Dosage Forms
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:
Generic: 1 g (1 ea [DSC])
Solution Reconstituted, Injection, as hydrochloride [preservative free]:
Maxipime: 1 g (1 ea [DSC]); 2 g (1 ea [DSC])
Generic: 1 g (1 ea); 2 g (1 ea)
Solution Reconstituted, Intravenous, as hydrochloride [preservative free]:
Maxipime: 1 g (1 ea [DSC]); 2 g (1 ea [DSC])
Generic: 1-5 GM-%(50ML) (1 ea); 2-5 GM-%(50ML) (1 ea)
Pharmacology
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/Pharmacodynamics
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 and Children 2 months to 11 years: 0.3 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
Metabolism
Minimally hepatic
Excretion
Urine (85% as unchanged drug)
Time to Peak
IM: 1 to 2 hours; IV: 0.5 hours
Half-Life Elimination
Neonates: 4 to 5 hours (Lima-Rogel 2008)
Children 2 months to 6 years: 1.77 to 1.96 hours
Adults: 2 hours
Hemodialysis: 13.5 hours
Continuous peritoneal dialysis: 19 hours
Protein Binding
Plasma: ~20%
Use in Specific Populations
Special Populations: Renal Function Impairment
Total body clearance is decreased proportionally with creatinine clearance.
Use: Labeled Indications
Intra-abdominal infection: Treatment, in combination with metronidazole, of complicated intra-abdominal infections caused by Escherichia coli, viridans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis.
Neutropenic fever: Empiric treatment of febrile neutropenic patients.
Pneumonia (moderate to severe): Treatment of moderate to severe pneumonia caused by Streptococcus pneumoniae, including cases associated with concurrent bacteremia, P. aeruginosa, K. pneumoniae, or Enterobacter species.
Skin and soft tissue infection: Treatment of moderate to severe skin and soft tissue infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes.
Urinary tract infection, including pyelonephritis: Treatment of urinary tract infections, including pyelonephritis, caused by E. coli, K. pneumoniae, or Proteus mirabilis, including cases associated with concurrent bacteremia with these microorganisms.
Use: Off Label
Bloodstream infection (gram-negative bacteremia)cyes
Data from a prospective, randomized, open-comparison study support the use of cefepime in the treatment of gram-negative bacteremia Schrank 1995.
Based on the Infectious Diseases Society of America (IDSA) clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection, cefepime is effective and recommended for the treatment of intravascular catheter-related infection caused by Pseudomonas aeruginosa.
Cystic fibrosis, exacerbationyes
Based on the Cystic Fibrosis Foundation's cystic fibrosis pulmonary guidelines, cefepime, as part of an appropriate combination regimen (which should include an additional antipseudomonal agent), is effective and recommended for the treatment of P. aeruginosa infection during an acute exacerbation of cystic fibrosis pulmonary disease.
Diabetic foot infection, moderate to severeyes
Based on the IDSA guidelines for the diagnosis and treatment of diabetic foot infections, cefepime, in combination with other appropriate agents, is an effective and recommended treatment option for diabetic foot infections.
Intracranial abscess (brain abscess, intracranial epidural abscess) and spinal epidural abscessc
Clinical experience suggests the utility of cefepime in the management of brain abscess, intracranial epidural abscess, and spinal epidural abscess Bond 2016, Sexton 2019a, Sexton 2019b, Southwick 2018.
Meningitis, bacterialyes
Based on the IDSA guidelines for the management of bacterial meningitis and healthcare-associated ventriculitis and meningitis, cefepime is effective and recommended for the treatment of bacterial meningitis caused by P. aeruginosa; as an alternative agent for the treatment of meningitis caused by extended-spectrum beta-lactamase-producing gram-negative bacilli, H. influenzae, or S. pneumoniae (with a penicillin MIC ≥0.12 mcg/mL and cefotaxime or ceftriaxone MIC <1 mcg/mL); and as empiric therapy (in combination with vancomycin) for health care-associated ventriculitis or meningitis.
Neutropenic enterocolitis (typhlitis)yes
Based on the IDSA clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer, cefepime, in combination with metronidazole, is effective and recommended for the management of neutropenic enterocolitis (typhlitis).
Osteomyelitiscyes
Data from a limited number of patients suggest that cefepime may be beneficial for the treatment of osteomyelitis Jauregui 1993.
Based on the IDSA guidelines for the diagnosis and treatment of native vertebral osteomyelitis in adults, cefepime is an effective and recommended agent for the treatment of native vertebral osteomyelitis due to P. aeruginosa or Enterobacteriaceae.
