Label: SCANDONEST 3% PLAIN- mepivacaine hydrochloride injection, solution

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

Drug Label Information

Updated May 29, 2025

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  • SPL UNCLASSIFIED SECTION
    Rx Only - THIS SOLUTION IS INTENDED FOR DENTAL USE ONLY.
  • DESCRIPTION:
    Mepivacaine Hydrochloride, a tertiary amine used as a local anesthetic, is 1-methyl-2', 6' - pipecoloxylidide monohydrochloride with the following structural formula:               C15H22N2O ...
  • COMPOSITION:
    CARTRIDGE -  Each mL contains: 3%  Mepivacaine Hydrochloride 30 mg -  Sodium Chloride 6 mg -  Sodium Hydroxide or Hydrochloric Acid q.s. to adjust pH -  Water For Injection, qs. ad. 1 ...
  • CLINICAL PHARMACOLOGY:
    SCANDONEST® stabilizes the neuronal membrane and prevents the initiation and transmission of nerve impulses, thereby effecting local anesthesia. SCANDONEST® is rapidly metabolized, with only a ...
  • INDICATIONS AND USAGE:
    Mepivacaine is indicated for production of local anesthesia for dental procedures by infiltration or nerve block in adults and pediatric patients.
  • CONTRAINDICATIONS:
    SCANDONEST® is contraindicated in patients with a known hypersensitivity to amide-type local anesthetics.
  • WARNINGS:
    RESUSCITATIVE EQUIPMENT AND DRUGS SHOULD BE IMMEDIATELY AVAILABLE. (See ADVERSE REACTIONS). Reactions resulting in fatality have occurred on rare occasions with the use of local anesthetics, even ...
  • PRECAUTIONS:
    The safety and effectiveness of mepivacaine depend upon proper dosage, correct technique, adequate precautions, and readiness for emergencies. The lowest dose that results in effective anesthesia ...
  • ADVERSE REACTIONS:
    Reactions to SCANDONEST® are characteristic of those associated with other amide-type local anesthetics. Systemic adverse reactions involving the central nervous system and the cardiovascular ...
  • OVERDOSAGE:
    Treatment of a patient with toxic manifestations consists of assuring and maintaining a patent airway and supporting ventilation (respiration) as required. This usually will be sufficient in the ...
  • DOSAGE AND ADMINISTRATION:
    As with all local anesthetics, the dose varies and depends upon the area to be anesthetized, the vascularity of the tissues, individual tolerance and the technique of anesthesia. The lowest dose ...
  • DISINFECTION OF CARTRIDGES:
    As in the case of any cartridge, the diaphragm should be disinfected before needle puncture. The diaphragm should be thoroughly swabbed with either pure 91% isopropyl alcohol or 70% ethyl alcohol ...
  • HOW SUPPLIED:
    SCANDONEST® 3% Plain; (Mepivacaine Hydrocholoride Injection USP) (NDC 0362-1098-90) is available in cardboard boxes containing 5 blisters of 10 x 1.7 mL single-dose dental cartridges, 50 per ...
  • SPL UNCLASSIFIED SECTION
    Manufactured for SEPTODONT, Inc., 205 Granite Run Dr., Suite 150, Lancaster, PA, USA 17601 - by Novocol® Pharmaceutical of Canada Inc., 25 Wolseley Court, Cambridge, Ontario, Canada N1R 6X3 - Rev ...
  • PRINCIPAL DISPLAY PANEL - 1.7 mL Cartridge Carton
    FOR DENTAL BLOCK AND INFILTRATION ANESTHESIA NDC 0362-1098-90 - Scandonest® 3% Plain - (Mepivacaine Hydrochloride Injection, USP) Mepivacaine Hydrochloride 3% (51 mg/1.7 mL) (30mg/mL) without ...
  • INGREDIENTS AND APPEARANCE
    Product Information