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Cefepime: Pediatric drug information

Cefepime: Pediatric drug information
(For additional information see "Cefepime: Drug information" and see "Cefepime: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Maxipime [DSC]
Brand Names: Canada
  • APO-Cefepime
Therapeutic Category
  • Antibiotic, Cephalosporin (Fourth Generation)
Dosing: Neonatal

General dosing, susceptible infection: Limited data available:

Age-directed dosing (Ref): Note: Dosing based on pharmacokinetic evaluations and modeling from neonates and young infants, including patients with GA ranging from 22 to 42 weeks.

Preterm and term neonates: IV:

Postnatal Age

Dose

a Consider dosing at the lower end of the range in less mature patients (including PNA <14 days) and/or for more susceptible pathogens (ie, minimum inhibitory concentration [MIC] <4 mg/L).

b If pathogen MIC is ≥8 mg/L, doses may need to be infused over 3 hours or frequency increased to every 6 hours to achieve desired time > MIC.

<30 days

30 to 50 mg/kg/dose every 12 hoursa

≥30 days

50 mg/kg/dose every 8 hoursb

Weight-directed dosing (Ref): IV, IM:

Body Weight

Postnatal Age

Dose

aIf pathogen MIC is ≥8 mg/L, doses may need to be infused over 3 hours or frequency increased to every 6 hours.

≤2 kg

≤28 days

30 mg/kg/dose every 12 hours

29 to 60 days

50 mg/kg/dose every 8 hoursa

>2 kg

≤28 days

50 mg/kg/dose every 12 hours

29 to 60 days

50 mg/kg/dose every 8 hoursa

Dosing: Pediatric

General dosing, susceptible infection:

Traditional intermittent-infusion method: Infants, Children, and Adolescents:

Non-Pseudomonas spp. infections: IM, IV: 50 mg/kg/dose every 12 hours; maximum dose: 2,000 mg/dose (Ref). Note: Every-12-hour dosing may be suboptimal for infections caused by bacteria with minimum inhibitory concentrations (MICs) ≥1 mg/L based on pharmacokinetic modeling (Ref).

Pseudomonas spp. infections (suspected or proven): IM, IV: 50 mg/kg/dose every 8 hours; maximum dose: 2,000 mg/dose (Ref).

Extended-infusion method: Limited data available: Infants, Children, and Adolescents: IV: 50 mg/kg/dose infused over 3 to 4 hours every 8 hours; maximum dose: 2,000 mg/dose; dosing based on a pharmacokinetic modeling study, a case series, and a retrospective comparative study (Ref). Note: Extended-infusion dosing may be preferred for susceptible dose-dependent pathogens (MIC of 4 or 8 mg/L) (Ref).

Cystic fibrosis, acute pulmonary exacerbation

Cystic fibrosis, acute pulmonary exacerbation: Infants, Children, and Adolescents: IV: 50 mg/kg/dose every 8 hours; maximum dose: 2,000 mg/dose; patients with more resistant pseudomonal isolates (MIC ≥16 mg/L) may require 50 mg/kg/dose every 6 hours (Ref). Note: Some experts prefer extended or continuous infusion methods to optimize antipseudomonal beta-lactam exposure in patients with cystic fibrosis (Ref).

Endocarditis, prosthetic valve, treatment within 1 year of replacement

Endocarditis, prosthetic valve, treatment within 1 year of replacement: Children and Adolescents: IV: 50 mg/kg/dose every 8 to 12 hours in combination with vancomycin and rifampin for 6 weeks plus gentamicin for the first 2 weeks; maximum dose: 2,000 mg/dose (Ref).

Febrile neutropenia, empiric therapy

Febrile neutropenia, empiric therapy: Infants, Children, and Adolescents: IV: 50 mg/kg/dose every 8 hours; maximum dose: 2,000 mg/dose (Ref); duration of therapy dependent upon febrile neutropenia risk-status; in high-risk patients, may discontinue empiric antibiotics if all of the following criteria met: Negative blood cultures at 48 hours; afebrile for at least 24 hours, and evidence of marrow recovery. In low-risk patients, may discontinue empiric antibiotics after 72 hours duration in patients with a negative blood culture and who have been afebrile for 24 hours regardless of marrow recovery status; follow-up closely (Ref).

Intra-abdominal infection, complicated

Intra-abdominal infection, complicated: Infants, Children, and Adolescents: IV: 50 mg/kg/dose every 12 hours in combination with metronidazole; maximum dose: 2,000 mg/dose. Note: IDSA guidelines recommend duration of 4 to 7 days (provided source controlled) (Ref).

Meningitis, including health care-associated ventriculitis/meningitis

Meningitis, including health care-associated ventriculitis/meningitis: Infants, Children, and Adolescents: IV: 50 mg/kg/dose every 8 hours; maximum dose: 2,000 mg/dose. Duration should be individualized based on patient characteristics and response; treatment duration for gram-negative bacilli is a minimum of 10 to 14 days, although some experts recommend ≥21 days and at least 14 days after first negative cerebrospinal fluid culture (Ref).

Peritonitis

Peritonitis (peritoneal dialysis) (Ref): Infants, Children, and Adolescents: Intraperitoneal:

Intermittent: 15 mg/kg/dose every 24 hours into the long dwell.

Continuous: Loading dose: 500 mg per liter of dialysate; maintenance dose: 125 mg per liter.

Pneumonia, moderate to severe

Pneumonia, moderate to severe: Infants ≥2 months, Children, and Adolescents:

Due to P. aeruginosa: IV: 50 mg/kg/dose every 8 hours for 10 days; maximum dose: 2,000 mg/dose.

Not due to P. aeruginosa: IV: 50 mg/kg/dose every 12 hours for 10 days; maximum dose: 2,000 mg/dose.

Skin and skin structure infection, uncomplicated

Skin and skin structure infection, uncomplicated: Infants ≥2 months, Children, and Adolescents: IV: 50 mg/kg/dose every 12 hours for 10 days; maximum dose: 2,000 mg/dose.

Urinary tract infection, complicated and uncomplicated

Urinary tract infection, complicated and uncomplicated: Infants ≥2 months, Children, and Adolescents:

Mild to moderate infection: IM, IV: 50 mg/kg/dose every 12 hours for 7 to 10 days; maximum dose: 1,000 mg/dose. Note: IM may only be considered for mild to moderate infections due to E. coli.

Severe infection: IV: 50 mg/kg/dose every 12 hours for 10 days; maximum dose: 2,000 mg/dose.

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

Note: Dosing is based on pharmacokinetic parameters, limited pediatric studies, adult studies, manufacturer labeling, and expert opinion.

Altered kidney function:

Infants, Children, and Adolescents: IV, IM:

Cefepime Dosing Adjustments for Maintenance Dose in Renal Impairment

CrCl

Recommended Dosing Schedule

Note: Dosing regimens reflect the similarity in cefepime pharmacokinetics between adult and pediatric patients and are generally proportional to the changes made in adult patients. Based on minimum inhibitory concentrations (MIC) of bacteria, higher doses may be indicated (Shoji 2016).

a Choose usual recommended dose based on indication and disease severity (see "Dosing: Pediatric"), then choose the adjusted dose from that column corresponding to the patient's CrCl.