Prosthetic joint infectionyes
Based on the IDSA guidelines for the diagnosis and management of prosthetic joint infection, cefepime is an effective and recommended agent for the treatment of prosthetic joint infection due to P. aeruginosa or Enterobacter spp.
Sepsis and septic shockyes
Based on the Society of Critical Care Medicine international guidelines for management of sepsis and septic shock, cefepime, in combination with other appropriate agents, is effective and recommended for broad-spectrum antibacterial coverage (including P. aeruginosa) in the management of sepsis and septic shock.
Septic arthritisc
Clinical experience suggests the utility of cefepime for the treatment of septic arthritis Goldenberg 2019.
Contraindications
Hypersensitivity to cefepime, other cephalosporins, penicillins, other beta-lactam antibiotics, or any component of the formulation
Dosage and Administration
Dosing: Adult
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 (Crandon 2010; Koomanachai 2010; Su 2017). 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 (Lodise 2006; Roos 2006; Tam 2003).
Extended-infusion method (off label): IV: 2 g every 8 hours infused over 3 or 4 hours (Arnold 2013; Bauer 2013; Koomanachai 2010; Nicasio 2009; Wrenn 2018); may consider giving first dose over 30 minutes (Wrenn 2018). Extended-infusion method is supported by data suggesting equal or better attainment of pharmacokinetic targets and theoretical clinical benefit in patients with critical illness or altered pharmacokinetics (MacVane 2014; Moehring 2019a) and possible clinical benefit among patients infected with P. aeruginosa (Bauer 2013).
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 (Moehring 2019b).
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 (IDSA [Mermel 2009]; Moehring 2019b; Su 2017). 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 (Kanj 2018b; Moehring 2019b; SCCM [Rhodes 2017]). Some experts also prefer the extended-infusion method in critical illness or if treating a susceptible organism with an elevated MIC (Moehring 2019a; SCCM [Rhodes 2017]).
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 (Moehring 2019b; Yahav 2018). If neutropenic, extend treatment until afebrile for ≥48 hours and recovery of neutrophils (ANC ≥500 cells/mm3 and increasing) (IDSA [Freifeld 2011]). For P. aeruginosa bacteremia in neutropenic patients, some experts treat for a minimum of 14 days and until recovery of neutrophils (Kanj 2018b).
Cystic fibrosis, severe acute pulmonary exacerbation or failure of oral therapy, for coverage of P. aeruginosa (off-label use): IV: 2 g every 8 hours (Zobell 2013). Note: Most often given as part of a combination regimen, which should include an additional antipseudomonal agent (Flume 2009; Simon 2019). The optimal duration is not well defined and should be individualized based on clinical response (Flume 2009); duration is usually 10 days to 3 weeks or longer (Simon 2019).
Diabetic foot infection, moderate to severe (off-label use): IV: 2 g every 8 to 12 hours in combination with other appropriate agents; for P. aeruginosa infection, use 2 g every 8 hours (Gentry 1991; So 2016; Weintrob 2019). Note: Empiric P. aeruginosa coverage with this dose is usually not indicated unless patient is at risk (eg, significant water exposure, warm climate) (IDSA [Lipsky 2012]; Weintrob 2019).
Duration of therapy: Duration (which may include oral step-down therapy) is usually 2 to 4 weeks in the absence of osteomyelitis but varies based on patient-specific factors, including clinical response (IDSA [Lipsky 2012]; Weintrob 2019).
Intra-abdominal infection, health care-associated or high-risk community-acquired infection: 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. Duration of therapy may be limited to 4 to 7 days in patients with adequate source control (IDSA [Solomkin 2010]; SIS [Mazuski 2017]); a longer duration of therapy may be necessary in certain situations (eg, source control is suboptimal, the patient is managed nonoperatively) (Barshak 2018).
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, but some patients require a longer course. The appropriate duration depends on cultured pathogen(s) and patient-specific factors, including clinical response (Bodilsen 2018; Sexton 2019a; Sexton 2019b; Southwick 2018).
Meningitis, bacterial (off-label use): Note: As a component of empiric therapy for health care-associated 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 (IDSA [Tunkel 2004]; IDSA [Tunkel 2017]).
Neutropenic enterocolitis (typhlitis) (off-label use): IV: 2 g every 8 hours in combination with metronidazole (IDSA [Freifeld 2011]; Wong Kee Song 2018). 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 (Wong Kee Song 2018).
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) (IDSA [Freifeld 2011]; some experts use an ANC cutoff of <500 cells/mm3 to define high-risk patients (Wingard 2019).
