Label: PENICILLIN G POTASSIUM injection, powder, for solution

  • NDC Code(s): 70860-126-20, 70860-126-41, 70860-127-51
  • Packager: Athenex Pharmaceutical Division, LLC.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 28, 2025

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  • SPL UNCLASSIFIED SECTION
    Athenex - Rx only - To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin G Potassium for Injection, USP and other antibacterial drugs ...
  • DESCRIPTION
    Penicillin G Potassium, USP is a natural penicillin. It is chemically designated 4-Thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid,3,3-dimethyl-7-oxo-6-[(phenylacetyl)amino]-, monopotassium ...
  • CLINICAL PHARMACOLOGY
    After an intravenous infusion of penicillin G, peak serum concentrations are attained immediately after completion of the infusion. In a study of ten patients administered a single 5 million unit ...
  • INDICATIONS AND USAGE
    Therapy - Penicillin G Potassium for Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed ...
  • CONTRAINDICATIONS
    A history of a hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication.
  • WARNINGS
    Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a ...
  • PRECAUTIONS
    General - Penicillin should be used with caution in individuals with histories of significant allergies and/or asthma (see - WARNINGS). Whenever allergic reactions occur, penicillin should be ...
  • ADVERSE REACTIONS
    Body as a whole - The Jarisch-Herxheimer reaction is a systemic reaction, that may occur after the initiation of penicillin therapy in patients with syphilis or other spirochetal infections ...
  • OVERDOSAGE
    Dose related toxicity may arise with the use of massive doses of intravenous penicillins (40 to 100 million units per day), particularly in patients with severe renal impairment (see ...
  • DOSAGE AND ADMINISTRATION
    Penicillin G Potassium for Injection, USP may be given intravenously or intramuscularly. The usual dose recommendations are as follows: Adult patients - (*) Because of its short half-life ...
  • HOW SUPPLIED
    Penicillin G Potassium for Injection, USP is supplied as follows: NDCPenicillin G Potassium for Injection, USPPackage Factor - 70860-126-205,000,000 units per vial10 vials per ...
  • PRINCIPAL DISPLAY PANEL
    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – VIAL LABEL - NDC 70860-126-20 - Penicillin G Potassium for Injection, USP - 5,000,000 units per vial (5 million units per vial) For Intramuscular or Intravenous ...
  • PRINCIPAL DISPLAY PANEL
    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – VIAL LABEL - NDC 70860-127-51 - Penicillin G Potassium for Injection, USP - 20,000,000 units per vial (20 million units per vial) For Intravenous Infusion ...
  • INGREDIENTS AND APPEARANCE
    Product Information