Usual Adult Dose for Skin or Soft Tissue Infection

600,000 to 1,000,000 units/day IM for at least 10 days

Uses: Moderately severe to severe group A streptococcal infections (tonsillitis, erysipelas, scarlet fever, upper respiratory tract, skin and soft tissue)/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)

Usual Adult Dose for Upper Respiratory Tract Infection

600,000 to 1,000,000 units/day IM for at least 10 days

Uses: Moderately severe to severe group A streptococcal infections (tonsillitis, erysipelas, scarlet fever, upper respiratory tract, skin and soft tissue)/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)

Usual Adult Dose for Tonsillitis/Pharyngitis

600,000 to 1,000,000 units/day IM for at least 10 days

Uses: Moderately severe to severe group A streptococcal infections (tonsillitis, erysipelas, scarlet fever, upper respiratory tract, skin and soft tissue)/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)

Usual Adult Dose for Streptococcal Infection

600,000 to 1,000,000 units/day IM for at least 10 days

Uses: Moderately severe to severe group A streptococcal infections (tonsillitis, erysipelas, scarlet fever, upper respiratory tract, skin and soft tissue)/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)

Usual Adult Dose for Endocarditis

600,000 to 1,000,000 units/day IM

Uses:

• Moderately severe (uncomplicated) pneumococcal pneumonia/moderately severe infections of the respiratory tract due to susceptible pneumococci
• Moderately severe to severe staphylococcal infections/moderately severe infections of the skin and soft tissues due to susceptible staphylococci (penicillin G-susceptible)
• Subacute bacterial endocarditis (only in extremely sensitive infections) due to susceptible group A streptococci
• Cutaneous anthrax due to Bacillus anthracis
• Vincent's infection (fusospirochetosis)/moderately severe infections of the oropharynx due to susceptible fusiform bacilli and spirochetes (fusospirochetosis [Vincent's gingivitis and pharyngitis])
• Erysipeloid due to Erysipelothrix rhusiopathiae
• Rat-bite fever due to susceptible Streptobacillus moniliformis and Spirillum minus organisms

Usual Adult Dose for Fusospirochetosis

600,000 to 1,000,000 units/day IM

Uses:

• Moderately severe (uncomplicated) pneumococcal pneumonia/moderately severe infections of the respiratory tract due to susceptible pneumococci
• Moderately severe to severe staphylococcal infections/moderately severe infections of the skin and soft tissues due to susceptible staphylococci (penicillin G-susceptible)
• Subacute bacterial endocarditis (only in extremely sensitive infections) due to susceptible group A streptococci
• Cutaneous anthrax due to Bacillus anthracis
• Vincent's infection (fusospirochetosis)/moderately severe infections of the oropharynx due to susceptible fusiform bacilli and spirochetes (fusospirochetosis [Vincent's gingivitis and pharyngitis])
• Erysipeloid due to Erysipelothrix rhusiopathiae
• Rat-bite fever due to susceptible Streptobacillus moniliformis and Spirillum minus organisms

Usual Adult Dose for Pneumonia

600,000 to 1,000,000 units/day IM

Uses:

• Moderately severe (uncomplicated) pneumococcal pneumonia/moderately severe infections of the respiratory tract due to susceptible pneumococci
• Moderately severe to severe staphylococcal infections/moderately severe infections of the skin and soft tissues due to susceptible staphylococci (penicillin G-susceptible)
• Subacute bacterial endocarditis (only in extremely sensitive infections) due to susceptible group A streptococci
• Cutaneous anthrax due to Bacillus anthracis
• Vincent's infection (fusospirochetosis)/moderately severe infections of the oropharynx due to susceptible fusiform bacilli and spirochetes (fusospirochetosis [Vincent's gingivitis and pharyngitis])
• Erysipeloid due to Erysipelothrix rhusiopathiae
• Rat-bite fever due to susceptible Streptobacillus moniliformis and Spirillum minus organisms

Usual Adult Dose for Bacterial Infection

600,000 to 1,000,000 units/day IM

Uses:

• Moderately severe (uncomplicated) pneumococcal pneumonia/moderately severe infections of the respiratory tract due to susceptible pneumococci
• Moderately severe to severe staphylococcal infections/moderately severe infections of the skin and soft tissues due to susceptible staphylococci (penicillin G-susceptible)
• Subacute bacterial endocarditis (only in extremely sensitive infections) due to susceptible group A streptococci
• Cutaneous anthrax due to Bacillus anthracis
• Vincent's infection (fusospirochetosis)/moderately severe infections of the oropharynx due to susceptible fusiform bacilli and spirochetes (fusospirochetosis [Vincent's gingivitis and pharyngitis])
• Erysipeloid due to Erysipelothrix rhusiopathiae
• Rat-bite fever due to susceptible Streptobacillus moniliformis and Spirillum minus organisms

