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Penicillin G (intravenous and short-acting intramuscular): Pediatric drug information

Penicillin G (intravenous and short-acting intramuscular): Pediatric drug information
(For additional information see "Penicillin G (intravenous and short-acting intramuscular): Drug information" and see "Penicillin G (intravenous and short-acting intramuscular): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Pfizerpen
Brand Names: Canada
  • Crystapen [DSC]
Therapeutic Category
  • Antibiotic, Penicillin
Dosing: Neonatal

General dosing, susceptible infection (non-CNS) (Red Book [AAP 2021]): IV, IM:

Gestational Age

Postnatal Age

Dose

≤34 weeks

≤7 days

50,000 units/kg/dose every 12 hours

8 to 28 days

50,000 units/kg/dose every 8 hours

>34 weeks

≤7 days

50,000 units/kg/dose every 12 hours

8 to 28 days

50,000 units/kg/dose every 8 hours

Anthrax, systemic (including meningitis); treatment:

Note: Consult public health officials for event-specific recommendations. Use as part of an appropriate combination regimen for ≥14 days if meningitis is excluded or ≥14 to 21 days if meningitis cannot be excluded, and until patient clinically stable. May transition to oral step-down therapy when clinically appropriate to complete course if meningitis has been excluded. Treatment should be followed by prophylaxis for a total antibiotic course of 60 days (AAP [Bradley 2014]).

IV:

Gestational Age

Postnatal Age

Dose

32 to 34 weeks

≤7 days

100,000 units/kg/dose every 12 hours

8 to 28 days

100,000 units/kg/dose every 8 hours

>34 weeks

≤7 days

100,000 units/kg/dose every 8 hours

8 to 28 days

100,000 units/kg/dose every 6 hours

Group B Streptococcus sepsis (non-meningitis):

Preterm and term neonates:

PNA ≤7 days: IV: 50,000 units/kg/dose every 12 hours for 10 days (AAP [Puopolo 2019]; Bradley 2021).

PNA 8 to 28 days: IV: 50,000 units/kg/dose every 8 hours for 10 days (AAP [Puopolo 2019]; Bradley 2021).

PNA 29 to 60 days: IV: 50,000 units/kg/dose every 6 hours for 10 days (Bradley 2021).

Meningitis, including Group B streptococcal (GBS): Note: Duration of therapy dependent upon pathogen and clinical response; in general, durations are as follows: GBS (uncomplicated courses): 14 days, GBS ventriculitis: ≥4 weeks, Listeria: ≥21 days; longer durations may be necessary for prolonged or complicated courses (AAP [Puopolo 2019]; IDSA [Tunkel 2004]; Red Book [AAP 2021]).

AAP dosing (Bradley 2021; Red Book [AAP 2021]): Preterm and term neonates:

PNA ≤7 days: IV, IM: 150,000 units/kg/dose every 8 hours.

PNA 8 to 60 days: IV, IM: 125,000 units/kg/dose every 6 hours.

IDSA dosing (Tunkel 2004): Neonates ≥2 kg:

PNA ≤7 days: IV: 150,000 units/kg/day in divided doses every 8 to 12 hours.

PNA 8 to 28 days: IV: 200,000 units/kg/day in divided doses every 6 to 8 hours.

Syphilis, congenital (with or without CNS involvement): Note: Preferred treatment of proven/highly probable or possible disease; see guidelines for criteria to determine probability of disease and treatment recommendations (CDC [Workowski 2015]; Red Book [AAP 2021]). If >1 day of therapy is missed, the entire course needs to be restarted (CDC [Workowski 2015]).

Preterm and term neonates:

PNA ≤7 days: IV: 50,000 units/kg/dose every 12 hours; at PNA 8 days increase to 50,000 units/kg/dose every 8 hours for a total of 10 days (Bradley 2021; CDC [Workowski 2015]; Red Book [AAP 2021]).

PNA 8 to 28 days: IV: 50,000 units/kg/dose every 8 hours for a total of 10 days (Bradley 2021; CDC [Workowski 2015]; Red Book [AAP 2021]).

PNA 29 to 60 days:

Preterm neonate: IV: 50,000 units/kg/dose every 6 hours for a total of 10 days (Bradley 2021; Red Book [AAP 2021]).

Term neonates: IV: 50,000 units/kg/dose every 4 to 6 hours for a total of 10 days (CDC [Workowski 2015]).

Dosing: Pediatric

General dosing, susceptible infection (non-CNS): Infants, Children, and Adolescents: IM, IV: 100,000 to 300,000 units/kg/day in divided doses every 4 to 6 hours; maximum daily dose: 24 million units/day (Red Book [AAP 2021]).

