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ATC Code

J01DE01 (Cefepime)

Active Substance

Cefepime (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Fourth generation cephalosporin

Pharmacotherapeutic Group

Antibiotic-cephalosporin

Pharmacological Action

Cephalosporin antibiotic of the IV generation for parenteral use. It exerts a bactericidal effect by disrupting the synthesis of the microbial cell wall.

It is active against most Gram-negative bacteria, including those producing β-lactamases, including Pseudomonas aeruginosa. It is more active than third-generation cephalosporins against Gram-positive cocci.

It is not active against Enterococcus spp., Listeria spp., Legionella spp., and some anaerobic bacteria (Bacteroides fragilis, Clostridium difficile).

Cefepime is characterized by high stability against various plasmid and chromosomal β-lactamases.

Pharmacokinetics

Plasma protein binding is less than 19% and does not depend on the serum concentration of cefepime.

Therapeutic concentrations of cefepime are found in urine, bile, peritoneal fluid, blister exudate, bronchial mucous secretion, sputum, prostate tissue, appendix, gallbladder, and cerebrospinal fluid in meningitis.

In healthy individuals, no accumulation in the body was observed after intravenous administration of cefepime at a dose of 2 g every 8 hours for 9 days.

The mean elimination half-life (T_1/2) is approximately 2 hours, and the mean total clearance is 120 ml/min. Cefepime is excreted by the kidneys, mainly by glomerular filtration (mean renal clearance is 110 ml/min). Approximately 85% of the administered cefepime is found unchanged in the urine.

In patients aged 65 years or older with normal renal function, the renal clearance value is lower than in younger patients.

In patients with impaired renal function, the T_1/2 increases. In patients with severe renal impairment requiring hemodialysis, the mean T_1/2 is 13 hours, and during peritoneal dialysis, it is 19 hours.

The pharmacokinetics of cefepime are unchanged in patients with impaired liver function and cystic fibrosis.

The age and sex of patients did not significantly affect the total body clearance and volume of distribution (V_d) when adjusted for body weight. No accumulation was noted when cefepime was administered at a dose of 50 mg/kg every 12 hours, and when administered at the same dose every 8 hours at steady state, C_max, AUC, and T_1/2 increased by approximately 15%.

Indications

Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to cefepime: lower respiratory tract infections (including pneumonia and bronchitis), urinary tract infections (both complicated and uncomplicated), skin and soft tissue infections, intra-abdominal infections (including peritonitis and biliary tract infections), gynecological infections, septicemia, neutropenic fever (as empirical therapy), bacterial meningitis in children.

Prophylaxis of infections during abdominal surgical operations.

ICD codes

Dosage Regimen

Determine the dosage individually based on infection severity, pathogen susceptibility, patient age, weight, and renal function.

Administer via intramuscular or intravenous routes. Use the intravenous route for severe, life-threatening infections, including septicemia and neutropenic fever.

For adults with normal renal function (CrCl > 60 mL/min), use a standard dose of 1 gram to 2 grams every 12 hours for most infections.

For severe infections, including pseudomonal infections, administer 2 grams every 8 hours.

For febrile neutropenia, administer 2 grams every 8 hours for the entire period of neutropenia.

For surgical prophylaxis, administer a single 2-gram dose 60 minutes before the procedure.

For pediatric patients over 2 months of age, administer 50 mg/kg per dose. Use a dosing interval of every 12 hours for most indications; use every 8 hours for febrile neutropenia.

Adjust the dosage regimen for patients with renal impairment. For CrCl 30-60 mL/min, administer a maximum of 2 grams every 24 hours or 1 gram every 12 hours.

For CrCl 10-30 mL/min, administer a maximum of 1 gram every 24 hours. For CrCl < 10 mL/min, administer a maximum of 0.5 gram every 24 hours.

Administer a supplemental dose after hemodialysis on dialysis days. For patients on continuous ambulatory peritoneal dialysis, administer 1 gram every 48 hours.

Reconstitute the powder for injection with a compatible diluent. For intravenous infusion, further dilute the reconstituted solution in 50-100 mL of a compatible IV fluid.

Infuse intravenous doses over approximately 30 minutes. The total duration of therapy is guided by clinical response; typically continue for at least 48-72 hours after fever abates or until eradication of the pathogen is confirmed.

Adverse Reactions

From the digestive system: diarrhea, nausea, vomiting, colitis (including pseudomembranous colitis) may occur; rarely – abdominal pain, constipation, taste alteration.

Allergic reactions: rash, itching, urticaria may occur; rarely – anaphylactic reactions.

From the central and peripheral nervous system: headache may occur; rarely – dizziness, paresthesia; in some cases – seizures.

Dermatological reactions: rarely – skin redness. Most frequently in children – rash.

From the hematopoietic system: anemia may occur.

From laboratory parameters: increased ALT, AST, ALP activity, increased total bilirubin, eosinophilia, increased prothrombin time may occur; rarely – temporary increase in blood urea nitrogen and/or serum creatinine, transient thrombocytopenia, transient leukopenia and neutropenia; frequently – positive Coombs’ test without hemolysis.

Other: fever, vaginitis, erythema may occur; rarely – genital itching, nonspecific candidiasis.

Local reactions: with intravenous infusion, phlebitis may occur, rarely – inflammation; with intramuscular injection, inflammation or pain may occur.

Contraindications

Hypersensitivity to cefepime or L-arginine, as well as to cephalosporin antibiotics, penicillins, or other beta-lactam antibiotics.

Use in Pregnancy and Lactation

Adequate and strictly controlled studies on the safety of cefepime use during pregnancy have not been conducted; use is possible only under medical supervision.

Cefepime is excreted in breast milk in very low concentrations. Use with caution during lactation.

In experimental studies, no effect on reproductive function and no fetotoxic effects of cefepime were identified.

Use in Renal Impairment

In case of impaired renal function (creatinine clearance less than 30 ml/min), adjustment of the dosage regimen is necessary. The initial dose of cefepime should be the same as for patients with normal renal function. Maintenance doses are determined depending on creatinine clearance values or serum creatinine concentration.

Pediatric Use

The safety and efficacy of cefepime use in children under 2 months of age have not been established. For children over 2 months of age, use is possible according to the dosage regimen. For children with impaired renal function, the same dosage adjustments are recommended as for adults, since the pharmacokinetics of cefepime in adults and children are similar.

Special Precautions

When used in patients at increased risk of infection due to mixed aerobic/anaerobic flora (including cases where one of the pathogens is Bacteroides fragilis), it is recommended to prescribe a drug active against anaerobes concomitantly with cefepime until the pathogen is identified.

Use with caution in patients at risk of developing allergic reactions, especially to medications.

If allergic reactions develop, Cefepime should be discontinued.

In case of serious immediate-type hypersensitivity reactions, the use of epinephrine (adrenaline) and other forms of supportive treatment may be required.

If diarrhea occurs during treatment, the possibility of pseudomembranous colitis should be considered. In such cases, Cefepime should be discontinued immediately and appropriate treatment instituted if necessary.

If superinfection develops, Cefepime should be discontinued immediately and appropriate treatment instituted.

The safety and efficacy of cefepime use in children under 2 months of age have not been established.

Use Cefepime with particular caution concomitantly with aminoglycosides and “loop” diuretics.

Drug Interactions

Pharmaceutical interaction is possible when cefepime solution is administered simultaneously with solutions of metronidazole, vancomycin, gentamicin, tobramycin sulfate, and netilmicin sulfate.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.