Usual Adult Dose for Cutaneous Bacillus anthracis

600,000 to 1,000,000 units/day IM

Uses:

• Moderately severe (uncomplicated) pneumococcal pneumonia/moderately severe infections of the respiratory tract due to susceptible pneumococci
• Moderately severe to severe staphylococcal infections/moderately severe infections of the skin and soft tissues due to susceptible staphylococci (penicillin G-susceptible)
• Subacute bacterial endocarditis (only in extremely sensitive infections) due to susceptible group A streptococci
• Cutaneous anthrax due to Bacillus anthracis
• Vincent's infection (fusospirochetosis)/moderately severe infections of the oropharynx due to susceptible fusiform bacilli and spirochetes (fusospirochetosis [Vincent's gingivitis and pharyngitis])
• Erysipeloid due to Erysipelothrix rhusiopathiae
• Rat-bite fever due to susceptible Streptobacillus moniliformis and Spirillum minus organisms

Usual Adult Dose for Rat-bite Fever

600,000 to 1,000,000 units/day IM

Uses:

• Moderately severe (uncomplicated) pneumococcal pneumonia/moderately severe infections of the respiratory tract due to susceptible pneumococci
• Moderately severe to severe staphylococcal infections/moderately severe infections of the skin and soft tissues due to susceptible staphylococci (penicillin G-susceptible)
• Subacute bacterial endocarditis (only in extremely sensitive infections) due to susceptible group A streptococci
• Cutaneous anthrax due to Bacillus anthracis
• Vincent's infection (fusospirochetosis)/moderately severe infections of the oropharynx due to susceptible fusiform bacilli and spirochetes (fusospirochetosis [Vincent's gingivitis and pharyngitis])
• Erysipeloid due to Erysipelothrix rhusiopathiae
• Rat-bite fever due to susceptible Streptobacillus moniliformis and Spirillum minus organisms

Usual Adult Dose for Anthrax Prophylaxis

1.2 million units IM every 12 hours
Total duration of therapy: 60 days

Comments:

• Safety of this drug at this dose has not been established for more than 2 weeks of use; the risks/benefits of continuing this drug beyond 2 weeks or switching to an effective alternate therapy should be considered.

Use: Inhalational anthrax (postexposure) to reduce incidence/progression of infection after exposure to aerosolized Bacillus anthracis

Usual Adult Dose for Neurosyphilis

600,000 units/day IM for 10 to 15 days
Total dosage: 6 to 9 million units

Use: Late syphilis (tertiary, neurosyphilis) due to susceptible Treponema pallidum

US CDC and Panel on Opportunistic Infections in Adults and Adolescents with HIV Recommendations: 2.4 million units IM once a day for 10 to 14 days

Comments:

• US CDC: If compliance can be ensured, recommended with probenecid as an alternative regimen for neurosyphilis
• Panel on Opportunistic Infections in Adults and Adolescents with HIV: Recommended with probenecid as alternative therapy for neurosyphilis or otic or ocular syphilis
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Tertiary Syphilis

600,000 units/day IM for 10 to 15 days
Total dosage: 6 to 9 million units

Use: Late syphilis (tertiary, neurosyphilis) due to susceptible Treponema pallidum

US CDC and Panel on Opportunistic Infections in Adults and Adolescents with HIV Recommendations: 2.4 million units IM once a day for 10 to 14 days

Comments:

• US CDC: If compliance can be ensured, recommended with probenecid as an alternative regimen for neurosyphilis
• Panel on Opportunistic Infections in Adults and Adolescents with HIV: Recommended with probenecid as alternative therapy for neurosyphilis or otic or ocular syphilis
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Syphilis - Latent

With a negative spinal fluid: 600,000 units/day IM for 8 days
Total dosage: 4,800,000 units

With positive or no spinal fluid examination: 600,000 units/day IM for 10 to 15 days
Total dosage: 6 to 9 million units

Use: Latent syphilis due to susceptible T pallidum

Usual Adult Dose for Syphilis - Early

600,000 units/day IM for 8 days
Total dosage: 4,800,000 units

Uses: Primary and secondary syphilis due to susceptible T pallidum

Usual Adult Dose for Bejel

The usual treatment is the same as for syphilis in the corresponding stage of disease.

Uses: Bejel, pinta, yaws due to susceptible organisms

Usual Adult Dose for Yaws

The usual treatment is the same as for syphilis in the corresponding stage of disease.

Uses: Bejel, pinta, yaws due to susceptible organisms

Usual Adult Dose for Pinta

The usual treatment is the same as for syphilis in the corresponding stage of disease.

