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Cefepime

Pronunciation

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: 1 g/50 mL (50 mL); 2% (100 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, Intravenous, as hydrochloride:

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

Generic: 1 g/50 mL (1 ea); 2 g/50 mL (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

Febrile neutropenia: Treatment (empiric monotherapy) of febrile neutropenic patients.

Intra-abdominal infections: Treatment of complicated intra-abdominal infections, in combination with metronidazole, caused by Escherichia coli, viridans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis.

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 skin structure infections: Treatment of moderate to severe uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes.

Urinary tract infections (including pyelonephritis): Treatment of complicated and uncomplicated urinary tract infections, including pyelonephritis, caused by E. coli or K. pneumoniae, when the infection is severe, or caused by E. coli, K. pneumoniae, or Proteus mirabilis, when the infection is mild to moderate, including cases associated with concurrent bacteremia with these microorganisms.

Use: Unlabeled

Brain abscess (postneurosurgical prevention); malignant otitis externa; prosthetic joint infection

Contraindications

Hypersensitivity (eg, anaphylaxis, serious skin reactions) to cefepime, other cephalosporins, penicillins, other beta-lactam antibiotics, or any component of the formulation

Dosing: Adult

Febrile neutropenia, monotherapy: IV: 2 g every 8 hours for 7 days or until the neutropenia resolves

Intra-abdominal infections, complicated, severe (in combination with metronidazole): IV: Note: 2010 IDSA guidelines recommend a duration of 4 to 7 days (provided source controlled). Not recommended for hospital-acquired intra-abdominal infections (IAI) associated with multidrug-resistant gram negative organisms or in mild-to-moderate community-acquired IAIs due to risk of toxicity and the development of resistant organisms (Solomkin, [IDSA] 2010).

Due to P. aeruginosa: 2 g every 8 hours for 7 to 10 days

Not due to P. aeruginosa: 2 g every 8 to 12 hours for 7 to 10 days

Pneumonia: IV: Note: Duration of therapy may vary considerably for healthcare associated pneumonia (7 to 21 days). In absence of Pseudomonas, and if appropriate empiric treatment used and patient responsive, it may be clinically appropriate to reduce duration of therapy to 7 to 10 days (American Thoracic Society Guidelines, 2005).

Due to P. aeruginosa: 1 to 2 g every 8 hours for 10 days; Note: Longer courses (eg, 14 to 21 days) may be required (American Thoracic Society Guidelines, 2005).

Not due to P. aeruginosa: 1 to 2 g every 8 to 12 hours for 10 days

Skin and skin structure infection, uncomplicated: IV: 2 g every 12 hours for 10 days

Urinary tract infections, complicated and uncomplicated:

Mild-to-moderate: IM, IV: 0.5 to 1 g every 12 hours for 7 to 10 days

Severe: IV: 2 g every 12 hours for 10 days

Brain abscess, postneurosurgical prevention (off-label use): IV: 2 g every 8 hours with vancomycin (Tunkel, 2004)

Prosthetic joint infection, Enterobacter spp. or Pseudomonas aeruginosa (off-label use): IV: 2 g every 12 hours for 4 to 6 weeks; Note: When treating P. aeruginosa, consider addition of an aminoglycoside (Osmon, 2013)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Infants ≥2 months, Children, and Adolescents ≤16 years (≤40 kg):

Febrile neutropenia: IV: 50 mg/kg/dose every 8 hours for 7 days or until neutropenia resolves (maximum dose: 2 g/dose)

Pneumonia: IV:

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

Not due to P. aeruginosa: 50 mg/kg/dose every 12 hours for 10 days (maximum dose: 2 g/dose)

Skin and skin structure infections (uncomplicated): IV: 50 mg/kg/dose every 12 hours for 10 days (maximum dose: 2 g/dose)

Urinary tract infections, complicated and uncomplicated: IV, IM: 50 mg/kg/dose every 12 hours for 7 to 10 days (maximum dose: 1 g/dose); Note: IM may be considered for mild-to-moderate infection only.

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

Children >40 kg and Adolescents >16 years:

Febrile neutropenia, monotherapy: IV: 2 g every 8 hours for 7 days or until the neutropenia resolves

Intra-abdominal infections, complicated, severe (in combination with metronidazole): IV: Note: IDSA 2010 guidelines recommend duration of 4 to 7 days (provided source controlled) (Solomkin, [IDSA] 2010).

Due to P. aeruginosa: 2 g every 8 hours for 7 to 10 days

Not due to P. aeruginosa: 2 g every 8 to 12 hours for 7 to 10 days

Pneumonia: IV:

Due to P. aeruginosa: 1 to 2 g every 8 hours for 10 days

Not due to P. aeruginosa: 1 to 2 g every 8 to 12 hours for 10 days

Skin and skin structure infections, uncomplicated: IV: 2 g every 12 hours for 10 days

Urinary tract infections, complicated and uncomplicated:

Mild-to-moderate: IM, IV: 0.5 to 1 g every 12 hours for 7 to 10 days

Severe: IV: 2 g every 12 hours for 10 days

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).

Children: No dosage adjustment 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

Inject deep IM into large muscle mass. Inject direct IV over 5 minutes (Garrelts, 1999). Infuse intermittent infusion over 30 minutes.

Compatibility

Stable in D5LR, D5NS, D5W, D10W, NS, bacteriostatic water, SWFI.

Y-site administration: Incompatible with acetylcysteine, acyclovir, amphotericin B, amphotericin B cholesteryl sulfate complex, caspofungin, chlorpromazine, cimetidine, ciprofloxacin, cisplatin, dacarbazine, daunorubicin, diazepam, diphenhydramine, doxorubicin, droperidol, enalaprilat, erythromycin lactobionate, etoposide, etoposide phosphate, famotidine, filgrastim, floxuridine, gallium nitrate, ganciclovir, haloperidol, hydroxyzine, idarubicin, ifosfamide, magnesium sulfate, mannitol, mechlorethamine, meperidine, metoclopramide, midazolam, mitomycin, mitoxantrone, morphine, nalbuphine, nicardipine, ondansetron, phenytoin, prochlorperazine edisylate, promethazine, streptozocin, theophylline, vinblastine, vincristine.

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. 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% (Limited to important or life-threatening): Agranulocytosis, anaphylactic shock, anaphylaxis, anemia, aphasia, brain disease, 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, neurotoxicity, neutropenia, oral candidiasis, pseudomembranous colitis, seizure, status epilepticus (nonconvulsive), stupor, thrombocytopenia, 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 any allergy (particularly drugs), penicillin allergy, or beta-lactam sensitivity. 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 or 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:

• Gastrointestinal disease: Use with caution in patients with a history of gastrointestinal disease, especially colitis.

• 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 the following: 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, vaginitis, severe injection site irritation, signs of Clostridium difficile (C. diff)-associated diarrhea (stomach pain or cramps, very loose or watery stools, or bloody stools), illogical thinking, 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.

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