Label: XYLOCAINE- lidocaine hydrochloride,epinephrine bitartrate injection, solution

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

Drug Label Information

Updated January 14, 2025

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  • SPL UNCLASSIFIED SECTION
    For Infiltration and Nerve Block - Rx only
  • DESCRIPTION
    Xylocaine (lidocaine HCl) Injections are sterile, nonpyrogenic, aqueous solutions that contain a local anesthetic agent with or without epinephrine and are administered parenterally by injection ...
  • CLINICAL PHARMACOLOGY
    Mechanism of Action - Lidocaine HCl stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses thereby effecting local anesthetic ...
  • INDICATIONS AND USAGE
    Xylocaine (lidocaine HCl) Injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by ...
  • CONTRAINDICATIONS
    Lidocaine HCl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.
  • WARNINGS
    XYLOCAINE INJECTIONS FOR INFILTRATION AND NERVE BLOCK SHOULD BE EMPLOYED ONLY BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE EMERGENCIES ...
  • PRECAUTIONS
    General - The safety and effectiveness of lidocaine HCl depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies.  Standard textbooks should be consulted ...
  • 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. Systemic - Adverse experiences following the ...
  • 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
    Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Xylocaine Injection for various types of anesthetic procedures.  The dosages suggested in this table are for ...
  • MAXIMUM RECOMMENDED DOSAGES
    Adults - For normal healthy adults, the individual maximum recommended dose of lidocaine HCl with epinephrine should not exceed 7 mg/kg (3.5 mg/lb) of body weight, and in general it is ...
  • STERILIZATION, STORAGE AND TECHNICAL PROCEDURES
    Disinfecting agents containing heavy metals, which cause release of respective ions (mercury, zinc, copper, etc) should not be used for skin or mucous membrane disinfection as they have been ...
  • HOW SUPPLIED:
    Xylocaine® (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:100,000 - 1% 200 mg per 20 mL - (10 mg per mL) NDC: 70518-4152-01 - NDC: 70518-4152-00 - NDC: 70518-4152-02 - NDC ...
  • PRINCIPAL DISPLAY PANEL
    DRUG: Xylocaine - GENERIC: LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE - DOSAGE: INJECTION, SOLUTION - ADMINSTRATION: INFILTRATION - NDC: 70518-4152-1 - NDC: 70518-4152-0 - NDC: 70518-4152-2 - NDC ...
  • INGREDIENTS AND APPEARANCE
    Product Information