Uses: Bejel, pinta, yaws due to susceptible organisms

Usual Adult Dose for Diphtheria

Adjunctive therapy with antitoxin: 300,000 to 600,000 units/day IM
Carrier state: 300,000 units/day IM for 10 days

Uses: Adjunct to antitoxin for prevention of carrier stage of diphtheria due to susceptible Corynebacterium diphtheriae; diphtheria carrier state

US CDC Recommendations: 600,000 units every 12 hours for 14 days

Comments:

• Antimicrobial therapy is necessary to stop toxin production, eradicate C diphtheriae organism, and prevent transmission; it is not a substitute for antitoxin.
• Patients usually are not contagious 48 hours after starting therapy.
• Eradication of the organism should be confirmed 24 hours after completion of therapy by 2 consecutive negative cultures from specimens taken 24 hours apart.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Pneumonia

Less than 27 kg: 300,000 units/day IM

Uses:

• Pneumonia/moderately severe infections of the respiratory tract due to susceptible pneumococci
• Streptococcal (group A) infections/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)
• Staphylococcal infections/moderately severe infections of the skin and soft tissues due to susceptible staphylococci (penicillin G-susceptible)

American Academy of Pediatrics (AAP) Recommendations:
Neonates: 50,000 units/kg IM every 24 hours
1 month or older: 50,000 units/kg/day IM divided in 1 or 2 doses

• Maximum dose: 1.2 million units/day

Comments:

• This drug is not safe for IV administration.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Skin or Soft Tissue Infection

Less than 27 kg: 300,000 units/day IM

Uses:

• Pneumonia/moderately severe infections of the respiratory tract due to susceptible pneumococci
• Streptococcal (group A) infections/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)
• Staphylococcal infections/moderately severe infections of the skin and soft tissues due to susceptible staphylococci (penicillin G-susceptible)

American Academy of Pediatrics (AAP) Recommendations:
Neonates: 50,000 units/kg IM every 24 hours
1 month or older: 50,000 units/kg/day IM divided in 1 or 2 doses

• Maximum dose: 1.2 million units/day

Comments:

• This drug is not safe for IV administration.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Upper Respiratory Tract Infection

Less than 27 kg: 300,000 units/day IM

Uses:

• Pneumonia/moderately severe infections of the respiratory tract due to susceptible pneumococci
• Streptococcal (group A) infections/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)
• Staphylococcal infections/moderately severe infections of the skin and soft tissues due to susceptible staphylococci (penicillin G-susceptible)

American Academy of Pediatrics (AAP) Recommendations:
Neonates: 50,000 units/kg IM every 24 hours
1 month or older: 50,000 units/kg/day IM divided in 1 or 2 doses

• Maximum dose: 1.2 million units/day

Comments:

• This drug is not safe for IV administration.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Bacterial Infection

Less than 27 kg: 300,000 units/day IM

Uses:

• Pneumonia/moderately severe infections of the respiratory tract due to susceptible pneumococci
• Streptococcal (group A) infections/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)
• Staphylococcal infections/moderately severe infections of the skin and soft tissues due to susceptible staphylococci (penicillin G-susceptible)

American Academy of Pediatrics (AAP) Recommendations:
Neonates: 50,000 units/kg IM every 24 hours
1 month or older: 50,000 units/kg/day IM divided in 1 or 2 doses

• Maximum dose: 1.2 million units/day

Comments:

• This drug is not safe for IV administration.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Streptococcal Infection

Less than 27 kg: 300,000 units/day IM

Uses:

• Pneumonia/moderately severe infections of the respiratory tract due to susceptible pneumococci
• Streptococcal (group A) infections/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)
• Staphylococcal infections/moderately severe infections of the skin and soft tissues due to susceptible staphylococci (penicillin G-susceptible)

American Academy of Pediatrics (AAP) Recommendations:
Neonates: 50,000 units/kg IM every 24 hours
1 month or older: 50,000 units/kg/day IM divided in 1 or 2 doses

• Maximum dose: 1.2 million units/day

Comments:

• This drug is not safe for IV administration.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Anthrax Prophylaxis

Children: 25,000 units/kg IM every 12 hours

• Maximum dose: 1.2 million units/dose

Total duration of therapy: 60 days

Comments:

• Safety of this drug at this dose has not been established for more than 2 weeks of use; the risks/benefits of continuing this drug beyond 2 weeks or switching to an effective alternate therapy should be considered.

