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Cefepime

Medically reviewed on Nov 15, 2018

Pronunciation

(SEF e pim)

Index Terms

  • Cefepime HCl
  • Cefepime HCl/D5W
  • Cefepime Hydrochloride

Dosage Forms

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

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:

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

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

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

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

Solution Reconstituted, Intravenous, as hydrochloride:

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

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

Brand Names: U.S.

  • Maxipime

Pharmacologic Category

  • Antibiotic, Cephalosporin (Fourth Generation)

Pharmacology

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.

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%

Special Populations: Renal Function Impairment

Total body clearance is decreased proportionally with creatinine clearance.

Use: Labeled Indications

Intra-abdominal infections: 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 infections: Treatment of moderate to severe skin and soft tissue infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes

Urinary tract infections, 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

Off Label Uses

Bloodstream infection (gram-negative bacteremia)

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.

Brain abscess, intracranial epidural abscess, or spinal epidural abscess

Clinical experience suggests the utility of cefepime in the management of brain abscess, intracranial epidural abscess, and spinal epidural abscess [Bond 2016], [Sexton 2018a], [Sexton 2018b], [Southwick 2018].

Cystic fibrosis, exacerbation

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 severe

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.

Endocarditis, prosthetic valve, treatment within 1 year of replacement (pediatric)

Based on the American Heart Association (AHA) scientific statement on infective endocarditis in childhood, cefepime, in combination with vancomycin, gentamicin, and rifampin, is effective and recommended for the treatment of prosthetic valve endocarditis within 1 year of replacement in children and adolescents.

Meningitis, bacterial

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)

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).

Osteomyelitis

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 infection

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 shock

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.

Contraindications

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

Dosing: Adult

Usual dosage range:

Traditional infusion method: IV: 1 to 2 g every 8 to 12 hours over 30 minutes. For coverage of serious Pseudomonas aeruginosa infections: 2 g every 8 hours (Crandon 2010; Koomanachai 2010; Su 2017).

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 2018a) 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 2018b)

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 2018b; 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 2018b; SCCM [Rhodes 2017]). Some experts also prefer the extended-infusion method in critical illness or if treating a susceptible organism with an elevated minimum inhibitory concentration (MIC) (Moehring 2018a; SCCM [Rhodes 2017]).

Duration of therapy: Individualize duration according to patient-specific factors and response; usual duration is 7 to 14 days (Moehring 2018b). 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).

Brain abscess, intracranial epidural abscess, or 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 in combination with other appropriate agents (Sexton 2018a; Sexton 2018b; Southwick 2018)

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: Must be given as part of a combination regimen, which should include an additional antipseudomonal agent (Flume 2009; Simon 2018).

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 2018). 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 2018).

Duration of therapy: Varies by patient-specific factors; usual duration is 2 to 4 weeks (in the absence of osteomyelitis). May switch to oral agents when appropriate to complete course of therapy (IDSA [Lipsky 2012]; Weintrob 2018).

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).

Meningitis, bacterial (off-label use): 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 (ANC expected to be ≤100 cells/mm3 for >7 days, clinically unstable, or significant comorbidity) (empiric therapy): Note: Some experts consider patients expected to have an ANC <500 cells/mm3 for >7 days to be at high risk for serious complications (Wingard 2018).

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]).

Osteomyelitis and/or discitis (off-label use): IV: 2 g every 8 to 12 hours for 6 weeks (IDSA [Berbari 2015]; Osmon 2018). For empiric therapy, use in combination with other appropriate agents (IDSA [Berbari 2015]).

Pneumonia:

Community-acquired pneumonia (CAP), as a component of empiric therapy for patients at risk for P. aeruginosa infection (hospitalized patient): IV: 2 g every 8 hours in combination with other appropriate agent(s). Note: Duration of therapy varies based on disease severity and response to therapy; treatment is typically given for 5 to 7 days, but longer courses may be warranted for severe or complicated infection. Patients should be afebrile for 48 to 72 hours and clinically stable prior to discontinuation (IDSA/ATS [Mandell 2007]).

Hospital-acquired pneumonia (HAP) or ventilator-associated pneumonia (VAP): IV: 2 g every 8 hours, in combination with other agent(s) when appropriate. Note: 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. 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 2018; Moehring 2018a; SCCM [Rhodes 2017]).

Manufacturer's labeling: Dosing in the prescribing information may not reflect current clinical practice: IV: 1 g every 8 hours or 2 g every 12 hours

Prosthetic joint infection, pathogen-specific therapy for gram-negative bacilli (off-label use): IV: 2 g every 12 hours (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 2018a; SCCM [Rhodes 2017]).