Anthrax, systemic (including meningitis); treatment: Note: Consult public health officials for event-specific recommendations.

Infants, Children, and Adolescents: IV: 400,000 units/kg/day in divided doses every 4 hours; maximum dose: 4 million units/dose. Use as part of an appropriate combination regimen for ≥14 days if meningitis is excluded or ≥14 to 21 days if meningitis cannot be excluded, and until patient clinically stable. Note: May transition to oral step-down therapy when clinically appropriate to complete course if meningitis has been excluded. Treatment must be followed by prophylaxis for a total antibiotic course of 60 days (AAP [Bradley 2014]).

Diphtheria: Infants, Children, and Adolescents: IM, IV: 150,000 to 250,000 units/kg/day in divided doses every 6 hours for 7 to 10 days (manufacturer's labeling). AAP suggests a duration of 14 days (Red Book [AAP 2021]).

Endocarditis, bacterial; treatment: Children and Adolescents: IV: 200,000 to 300,000 units/kg/day in divided doses every 4 hours; maximum daily dose: 24 million units/day; treat for ≥4 weeks; longer durations may be necessary; may use in combination with gentamicin for some resistant organisms (AHA [Baltimore 2015]). Note: For endocarditis from rat-bite fever/haverhill fever, the manufacturer recommends a lower dose of 150,000 to 250,000 units/kg/day in divided doses every 4 hours; maximum daily dose: 20 million units/day.

Lyme disease (Borrelia spp. infection) (alternative agent): Infants, Children, and Adolescents: IV: 200,000 to 400,000 units/kg/day in divided doses every 4 hours; maximum daily dose: 24 million units/day. Duration of therapy depends on clinical syndrome; treat meningitis or radiculopathy for 14 to 21 days (IDSA/AAN/ACR [Lantos 2021]).

Meningitis, including healthcare-associated ventriculitis and meningitis: Infants, Children, and Adolescents: IV: 300,000 to 400,000 units/kg/day divided every 4 to 6 hours; maximum dose: 4 million units/dose; maximum daily dose: 24 million units/day (IDSA [Tunkel 2004]; IDSA [Tunkel 2017]; Red Book [AAP 2021]).

Pneumonia, community-acquired (CAP): Infants >3 months and Children:

Empiric treatment or S. pneumoniae (moderate to severe; MICs to penicillin ≤2.0 mcg/mL): IV: 200,000 to 250,000 units/kg/day divided every 4 to 6 hours (IDSA/PIDS [Bradley 2011]).

Group A Streptococcus (moderate to severe): IV: 100,000 to 250,000 units/kg/day divided every 4 to 6 hours (IDSA/PIDS [Bradley 2011]).

Skin and soft tissue infections (Streptococcal infection or necrotizing infections due to Clostridium or Streptococcus species): Infants, Children, and Adolescents: IV: 60,000 to 100,000 units/kg/dose every 6 hours; maximum dose: 4 million units/dose; adult dose: 2 to 4 million units every 4 to 6 hours. For necrotizing infections, use in combination with clindamycin and continue until further debridement is not necessary, patient has clinically improved, and patient is afebrile for 48 to 72 hours (IDSA [Stevens 2014]).

Syphilis:

Congenital: Infants and Children: IV: 50,000 units/kg/dose every 4 to 6 hours for 10 days (CDC [Workowski 2015]).

Neurosyphilis (including ocular syphilis):

Infants and Children: IV: 50,000 units/kg/dose every 4 to 6 hours for 10 to 14 days; maximum daily dose: 24 million units/day.

Adolescents: IV: 3 to 4 million units every 4 hours or as a continuous infusion for 10 to 14 days; maximum daily dose: 24 million units/day (CDC [Workowski 2015]).

Tetanus; treatment: Infants, Children, and Adolescents: IV: 100,000 units/kg/day in divided doses every 6 hours in combination with tetanus immune globulin; maximum daily dose: 20 million units/day (Bradley 2021; manufacturer's labeling). Continue penicillin for 7 to 10 days (Red Book [AAP 2021]).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Infants, Children, and Adolescents: IM, IV:

Uremic patients with CrCl >10 mL/minute/1.73 m2: Administer a normal dose followed by 50% of the normal dose every 4 to 5 hours.

CrCl <10 mL/minute/1.73 m2: Administer a normal dose followed by 50% of the normal dose every 8 to 10 hours.

Hemodialysis: Dialyzable.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, the manufacturer's labeling recommends further adjustment of doses adjusted for renal impairment in patients with both renal and hepatic impairment.

Dosing: Adult

(For additional information see "Penicillin G (intravenous and short-acting intramuscular): Drug information")

Note: For ease of outpatient administration, the total daily dose may be administered as a 24-hour continuous infusion (AHA [Baddour 2015]; IDSA [Berbari 2015]; IDSA [Osmon 2013]; Walton 2007).

Actinomycosis, severe or extensive: IV: 10 to 20 million units/day as a continuous infusion or in divided doses every 4 to 6 hours for 4 to 6 weeks followed by appropriate long-term oral therapy (Brook 2008; Brook 2020).

Bloodstream infection:

Pathogen-directed therapy for Enterococcus spp. (off-label use): IV: 18 to 30 million units/day as a continuous infusion or in divided doses every 4 hours; use as part of an appropriate combination regimen in the setting of suspected endocarditis or critical illness (IDSA [Mermel 2009]; Murray 2020). Duration of therapy is 7 to 14 days for uncomplicated infection (ie, fever resolution within 72 hours and absence of metastatic focus of infection or endovascular hardware) (IDSA [Mermel 2009]). Some experts recommend a duration of 5 to 7 days for uncomplicated infection if blood cultures clear within 24 hours (Murray 2020).

Pathogen-directed therapy for Listeria monocytogenes: IV: 24 million units/day in divided doses every 4 hours; use in combination with gentamicin for nonpregnant patients. Duration should be individualized based on patient factors, source and extent of infection, and clinical response. Penicillin is usually continued for at least 2 weeks; patients who are immunocompromised warrant a longer course (eg, at least 3 to 6 weeks) (Gelfand 2020; Hof 1997).

Pathogen directed therapy for beta-hemolytic streptococci: IV: 18 to 24 million units/day in divided doses every 4 hours. Duration of therapy is generally 14 days; some experts suggest a shorter course (eg, 10 days) for patients with rapid clearance of bacteremia and clinical improvement (Barshak 2022; Wessels 2020).

Pathogen-directed therapy for group D streptococci (Streptococcus bovis/Streptococcus equinus complex) (alternative agent): IV: 12 to 24 million units/day in divided doses every 4 hours. Duration of therapy is 14 days in the absence of other clinical manifestations (Hoen 2020).

Botulism, wound (adjunctive agent following antitoxin administration): IV: 18 to 20 million units/day in divided doses every 4 to 6 hours in combination with wound debridement; duration depends on extent of the wound (Pegram 2020; manufacturer's labeling).

Diphtheria (adjunctive agent following antitoxin administration) (alternative agent): IV: 2 to 3 million units/day in divided doses every 4 to 6 hours for 10 to 12 days (manufacturer's labeling).

Endocarditis, treatment:

Enterococcus, native or prosthetic valve (penicillin-susceptible/gentamicin-susceptible) (off-label use): IV: 18 to 30 million units/day as a continuous infusion or in divided doses every 4 hours in combination with an aminoglycoside (eg, gentamicin). Duration is usually 6 weeks; for patients with native valve endocarditis and symptoms <3 months, antibiotic therapy may be given for 4 weeks. Note: Reserve this regimen for patients with CrCl >50 mL/minute (AHA [Baddour 2015]). For native-valve endocarditis due to ampicillin-susceptible Enterococcus faecalis, some experts prefer a different beta-lactam combination regimen (Sexton 2020a).

Viridans group streptococci and Streptococcus gallolyticus (S. bovis):

Native valve: Highly penicillin-susceptible (minimum inhibitory concentration [MIC] ≤0.12 mcg/mL): IV: 12 to 18 million units/day as a continuous infusion or in divided doses every 4 or 6 hours for 4 weeks; for patients with uncomplicated infection, rapid response to therapy, and no underlying disease, an alternative is 12 to 18 million units/day as a continuous infusion or in divided doses every 4 hours in combination with gentamicin for 2 weeks (AHA [Baddour 2015]).

Native valve: Relatively penicillin-resistant (MIC >0.12 to <0.5 mcg/mL): IV: 24 million units/day as a continuous infusion or in divided doses every 4 or 6 hours for 4 weeks in combination with gentamicin for the first 2 weeks (AHA [Baddour 2015]).

Native valve: Penicillin-resistant (MIC ≥0.5 mcg/mL): IV: 18 to 30 million units/day as a continuous infusion or in divided doses every 4 or 6 hours in combination with gentamicin. The duration of this regimen is not well established; infectious diseases consultation recommended (AHA [Baddour 2015]).

Prosthetic valve: Highly penicillin-susceptible (MIC ≤0.12 mcg/mL): IV: 24 million units/day as a continuous infusion or in divided doses every 4 or 6 hours for 6 weeks (with or without concomitant gentamicin for the first 2 weeks) (AHA [Baddour 2015]). Some experts prefer giving in combination with gentamicin for all patients without contraindications (Karchmer 2020).

Prosthetic valve: Relatively or fully penicillin-resistant (MIC >0.12 mcg/mL): IV: 24 million units/day as a continuous infusion or in divided doses every 4 or 6 hours in combination with gentamicin for 6 weeks (AHA [Baddour 2015]). For relatively resistant strains, some experts prefer a shorter duration of the gentamicin component (≥2 weeks) (Karchmer 2020).

Leptospirosis, severe (off-label use): IV: 1.5 million units every 6 hours for 7 days (Panaphut 2003; Suputtamongkol 2004; Watt 1988).

Lyme disease (Borrelia spp. infection) (alternative agent) (off-label use):

Carditis, severe disease (patients who are symptomatic, have second- or third-degree atrioventricular block, or have first-degree atrioventricular block with PR interval ≥300 msec): IV: 18 to 24 million units/day in divided doses every 4 hours until high-grade atrioventricular block resolved and PR interval <300 msec; may switch to oral therapy to complete a total of 14 to 21 days (Hu 2021; IDSA/AAN/ACR [Lantos 2021]).

Acute neurologic disease (eg, meningitis, radiculopathy), patients requiring hospitalization: IV: 18 to 24 million units/day in divided doses every 4 hours for 14 to 21 days (Halperin 2013; IDSA/AAN/ACR [Lantos 2021]; Sanchez 2016).

Late neurologic disease: IV: 18 to 24 million units/day in divided doses every 4 hours for 14 to 28 days (IDSA/AAN/ACR [Lantos 2021]); some experts favor a duration of 28 days (Hu 2021).

Recurrent arthritis after adequate oral regimen: IV: 18 to 24 million units/day in divided doses every 4 hours for 14 days; may extend to 28 days if inflammation is not resolving (IDSA/AAN/ACR [Lantos 2021]).

Meningitis, bacterial:

Pathogen-directed therapy for Cutibacterium acnes, L. monocytogenes, Neisseria meningitidis (with MIC <0.1 mcg/mL), Streptococcus agalactiae, or Streptococcus pneumoniae (with MIC ≤0.06 mcg/mL): IV: 4 million units every 4 hours (Hof 1997; IDSA [Tunkel 2004]; IDSA [Tunkel 2017]). For treatment of L. monocytogenes, use as part of an appropriate combination regimen (Drevets 1994; Hof 1997; IDSA [Tunkel 2004]). Treatment duration is 7 to 21 days, depending on causative pathogen(s) and clinical response (IDSA [Tunkel 2004]; IDSA [Tunkel 2017]).

Neurosyphilis (including ocular and otosyphilis ): Note: Penicillin desensitization and treatment is recommended in patients with a history of severe penicillin allergy (CDC [Workowski 2021]).

IV: 18 to 24 million units/day as a continuous infusion or in divided doses every 4 hours for 10 to 14 days. For late neurosyphilis (syphilis exposure >1 year ago), penicillin G benzathine may be used to complete a 3-week treatment course following initial IV penicillin G aqueous therapy (CDC [Workowski 2021]).

Odontogenic infection, pyogenic (alternative agent) : IV: 2 to 4 million units every 4 to 6 hours in combination with metronidazole; total duration (including oral step-down therapy) is 7 to 14 days (Chow 2020).

Osteomyelitis and/or discitis (off-label use):

Pathogen-directed therapy for C. acnes, Enterococcus spp. (penicillin-susceptible), or beta-hemolytic streptococci: IV: 20 to 24 million units/day as a continuous infusion or in divided doses every 4 hours, generally for ≥6 weeks depending on patient-specific factors such as organism, extent of infection, debridement, and clinical response. Shorter courses are appropriate if the affected bone is completely resected (eg, by amputation) (IDSA [Berbari 2015]; Osmon 2020).

Prosthetic joint infection (off-label use):

Pathogen-directed therapy for C. acnes, Enterococcus spp. (penicillin-susceptible), or Streptococcus spp.: IV: 20 to 24 million units/day as a continuous infusion or in divided doses every 4 hours (IDSA [Osmon 2013]). Duration varies but is generally 4 to 6 weeks depending on patient-specific factors, infection site, and intervention (Berbari 2022; IDSA [Osmon 2013]). Note: For enterococcal infections, the addition of an aminoglycoside is optional (IDSA [Osmon 2013]), but some experts prefer other regimens in the setting of retained hardware unless an aminoglycoside-impregnated implant is present, in which case beta-lactam monotherapy is likely sufficient (Berbari 2022).

