Label: POLOCAINE- MEPIVACAINE HCL injection, solution

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

Drug Label Information

Updated January 30, 2024

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  • SPL UNCLASSIFIED
    THESE SOLUTIONS ARE NOT INTENDED FOR SPINAL ANESTHESIA OR DENTAL USE - Rx only
  • DESCRIPTION
    Mepivacaine hydrochloride is 2-Piperidinecarboxamide, N-(2, 6-dimethylphenyl)-1-methyl-, monohydrochloride and has the following structural formula: C 15H 22N 2O • HCl - It is a white ...
  • 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 & USAGE
    POLOCAINE (Mepivacaine HCl Injection, USP), is indicated for production of local or regional analgesia and anesthesia by local infiltration, peripheral nerve block techniques, and central neural ...
  • CONTRAINDICATIONS
    Mepivacaine is contraindicated in patients with a known hypersensitivity to it or to any local anesthetic agent of the amide-type or to other components of solutions of mepivacaine.
  • 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 ...
  • 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
    To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Reactions to mepivacaine are characteristic of those ...
  • 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 & 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
    POLOCAINE (MEPIVACAINE HCl INJECTION, USP) is supplied in the following dosage forms. NDC 51662-1534-2 POLOCAINE (MEPIVACAINE HCl INJECTION, USP) 1% 500mg/50mL (10mg/mL) 50mL VIAL - NDC ...
  • PRINCIPAL DISPLAY PANAL - 51662-1534-2, POUCH
    VIAL LABEL - 51662-1534-2, POUCH LABELING
  • PRINCIPAL DISPLAY PANAL- 51662-1534-3 BOX LABELING
    51662-1534-3 SERIALIZEX LABELING - 51662-1534-3 BOX LABELING
  • INGREDIENTS AND APPEARANCE
    Product Information