>60 mL/minute/1.73 m2

(Usual recommended dose)a

50 mg/kg/dose every 12 hours; maximum dose: 1,000 mg/dose

50 mg/kg/dose every 12 hours; maximum dose: 2,000 mg/dose

50 mg/kg/dose every 8 hours; maximum dose: 2,000 mg/dose

30 to 60 mL/minute/1.73 m2

50 mg/kg/dose every 24 hours; maximum dose: 1,000 mg/dose

50 mg/kg/dose every 24 hours; maximum dose: 2,000 mg/dose

50 mg/kg/dose every 12 hours; maximum dose: 2,000 mg/dose

11 to 29 mL/minute/1.73 m2

25 mg/kg/dose every 24 hours; maximum dose: 500 mg/dose

25 to 50 mg/kg/dose every 24 hours; maximum dose: 1,000 mg/dose

50 mg/kg/dose every 24 hours; maximum dose: 2,000 mg/dose

<11 mL/minute/1.73 m2

25 mg/kg/dose every 24 hours; maximum dose: 250 mg/dose

25 to 50 mg/kg/dose every 24 hours; maximum dose: 500 mg/dose

25 to 50 mg/kg/dose every 24 hours; maximum dose: 1,000 mg/dose

Hemodialysis, intermittent: Dialyzable (based on adult studies: 70% to 85% reduction in serum concentration from a 3.5- to 4-hour hemodialysis treatment with high flux filters (Ref)).

Note: Appropriate dosing requires consideration of drug penetration to site of infection, MIC of bacteria, severity of illness, residual kidney function, interval between dialysis sessions, receipt of any initial loading doses, etc. Monitor closely for response and adverse reactions due to drug accumulation (eg, neurotoxicity) (Ref).

Infants, Children, and Adolescents: IV or via dialysis circuit return line:

Intermittent (posthemodialysis) dosing: 50 mg/kg/dose following dialysis; maximum dose: 2,000 mg/dose. Note: Regimen based on 3 to 4 hour dialysis sessions at least 3 times per week. For pediatric patients receiving <3 hours of hemodialysis, consider further dose reduction (Ref).

Daily dosing (when scheduled dose falls on a dialysis day, administer after dialysis): Initial (day 1): 50 mg/kg (maximum dose: 1,000 mg/dose) followed by 12.5 to 25 mg/kg/dose once daily. Note: Maintenance and maximum doses are determined based on the usual recommended dose for patient-specific clinical scenario; recommended doses are as follows: If usual recommended dose is 50 mg/kg/dose every 8 hours, use 25 mg/kg/dose (maximum dose: 1,000 mg/dose) once daily; if usual recommended dose is 50 mg/kg/dose every 12 hours, use 12.5 mg/kg/dose (maximum dose: 500 mg/dose) once daily (Ref).

Peritoneal dialysis (manual or automated):

Note: Appropriate dosing requires consideration of drug penetration to site of infection, MIC of bacteria, severity of illness, residual kidney function, receipt of any initial loading doses, etc. Monitor closely for response and adverse reactions due to drug accumulation (eg, neurotoxicity) (Ref).

Infants, Children, and Adolescents: IV, IM: 25 to 50 mg/kg/dose every 48 hours. Usual maximum dose: 1,000 mg/dose; in severe infections or for bacteria with elevated MICs, 2,000 mg/dose maximum may be considered. Alternatively, 25 to 50 mg/kg/dose every 24 hours may be considered for severe infections (eg, septic shock) (Ref).

CRRT:

Infants, Children, Adolescents:

Note: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Recommendations are based on high-flux dialyzers and effluent flow rates of ~2,000 mL/hour/1.73 m2 unless otherwise noted. Appropriate dosing requires consideration of drug penetration to site of infection, MIC of bacteria, severity of illness, receipt of any initial loading doses, etc. Monitor closely for response and adverse reactions due to drug accumulation (eg, neurotoxicity) (Ref). Due to minimal data in pediatric patients receiving CRRT, consider monitoring serum concentrations (eg, trough concentration) if available.

CVVH/CVVHD/CVVHDF: IV: 50 mg/kg/dose (maximum dose: 2,000 mg/dose) every 8 to 12 hours. Note: Adult data suggest that in severe infections or sepsis, the risks/benefits favor dosing on the higher side of the recommended frequency. For higher effluent rates (>2,000 mL/hour/1.73 m2), bacteria with higher MICs, or deep-seated infections in severely ill pediatric patients, consider extended infusions or more frequent administration (Ref).

Dosing: Hepatic Impairment: Pediatric

No dosage adjustments necessary.

Dosing: Adult

(For additional information see "Cefepime: Drug information")

Dosage guidance:

Dosing: Dosing is presented based on the traditional intermittent infusion method over 30 minutes, unless otherwise specified as the extended-infusion method over 3 to 4 hours or continuous infusion method over 24 hours (off-label methods).

Usual dosage range:

Traditional intermittent infusion method (over 30 minutes): IV: 1 to 2 g every 8 to 12 hours. For coverage of serious Pseudomonas aeruginosa infections: 2 g every 8 hours (Ref). For infections caused by an organism with a minimum inhibitory concentration (MIC) <4 mg/L, 1 g every 6 hours achieves pharmacodynamic parameters comparable to 2 g every 8 hours; reserve for use in less serious infections (Ref).

Extended infusion method (off-label method): IV: 2 g every 8 hours infused over 3 or 4 hours (Ref); may give first dose over 30 minutes (Ref). The extended infusion method is preferred for treatment of infections caused by AmpC beta-lactamase-producing Enterobacterales (eg, Enterobacter cloacae, Klebsiella aerogenes, Citrobacter freundii); however, cefepime should only be used for these infections when the MIC is ≤2 mcg/mL (Ref).

Continuous infusion method (off-label method): IV: 4 to 6 g infused over 24 hours (Ref); may give first dose of 2 g over 30 minutes, especially when rapid attainment of therapeutic drug concentrations (eg, sepsis) is desired (Ref).

Bloodstream infection

Bloodstream infection (gram-negative bacteremia) (off-label use):

Community-acquired infection, without sepsis or septic shock (immunocompetent host and no infections with P. aeruginosa in prior 3 to 6 months): IV: 2 g every 12 hours (Ref).

Health care–associated infection (including catheter-related infection, infection in immunocompromised hosts, patients with sepsis or septic shock, or for coverage of P. aeruginosa): IV: 2 g every 8 hours (Ref). Note: For empiric therapy of gram-negative bloodstream infection in patients with sepsis or septic shock and for empiric therapy of P. aeruginosa bloodstream infection in patients with neutropenia or severe burns, some experts recommend giving cefepime with a second gram-negative active agent (Ref). Some experts also prefer extended or continuous infusion for critical illness or when treating a susceptible organism with an elevated MIC (Ref).

Duration of therapy: Usual duration is 7 to 14 days; individualize duration depending on source and extent of infection as well as clinical response. A 7-day duration is recommended for patients with uncomplicated Enterobacteriaceae infection who respond appropriately to antibiotic therapy (Ref). If neutropenic, extend treatment until afebrile for ≥48 hours and recovery of neutrophils (ANC ≥500 cells/mm3 and increasing) (Ref). For P. aeruginosa bacteremia in patients who are neutropenic, some experts treat for a minimum of 14 days and until recovery of neutrophils (Ref).

