Label: BURAPREN 0.5%- bupivacaine hydrochloride injection, solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 22, 2022

If you are a consumer or patient please visit this version.

  • Bupivacaine Hydrochloride Injection USP
    Rx only
  • DESCRIPTION
    Bupivacaine hydrochloride USP is 2-Piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate, a white, odorless, crystalline powder that is freely soluble in 95 ...
  • CLINICAL PHARMACOLOGY
    Local anesthetics block the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve ...
  • INDICATIONS AND USAGE
    Bupivacaine hydrochloride injection USP is indicated for the production of local or regional anesthesia or analgesia for surgery, diagnostic and therapeutic procedures, and for obstetrical ...
  • CONTRAINDICATIONS
    Bupivacaine hydrochloride injection is contraindicated in obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death. Bupivacaine ...
  • WARNINGS
    THE 0.75% CONCENTRATION OF BUPIVACAINE HYDROCHLORIDE IS NOT RECOMMENDED FOR OBSTETRICAL ANESTHESIA. THERE HAVE BEEN REPORTS OF CARDIAC ARREST WITH DIFFICULT RESUSCITATION OR DEATH DURING USE ...
  • PRECAUTIONS
    General - The safety and effectiveness of local anesthetics depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies. Resuscitative equipment, oxygen, and ...
  • ADVERSE REACTIONS
    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 ...
  • OVERDOSAGE
    Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics or to unintended subarachnoid injection of local ...
  • DOSAGE AND ADMINISTRATION
    NOTE: The products accompanying this insert do not contain epinephrine. The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be anesthetized, the ...
  • HOW SUPPLIED
    These solutions are not for spinal anesthesia. Bupivacaine Hydrochloride Injection USP — Solution of Bupivacaine hydrochloride injection USP may be autoclaved. Autoclave at 15-pound pressure ...
  • Packaging
    Burap-2
  • INGREDIENTS AND APPEARANCE
    Product Information