Penicillin G Sodium Injection

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 PRECAUTIONS). The manifestations may include agitation, confusion, asterixis, hallucinations, stupor, coma, multifocal myocionus, seizures and encephalopathy. Hyperkalemia is also possible (see ADVERSE REACTIONS - Metabolic).

In case of overdosage, discontinue penicillin, treat symptomatically and institute supportive measures as required. If necessary, hemodialysis may be used to reduce blood levels of penicillin G, although the degree of effectiveness of this procedure is questionable.

Adult patients

Pediatric patients

This product should not be administered to patients requiring less than one million units per dose. (see PRECAUTIONS - Pediatric Use).

Renal Impairment

Penicillin G is relatively nontoxic, and dosage adjustments are generally required only in cases of severe renal impairment.

The recommended dosage regimens are as follows:

Creatinine clearance less than 10 mL/min/1.73 m2; administer a full loading dose (see recommended dosages in the tables above) followed by one-half of the loading dose every 8 to 10 hours.

Uremic patients with a creatinine clearance greater than 10 mL/min/1.73m2; administer a full loading dose (see recommended dosages in the tables above) followed by one-half of the loading dose every 4 to 5 hours.

Additional dosage modifications should be made in patients with hepatic disease and renal impairment.

For most acute infections, treatment should be continued for at least 48 to 72 hours after the patient becomes asymptomatic. Antibiotic therapy for Group A β-hemolytic straptococcal infections should be maintained for at least 10 days to reduce the risk of rheumatic fever.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Preparation of Solution

Solutions of penicillin should be prepared as follows: Loosen powder. Hold vial horizontally and rotate it while slowly directing the stream of diluent against the wall of the vial. Shake vial vigorously after all the diluent has been added. Depending on the route of administration, use Sterile Water for Injection, USP, 0.9% Sodium Chloride Injection, USP, or Dextrose Injections, USP.

Note: Penicillins are rapidly inactivated in the presence of carbohydrate solutions at alkaline pH.

5 to 24 million units/day IV in equally divided doses every 4 to 6 hours

Comments:
-Dose depends on the nature and severity of the infection.

Uses: For the treatment of serious infections (septicemia, empyema, pneumonia, pericarditis, endocarditis, meningitis) due to Streptococcus pyogenes, other beta-hemolytic streptococci (including groups C, H, G, L, M), S pneumoniae, Staphylococcus species (non-penicillinase-producing strains)

5 to 24 million units/day IV in equally divided doses every 4 to 6 hours

Comments:
-Dose depends on the nature and severity of the infection.

Uses: For the treatment of serious infections (septicemia, empyema, pneumonia, pericarditis, endocarditis, meningitis) due to Streptococcus pyogenes, other beta-hemolytic streptococci (including groups C, H, G, L, M), S pneumoniae, Staphylococcus species (non-penicillinase-producing strains)

12 to 24 million units/day, administered as 2 to 4 million units IV every 4 hours for 10 to 14 days

Comments:
-Many experts recommend additional therapy with penicillin G benzathine after completion of IV therapy.
-Adequate follow-up (including clinical and serological examinations) recommended for all cases of penicillin-treated syphilis; US CDC guidelines should be consulted.

Use: For the treatment of neurosyphilis due to Treponema pallidum

US CDC Recommendations: 18 to 24 million units/day, administered as 3 to 4 million units IV every 4 hours or a continuous IV infusion for 10 to 14 days

Comments:
-Recommended as the preferred regimen for neurosyphilis and ocular syphilis
-US CDC, National Institutes of Health (NIH), and HIV Medicine Association of the IDSA (HIVMA/IDSA) also recommend this as the preferred regimen for neurosyphilis, ocular syphilis, and otic syphilis in HIV-infected adults.
-Duration of neurosyphilis therapy is shorter than the duration for latent syphilis therapy; penicillin G benzathine can be considered after completing this drug to provide comparable total duration of therapy.
-The patient's sexual partner(s) should also be evaluated/treated.
-Current guidelines should be consulted for additional information.

Minimum of 8 million units/day IV in divided doses every 6 hours

Comments:
-Higher doses may be needed depending on susceptibility of organism.