Cystic fibrosis, acute pulmonary exacerbation

Cystic fibrosis, acute pulmonary exacerbation (off-label use): For empiric or targeted therapy of P. aeruginosa or other gram-negative bacilli:

IV: 2 g every 8 hours, usually given as part of an appropriate combination regimen (Ref). Note: Some experts prefer the extended or continuous infusion method to optimize exposure (Ref).

Duration of therapy: Duration is usually 10 to 14 days depending on clinical response (Ref).

Diabetic foot infection, moderate to severe

Diabetic foot infection, moderate to severe (off-label use): IV: 2 g every 8 to 12 hours in combination with other appropriate agents (Ref).

Duration of therapy: Duration (which may include oral step-down therapy) is usually 2 to 4 weeks in the absence of osteomyelitis (Ref).

Intra-abdominal infection, health care–associated or high-risk community-acquired infection

Intra-abdominal infection, health care–associated or high-risk community-acquired infection:

Note: For community-acquired infection, reserve for severe infection or patients at high risk of adverse outcome and/or resistance (Ref):

Cholecystitis, acute: IV: 2 g every 8 to 12 hours; if P. aeruginosa is suspected, use 2 g every 8 hours. Continue for 1 day after gallbladder removal or until clinical resolution in patients managed nonoperatively (Ref).

Other intra-abdominal infections (eg, cholangitis, appendicitis, diverticulitis, intra-abdominal abscess): IV: 2 g every 8 to 12 hours in combination with metronidazole, and, when appropriate, other agents; if P. aeruginosa is suspected, use 2 g every 8 hours. Total duration of therapy (which may include transition to oral antibiotics) is 4 to 5 days following adequate source control (Ref). For diverticulitis or uncomplicated appendicitis managed without intervention, duration is 10 to 14 days (Ref); for perforated appendicitis managed with laparoscopic appendectomy, 2 to 4 days may be sufficient (Ref). Note: For patients who are critically ill or are at high risk for infection with drug-resistant pathogens, some experts favor the extended or continuous infusion method (Ref).

Intracranial abscess and spinal epidural abscess

Intracranial abscess (brain abscess, intracranial epidural abscess) and spinal epidural abscess (off-label use): As a component of empiric therapy in patients at risk for P. aeruginosa or another resistant gram-negative bacteria (eg, neurosurgical or immunocompromised patients):

IV: 2 g every 8 hours as part of an appropriate combination regimen; duration generally ranges from 4 to 8 weeks for brain abscess and spinal epidural abscess and 6 to 8 weeks for intracranial epidural abscess (Ref).

Meningitis, bacterial

Meningitis, bacterial (off-label use): Note: As a component of empiric therapy for health careassociated infections or infections in immunocompromised patients, or as pathogen-specific therapy (eg, gram-negative bacteria, including P. aeruginosa):

IV: 2 g every 8 hours; for empiric therapy, use in combination with other appropriate agents (Ref). Treatment duration for gram-negative bacilli is a minimum of 10 to 14 days, although some experts recommend ≥21 days (Ref).

Neutropenic enterocolitis

Neutropenic enterocolitis (typhlitis) (off-label use): IV: 2 g every 8 hours in combination with metronidazole (Ref). In patients who have clinical resolution following neutropenia and who did not have signs of severe disease at the time of diagnosis, the duration of antibiotics is 14 days following recovery from neutropenia; many patients can be switched to an appropriate oral antibiotic regimen once neutropenia has resolved (Ref).

Neutropenic fever, high-risk cancer patients

Neutropenic fever, high-risk cancer patients (empiric therapy): Note: High-risk patients are those expected to have an ANC ≤100 cells/mm3 for >7 days or an ANC ≤100 cells/mm3 for any expected duration if there are ongoing comorbidities (eg, sepsis, mucositis, significant hepatic or renal dysfunction) (Ref); some experts use an ANC cutoff of <500 cells/mm3 to define high-risk patients (Ref).

IV: 2 g every 8 hours until afebrile for ≥48 hours and resolution of neutropenia (ANC ≥500 cells/mm3 and increasing) or standard duration for the specific infection identified, if longer than the duration of neutropenia. Additional agent(s) may be needed depending on clinical status (Ref). Some experts prefer extended or continuous infusions for critical illness (Ref).

Osteomyelitis and/or discitis

Osteomyelitis and/or discitis (off-label use): IV: 2 g every 8 to 12 hours for ≥6 weeks (Ref). For empiric therapy, use in combination with other appropriate agents (Ref).

Peritonitis, treatment

Peritonitis, treatment (patients receiving peritoneal dialysis) (off-label use): As a component of empiric therapy or as pathogen-directed therapy for gram-negative bacteria (eg, P. aeruginosa):

Note: Intraperitoneal is preferred to IV administration unless the patient shows signs of systemic infection, then IV is preferred (Ref).

Automated peritoneal dialysis (APD): Intraperitoneal: 1 g every 24 hours given in the longest dwell is preferred (Ref).

CAPD:

Intermittent: Intraperitoneal: 1 g added to one exchange of dialysis solution every 24 hours (to be given in the longest daily dwell) (Ref).

Continuous (with every exchange): Intraperitoneal: Loading dose: 250 to 500 mg/L of dialysate with first exchange of dialysate. Maintenance dose: 100 to 125 mg/L of dialysate with each subsequent exchange of dialysate (Ref).

Note: Consider 25% dose increase in patients on APD or CAPD with significant residual kidney function (urine output >100 mL/day) (Ref).

Pneumonia

Pneumonia:

Community-acquired pneumonia:For empiric therapy of inpatients at risk of infection with a resistant gram-negative pathogen(s), including P. aeruginosa:

IV: 2 g every 8 hours as part of an appropriate combination regimen. Total duration (which may include oral step-down therapy) is a minimum of 5 days; a longer course may be required for patients with an immunocompromising condition, severe or complicated infection, or for P. aeruginosa infection. Patients should be clinically stable with normal vital signs prior to discontinuation (Ref).

Hospital-acquired pneumonia or ventilator-associated pneumonia:For empiric therapy (often as part of an appropriate combination regimen) or pathogen-specific therapy of resistant gram-negative pathogen(s), including P. aeruginosa:

IV: 2 g every 8 hours. Duration of therapy varies based on disease severity and response to therapy; treatment is typically given for 7 days (Ref). Note: Some experts prefer extended or continuous infusions for critical illness or when treating a susceptible organism with an elevated MIC (Ref).

Prosthetic joint infection, pathogen-specific therapy for gram-negative bacilli

Prosthetic joint infection, pathogen-specific therapy for gram-negative bacilli (off-label use): IV: 2 g every 8 to 12 hours; duration varies but is generally 4 to 6 weeks for patients who undergo resection arthroplasty (Ref).

Sepsis and septic shock

Sepsis and septic shock (broad-spectrum empiric coverage, including P. aeruginosa) (off-label use): IV: 2 g every 8 hours (Alves 2014); use in combination with other appropriate agents when applicable. Initiate therapy as soon as possible and preferably within 1 hour of recognition of sepsis or septic shock. Duration is dependent on underlying source and patient response; short courses are preferred, when appropriate. Consider discontinuation if a noninfectious etiology is identified (Ref). Some experts prefer extended or continuous infusions (Ref).

Septic arthritis

Septic arthritis (off-label use): As a component of empiric therapy or pathogen-specific therapy for gram-negative pathogens (including P. aeruginosa): IV: 2 g every 8 to 12 hours; for empiric therapy, use in combination with other appropriate agents. Total treatment duration is 3 to 4 weeks (in the absence of osteomyelitis), including oral step-down therapy (Ref).

