Penicillin G Sodium
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Questions & Answers
Side Effects & Adverse Reactions
SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (anaphylactic) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE INITIATING THERAPY WITH PENICILLIN G, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, PENICILLIN G SHOULD BE DISCONTINUED AND APPROPRIATE THERAPY INSTITUTED. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including penicillin G sodium, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Penicillin G Sodium for 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 Sodium for 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) |
ActinomycesIsraelil |
| Botulism (adjunctive therapy to antitoxin), gas gangrene, and tetanus (adjunctive therapy to human tetanus immune globulin) |
Clostridium species |
| Diphtheria (adjunctive therapy to antitoxin and prevention of the carrier state) |
Corynebacterium diphtheriae |
| Erysipelothrix endocarditis |
Erysipelothrix rhusiopthiae |
| 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 |
Pasteurellamultocida |
| Haverhill fever |
Streptobacillus moniliformis |
| Rat-bite fever |
Spirillum minus or Streptobacillus moniliformis |
| Disseminated gonococcal infections |
Neisseria gonorrhoeae (penicillin-susceptible) |
| Syphilis (congenital and neurosyphilis) |
Treponemapallidum |
| Meningococcal meningitis and/or septicemia |
Neisseria meningitidis |
| Gram-negative bacillary infections (bacteremias) |
Escherichia coli, Enterobacter aerogenes, Alcaligenes faecalis, salmonella, shigella and Proteus mirabilis, Penicillin G is not the drug of choice in the treatment of gram-negative bacillary infections. |
To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin G sodium and other antibacterial drugs, penicillin G sodium 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.
History
There is currently no drug history available for this drug.
Other Information
Penicillin G sodium for Injection, USP is sterile penicillin G sodium powder for reconstitution. It is an antibacterial agent intended for intravenous or intramuscularly use.
Chemically, penicillin G sodium is designated 4-Thia-1-azabicyclo(3.2.0)-heptane-2-carboxylic acid,3,3-dimethyl-7-oxo-6-[(phenylacetyl)amino]-, [2S -(2α, 5α, 6β)]-, monosodium salt and has the following structural formula:
Penicillin G sodium, a water soluble benzylpenicillin, is a white to almost white crystalline powder which is almost odorless and/or after reconstitution a colorless solution. The pH of freshly constituted solutions usually ranges from 5.0 to 7.5.
Penicillin G sodium for Injection, USP is supplied in vials equivalent to 5,000,000 units (5 million units) of penicillin G as the sodium salt, with 1.68 mEq of sodium per million units of penicillin G.
Sources
Penicillin G Sodium Manufacturers
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Sandoz Inc
![Penicillin G Sodium Injection, Powder, For Solution [Sandoz Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Penicillin G Sodium | Sandoz Inc
Penicillin G Sodium for lnjection, USP may be given intravenously or intramuscularly. The usual dose recommendations are as follows:
Adult Patients Clinical Indication DosageSerious infections due to
susceptible strains of
streptococci (including
S. pneumoniae) and
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 to 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
1 to 6 million units/day(*)
Thoracic and abdominal
disease
10 to 20 million units/day(*)
Clostridial infections
Botulism (adjunctive
therapy to antitoxin)
Gas gangrene
(debridement and/or
surgery as indicated)
Tetanus (adjunctive
therapy to human tetanus
immune 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 to
12 days(*)
Erysipelothrix
endocarditis
12 to 20 million units/day for
4 to 6 weeks(*)
Fusospirochetosis
(severe infections of the
oropharnyx [Vincent’s], lower
respiratory tract
and genital area)
5 to 10 million
units/day(*)
Listeria infections
Meningitis
15 to 20 million units/day for
2 weeks(*)
Endocarditis
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 to 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 to 4 MU every 4 hours for
10 to 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
Serious infections, such as
pneumonia and endocarditis,
due to susceptible strains of
streptococci (including S.
pneumoniae) and
meningococcus
150,000 units/kg/day
divided in equal doses every
4 to 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 to 14 days
depending on the infecting
organism (maximum dose of
12 to 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 to 10 days
Meningitis
250,000 units/kg/day in
equal doses every
4 hours for 10 to 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 to 300,000
units/kg/day (administered as
50,000 units/kg every 4 to 6
hours) for 10 to 14 days
Diphtheria (adjunctive therapy
to antitoxin and for prevention
of the carrier state)
150,000 to 250,000
units/kg/day in equal doses
every 6 hours for 7 to 10
days
Rat-bite fever; Haverhill fever
(with endocarditis caused by
S. moniliformis)
150,000 to 250,000
units/kg/day in equal doses
every 4 hours for 4 weeks
*Because of its short half-life, Penicillin G is administered in divided doses, usually every 4 to 6 hours with the exception of meningococcal meningitis/septicemia, i.e., every 2 hours.
Pediatric PatientsThis product should not be administered to patients requiring less than one million units per dose. (see PRECAUTIONS: Pediatric Use).
Renal ImpairmentPenicillin 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 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.
Preparation of SolutionSolutions 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.
PREPARATION OF SOLUTION – 5 million units Diluent Added Final Concentration8 mL
500,000 units/mL
3 mL
1,000,000 units/mL
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