Rat bite fever:

Uncomplicated infection: IV: 200,000 units every 4 hours; if patient clinically improves, may switch to an oral antibiotic after 5 to 7 days to complete a 14-day course (CDC 2005; Elliott 2007; King 2022; Roughgarden 1965).

Serious invasive infection (including bacteremia, meningitis, endocarditis, and other focal organ involvement): IV: 12 to 18 million units/day as a continuous infusion or in divided doses every 4 to 6 hours; may increase dose to 24 million units/day in patients with an isolate that is not highly penicillin-susceptible (eg, MIC >0.1 mcg/mL) or in patients with prosthetic valve endocarditis. Duration depends on site of infection and extent of disease (eg, 4 weeks for endocarditis) (King 2022).

Skin and soft tissue infection, streptococcal (group A Streptococcus, beta-hemolytic streptococci) (off-label use):

Erysipelas: IV: 2 to 4 million units every 4 to 6 hours. Total duration of therapy is ≥5 days (including oral step-down therapy); may extend to 14 days depending on severity and clinical response (IDSA [Stevens 2014]; Spelman 2020). Note: Some experts favor other regimens unless a streptococcal- or penicillin-susceptible infection has been microbiologically confirmed (Spelman 2020).

Necrotizing soft tissue infection: Note: Use in conjunction with early and aggressive surgical exploration and debridement of necrotic tissue.

IV: 4 million units every 4 hours in combination with clindamycin. Once the patient is clinically and hemodynamically stable for 48 to 72 hours, can give penicillin monotherapy. Total duration is individualized and depends on need for further debridement and patient clinical status (IDSA [Stevens 2014]; Stevens 2021).

Streptococcus (group B), maternal prophylaxis for prevention of neonatal disease (off-label use): IV: 5 million units as a single dose at onset of labor or prelabor rupture of membranes, then 2.5 to 3 million units every 4 hours until delivery (ACOG 2020).

Tetanus (Clostridium tetani infection) (adjunctive agent following tetanus immune globulin and vaccine administration) (alternative agent): IV: 2 to 4 million units every 4 to 6 hours for 7 to 10 days (Sexton 2020b; manufacturer's labeling).

Toxic shock syndrome, streptococcal: IV: 4 million units every 4 hours in combination with clindamycin. Duration of therapy depends on extent and severity of infection and response to treatment; treat patients who are bacteremic for ≥14 days (Stevens 2021; Walker 2014).

Dosing: Kidney Impairment: Adult

Manufacturer's labeling:

Uremic patients with CrCl >10 mL/minute/1.73 m2: Administer a usual recommended dose followed by 50% of the usual recommended dose every 4 to 5 hours.

CrCl <10 mL/minute/1.73 m2: Administer a normal dose followed by 50% of the normal dose every 8 to 10 hours.

Alternative recommendation:

GFR >50 mL/minute: No dosage adjustment necessary (Aronoff 2007).

GFR 10-50 mL/minute: Administer 75% of the normal dose (Aronoff 2007).

GFR <10 mL/minute: Administer 20% to 50% of the normal dose (Aronoff 2007).

End-stage renal disease on intermittent hemodialysis (IHD) (administer after hemodialysis on dialysis days) (Heintz 2009): Administer a normal dose followed by either 25% to 50% of normal dose every 4 to 6 hours or 50% to 100% of normal dose every 8 to 12 hours. For mild-to-moderate infections, administer 0.5 to 1 million units every 4 to 6 hours or 1 to 2 million units every 8 to 12 hours. For neurosyphilis, endocarditis, or serious infections, administer up to 2 million units every 4 to 6 hours; administer after dialysis on dialysis days or supplement with 500,000 units after dialysis. Note: Dosing dependent on the assumption of 3-times-weekly, complete IHD sessions.

Continuous renal replacement therapy (CRRT) (Heintz 2009; Trotman 2005): Drug clearance is highly dependent on the method of renal replacement, filter type, and flow rate. Appropriate dosing requires close monitoring of pharmacologic response, signs of adverse reactions due to drug accumulation, as well as drug concentrations in relation to target trough (if appropriate). The following are general recommendations only (based on dialysate flow/ultrafiltration rates of 1 to 2 L/hour and minimal residual renal function) and should not supersede clinical judgment:

CVVH: Loading dose of 4 million units, followed by 2 million units every 4 to 6 hours.

CVVHD: Loading dose of 4 million units, followed by 2 to 3 million units every 4 to 6 hours.

CVVHDF: Loading dose of 4 million units, followed by 2 to 4 million units every 4 to 6 hours.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, the manufacturer's labeling recommends further adjustment of doses adjusted for renal impairment in patients with both renal and hepatic impairment.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous, as potassium [preservative free]:

Generic: 20,000 units/mL (50 mL); 40,000 units/mL (50 mL); 60,000 units/mL (50 mL)

Solution Reconstituted, Injection, as potassium [preservative free]:

Pfizerpen: 5,000,000 units (1 ea); 20,000,000 units (1 ea)

Pfizerpen: 5,000,000 units (1 ea); 20,000,000 units (1 ea) [pyrogen free]

Generic: 5,000,000 units (1 ea); 20,000,000 units (1 ea)

Solution Reconstituted, Injection, as sodium [preservative free]:

Generic: 5,000,000 units (1 ea)

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution Reconstituted, Injection:

Generic: 1,000,000 units (1 ea); 10,000,000 units (1 ea)

Solution Reconstituted, Injection, as sodium:

Crystapen: 5,000,000 units ([DSC])

Generic: 5,000,000 units (1 ea)

Administration: Pediatric

Parenteral:

IM: Administer IM by deep injection in the upper outer quadrant of the buttock. Administer injection around-the-clock to promote less variation in peak and trough levels.

IV: Usually administered by intermittent infusion. In some centers, large doses may be administered by continuous IV infusion. The potassium or sodium content of the dose should be considered when determining the infusion rate.

Intermittent IV: Infuse over 15 to 30 minutes

Continuous IV infusion: Daily dose may be administered as a continuous infusion over 24 hours, or smaller increments (eg, 24 hour dose divided into two 12-hour infusions)

Administration: Adult

IM: Administer IM by deep injection in the upper outer quadrant of the buttock. Administer injection around-the-clock to promote less variation in peak and trough levels.

IV: Usually administered by intermittent infusion. In some centers, large doses may be administered by continuous IV infusion. Note: The 20 million unit dosage form may be administered by IV infusion only.

Intermittent IV: Infuse over 15 to 30 minutes.

Storage/Stability

Penicillin G potassium powder for injection should be stored below 86°F (30°C). Following reconstitution, solution may be stored for up to 7 days under refrigeration. Premixed bags for infusion should be stored at -20°C or -4°F; frozen bags may be thawed at 25°C (77°F) or in a refrigerator (5°C [41°F]). Once thawed, solution is stable for 14 days at 5°C (41°F) or for 24 hours at 25°C (77°F). Do not refreeze once thawed.

Penicillin G sodium powder for injection should be stored at 20°C to 25°C (68°F to 87°F). Once reconstituted, the manufacturer recommends refrigeration (2°C to 8°C [36°F to 46°F]) and use within 3 days of reconstitution. After further dilution to 2,500 to 50,000 units/mL in either D5W or NS (in PVC bags or elastomeric pump containers), one study demonstrated stability when stored under refrigeration for up to 21 days (Hossain 2014).

Use

Treatment of infections (including sepsis, empyema, pneumonia, pericarditis, endocarditis, meningitis, anthrax, botulism, gas gangrene, and tetanus) caused by susceptible organisms; active against some gram-positive organisms, generally not Staphylococcus aureus; some gram-negative organisms such as Neisseria gonorrhoeae and some anaerobes and spirochetes (FDA approved in all ages).

Medication Safety Issues
Sound-alike/look-alike issues:

Penicillin may be confused with penicillamine

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Frequency not defined:

Cardiovascular: Local thrombophlebitis, localized phlebitis

Central nervous system: Coma (high doses), hyperreflexia (high doses), myoclonus (high doses), seizure (high doses)

Dermatologic: Exfoliative dermatitis, maculopapular rash, skin rash

Endocrine & metabolic: Electrolyte disorder (high doses)

Gastrointestinal: Clostridioides difficile associated diarrhea, Clostridioides difficile colitis

Hematologic & oncologic: Neutropenia, positive direct Coombs test (rare, high doses)

Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction (immediate and delayed), serum sickness-like reaction

Immunologic: Jarisch-Herxheimer reaction

Local: Pain at injection site

Renal: Acute interstitial nephritis (high doses), renal tubular disease (high doses)

Contraindications

Hypersensitivity to any penicillin or any component of the formulation

Documentation of allergenic cross-reactivity for beta-lactams (eg, penicillins and cephalosporins) is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactic/hypersensitivity reactions: Serious and occasionally severe or fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy, especially with a history of beta-lactam hypersensitivity (including cephalosporins) or history of sensitivity to multiple allergens. Use with caution in asthmatic patients. If a serious reaction occurs, discontinue treatment and institute supportive measures.