Skin and soft tissue infection, moderate to severe

Skin and soft tissue infection, moderate to severe:

Note: For empiric or pathogen-directed therapy in patients with or at risk for gram-negative bacteria resistant to other antibiotics (eg, P. aeruginosa) (Ref).

IV: 2 g every 8 to 12 hours; often used as part of an appropriate combination regimen. Usual duration (including oral step-down therapy) is 5 to 14 days based on severity and clinical response (Ref).

Urinary tract infection, complicated

Urinary tract infection, complicated (pyelonephritis or urinary tract infection with systemic signs/symptoms): IV: 1 to 2 g every 12 hours (Ref). Switch to an appropriate oral regimen once symptoms improve if culture and susceptibility results allow. Total duration of therapy ranges from 5 to 14 days and depends on clinical response and the antimicrobial chosen to complete the regimen (Ref).

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: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function: IV:

Cefepime Dosage Adjustments in Altered Kidney Functiona

CrClb

If the usual recommended dose is 1 g every 12 hours

If the usual recommended dose is 2 g every 12 hours

If the usual recommended dose is 1 g every 6 hours

If the usual recommended dose is 2 g every 8 hours

a Kuti 2010; Lodise 2006; Tam 2003; manufacturer's labeling.

b CrCl can be calculated using the Cockcroft-Gault equation (Jonckheere 2016).

c Lodise 2006.

d 1 g every 12 hours increases the likelihood of pharmacodynamic target attainment and is preferred for serious infections or organisms with less susceptible MICs (Kuti 2010; Tam 2003). Administer a 2 g loading dose when rapid attainment of therapeutic concentrations is desired (expert opinion).

>60 mL/minute

No dosage adjustment necessary

No dosage adjustment necessary

No dosage adjustment necessary

No dosage adjustment necessary

30 to 60 mL/minute

1 g every 24 hours

1 g every 12 hours

CrCl 50 to 60 mL/minute: No dosage adjustment necessary.

CrCl 30 to 49 mL/minute: 1 g every 8 hours.c

2 g every 12 hours

11 to 29 mL/minute

500 mg every 24 hours

1 g every 24 hours

1 g every 12 hours

1 g every 12 hoursd or 2 g every 24 hours

<11 mL/minute

250 mg every 24 hours

500 mg every 24 hours

1 g every 24 hours

1 g every 24 hours

Augmented renal clearance (measured urinary CrCl ≥130 mL/minute/1.73 m2): Augmented renal clearance (ARC) is a condition that occurs in certain critically-ill patients without significant organ dysfunction. Younger patients (<55 years of age) admitted post trauma or major surgery are at highest risk for ARC, as well as those with sepsis, burns, or hematological malignancies. A measured urinary clearance is necessary to identify these patients.

Note: Limited data available; dosing based on Monte Carlo simulation and expert opinion.

IV: Initial: 2 g every 6 hours infused over 3 hours when used empirically or in patients with known minimum inhibitory concentrations (MICs) >4 mg/L (Ref). Closely monitor patient for response and adverse reactions (eg, neurotoxicity) due to drug accumulation. Consider obtaining drug concentrations when available.

Hemodialysis, intermittent (thrice weekly): Note: Achievement of cefepime pharmacodynamic targets is dependent on organism MIC, the absence or presence of residual kidney function, and interval between dialysis sessions (ie, 2- or 3-day interdialytic interval) (Ref). Factors such as severity of illness, location of infection, and patient weight should be considered when selecting between the higher and lower dosing regimens as well.

IV: Dialyzable (70% to 85% reduction in serum concentration from a 3.5- to 4-hour hemodialysis treatment with high flux filters (Ref)).

Daily dosing (administer after hemodialysis on dialysis days): IV: Initial: 1 g (single dose) on day 1. Maintenance: 500 mg to 1 g every 24 hours (Ref). Note: If the usual recommended dose for normal renal function is 2 g every 8 hours or 1 g every 6 hours, utilize 1 g every 24 hours; use 500 mg every 24 hours for all other doses (Ref).

Thrice-Weekly (Postdialysis) Cefepime Dosinga

Residual kidney function and organism susceptibility

Cefepime dose for a 2-day interdialytic interval (ie, next dialysis expected in 48 hours)

Cefepime dose for a 3-day interdialytic interval (ie, next dialysis expected in 72 hours)

a Expert opinion derived from Descombes 2016; Perez 2012; Schmaldienst 2000.

Patient is anuric AND the organism MIC <4 mg/L

1.5 g after hemodialysis

2 g after hemodialysis

Any of the following:

Empiric therapy OR

Patient has residual kidney function OR

Organism MIC ≥4 mg/L

2 g after hemodialysis

2 g after hemodialysis

Peritoneal dialysis:

IV: 1 g every 24 hours (Ref).

CRRT: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Recommendations are based on high-flux dialyzers and effluent flow rates of 20 to 25 mL/kg/hour (or approximately 1,500 to 3,000 mL/hour) unless otherwise noted. Appropriate dosing requires consideration of adequate drug concentrations (eg, site of infection), organism MIC, residual kidney function, and consideration of initial loading doses. Close monitoring of response and adverse reactions (eg, neurotoxicity) due to drug accumulation is important.

CVVH/CVVHD/CVVHDF: IV: 2 g every 8 to 12 hours (Ref).

Note: For severe infections or sepsis, the risks/benefits favor dosing on the higher side of the recommended frequency (Ref). For CRRT with other effluent rates: If effluent rate is <20 mL/kg/hour, 2 g every 12 hours is preferred (Ref). If effluent rate is ≥35 mL/kg/hour, 2 g every 8 hours is preferred (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Appropriate dosing requires consideration of adequate drug concentrations (eg, site of infection), organism MIC, residual kidney function, and consideration of initial loading doses. Close monitoring of response and adverse reactions (eg, neurotoxicity) due to drug accumulation is important.

Note: Regimens developed through Monte Carlo simulation only and based on daily treatments with 4 to 5 L/hour of dialysate/ultrafiltrate flow rate for each 8- to 10-hour session (Ref).

Option 1: IV: 2 g loading dose, followed by 1 g every 6 hours regardless of when prolonged intermittent renal replacement therapy (PIRRT) treatments occur relative to cefepime infusions (Ref).

Option 2 (if every 6 hours not desired [eg, patient self-administering]): IV: 2 g at beginning of PIRRT session, then 3 g after PIRRT session ends. Repeat regimen with every PIRRT session (Ref).

Non-PIRRT days: IV: Select dose based on assessment of nondialysis kidney function (eg, CrCl <11, then 1 g every 24 hours).

Dosing: Hepatic Impairment: Adult

No dosage adjustment necessary.

Adverse Reactions (Significant): Considerations
Clostridioides difficile infection

Clostridioides difficile infection (CDI) has been reported with use in adult and pediatric patients (Ref). In one retrospective cohort study, cefepime and meropenem increased CDI risk relative to piperacillin-tazobactam (Ref).

Mechanism: Dose- and time-related; potentially related to recent or cumulative antibiotic exposure. Cefepime may cause disruption of the intestinal microbiota resulting in the overgrowth of pathogens, such as C. difficile (Ref).

Onset: Varied; may start on the first day of antibiotic therapy or up to 3 months postantibiotic (Ref).

