Detailed Product Description

Procaine Penicillin powder for injection

INDICATIONS AND USAGE

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

CONTRAINDICATIONS

A previous hypersensitivity reaction to any penicillin is a contraindication.

DOSAGE AND ADMINISTRATION

Penicillin G procaine (aqueous) is for intramuscular injection only.

Pneumonia (pneumococcal), moderately severe (uncomplicated): 600,000 to 1,000,000 units daily.

Streptococcal infections (Group A), moderately severe to severe tonsillitis, erysipelas, scarlet fever, upper respiratory tract, skin and soft tissue: 600,000 to 1,000,000 units daily for 10-day minimum.

Staphylococcal infections, moderately severe to severe: 600,000 to 1,000,000 units daily.

In pneumonia, streptococcal (Group A) and staphylococcal infections in pediatric patients under 60 pounds: 300,000 units daily.

Bacterial endocarditis (Group A streptococci) only in extremely sensitive infections: 600,000 to 1,000,000 units daily.

Penicillin G procaine is not recommended for prophylaxis against bacterial endocarditis. For prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when undergoing dental procedures or surgical procedures of the upper respiratory tract, use penicillin V. For patients unable to take oral medications, aqueous penicillin G is recommended.

Syphilis

Primary, secondary, and latent with a negative spinal fluid in adults and pediatric patients over 12 years of age: 600,000 units daily for 8 days-total 4,800,000 units.

Late (tertiary, neurosyphilis, and latent syphilis with positive spinal-fluid examination or no spinal-fluid examination): 600,000 units daily for 10 to 15 days-total 6 to 9 million units.

Congenital syphilis under 70-lb. body weight: 50,000 units/kg/day for 10 days.

Yaws, Bejel, and Pinta: Treatment as for syphilis in corresponding stage of disease.

Diphtheria-adjunctive therapy with antitoxin: 300,000 to 600,000 units daily.

Diphtheria carrier state: 300,000 units daily for 10 days.

Anthrax-cutaneous: 600,000 to 1,000,000 units/day.

Anthrax-inhalational (post-exposure): 1,200,000 units every 12 hours in adults, 25,000 units per kilogram of body weight (maximum 1,200,000 unit) every 12 hours in children. The available safety data for penicillin G procaine at this dose would best support a duration of therapy of 2 weeks or less. Treatment for inhalational anthrax (post-exposure) must be continued for a total of 60 days. Physicians must consider the risks and benefits of continuing administration of penicillin G procaine for more than 2 weeks or switching to an effective alternative treatment.

Vincent's infection (fusospirochetosis): 600,000 to 1,000,000 units/day.

Erysipeloid: 600,000 to 1,000,000 units/day.

Streptobacillus moniliformis and Spirillum minus (rat-bite fever): 600,000 to 1,000,000 units/day.

ADVERSE REACTIONS Allergic Reactions

Penicillin is a substance of low toxicity but does possess a significant index of sensitization. The following hypersensitivity reactions associated with use of penicillin have been reported: Skin rashes, ranging from maculopapular eruptions to exfoliative dermatitis; urticaria; serum-sicknesslike reactions, including chills, fever, edema, arthralgia, and prostration. Severe and often fatal anaphylaxis has been reported. As with other treatments for syphilis, the Jarisch-Herxheimer reaction has been reported.

Procaine toxicity manifestations and hypersensitivity reactions have been reported

Gastrointestinal

Pseudomembranous colitis has been reported with the use of penicillin G. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment