INDICATIONS AND USAGE
Therapy: Penicillin G Potassium 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 Potassium for Injection, USP may be indicated 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) |
Clostridium species
|
| 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 for Injection, USP and other antibacterial drugs, Penicillin G Potassium for 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 may be given intravenously or intramuscularly. 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 to 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 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 |
|
| Cervico-facial disease |
1 to 6 million units/day
|
| Thoracic and abdominal disease |
10 to 20 million units/day
|
| Clostridial Infections |
|
| Botulism (adjunctive therapy to antitoxin) |
20 million units/day
|
| Gas gangrene (debridement and/or surgery as indicated) |
|
| Tetanus (adjunctive therapy to human tetanus immune globulin) |
|
| 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 oropharynx [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 penicillinsusceptible
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 |
|
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 to 6 hours; duration depends on infecting organ-ism and type of infection |
| Meningitis caused by susceptible strains of pneumococcus and menin-gococcus |
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 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 |
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 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 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 or Sterile Isotonic Sodium Chloride for Parenteral use.
Note: Penicillins are rapidly inactivated in the presence of carbohydrate solutions at alkaline pH.
Reconstitution: The following table shows the amount of solvent required for solution of various concentrations:
|
Approx. Desired
Concentration
(units/ mL) |
Approx. Volume
for 1,000,000
units (mL) |
Solvent for Vial of
5,000,000
units (mL) |
Infusion Only
20,000,000
units (mL) |
| 50,000 |
20 |
- |
- |
| 100,000 |
10 |
- |
- |
| 250,000 |
4 |
18.2 |
75 |
| 500,000 |
1.8 |
8.2 |
33 |
| 750,000 |
- |
4.8 |
- |
| 1,000,000 |
- |
3.2 |
11.5 |
When the required volume of solvent is greater than the capacity of the vial, the penicillin can be dissolved by first injecting only a portion of the solvent into the vial, then withdrawing the resultant solution and combining it with the remainder of the solvent in a larger sterile container.
Penicillin G potassium is highly water soluble. It may be dissolved in small amounts of Water for Injection, or Sterile Isotonic Sodium Chloride Solution for Parenteral Use. All solutions should be stored in a refrigerator. When refrigerated, penicillin solutions may be stored for seven days without significant loss of potency.
Penicillin G potassium may be given intramuscularly or by continuous intravenous drip for dosages of 500,000, 1,000,000, or 5,000,000 units. It is also suitable for intrapleural, intraarticular, and other local instillations.
THE 20,000,000 UNITS (20 MILLION UNITS) DOSAGE MAY BE ADMINISTERED BY INTRAVENOUS INFUSION ONLY.
(1) Intramuscular Injection: Keep total volume of injection small. The intramuscular route is the preferred route of administration. Solutions containing up to 100,000 units of penicillin per mL of diluent may be used with a minimum of discomfort. Greater concentration of penicillin G per mL is physically possible and may be employed where therapy demands. When large doses are required, it may be advisable to administer aqueous solutions of penicillin by means of continuous intravenous drip.
(2) Continuous Intravenous Drip: Determine the volume of fluid and rate of its administration required by the patient in a 24 hour period in the usual manner for fluid therapy, and add the appropriate daily dosage of penicillin to this fluid. For example, if an adult patient requires 2 liters of fluid in 24 hours and a daily dosage of 10 million units of penicillin, add 5 million units to 1 liter and adjust the rate of flow so the liter will be infused in 12 hours.
(3) Intrapleural or Other Local Infusion: If fluid is aspirated, give infusion in a volume equal to ¼ or ½ the amount of fluid aspirated, otherwise, prepare as for an intramuscular injection.
(4) Intrathecal Use: The intrathecal use of penicillin in meningitis must be highly individualized. It should be employed only with full consideration of the possible irritating effects of penicillin when used by this route. The preferred route of therapy in bacterial meningitides is intravenous, supplemented by intramuscular injection.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Sterile solution may be left in refrigerator for one week without significant loss of potency.
|
HOW SUPPLIED
Penicillin G Potassium for Injection, USP is supplied in dry powder form in vials containing 1,000,000 units (1 million units), 5,000,000 units (5 million units) or 20,000,000 units (20 million units) of crystalline penicillin G as the potassium salt, buffered with sodium citrate to an optimum pH. Each million units contains approximately 6.9 milligrams of sodium (0.3 mEq) and 65.8 milligrams of potassium (1.68 mEq).
| NDC 44567-310-10 |
1,000,000 units (1 million units) vial |
(carton of 10) |
| NDC 44567-311-10 |
5,000,000 units (5 million units) vial |
(carton of 10) |
| NDC 44567-312-01 |
20,000,000 units (20 million units) vial |
(single carton) |
| NDC 44567-312-10 |
20,000,000 units (20 million units) vial |
(carton of 10) |
Store the dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room
Temperature].
Sterile constituted solution may be kept in refrigerator 2° to 8°C (36° to 46°F) for 7 days without significant loss of potency.
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