Risk factors:

• Antibiotic exposure (highest risk factor) (Ref)

• Type of antibiotic (third-/fourth-generation cephalosporins among the highest risk) (Ref)

• Long durations in a hospital or other health care setting (recent or current) (Ref)

• Older patients (Ref)

• Immunocompromised conditions (Ref)

• A serious underlying condition (Ref)

• GI surgery/manipulation (Ref)

• Antiulcer medications (eg, proton pump inhibitors, H2 blockers) (Ref)

• Chemotherapy (Ref)

Hypersensitivity reactions (immediate and delayed)

Immediate hypersensitivity reactions (including anaphylaxis, angioedema, and urticaria) (Ref) and delayed hypersensitivity reactions have been reported. Delayed hypersensitivity reactions range from maculopapular skin rash to rare severe cutaneous adverse reactions (SCARs), including acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis (Ref).

Mechanism: Non–dose-related; immunologic. Immediate hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria) are IgE-mediated (Ref). Delayed hypersensitivity reactions, including maculopapular rash and SCARs, are mediated by T-cells (Ref).

Onset: Immediate hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria): Rapid; generally occur within 1 hour of administration but may occur up to 6 hours after exposure (Ref). Delayed hypersensitivity reactions: Varied; maculopapular reactions typically occur 7 to 10 days after initiation. Other delayed hypersensitivity reactions, including SCARs, may occur 7 to 14 days up to 3 months after initiation (Ref).

Risk factors:

• Cross-reactivity between penicillins and cephalosporins, and among cephalosporins, is mainly related to side chain similarity (Ref).

• Potential cross-reactions may occur between cefepime, ceftriaxone, cefuroxime, ceftazidime, and cefotaxime (Ref).

Neurotoxicity

Cefepime-induced neurotoxicity (CIN) may occur and has been reported with use in adult and pediatric patients, including altered mental status, aphasia, encephalopathy, impaired consciousness, myoclonus, seizure, and nonconvulsive status epilepticus (Ref). Resolution of symptoms has been reported a median of 2 to 3 days after intervention (Ref).

Mechanism: Not clearly established; may be associated with concentration-dependent inhibition of GABAA-mediated neurotransmission (Ref)

Onset: Rapid; a median of 2 to 4 days after initiation has been reported (Ref).

Risk factors:

• Excessive dosing; however, may also occur at appropriately adjusted doses (eg, for kidney impairment) (Ref)

• Elevated Cmin (trough) concentrations; risk also increases with increasing Cmin (Ref)

• Kidney impairment (Ref)

• Older age (Ref)

• Preexisting brain injury (Ref)

Adverse Reactions

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

>10%: Hematologic & oncologic: Positive direct Coombs test (without hemolysis: 16%)

1% to 10%:

Dermatologic: Pruritus (≤1%), skin rash (1% to 4%)

Endocrine & metabolic: Hypophosphatemia (3%)

Gastrointestinal: Diarrhea (≤3%), nausea (≤2%), vomiting (≤1%)

Hematologic & oncologic: Abnormal partial thromboplastin time (2%), change in prothrombin time (1%), eosinophilia (2%)

Hepatic: Increased serum alanine aminotransferase (3%), increased serum aspartate aminotransferase (2%)

Hypersensitivity: Hypersensitivity reaction (in patients with a history of penicillin allergy: ≤10%)

Local: Localized phlebitis (1%)

Nervous system: Headache (≤1%)

Miscellaneous: Fever (≤1%)

<1%:

Dermatologic: Erythema of skin, urticaria

Endocrine & metabolic: Hypercalcemia, hyperkalemia, hyperphosphatemia, hypocalcemia

Gastrointestinal: Clostridioides difficile colitis, oral candidiasis

Genitourinary: Vaginitis

Hematologic & oncologic: Anemia

Hepatic: Increased serum alkaline phosphatase, increased serum bilirubin

Local: Local inflammation, local pain

Renal: Increased blood urea nitrogen, increased serum creatinine

Postmarketing:

Dermatologic: Acute generalized erythematous pustulosis (Botelho 2010), Stevens-Johnson syndrome (Marco-del Rio 2017)

Gastrointestinal: Clostridioides difficile-associated diarrhea (Thabit 2019)

Hematologic & oncologic: Agranulocytosis (Medrano-Casique 2015), leukopenia (Jauregui 1993), neutropenia (Malincarne 2010), thrombocytopenia (Lim 2011)

Hepatic: Cholestatic hepatitis (Malhotra 2023, Yang 2022)

Hypersensitivity: Anaphylaxis (Moreno 2007), angioedema (Orhan 2004), drug reaction with eosinophilia and systemic symptoms (Qadri 2017)

Nervous system: Neurotoxicity (including abnormal gait [Shah 2021], agitation [Hambrick 2022], altered mental status [Payne 2017], aphasia [Isitan 2017], coma [Sonck 2008], confusion [Triplett 2019], encephalopathy [Triplett 2019], fine motor control disorder [Shah 2021], hallucination [Lamoth 2010], impaired consciousness [Payne 2017], myoclonus [Lizarraga 2019], seizure [Triplett 2019], slurred speech [Khorasani-Zadeh 2020], status epilepticus [nonconvulsive] [Garin 2019], stupor [Kim 2013], tremor [Hambrick 2022])

Renal: Acute interstitial nephritis (Qadri 2017)

Respiratory: Eosinophilic pneumonitis (Jones 2021)

Contraindications

Hypersensitivity to cefepime, other cephalosporins, penicillins, other beta-lactam antibiotics, or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Elevated INR: May be associated with increased INR, especially in nutritionally deficient patients, prolonged treatment, hepatic or renal disease.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection.

Disease-related concerns:

• Seizure disorders: Use with caution in patients with a history of seizure disorder.

Special populations:

• Older adult: Serious adverse reactions have occurred in elderly patients with renal insufficiency given unadjusted doses of cefepime, including life-threatening or fatal occurrences of encephalopathy, myoclonus, and seizures.

Warnings: Additional Pediatric Considerations

The manufacturer does not recommend the use of cefepime in pediatric patients for the treatment of serious infections due to Haemophilus influenzae type b, for suspected meningitis, or for meningeal seeding from a distant infection site. However, cefepime has been shown to achieve adequate concentrations in the cerebrospinal fluid and has been evaluated in the treatment of CNS infections (including those caused by H. influenzae type b) (Ellis 2007; Sáez-Llorens 1995; Sáez-Llorens 2001; Sullins 2013). It is currently recommended for empiric treatment of health care-associated ventriculitis or meningitis, in combination with vancomycin, or for the directed treatment of susceptible bacterial meningitis (including that caused by Pseudomonas aeruginosa) (IDSA [Tunkel 2004]; IDSA [Tunkel 2017]).

Dosage Forms: US

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

Solution, Intravenous, as hydrochloride:

Generic: 2 g/100 mL (100 mL)

Solution, Intravenous, as hydrochloride [preservative free]:

Generic: 1 g/50 mL (50 mL)

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

Maxipime: 2 g (1 ea [DSC])

Generic: 1 g (1 ea)

Solution Reconstituted, Intravenous, as hydrochloride [preservative free]:

Generic: 2 g (1 ea); 100 g (1 ea); 1-5 GM-%(50ML) (1 ea); 2-5 GM-%(50ML) (1 ea)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Cefepime HCl Intravenous)

1 gm/50 mL (per mL): $0.65

2 g/100 mL (per mL): $0.51

Solution (reconstituted) (Cefepime HCl Injection)

1 g (per each): $3.10 - $20.33

Solution (reconstituted) (Cefepime HCl Intravenous)

2 g (per each): $5.76 - $40.36

100 g (per each): $570.00

Solution (reconstituted) (Cefepime-Dextrose Intravenous)

1GM 5%(50ML) (per each): $23.62

2GM 5%(50ML) (per each): $35.82

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.

