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Penicillin G Potassium

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Penicillin G Potassium

INDICATIONS

Therapy

Penicillin G Potassium 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 Injection, USP may be initiated 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) Clostridiumspecies
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 Injection, USP and other antibacterial drugs, Penicillin G Potassium Injection, USP should be used only to treat or prevent 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.

DOSAGE AND ADMINISTRATION

Penicillin G Potassium Injection, USP should be administered by intravenous infusion. The usual dose recommendations are as follows:

Adult patients

(*) Because of its short half-life, Penicillin G is administered in divided doses, usually every 4-6 hours with the exception of meningococcal meningitis/septicemia, i.e., every 2 hours.

CLINICAL INDICATION DOSAGE
Serious infections due to susceptible strains of streptococci (including S. pneumoniae)
-septicemia, empyema, pneumonia, pericarditis, endocarditis and meningitis
12 to 24 million units/day depending on the infection and its severity administered in equally divided doses every 4-6 hours.
Serious infections due to susceptible strains of staphylococci
- septicemia, empyema, pneumonia, pericarditis, endocarditis and meningitis
5 to 24 million units/day depending on the infection and its severity administered in equally divided doses every 4-6 hours.
Anthrax Minimum of 8 million units/day in divided doses every 6 hours. Higher doses may be required depending on susceptibility of organism.
Actinomycosis
  Cervicofacial disease
  Thoracic and abdominal disease

1 to 6 million units/day(*)
10 to 20 million units/day(*)
Clostridial infections
  Botulism (adjunctive therapy to antitoxin)
  Gas gangrene (debridement and/or surgery asindicated)
  Tetanus (adjunctive therapy to human tetanusimmune globulin)
20 million units/day(*)
Diphtheria (adjunctive therapy to antitoxin and for the prevention of the carrier state) 2 to 3 million units/day in divided doses for 10-12 days(*)
Erysipelothrix endocarditis 12 to 20 million units/day for 4-6 weeks(*)
Fusospirochetosis (severe infections of the oropharynx [Vincent's], lower respiratory tract and genital area) 5 to 10 million units/day(*)
Listeria infections
  Meningitis
  Endocarditis

15 to 20 million units/day for 2 weeks(*)
15 to 20 million units/day for 4 weeks(*)
Pasteurella infections including bacteremia and meningitis 4 to 6 million units/day for 2 weeks(*)
Haverhill fever; Rat-bite fever 12 to 20 million units/day for 3-4 weeks(*)
Disseminated gonococcal infections, such as meningitis endocarditis, arthritis, etc., caused by penicillin - susceptible organisms 10 million units/day(*); duration depends on the type of infection
Syphilis (neurosyphilis) 12 to 24 million units/day, as 2-4 MU every 4 hours for 10-14 days; many experts recommend additional therapy with Benzathine PCN G 2.4 MU IM weekly for 3 doses after completion of IV therapy
Meningococcal meningitis and/or septicemia 24 million units/day as 2 million units every 2 hours

Pediatric patients

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

CLINICAL INDICATION DOSAGE
Serious infections, such as pneumonia and endocarditis, due to susceptible strains of streptococci (including S. pneumoniae) and meningococcus 150,000-300,000 units/kg/day divided in equal doses every 4-6 hours; duration depends on infecting organism and type of infection
Meningitis caused by susceptible strains of pneumococcus and meningococcus 250,000 units/kg/day divided in equal doses every 4 hours for 7-14 days depending on the infecting organism (maximum dose of 12-20 million units/day)
Disseminated Gonococcal Infections (penicillin- susceptible strains) Weight less than 45 kg:
  Arthritis 100,000 units/kg/day in 4 equally divided doses for 7-10 days
  Meningitis 250,000 units/kg/day in equal doses every 4 hours for 10-14 days
  Endocarditis 250,000 units/kg/day in equal doses every 4 hours for 4 weeks
  Arthritis, meningitis, endocarditis Weight 45 kg or greater: 10 million units/day in 4 equally divided doses with the duration of therapy depending on the type of infection
Syphilis (congenital and neurosyphilis) after the newborn period 200,000-300,000 units/kg/day (administered as 50,000 units/kg every 4-6 hours) for 10-14 days
Diphtheria (adjunctive therapy to antitoxin and for prevention of the carrier state) 150,000-250,000 units/kg/day in equal doses every 6 hours for 7-10 days
Rat-bite fever; Haverhill fever (with endocarditis caused by S. moniliformis) 150,000-250,000 units/kg/day in equal doses every 4 hours for 4 weeks

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/1.73m2; administer a full loading dose (see recommended dosages in the tables above) followed by one-half of the loading dose every 8-10 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- 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 streptococcal 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.

DIRECTIONS FOR USE OF GALAXY CONTAINER (PL 2040 PLASTIC)

Penicillin G Potassium Injection, USP in GALAXY Container (PL 2040 Plastic) is for intravenous administration using sterile equipment.

Storage

Store in a freezer capable of maintaining a temperature of -20°C/-4°F.

Thawing of Plastic Container

Thaw frozen container at room temperature (25°C/77°F) or in a refrigerator (5°C/41°F). DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION.

Check for minute leaks by squeezing container firmly. If leaks are detected, discard solution as sterility may be impaired.

Do not add supplementary medication.

The container should be visually inspected. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected. Agitate after solution has reached room temperature. If after visual inspection the solution remains cloudy or if an insoluble precipitate is noted or if any seals or outlet ports are not intact, the container should be discarded. The thawed solution is stable for 14 days under refrigeration (5°C/41°F) or for 24 hours at room temperature (25°C/77°F). Do not refreeze thawed antibiotics.

CAUTION: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

Preparation for Intravenous Administration:

  1.  Suspend container from eyelet support.
  2. Remove protector from outlet port at bottom of container.
  3. Attach administration set. Refer to complete directions accompanying set.

HOW SUPPLIED

Penicillin G Potassium Injection, USP is supplied as a premixed frozen iso-osmotic solution in 50 mL single dose GALAXY containers (PL 2040 Plastic) as follows:

2G3542      NDC 0338-1021-41      1,000,000 units Penicillin G
2G3543      NDC 0338-1023-41      2,000,000 units Penicillin G
2G3544      NDC-0338-1025-41      3,000,000 units Penicillin G

Store at or below -20°C/-4°F. [See Directions for Use of GALAXY Container (PL 2040 Plastic).]

Baxter Healthcare Corporation Deerfield, IL 60015, USA. Baxter and GALAXY are trademarks of Baxter International Inc. Rev. February 2008. FDA Rev date: 3/1/2008

Last reviewed on RxList: 3/27/2008
This monograph has been modified to include the generic and brand name in many instances.

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