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 (IDSA [Freifeld 2011]). Some experts prefer the extended infusion method, particularly in those who are critically ill (Moehring 2019a; SCCM [Rhodes 2017]; Wingard 2019).
Osteomyelitis and/or discitis (off-label use): IV: 2 g every 8 to 12 hours for ≥6 weeks (IDSA [Berbari 2015]; Osmon 2019). For empiric therapy, use in combination with other appropriate agents (IDSA [Berbari 2015]).
Peritonitis, treatment (peritoneal dialysis patients) (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 (ISPD [Li 2016]).
Automated peritoneal dialysis (APD): Intraperitoneal: 1 g every 24 hours given in the longest dwell is preferred (ISPD [Li 2016]).
CAPD:
Intermittent: Intraperitoneal: 1 g added to one exchange of dialysis solution every 24 hours (to be given in the longest daily dwell) (ISPD [Li 2016]).
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 (ISPD [Li 2016]).
Note: Consider 25% dose increase in patients on APD or CAPD with significant residual kidney function (urine output >100 mL/day) (Mancini 2018; Szeto 2018).
Pneumonia:
Community-acquired pneumonia, as a component of empiric therapy for 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 and varies based on disease severity and response to therapy; a longer course may be required for severe or complicated infection or for P. aeruginosa infection (File 2019; Kanj 2019). Patients should be afebrile for ≥48 hours and clinically stable prior to discontinuation (File 2019; IDSA/ATS [Mandell 2007]).
Hospital-acquired pneumonia or ventilator-associated pneumonia, as empiric therapy or pathogen-specific therapy for resistant gram-negative bacilli (eg, P. aeruginosa): IV: 2 g every 8 hours, as part of an appropriate combination regimen. Duration of therapy varies based on disease severity and response to therapy; treatment is typically given for 7 days (IDSA/ATS [Kalil 2016]), but longer courses may be warranted for severe or complicated infection or for P. aeruginosa infection (Kanj 2019; Klompas 2019). Note: Some experts prefer the extended-infusion method, particularly in those who are critically ill or to optimize exposure if treating a susceptible organism with an elevated MIC (Klompas 2019; Moehring 2019a; SCCM [Rhodes 2017]).
Prosthetic joint infection, pathogen-specific therapy for gram-negative bacilli (off-label use): IV: 2 g every 8 to 12 hours (Berbari 2019; IDSA [Osmon 2013]).
Sepsis and septic shock (broad-spectrum coverage, including P. aeruginosa) (off-label use): IV: 2 g every 8 hours (Alves 2014); use in combination with other appropriate agents. Initiate therapy as soon as possible and preferably within 1 hour of recognition of sepsis or septic shock. Usual duration of treatment is 7 to 10 days but may be longer or shorter depending on clinical response and/or source of infection (SCCM [Rhodes 2017]). Some experts prefer the extended-infusion method (Moehring 2019a; SCCM [Rhodes 2017]).
Septic arthritis, without prosthetic material (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 (Goldenberg 2019).
Skin and soft tissue infections, moderate to severe: IV: 2 g every 12 hours. Usual duration of treatment is 5 to 14 days and is individualized based on response to therapy (Kanj 2018a; Spelman 2018).
Urinary tract infection, complicated (including pyelonephritis): IV: 1 to 2 g every 12 hours; some experts prefer 2 g every 8 hours if P. aeruginosa is suspected. Switch to an appropriate oral regimen once patient has improvement in symptoms, if culture and susceptibility results allow. Duration of therapy depends on the antimicrobial chosen to complete the regimen and ranges from 5 to 14 days (Hooton 2019; IDSA [Gupta 2011]).
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
General dosing, susceptible infection (Red Book [AAP 2015]): Infants, Children, and Adolescents: IM, IV:
Mild to moderate infection: 50 mg/kg/dose every 12 hours; maximum dose: 2,000 mg/dose
Severe infection: 50 mg/kg/dose every 8 to 12 hours; maximum dose: 2,000 mg/dose
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 (Zobell 2013)
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 (AHA [Baltimore 2015])
Febrile neutropenia, empiric therapy: Infants, Children, and Adolescents: IV: 50 mg/kg/dose every 8 hours; maximum dose: 2,000 mg/dose (Red Book [AAP 2015]); 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 (Lehrnbecher 2017).
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) (IDSA [Solomkin 2010]).
Meningitis: Infants, Children, and Adolescents: IV: 50 mg/kg/dose every 8 hours; maximum dose: 2,000 mg/dose (Tunkel 2004)
Peritonitis (peritoneal dialysis) (ISPD [Warady 2012]): 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: 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 infections, 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: 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
Reconstitution
IV: Reconstitute 500 mg vial with 5 mL and 1 or 2 g vial with 10 mL of a compatible diluent (resulting concentration of 100 mg/mL for 500 mg and 1 g vial and 160 mg/mL for 2 g vial) and further dilute in a compatible IV infusion fluid.