Dosage Forms: Canada

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

Solution Reconstituted, Injection, as hydrochloride:

Generic: 1 g (1 ea); 2 g (1 ea)

Administration: Pediatric

Parenteral:

Intermittent IV infusion: Administer as an intermittent IV infusion over 30 minutes.

Extended IV infusion: Administer over 3 to 4 hours (Ref).

IV push: In adults, limited data with IV push administration over 2 to 5 minutes at concentrations of 40 to 200 mg/mL have demonstrated this method to be generally safe and tolerable, but clinical outcomes have not been assessed (Ref).

IM: Administer by deep IM injection into large muscle mass.

Administration: Adult

IM: Inject deep IM into large muscle mass.

IV: Administer as an intermittent infusion over 30 minutes. For extended-infusion administration (off-label method), administer over 3 to 4 hours (Ref).

IV push: Limited data with IV push administration over 2 to 5 minutes at concentrations of 40 to 200 mg/mL have demonstrated this method to be generally safe and tolerable, but outcomes have not been assessed (Ref).

Storage/Stability

Vials: Store intact vials at 20°C to 25°C (68°F to 77°F). Protect from light. After reconstitution, stable in NS and D5W for 24 hours at 20°C to 25°C (68°F to 77°F) and 7 days at 2°C to 8°C (36°F to 46°F). Refer to the manufacturer's product labeling for other acceptable reconstitution solutions.

Dual chamber containers: Store unactivated containers at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 85°F). Do not freeze. Following reconstitution, use within 12 hours if stored at room temperature or within 5 days if stored under refrigeration.

Premixed solution: Store frozen at -20°C (-4°F). Thawed solution is stable for 24 hours at room temperature or 7 days under refrigeration; do not refreeze.

Use

Treatment of pneumonia, uncomplicated skin and soft tissue infections, and complicated and uncomplicated urinary tract infections (including pyelonephritis) caused by susceptible organisms; empiric therapy for febrile neutropenic patients (FDA approved in ages ≥2 months and adults); treatment of complicated intra-abdominal infections in combination with metronidazole (FDA approved in adults); has also been used for meningitis, endocarditis, and the treatment of peritonitis in patients with peritoneal catheters.

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

Cefepime may be confused with cefixime, cefTAZidime

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Aminoglycosides: Cephalosporins may enhance the nephrotoxic effect of Aminoglycosides. Cephalosporins may decrease the serum concentration of Aminoglycosides. 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

Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination

Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination

Furosemide: May enhance the nephrotoxic effect of Cephalosporins. Risk C: Monitor therapy

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy

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

Probenecid: May increase the serum concentration of Cephalosporins. 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

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): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy

Pregnancy Considerations

Cefepime crosses the placenta (Ozyuncu 2010).

An increased risk of major birth defects or other adverse fetal or maternal outcomes has generally not been observed following use of cephalosporin antibiotics during pregnancy.

When an antibiotic is needed for the treatment of maternal infection, cefepime can be considered. However, other, more well-studied cephalosporins are preferred for use in pregnancy (Betschart 2020; ERS/TSANZ [Middleton 2020]; Panchaud 2016).

Monitoring Parameters

With prolonged therapy, monitor renal and hepatic function periodically; number and type of stools/day for diarrhea; serum phosphorus (Knoderer 2018); CBC with differential. Monitor closely for signs and symptoms of hypersensitivity including anaphylaxis.

Reference Range

Cefepime concentration monitoring is not routine, but may be considered in certain scenarios (eg, critically ill patients, patients with organ failure or the expectation of altered pharmacokinetics [ie, extracorporeal membrane oxygenation, continuous renal replacement therapy, augmented renal clearance], or pathogens with minimum inhibitory concentrations (MICs) at, near, or above the susceptibility breakpoint) (Cies 2018; Fratoni 2021; Roberts 2018; Stitt 2019; Zuppa 2019).

Note: Monitoring approaches are not standardized; various approaches and suggested targets exist. Refer to institutional protocols if available (Fratoni 2021; Morales 2022).

Target:

Efficacy: Non-protein bound (free) serum concentration should exceed the pathogen MIC for ~60% to 100% of the dosing interval (ie, fT>MIC of ≥60% to 100%) (Fratoni 2021; Roberts 2014; Shoji 2016; Stitt 2019; Zuppa 2019). Some authors have suggested more aggressive targets, such as concentration exceeding 4 times the pathogen MIC for 40% to 100% of the dosing interval, but it's unclear whether these targets are necessary (Cies 2018; Fratoni 2021; Roberts 2018; Stitt 2019).

Toxicity: Neurotoxicity risk increases with increasing concentration. In adults, trough concentrations >16 to 22 mg/L for intermittent dosing or steady state concentrations >35 mg/L for continuous infusion dosing have been associated with increased risk of neurotoxicity; pediatric-specific data are not available (Boschung-Pasquier 2020; Fratoni 2021; Guilhaumou 2019; Huwyler 2017).

Timing of serum sampling: Several methods have been described:

Single sample: A single concentration obtained midway through the dosing interval (eg, 50%) or at the end of the dosing interval (trough; just before the next dose) can be compared to desired threshold (Fratoni 2021).

Multiple sample: ≥2 to 3 concentrations may be obtained during the dosing interval (eg, peak and trough, multiple mid-interval concentrations). Values may then be utilized with population PK and Bayesian modeling software, or for calculation of patient-specific pharmacokinetic parameters and time above MIC using standard pharmacokinetic equations (Cies 2018; Fratoni 2021).

Mechanism of Action

Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysis and murein hydrolases) while cell wall assembly is arrested.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: IM: Rapid and complete.

Distribution:

Vd:

Neonates (Capparelli 2005):

PMA <30 weeks: 0.51 L/kg.

PMA >30 weeks: 0.39 L/kg.

Infants ≥2 months and children ≤11 years: 0.3 ± 0.1 L/kg.

Adults: 18 L, 0.26 L/kg; penetrates into inflammatory fluid at concentrations ~80% of serum concentrations and into bronchial mucosa at concentrations ~60% of plasma concentrations; crosses the blood-brain barrier.

Cerebrospinal fluid (CSF):

Neonates (Ellis 2007):

Preterm (n=2): CSF:serum ratio (Cmin): ~30% to 87.6%.

Term (n=7): CSF:serum ratio (Cmin): ~3.1% to 59.7%.

Infants ≥2 months, Children, and Adolescents ≤15 years: CSF:serum ratio: 9% at 30 minutes after dose, increasing to 67% at 8 hours after dose (Sáez-Llorens 1995).

Adults: CSF:serum ratio: 4% to 34% (AUC); 5% to 58% (Cmin) (Rhoney 2003).

Lung:

Epithelial lining fluid:serum ratio: ~100% (Boselli 2003; Breilh 2001).

Protein binding, plasma: ~20%.

