen, other resuscitative drugs, cardiopulmonary resuscitative equipment, and the personnel resources needed for proper management of toxic reactions and related emergencies.
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.