Penicillin G Potassium
Penicillin G Potassium for Injection, USP
e0ced9d8-b9ea-466e-bf2c-10e9cc636f3f
HUMAN PRESCRIPTION DRUG LABEL
Oct 24, 2022
WG Critical Care, LLC
DUNS: 829274633
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Penicillin G Potassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (2)
Penicillin G Potassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (2)
Penicillin G Potassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (2)
Drug Labeling Information
INDICATIONS & USAGE SECTION
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 below.
Appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin G.
Therapy with penicillin G Potassium for Injection, USP may be indicated before results of such tests are known when there is reason to believe the infection may involve any of the organisms listed below, however, once these results become available, appropriate therapy should be continued.
|
Clinical Indication |
Infecting Organism |
|
Septicemia, empyema, pneumonia, pericarditis, endocarditis, meningitis |
Streptococcus pyogenes (group A β-hemolytic streptococcus), other β-hemolytic streptococci including groups C,H,G,L and M, Streptococcus pneumoniae and Staphylococcus species (non-penicillinase producing strains) |
|
Anthrax |
Bacillus anthracis |
|
Actinomycosis (cervico-facial disease and thoracic and abdominal disease) |
Actinomyces israelii |
|
Botulism (adjunctive therapy to antitoxin), gas gangrene, and tetanus (adjunctive therapy to human tetanus immune globulin) |
Clostridium species |
|
Diphtheria (adjunctive therapy to antitoxin and prevention of the carrier state) |
Corynebacterium diphtheriae |
|
Erysipelothrix endocarditis |
Erysipelothrix rhusiopathiae |
|
Fusospirochetosis (severe infections of the oropharynx [Vincent’s], lower respiratory tract and genital area) |
Fusobacterium species and spirochetes |
|
Listeria infections including meningitis and endocarditis |
Listeria monocytogenes |
|
Pasteurella infections including bacteremia and meningitis |
Pasteurella multocida |
|
Haverhill fever |
Streptobacillus moniliformis |
|
Rat bite fever |
Spirillum minus or Streptobacillus moniliformis |
|
Disseminated gonococcal infections |
Neisseria gonorrhoeae (penicillin-susceptible) |
|
Syphilis (congenital and neurosyphilis) |
Treponema pallidum |
|
Meningococcal meningitis and / or septicemia |
Neisseria meningitidis |
|
Gram-negative bacillary infections (bacteremias) Penicillin G is not the drug of choice in the treatment of gram-negative bacillary infections. |
Gram-negative bacillary organisms (i.e. Enterobacteriaceae) |
****To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin G Potassium for Injection, USP and other antibacterial drugs, Penicillin G Potassium for Injection, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.