Metabolism: Minimally hepatic.

Half-life elimination:

Neonates: 4 to 5 hours (Lima-Rogel 2008).

Children 2 months to 6 years of age: 1.77 to 1.96 hours.

Adults: 2 hours.

Hemodialysis: 13.5 hours.

Continuous peritoneal dialysis: 19 hours.

Time to peak: IM: 1 to 2 hours; IV: 0.5 hours.

Excretion: Urine (85% as unchanged drug).

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Total body clearance is decreased proportionally with creatinine clearance.

Anti-infective considerations:

Parameters associated with efficacy: Time dependent; associated with time free drug concentration (fT) > minimum inhibitory concentration (MIC).

Organism specific:

Staphylococcus spp.: Goal: 40% fT > MIC (bactericidal in vitro) (Craig 1995).

Streptococcus spp.: Goal: 40% fT > MIC (bacteriostatic in vitro), 60% to 70% fT > MIC (bactericidal in vitro) (Craig 1995).

Gram negative bacteria (including P. aeruginosa): Goal: 40% fT > MIC (bacteriostatic in vitro); 60% to 70% fT > MIC (bactericidal in vitro); 53% to 60% fT > MIC (microbiological response) (Craig 1995; Craig 1998; Crandon 2010; MacVane 2014a; Roos 2006).

Population specific:

Critically ill patients in the ICU: Minimum goal: ≥50% fT > MIC; preferred goal: ≥100% fT > MIC (Roberts 2014); some experts favor ≥100% fT >4 times the MIC (Guilhaumou 2019).

Postantibiotic effect: Generally little to no postantibiotic effect for Streptococcus spp. and gram negative bacilli (including P. aeruginosa); prolonged postantibiotic effect for Staphylococcus spp. (Craig 1991; Craig 1995; Craig 1998; Ozbek 2009).

Parameters associated with toxicity: Neurotoxicity (eg, confusion, altered consciousness, seizures) is associated with elevated Cmin (trough) concentrations and risk increases with increasing Cmin; however, a specific Cmin associated with neurotoxicity has not been well established (Boschung-Pasquier 2020; Huwyler 2017; Lamoth 2010; Payne 2017). In 2 small studies, Cmin of ≥22 mg/L and >35 mg/L were associated with neurotoxicity (Huwyler 2017; Lamoth 2010). In a study assessing cefepime therapeutic drug monitoring in adults, Cmin <7.7 mg/L resulted in no neurotoxicity, Cmin ≥12 mg/L was associated with a 25% probability of neurotoxicity, Cmin ≥16 mg/L was associated with a 50% probability of neurotoxicity, and Cmin ≥38.1 mg/L was always associated with neurotoxicity (Boschung-Pasquier 2020).

Expected drug concentrations in patients with normal renal function:

Neonates (Shoji 2016): Cmax (peak): IV:

GA <36 weeks: ~50 mg/kg/dose every 12 hours, steady state: 190.02 ± 31.25 mg/L.

GA ≥36 weeks: ~50 mg/kg/dose every 12 hours, steady state: 192.92 ± 19.64 mg/L.

Infants and children 2 months to 16 years of age; hospitalized: Cmax (peak): IV:

50 mg/kg/dose every 8 hours, steady state: 184.2 ± 38 mg/L (Reed 1997).

Adults: Cmax (peak): IV:

30-minute infusion, healthy volunteers:

1 g, single dose: 81.7 ± 5.1 mg/L.

1 g every 8 hours, steady state (day 6): 70.5 ± 8.5 mg/L (Barbhaiya 1992).

2 g, single dose: 163.9 ± 25.3 mg/L.

2 g every 8 hours, steady state (day 6): 129 ± 27.1 mg/L (Barbhaiya 1992).

4-hour infusion, hospitalized patients requiring antibiotics:

1 g every 8 hours, steady state: 32.5 ± 13.5 mg/L (Cheatham 2011).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Maxipime | Pozineg | Protec | Qpime;
  • (AR) Argentina: Cefepime northia | Cefepime pharmavia | Cefepime richet | Cefimen K | Fada cefepime | Maxcef | Rivepime;
  • (AT) Austria: Cefepim Amomed | Cefepim mip | Cefepim Sandoz | Cefepime accord | Maxipime;
  • (AU) Australia: Cefepime aft | Cefepime alphapharm | Cefepime Kabi | DBL Cefepime | Maxipime | Omegapharm Cefepime;
  • (BD) Bangladesh: Axepime | Cefa 4 | Ceftipime | Efepime | Forgen | Japime | Magnova | Maxpime | Megapime | Superpime | Tetracef | Ultrapime | Winnipime | Xenim | Ximepime | Zopime;
  • (BE) Belgium: Cefepim Fresenius Kabi | Cefepim mip | Cefepim Sandoz | Cefepime ldp laboratorios torlan | Cefepime noridem | Maxipime;
  • (BF) Burkina Faso: Kefpime | Pozineg | Zipime;
  • (BG) Bulgaria: Alphacef | Bacteripime | Cefepim | Cefepime Kabi | Cefepime panpharma | Critipime | Maxipime;
  • (BR) Brazil: Cefepima Cloridrato | Cemax | Cloridrato de cefepima | Cloridrato de cefepime | Maxcef | Nepecef;
  • (CH) Switzerland: Cefepim Sandoz | Cefepime Orpha | Maxipime;
  • (CI) Côte d'Ivoire: Kefpime | Micropime | Pozineg | Sanpime | Ultrapime | Zipime;
  • (CL) Chile: Cefepima | Maxipime;
  • (CN) China: Cefepime dihydrochloride | Da li neng | Heng su | Ka luo xin | Kang li wo pu | Lai bi xin | Li si ping | Maxipime | Maxipimg | Pai nai xin | Xin li wei;
  • (CO) Colombia: Cefdeltime | Cefemin | Cefepima | Cefepime | Imation | Maxipime | Pimecef | Pozineg | Salapime;
  • (CZ) Czech Republic: Cefepim noridem | Cefepime accord | Maxipime;
  • (DE) Germany: Cefepim mip | Cefepim panpharma | Cefepim qilu | Cefepim stragen | Cefepime rotexmedica | Maxipime;
  • (DO) Dominican Republic: Cefepima | Cefepime | Cefepime sintesis | Cefime | Cipime | Efectus | Kabol | Maxipime | Pramur;
  • (EC) Ecuador: Cefepima | Cefepime | Cefepime richet | Cefimen-k | Maxipime;
  • (EE) Estonia: Alphacef | Cefepime | Cefepime norameda | Maxipime | Renapime;
  • (EG) Egypt: Cefepime | Cepimax | Curafep | Forcetex | Kempopim | Maxipime | Pimfast | Vanzapro | Wincef | Zovijectin;
  • (ES) Spain: Cefepima | Cefepima combino | Cefepima hospira | Cefepima kabi | Cefepima normon | Cefepima qilu | Cefepima sala | Maxipime;
  • (ET) Ethiopia: Cefepime HCL | Injpime | Necpime | Pozineg | Protec | Sanpime;
  • (FI) Finland: Cefepim MIP Pharma | Cefepime norameda | Maxipime;
  • (FR) France: Axepim | Cefepime accord | Cefepime Dci | Cefepime gerda | Cefepime Mylan | Cefepime noridem | Cefepime panpharma | Cefepime stragen;
  • (GB) United Kingdom: Renapime;
  • (GR) Greece: Cefepime/alvia | Cefepime/kabi | Gencef | Maxinject | Maxipime | Verapime | Zefipime;
  • (HK) Hong Kong: Maxipime;
  • (HR) Croatia: Cefepime Kabi | Maxipime;
  • (HU) Hungary: Cefepime mip | Maxipime;
  • (ID) Indonesia: Actacef | Biocepime | Caprifim | Cefepime | Cefinov | Daryacef | Emax | Exepime | Falocef | Futapim | Interpim | Macef | Maxicef | Maxilan | Maximer | Maxipime | Procepim | Sandocef | Sopime | Vipime;
  • (IL) Israel: Maxcef;
  • (IN) India: Adpime | Biopime | Blucef XL | C pime | Cachepime | Cefdiel-i | Cefeprime | Ceficad | Cefpy | Celrim | Cepime | Cepy | Epime | Forpar | Ivipime | Kefage | Kefpime | Kepime | Kingcef | Mapime | Maxicef | Maxopime | Megapime | Micropime | Nitipime | Novapime | Orpime | Pozineg | Pryme | Radipime | Refpim | Safepime | Scud | Sefdin | Ultipime | Vegapime | Winpime | Zipime | Zwiter;
  • (IT) Italy: Cepim | Cepimex | Maxipime;
  • (JO) Jordan: Cepim | Maxipime;
  • (JP) Japan: Cefepime HCL | Cefepime hydrochloride Cmx | Maxipime bristol myers | Maxipime meiji;
  • (KE) Kenya: C pime | Cefepimark | Ceficad | Ceftipime | Forpar | Injpime | Inno pime | Kopime | Maxime | Megapime | Micropime | Necpime | Pimcef | Pimefast | Pozineg | Skypime | Teico | Totacef | Ultrapime;
  • (KR) Korea, Republic of: Acepime | Alvogen cefepime hcl | Cefem | Maxipime boryung | Newcepim | Newsepim;
  • (KW) Kuwait: Deltacef | Maxipime | Protec;
  • (LB) Lebanon: Cefepime panpharma | Cefipex | Maxipime | Qpime;
  • (LT) Lithuania: Cefepime mip | Cefepime norameda | Maxipime;
  • (LU) Luxembourg: Maxipime;
  • (LV) Latvia: Cefepime mip | Cefepime norameda | Maxipime;
  • (MA) Morocco: Protec;
  • (MX) Mexico: Cefepima | Feriticefin | Imation | Makenpime | Maxef | Maxipime | Pimerzen | Pozineg | Suloval | Toblefam | Vipefime;
  • (MY) Malaysia: Cefepen | Ceficad | Cefmex | Forpar | Maxipime | Sefepim | Verapime;
  • (NG) Nigeria: Asceftra;
  • (NO) Norway: Cefepim;
  • (NZ) New Zealand: Cefepime | Cefepime aft | Cefepime Kabi | DBL Cefepime | Maxipime;
  • (OM) Oman: Protec;
  • (PE) Peru: Cefepima | Cefepimek | Maxipime | Megapime | Norcef | Pimcef;
  • (PH) Philippines: 4 gen 1000 | Alcemax | Altamax | Axera | Cefepime | Cefevex | Cefime | Cepimax | Cepiram | Dimipra | Extemax | Kevon | Medipime | Megapime | Neupime | Pimevex | Pozineg | Sanpime | Sefepim | Sefpime | Sepime | Spectrax | Stafipime | Supime | Vipefime | Zepim;
  • (PK) Pakistan: Adpime | Afipime | Aleeva | Alipime | Axepime | Axipime | Baxipime | Cef hy | Cefevial | Cefgram | Cefi | Cefigen | Cefipar | Cefipime | Cefstar | Cerapime | Daypime | Dizma 4 | Elide | Emipref | Emty | Endopime | Feldopim | Fredipime | Gepin | Gu pime | Jewpime | Kanpime | Magnapime | Markpime | Maxipime | Maxpin | Maxum | Medipime | Megapime | Mepime | Neupime | New pime | Novapime | Nuxipim | Olipime | On cef | Palfepim | Pefmad | Perin | Pimalin | Pimazon | Pime | Pimecef | Pimeranis | Pimerive | Pimestar | Pimporin | Puna | Siodime | Solopime | Swisspime | Uceph | Unipime | Uspime | Vegapime | Verapime | Voco | Winpime | Zepim;
  • (PL) Poland: Cefepim MIP Pharma | Cefepime Kabi | Cefepime panpharma | Critipeme | Maxipime;
  • (PR) Puerto Rico: Cefepime | Cefepime HCL | Maxipime;
  • (PT) Portugal: Cefepima accord | Cefepima basi | Cefepima hospira | Cefepima kabi | Cefepima normon | Maxipime;
  • (PY) Paraguay: Acedrin | Cefepima libra | Cefepima medicine | Cefepima vmg | Cefepime prosalud | Cefepime richet | Cefinina | Clorhidrato de cefepima | Fada cefepime;
  • (QA) Qatar: Cepim | Deltacef | Pozineg | Protec;
  • (RO) Romania: Cefepime Kabi;
  • (RU) Russian Federation: Cefepim | Cefepime | Cefepime agio | Cefepime alkem | Cefepime jodas | Cefepime vial | Cefomax | Cepim | Cling | Decefim | Efipime | Kefsepim | Ladef | Maxicef | Maxipime | Maxycef | Movizar;
  • (SA) Saudi Arabia: Cefepime | Deltacef | Maxipime | Vanzapro;
  • (SE) Sweden: Cefepim mip | Maxipime;
  • (SG) Singapore: Maxipime;
  • (SI) Slovenia: Cefepim kabi | Maxipime;
  • (SK) Slovakia: Cefepim noridem | Maxipime;
  • (TH) Thailand: Aspime | Cefamax | Maxipime | Megapime | Orpime | Pime | Sefpime;
  • (TR) Turkey: Avipim | Ekipim | Maxipime | Roxipime | Unisef;
  • (TW) Taiwan: Antifect | Cefemax | Cefepime | Cefepin | Cefim | Funjapin | Macepim | Maxipime | Supecef | Tisan | Yupime;
  • (UA) Ukraine: Abypim | Blipime | Brodipime | Cebopime | Cefepim | Cefepime | Cefepime vista | Cefepimum | Ceficad | Cefimek | Cefotrine | Cepim | Espim | Exipime | Extencef | Fortacef | Kefpime | Maxinort | Maxipim | Megapim | Novapim | Pikcef | Pozineg | Quadrocef | Quartacef | Roxipim | Sanpime | Septipim | Ukpime 1000;
  • (UG) Uganda: Ceficad | Megapime | Necpime | Pimcef | Pozineg | Sanpime | Teico | Vaxcel cefepime | Welzpime;
  • (UY) Uruguay: Cefepime northia | Cepim | Maxcef;
  • (VE) Venezuela, Bolivarian Republic of: Cefepima | Forpar | Maxipime | Necpime | Pimcef | Sanpime;
  • (VN) Viet Nam: Bapexim | Cefeme | Cefpas | Dixapim;
  • (ZA) South Africa: Auro cefepime | Cefepime actor | Cefepime safeline | Critipeme | Maxipime;
  • (ZM) Zambia: Forcepime | Micropime | Necpime | Novapime | Orpime
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