Use: Inhalational anthrax (postexposure) to reduce incidence/progression of infection after exposure to aerosolized B anthracis

Usual Pediatric Dose for Congenital Syphilis

Less than 32 kg: 50,000 units/kg/day IM for 10 days

US CDC and AAP Recommendations: 50,000 units/kg IM once a day for 10 days

• Maximum dose: 2.4 million units/day

Comments:

• Recommended for neonates with proven or highly probable congenital syphilis, neonates with possible congenital syphilis, and neonates with or without clinical evidence of congenital syphilis (proven/highly probable, possible, or less likely) when aqueous crystalline penicillin G is unavailable
• Recommended for infants and children with or without clinical evidence of congenital syphilis (proven/highly probable, possible, or less likely) when aqueous crystalline penicillin G is unavailable
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Syphilis - Early

Greater than 12 years: 600,000 units/day IM for 8 days
Total dosage: 4,800,000 units

Use: Primary, secondary, and latent with a negative spinal fluid

Usual Pediatric Dose for Syphilis - Latent

Greater than 12 years: 600,000 units/day IM for 8 days
Total dosage: 4,800,000 units

Use: Primary, secondary, and latent with a negative spinal fluid

Usual Pediatric Dose for Neurosyphilis

Panel on Opportunistic Infections in Adults and Adolescents with HIV Recommendations: 2.4 million units IM once a day for 10 to 14 days

Comments:

• Recommended with probenecid as alternative therapy for neurosyphilis or otic or ocular syphilis in adolescents
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Diphtheria

US CDC Recommendations:

• Up to 10 kg: 300,000 units IM every 12 hours
• Greater than 10 kg: 600,000 units IM every 12 hours

AAP Recommendations:

• Aged 1 month or older: 50,000 units/kg/day IM divided in 1 or 2 doses
• Maximum dose: 1.2 million units/day

Duration of Therapy: 14 days

Comments:

• Antimicrobial therapy is necessary to stop toxin production, eradicate C diphtheriae organism, and prevent transmission; it is not a substitute for antitoxin.
• Patients usually are not contagious 48 hours after starting therapy.
• Eradication of the organism should be confirmed 24 hours after completion of therapy by 2 consecutive negative cultures from specimens taken 24 hours apart.
• Current guidelines should be consulted for additional information.

Renal Dose Adjustments

Data not available

Comments:

• Excretion is considerably delayed in patients with impaired renal function.

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNING:

• The warnings, adverse reactions, and dosage and administration sections of the manufacturer product information should be carefully read before administering this drug.

CONTRAINDICATIONS:
Previous hypersensitivity reaction to any penicillin

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For IM injection only; do not inject into or near an artery or nerve; may cause permanent neurologic damage if injected into or near a nerve
• Administer by deep IM injection in the upper, outer quadrant of the buttock (dorsogluteal) or the ventrogluteal site; may prefer the midlateral aspect of the thigh in neonates, infants, and small children
• The needle may be blocked if the drug is not injected at a slow, steady rate (due to high concentration of suspended material in product).
• Rotate the injection site when doses are repeated.
• Do not use this drug for severe infections (e.g., severe pneumonia, empyema, bacteremia [including streptococcal infections with bacteremia], pericarditis, meningitis, peritonitis, pneumococcal arthritis) during the acute stage or when high, sustained serum drug levels are required; use aqueous penicillin G (IM or IV).
• Do not use this drug for prophylaxis against bacterial endocarditis; use penicillin V (or aqueous penicillin G if patient unable to take oral medications) when prophylaxis is necessary.
• Do not use this drug to treat beta-lactamase-producing organisms (including most strains of Neisseria gonorrhoeae); this drug is no longer indicated to treat gonorrhea.

Storage requirements:

• Store in refrigerator at 2C to 8C (36F to 46F); keep from freezing.

General:

• To reduce the development of drug-resistant organisms and maintain effective therapy, antibiotics should be used only to treat or prevent infections proven or strongly suspected to be caused by susceptible bacteria.
• Culture and susceptibility information should be considered when selecting/modifying antibacterial therapy or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy.
• This drug should only be used for indications listed in the manufacturer product information; this drug is for the treatment of moderately severe infections due to penicillin-G-sensitive microorganisms susceptible to the low and persistent serum levels typical of this formulation.
• Bacteriological studies (including susceptibility tests) and clinical response should guide therapy.
• Groups A, C, G, H, L, and M streptococci are very susceptible to penicillin G; other groups (including group D [enterococci]) are resistant; aqueous penicillin is recommended for streptococcal infections with bacteremia.
• An increasing number of strains of staphylococci are resistant to penicillin G, emphasizing the importance of culture and sensitivity studies when treating suspected staphylococcal infections; indicated surgical procedures should be performed.
• Completion of necessary dental care recommended with infections involving gum tissue.
• Excretion is considerably delayed in neonates and young infants.

Monitoring:

• General: Laboratory studies, including susceptibility tests with suspected staphylococcal infections; serological tests if concomitant syphilis suspected (monthly for at least 4 months)
• Hematologic: Hematopoietic systems (during prolonged therapy, especially with high-dose regimens)
• Renal: Renal systems (during prolonged therapy, especially with high-dose regimens); renal function in elderly patients

Patient advice:

• Avoid missing doses and complete the entire course of therapy.
• Seek immediate medical attention if the following signs/symptoms develop: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.
• Consult physician at once if watery and bloody stools (with or without stomach cramps and fever) develop.