IM: Reconstitute 500 mg or 1 g vial with 1.3 mL or 2.4 mL, respectively, of SWFI, NS, D5W, lidocaine 0.5% or 1%, or bacteriostatic water for injection; resulting concentration is 280 mg/mL.
Administration
IM: Inject deep IM into large muscle mass.
IV: Administer as an intermittent infusion over 30 minutes.
Off-label:
Direct IV: Inject direct IV over 5 minutes (Garrelts 1999)
Extended infusion: In certain patients where extended infusions may be appropriate, doses are usually infused over 3 to 4 hours (Bauer 2013; Nicasio 2010).
Storage
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.
Drug Interactions
Aminoglycosides: Cephalosporins (4th Generation) may enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). 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. Avoid combination
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy
Probenecid: May increase the serum concentration of Cephalosporins. 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. Consider therapy modification
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy
Test Interactions
Positive direct Coombs', false-positive urinary glucose test using cupric sulfate (Benedict's solution, Clinitest®, Fehling's solution), false-positive serum or urine creatinine with Jaffé reaction, false-positive urinary proteins and steroids
Adverse Reactions
>10%: Hematologic & oncologic: Positive direct Coombs test (without hemolysis; 16%)
1% to 10%:
Cardiovascular: Localized phlebitis (1%)
Central nervous system: Headache (≤1%)
Dermatologic: Skin rash (1% to 4%), pruritus (≤1%)
Endocrine & metabolic: Hypophosphatemia (3%)
Gastrointestinal: Diarrhea (≤3%), nausea (≤2%), vomiting (≤1%)
Hematologic & oncologic: Eosinophilia (2%)
Hepatic: Increased serum ALT (3%), abnormal partial thromboplastin time (2%), increased serum AST (2%), abnormal prothrombin time (1%)
Hypersensitivity: Hypersensitivity (in patients with a history of penicillin allergy: ≤10%)
Miscellaneous: Fever (≤1%)
<1%, postmarketing, and/or case reports: Agranulocytosis, anaphylactic shock, anaphylaxis, anemia, aphasia, brain disease, Clostridioides (formerly Clostridium) difficile-associated diarrhea, colitis, coma, confusion, decreased hematocrit, erythema, hallucination, hypercalcemia, hyperkalemia, hyperphosphatemia, hypocalcemia, increased blood urea nitrogen, increased serum alkaline phosphatase, increased serum bilirubin, increased serum creatinine, leukopenia, local inflammation, local pain, myoclonus, neurotoxicity, neutropenia, oral candidiasis, pseudomembranous colitis, seizure, status epilepticus (nonconvulsive), stupor, thrombocytopenia, urticaria, vaginitis
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.
- Hypersensitivity: May occur; use caution in patients with a history of penicillin sensitivity; cross-hypersensitivity may occur. If a hypersensitivity reaction occurs, discontinue therapy and institute supportive measures.
- Neurotoxicity: Severe neurological reactions (some fatal) have been reported, including encephalopathy, aphasia, myoclonus, seizures, and nonconvulsive status epilepticus. Risk may be increased in the presence of renal impairment; ensure dose adjusted for renal function and discontinue therapy if patient develops neurotoxicity; effects are often reversible upon discontinuation of cefepime.
- 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 (CrCl ≤60 mL/minute); dosage adjustments recommended. May increase risk of encephalopathy, myoclonus, and seizures.
- 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.
Concurrent drug therapy issues:
- Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Special populations:
- Elderly: 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.
Monitoring Parameters
Monitor renal function. Observe for signs and symptoms of anaphylaxis during first dose.
Pregnancy
Pregnancy Risk Factor
B
Pregnancy Considerations
Adverse events were not observed in animal reproduction studies. Cefepime crosses the placenta.
Patient Education
What is this drug used for?
- It is used to treat bacterial infections.
Frequently reported side effects of this drug
- Diarrhea
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Severe dizziness
- Passing out
- Severe fatigue
- Bruising
- Bleeding
- Severe loss of strength and energy
- Chills
- Sore throat
- Unable to pass urine
- Change in amount of urine passed
- Dark urine
- Yellow skin
- Clostridioides (formerly Clostridium) difficile-associated diarrhea like abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools.
- Confusion
- Seizures
- Difficulty speaking
- Sensing things that seem real but are not
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