• Neurovascular damage: Avoid intra-arterial administration or injection into or near major peripheral nerves or blood vessels since such injections may cause severe and/or permanent neurovascular damage.

• Severe cutaneous adverse reactions: Severe cutaneous adverse reactions (SCAR) (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis) have been reported; discontinue immediately if SCAR is suspected.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment recommended. In the presence of concomitant hepatic impairment, further dosage adjustment may be needed.

• Seizure disorders: Use with caution in patients with a history of seizure disorder; high levels, particularly in the presence of renal impairment, may increase risk of seizures.

Special populations:

• Neonates: Neonates may have decreased renal clearance of penicillin and require frequent dosage adjustments depending on age.

Other warnings/precautions:

• Electrolyte imbalance: Product contains sodium and potassium; high doses of IV therapy may alter serum levels. If high doses (eg, >10 million units) are used, administer at a slower rate (eg, >30 minutes for intermittent IV infusion).

Metabolism/Transport Effects

Substrate of OAT1/3

Drug Interactions

Acemetacin: May increase the serum concentration of Penicillins. Risk C: Monitor therapy

Aminoglycosides: Penicillins may decrease the serum concentration of Aminoglycosides. Primarily associated with extended spectrum penicillins, and patients with renal dysfunction. Risk C: Monitor therapy

Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination

Dichlorphenamide: Penicillins may enhance the hypokalemic effect of Dichlorphenamide. Risk C: Monitor therapy

Fexinidazole: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Management: Avoid use of fexinidazole with OAT1/3 substrates when possible. If combined, monitor for increased OAT1/3 substrate toxicities. Risk D: Consider therapy modification

Immune Checkpoint Inhibitors: Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors. Risk C: Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy

Methotrexate: Penicillins may increase the serum concentration of Methotrexate. Risk C: Monitor therapy

Mycophenolate: Penicillins may decrease serum concentrations of the active metabolite(s) of Mycophenolate. This effect appears to be the result of impaired enterohepatic recirculation. Risk C: Monitor therapy

Nitisinone: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor therapy

Pretomanid: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor therapy

Probenecid: May increase the serum concentration of Penicillins. Risk C: Monitor therapy

Sodium Benzoate: Penicillins may diminish the therapeutic effect of Sodium Benzoate. Risk C: Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification

Teriflunomide: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor therapy

Tetracyclines: May diminish the therapeutic effect of Penicillins. Risk C: Monitor therapy

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Penicillins may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy

Dietary Considerations

Some products may contain potassium and/or sodium.

Pregnancy Considerations

Penicillin G crosses the placenta.

In a study of women administered IV penicillin G (parenteral/aqueous) for group B streptococcal (GBS) disease, peak fetal concentrations occurred within 1 hour (Barber 2008).

Penicillin is widely used in pregnant women. Based on available data, penicillin is generally considered compatible for use during pregnancy (Ailes 2016; Bookstaver 2015; Crider 2009; Damkier 2019; Erić 2012; Heinonen 1977; Lamont 2014; Muanda 2017a; Muanda 2017b).

Maternal penicillin G serum concentrations are not decreased in obese patients following IV administration for GBS prophylaxis; however, cord blood concentrations may be less. Based on available data, minimum inhibitory concentrations for GBS are still achieved (McCoy 2020). Penicillin G (parenteral/aqueous) is the drug of choice for intrapartum prophylaxis to prevent neonatal GBS early onset disease. Untreated asymptomatic GBS disease can result in maternal urinary tract infection, intraamniotic infection, endometritis, preterm labor, and/or stillbirth. Vertical transmission from the mother can cause sepsis, pneumonia, or meningitis in the newborn. Treatment is intended to prevent early-onset disease in newborns. Prophylaxis is reserved for pregnant patients with a positive GBS vaginal or rectal screening in late gestation, GBS bacteriuria during the current pregnancy, history of birth of an infant with early-onset GBS disease, and unknown GBS culture status with any of the following: birth <37 0/7 weeks gestation, intrapartum fever, prolonged rupture of membranes, known GBS positive in a previous pregnancy, or intrapartum nucleic acid amplification testing positive for GBS (ACOG 2020).