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, acute complicated (including pyelonephritis): IV: 1 to 2 g every 12 hours; some experts prefer 2 g every 8 hours if P. aeruginosa is suspected (Hooton 2018). Duration of therapy is 10 to 14 days for complicated UTI, including pyelonephritis (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

Endocarditis, prosthetic valve, treatment within 1 year of replacement (off-label use): 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: Infants, Children, and Adolescents: IV: 50 mg/kg/dose every 8 hours (maximum dose: 2,000 mg/dose) (Red Book [AAP 2015])

Intra-abdominal infection, complicated (off-label): Infants, Children, and Adolescents: IV: 50 mg/kg/dose every 12 hours in combination with metronidazole (maximum dose: 2,000 mg/dose). Note: IDSA 2010 guidelines recommend duration of 4 to 7 days (provided source controlled) (IDSA [Solomkin 2010]).

Pneumonia: Infants ≥2 months, Children, and Adolescents: IV:

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

Not due to P. aeruginosa: 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 infections, complicated and uncomplicated: Infants ≥ 2 months, Children, and Adolescents: IV, IM: Note: IM may be considered for mild to moderate infection only.

Mild to moderate infection: IV, IM: 50 mg/kg/dose every 12 hours for 7 to 10 days (maximum dose: 1,000 mg/dose)

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

Dosing: Renal Impairment

Adults: Recommended maintenance schedule based on creatinine clearance (may be estimated using the Cockcroft-Gault formula), compared to normal dosing schedule: See table.

Cefepime Hydrochloride

Creatinine Clearance

(mL/minute)

Recommended Maintenance Schedule

>60

(normal recommended dosing schedule)

500 mg every 12 hours

1 g every 12 hours

2 g every 12 hours

2 g every 8 hours

30-60

500 mg every 24 hours

1 g every 24 hours

2 g every 24 hours

2 g every 12 hours

11-29

500 mg every 24 hours

500 mg every 24 hours

1 g every 24 hours

2 g every 24 hours

<11

250 mg every 24 hours

250 mg every 24 hours

500 mg every 24 hours

1 g every 24 hours

Table has been converted to the following text.

Dosage Adjustment Schedule

When normal (CrCl >60 mL/minute) dosing schedule is 500 mg every 12 hours, adjust dose as follows:

• CrCl 30-60 (mL/minute): 500 mg every 24 hours

• CrCl 11-29 (mL/minute): 500 mg every 24 hours

• CrCl <11 (mL/minute): 250 mg every 24 hours

When normal (CrCl >60 mL/minute) dosing schedule is 1 g every 12 hours, adjust dose as follows:

• CrCl 30-60 (mL/minute): 1 g every 24 hours

• CrCl 11-29 (mL/minute): 500 mg every 24 hours

• CrCl <11 (mL/minute): 250 mg every 24 hours

When normal (CrCl >60 mL/minute) dosing schedule is 2 g every 12 hours, adjust dose as follows:

• CrCl 30-60 (mL/minute): 2 g every 24 hours

• CrCl 11-29 (mL/minute): 1 g every 24 hours

• CrCl <11 (mL/minute): 500 mg every 24 hours

When normal (CrCl>60 mL/minute) dosing schedule is 2 g every 8 hours, adjust dose as follows:

• CrCl 30-60 (mL/minute): 2 g every 12 hours

• CrCl 11-29 (mL/minute): 2 g every 24 hours

• CrCl <11 (mL/minute): 1 g every 24 hours

Intermittent hemodialysis (IHD) (administer after hemodialysis on dialysis days): IV: Initial: 1 g (single dose) on day 1. Maintenance: 0.5-1 g every 24 hours or 1-2 g every 48-72 hours (Heintz 2009) or 2 g 3 times weekly after dialysis (Perez 2012). Note: Dosing dependent on the assumption of 3 times weekly, complete IHD sessions.

Peritoneal dialysis (PD): Removed to a lesser extent than hemodialysis; administer normal recommended dose every 48 hours

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 1-2 L/hour and minimal residual renal function) and should not supersede clinical judgment:

CVVH: Loading dose of 2 g followed by 1-2 g every 12 hours

CVVHD/CVVHDF: Loading dose of 2 g followed by either 1 g every 8 hours or 2 g every 12 hours. Note: Dosage of 1 g every 8 hours results in similar steady-state concentrations as 2 g every 12 hours and is more cost effective (Heintz 2009).

Note: Consider higher dosage of 4 g/day if treating Pseudomonas or life-threatening infections in order to maximize time above MIC (Trotman 2005). Dosage of 2 g every 8 hours may be needed for gram-negative rods with MIC ≥4 mg/L (Heintz 2009).

Infants ≥ 2 months, Children, and Adolescents: There are no dosage adjustments provided in the manufacturer’s labeling; however, similar dosage adjustments to adults would be anticipated based on comparable pharmacokinetics between children and adults.

Dosing: Hepatic Impairment

No dosage adjustment necessary.

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

May be administered either IM or IV

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 Risk Factor

B

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. Cefepime crosses the placenta.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea. Have patient report immediately to prescriber severe dizziness, passing out, severe fatigue, bruising, bleeding, severe loss of strength and energy, chills, pharyngitis, urinary retention, change in amount of urine passed, dark urine, jaundice, signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools), confusion, seizures, difficulty speaking, or hallucinations (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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