Use: For the treatment of anthrax due to Bacillus anthracis

US CDC Recommendations: 4 million units IV every 4 hours

Duration of Therapy:
-With possible/confirmed meningitis: At least 2 to 3 weeks or until patient is clinically stable (whichever is longer)
-When meningitis has been excluded: At least 2 weeks or until patient is clinically stable (whichever is longer)
-Patients exposed to aerosolized spores will require prophylaxis to complete an antimicrobial regimen of 60 days from onset of illness.

Comments:
-Recommended as an alternative agent for the treatment of systemic anthrax due to penicillin-susceptible strains (MIC less than 0.125 mcg/mL)
-Recommended for use with a protein synthesis inhibitor; the addition of a bactericidal fluoroquinolone is recommended with possible/confirmed meningitis.
-Systemic anthrax includes anthrax meningitis, inhalation anthrax, injection anthrax, gastrointestinal anthrax, and cutaneous anthrax with systemic involvement, extensive edema, or lesions of the head or neck.
-Current guidelines should be consulted for additional information.

American Academy of Neurology (AAN) and IDSA Recommendations: 18 to 24 million units/day IV in divided doses every 4 hours
Duration of therapy: 14 days

Comments:
-IDSA recommends this drug as an alternative parenteral regimen for early neurologic disease (meningitis or radiculopathy), cardiac disease, and late disease (recurrent arthritis after oral regimen, central or peripheral nervous system disease).
-Duration of therapy has ranged from 10 to 28 days.
-Current guidelines should be consulted for additional information.

American Academy of Pediatrics (AAP) Recommendations:
7 days or younger: 25,000 to 50,000 units/kg IM or IV every 12 hours
8 to 28 days: 25,000 to 50,000 units/kg IM or IV every 8 hours

1 month or older:
Mild to moderate infections: 100,000 to 150,000 units/kg/day IM or IV in 4 divided doses
Maximum dose: 8 million units/day

Severe infections: 200,000 to 300,000 units/kg/day IM or IV in 4 to 6 divided doses
Maximum dose: 24 million units/day

150,000 units/kg/day IV in equally divided doses every 4 to 6 hours
Duration of therapy: Depends on nature and severity of infection

Uses: For the treatment of serious infections (such as pneumonia, endocarditis) due to susceptible strains of streptococci (including S pneumoniae) and meningococcus

AAP Recommendations:
-Invasive pneumococcal infections in patients 1 month or older: 250,000 to 400,000 units/kg/day IV in divided doses every 4 to 6 hours

PIDS and IDSA Recommendations:
Community-acquired pneumonia in infants and children older than 3 months:
-S pneumoniae with penicillin MIC up to 2 mcg/mL: 200,000 to 250,000 units/kg/day IV in divided doses every 4 to 6 hours
-Group A Streptococcus: 100,000 to 250,000 units/kg/day IV in divided doses every 4 to 6 hours

Comments:
-PIDS/IDSA: Recommended as preferred parenteral therapy
-Current guidelines should be consulted for additional information.

AAN, AAP, and IDSA Recommendations:
Children: 200,000 to 400,000 units/kg/day IV in divided doses every 4 hours
Maximum dose: 18 to 24 million units/day
Duration of therapy: 14 days

Comments:
-AAP recommends this drug as an alternative parenteral regimen for recurrent arthritis, carditis, meningitis, and encephalitis/other late neurologic disease (including peripheral neuropathy, encephalopathy).
-IDSA recommends this drug as an alternative parenteral regimen for early neurologic disease (meningitis or radiculopathy), cardiac disease, and late disease (recurrent arthritis after oral regimen, central or peripheral nervous system disease).
-Duration of therapy has ranged from 10 to 28 days.
-Current guidelines should be consulted for additional information.

AAN, AAP, and IDSA Recommendations:
Children: 200,000 to 400,000 units/kg/day IV in divided doses every 4 hours
Maximum dose: 18 to 24 million units/day
Duration of therapy: 14 days

Comments:
-AAP recommends this drug as an alternative parenteral regimen for recurrent arthritis, carditis, meningitis, and encephalitis/other late neurologic disease (including peripheral neuropathy, encephalopathy).
-IDSA recommends this drug as an alternative parenteral regimen for early neurologic disease (meningitis or radiculopathy), cardiac disease, and late disease (recurrent arthritis after oral regimen, central or peripheral nervous system disease).
-Duration of therapy has ranged from 10 to 28 days.
-Current guidelines should be consulted for additional information.