Penicillin G is the drug of choice for treatment of syphilis during pregnancy (CDC [Workowski 2021]). Untreated maternal syphilis can cause congenital syphilis which is associated with bone deformities, neurologic impairment, stillbirth, or neonatal death (USPSTF 2018). Symptoms of congenital syphilis may include hepatosplenomegaly, jaundice, nonimmune hydrops, pseudoparalysis of an extremity, rhinitis, or skin rash. The CDC Sexually Transmitted Diseases Treatment Guidelines provide recommendations for the treatment of syphilis in pregnant patients. The penicillin regimen (dose, duration, and preparation) for the treatment of pregnant patients is the same as for a nonpregnant patient and depends on the stage of syphilis. Parenteral penicillin G is the only agent with documented efficacy in pregnancy. Patients who are allergic to penicillin should be desensitized and treated with penicillin. Pregnant patients being treated for latent syphilis must repeat the full course of therapy if any doses are missed. A Jarisch-Herxheimer reaction may occur in any patient within the first 24 hours of therapy, including pregnant patients. This reaction may induce early labor, fetal distress, or stillbirth (rare); however, it is not a reason to prevent or delay maternal therapy (CDC [Workowski 2021]).

Maternal infection with Bacillus anthracis may cause preterm labor, fetal infection, fetal distress, or fetal loss. Maternal death may also occur. When IV therapy is required for anthrax infection in pregnant and postpartum patients, penicillin G may be used as an alternative agent. The dose and duration of antibiotic therapy in pregnant and postpartum patients is the same as in nonpregnant adults. Adjustments in dose for pregnancy are not recommended until additional pharmacokinetic data becomes available (Meaney-Delman 2014).

Monitoring Parameters

Periodic serum electrolytes, renal and hematologic function tests, cardiac and hematologic function tests during prolonged/high-dose therapy; observe for signs and symptoms of anaphylaxis during first dose and changes in bowel frequency.

Mechanism of Action

Interferes with bacterial cell wall synthesis during active multiplication, causing cell wall death and resultant bactericidal activity against susceptible bacteria

Pharmacokinetics (Adult data unless noted)

Distribution: Poor penetration across blood-brain barrier, despite inflamed meninges

Relative diffusion from blood into CSF: Poor unless meninges inflamed (exceeds usual MICs)

CSF:blood level ratio: Inflamed meninges: 2% to 6%

Half-life elimination:

Neonates: <6 days of age: 3.1 hours; ≥14 days of age: 1.4 hours

Adults: Normal renal function: 31 to 50 minutes

End-stage renal disease (ESRD): 6 to 20 hours (Aronoff 2007)

Time to peak, serum: IV: Immediately after infusion

Excretion: Urine (58% to 85% as unchanged drug)

Pharmacokinetics: Additional Considerations

Renal function impairment: Excretion is delayed.

Hepatic function impairment: When combined with impaired renal function, elimination is further delayed.

Geriatric: Renal clearance may be delayed (caused by decreased renal function).

Anti-infective considerations:

Parameters associated with efficacy:

Time dependent, associated with time free drug concentration (fT) > minimum inhibitory concentration (MIC), goal: ≥50% fT > MIC (bactericidal) (Craig 1996; Craig 1998).

Expected drug exposure in adults with normal renal function:

5 million units over 3 to 5 minutes (single dose): 400 mg/L (5 to 6 minutes postinfusion); 273 mg/L (10 minutes postinfusion); 3 mg/L (4 hours postinfusion).

Postantibiotic effect: Minimal bacterial killing continues after penicillin concentration falls below the MIC of targeted pathogen and varies based on the organism:

Gram-positive cocci: 1.5 to 3.5 hours (Craig 1991; Garcia 1995; Zhanel 1991).

Gram-negative bacilli: 0 to 1.5 hours (Craig 1991; Zhanel 1991).

Additional Information

Penicillin G potassium: 1.7 mEq of potassium and 0.3 mEq of sodium per 1 million units of penicillin G

Penicillin G sodium: 2 mEq of sodium per 1 million units of penicillin G

Pricing: US

Solution (reconstituted) (Penicillin G Potassium Injection)

5000000 unit (per each): $4.80 - $42.18

20000000 unit (per each): $59.99 - $160.26

Solution (reconstituted) (Penicillin G Sodium Injection)

5000000 unit (per each): $57.60

Solution (reconstituted) (Pfizerpen Injection)

5000000 unit (per each): $15.26

20000000 unit (per each): $61.06

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Benpen (AU, NZ);
  • Pengesod (MX);
  • Penicilina Northia (AR);
  • Penicillin G (BG);
  • Pisacilina (CO);
  • Sodipen (MX)


For country abbreviations used in Lexicomp (show table)
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