SUMMARY
Penicillin G Procaine Injectable Suspension
TUBEX® 1 mL and 2 mL
for deep IM injection only
This product is designed to provide a stable aqueous suspension of penicillin G procaine, ready for immediate use. This eliminates the necessity for addition of any diluent, required for the usual dry formulation of injectable penicillin.
Penicillin G procaine is indicated in the treatment of moderately severe infections in both adults and pediatric patients due to penicillin-G-susceptible microorganisms that are susceptible to the low and persistent serum levels common to this particular dosage form in the indications listed below. Therapy should be guided by bacteriological studies (including susceptibility tests) and by clinical response.
NOTE: When high, sustained serum levels are required, aqueous penicillin G, either IM or IV, should be used.
The following infections will usually respond to adequate dosages of intramuscular penicillin G procaine: Moderately severe to severe infections of the upper respiratory tract, skin and soft-tissue infections, scarlet fever, and erysipelas due to susceptible streptococci (Group A-without bacteremia).
NOTE: Streptococci in Groups A, C, G, H, L, and M are very sensitive to penicillin G. Other groups, including Group D (enterococcus), are resistant. Aqueous penicillin is recommended for streptococcal infections with bacteremia.
Moderately severe infections of the respiratory tract due to susceptible pneumococci.
NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, peritonitis, and arthritis of pneumococcal etiology are better treated with aqueous penicillin G during the acute stage.
Moderately severe infections of the skin and soft tissues due to susceptible staphylococci (penicillin G-susceptible).
NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections. Indicated surgical procedures should be performed.
Fusospirochetosis (Vincent's gingivitis and pharyngitis). Moderately severe infections of the oropharynx due to susceptible fusiform bacilli and spirochetes.
NOTE: Necessary dental care should be accomplished in infections involving the gum tissue.
Syphilis (all stages) due to susceptible Treponema pallidum.
NOTE: This drug should not be used in the treatment of beta-lactamase producing organisms which include most strains of Neisseria gonorrhea.
Yaws, Bejel, Pinta due to susceptible organisms.
Penicillin G procaine is an adjunct to antitoxin for prevention of the carrier stage of diphtheria due to susceptible C. diphtheriae.
Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of the disease following exposure to aerosolized Bacillus anthracis.
Rat-bite fever due to susceptible Streptobacillus moniliformis and Spirillum minus organisms.
Erysipeloid due to susceptible Erysipelothrix rhusiopathiae.
Subacute bacterial endocarditis, only in extremely sensitive infections, due to susceptible Group A streptococci.
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