Label: DURAPREN 0.75%- bupivacaine hydrochloride injection, solution

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

Drug Label Information

Updated February 22, 2022

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  • SPL UNCLASSIFIED SECTION
    MarcaineTM - Bupivacaine Hydrochloride Injection, USP - MarcaineTM - With Epinephrine 1:200,000 (as bitartrate) Bupivacaine Hydrochloride and Epinephrine Injection, USP ...
  • DESCRIPTION
    Bupivacaine hydrochloride is 2-Piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, monohydrate, a white crystalline powder that is freely soluble in 95 percent ethanol ...
  • 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
    MARCAINE is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical ...
  • CONTRAINDICATIONS
    MARCAINE is contraindicated in obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death. MARCAINE is contraindicated in patients with a ...
  • WARNINGS
    THE 0.75% CONCENTRATION OF MARCAINE IS NOT RECOMMENDED FOR OBSTETRICAL ANESTHESIA. THERE HAVE BEEN REPORTS OF CARDIAC ARREST WITH DIFFICULT RESUSCITATION OR DEATH DURING USE OF MARCAINE FOR ...
  • 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 MARCAINE 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 ...
  • 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
    The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the ...
  • HOW SUPPLIED
    These solutions are not for spinal anesthesia. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] MARCAINE―Solutions of MARCAINE that do not contain epinephrine may be ...
  • Packaging
    Durap75-1
  • INGREDIENTS AND APPEARANCE
    Product Information