Cefepim, 1 g

Cefepim is an antibacterial agent of the IV generation of cephalosporins.

It acts bactericidally by disrupting synthesis of the cell wall of microorganisms.

It has a broad spectrum of action against Gram-positive and Gram-negative bacteria and strains resistant to aminoglycosides and/or 3rd generation cephalosporin antibiotics.

Highly resistant to hydrolysis of most beta-lactamases and quickly penetrates Gram-negative bacterial cells. Penicillin-binding proteins are the molecular target inside the bacterial cell.

It is active in vivo and in vitro against Gram-positive aerobes: Staphylococcus aureus (only methicillin-sensitive strains), Streptococcus pneumoniae, Streptococcus pyogenes (group A), Streptococcus group viridans; Gram-negative aerobes: Enterobacter spp., Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa. In vitro active (but clinical significance is unknown) against Gram-positive aerobes: Staphylococcus epidermidis (methicillin-sensitive strains only), Staphylococcus saprophyticus, Streptococcus agalactiae (group B); Gram-negative aerobes: Acinetobacter lwoffii, Citrobacter diversus, Citrobacter freundii, Enterobacter agglomerans, Haemophilus influenzae (including beta-lactamase-producing strains), Hafnia alvei, Klebsiella oxytoca, Moraxella catarrhalis (including beta-lactamase-producing strains), Morganella morganii, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens. Most strains of Enterococcus, including Enterococcus faecalis, methicillin-resistant staphylococci, Stenotrophomonas (formerly known as Xanthomonas maltophilia and Pseudomonas maltophilia), Clostridium difficile are not sensitive to cefepime.

Indications

Adults

Treatment of infections caused by sensitive strains of relevant microorganisms:

– pneumonia (moderate to severe) caused by Streptococcus pneumoniae, including cases with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumonia or Enterobacter species;

– empirical treatment of patients with neutropenic fever. Cefepime as monotherapy is indicated for the empirical treatment of patients with febrile neutropenia. In patients at high risk of severe infection (including patients with a recent history of bone marrow transplantation (there is insufficient data to support the effectiveness of cefepime monotherapy in these patients; if necessary, combination therapy with aminoglycoside or glycopeptide antibiotics is recommended, taking into account the individual risk profile of the patient), hypotension, hematological malignancy, severe or prolonged neutropenia) – as part of combination therapy;

– uncomplicated and complicated urinary tract infections (including pyelonephritis) caused by Escherichia coli or Klebsiella pneumoniae, of any severity, as well as mild and moderately severe infections caused by Proteus mirabilis, including cases associated with simultaneous bacteremia by these microorganisms;

– uncomplicated infections of the skin and its structures caused by Staphylococcus aureus (only methicillin-sensitive strains) or Streptococcus pyogenes;

– complicated intra-abdominal infections (in combination with metronidazole) caused by Echerichia coli, viridens group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species or Bacteroides fragilis.

Children

Infections caused by microorganisms sensitive to cefepime:

– bacteremia associated with one of the mentioned infections, or presumably associated;

– severe pneumonia;

– severe urinary tract infections;

– bacterial meningitis;

– empirical treatment of febrile episodes in patients with moderate (neutrophils < 1000/mm3) or severe (neutrophils ≤ 500/mm3) neutropenia. In patients at high risk of serious infection (eg, patients with recent bone marrow transplantation, low initial blood pressure, hematologic malignancies, or severe or prolonged neutropenia), antimicrobial monotherapy is not appropriate. Available data on the effectiveness of cefepime monotherapy in such patients are insufficient. If necessary, combination therapy with an aminoglycoside or glycopeptide antibiotic is recommended, taking into account the patient's individual risk profile.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefepime and other antibacterial drugs, the drug should be used only to treat infections that are caused by susceptible bacteria. When culture and susceptibility information is available, the drug should be used only to treat infections that are caused by susceptible bacteria. In the absence of such data, epidemiological data may help guide the choice of empirical therapy.

Pharmacological effect

Cefepime is an antibacterial agent from the group of IV generation cephalosporins.

It acts bactericidal, disrupting the synthesis of the cell wall of microorganisms.

It has a wide spectrum of action against gram-positive and gram-negative bacteria, strains resistant to aminoglycosides and/or third generation cephalosporin antibiotics.

Highly resistant to hydrolysis by most beta-lactamases and quickly penetrates gram-negative bacterial cells. Inside the bacterial cell, the molecular target is penicillin-binding proteins.

Active in vivo and in vitro against gram-positive aerobes: Staphylococcus aureus (only methicillin-sensitive strains), Streptococcus pneumoniae, Streptococcus pyogenes (group A), Streptococcus viridans group; gram-negative aerobes: Enterobacter spp., Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa. In vitro active (but clinical significance unknown) against gram-positive aerobes: Staphylococcus epidermidis (only methicillin-sensitive strains), Staphylococcus saprophyticus, Streptococcus agalactiae (group B); gram-negative aerobes: Acinetobacter lwoffii, Citrobacter diversus, Citrobacter freundii, Enterobacter agglomerans, Haemophilus influenzae (including strains producing beta-lactamase), Hafnia alvei, Klebsiella oxytoca, Moraxella catarrhalis (including strains producing beta-lactamase), Morganella morganii, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens. Most strains of Enterococcus, incl. Enterococcus faecalis, methicillin-resistant staphylococci, Stenotrophomonas (formerly known as Xanthomonas maltophilia and Pseudomonas maltophilia), Clostridium difficile are not sensitive to cefepime.

Special instructions

If pseudomembranous colitis occurs with prolonged diarrhea, stop taking it and prescribe vancomycin (orally) or metronidazole. Cross-hypersensitivity is possible in patients with allergic reactions to penicillins. In case of combined severe renal and liver failure, the concentration of the drug in plasma should be regularly determined (dose adjustment is carried out depending on QC).

With long-term treatment, regular monitoring of peripheral blood, indicators of the functional state of the liver and kidneys is necessary. In case of mixed aerobic-anaerobic infection, before identifying the pathogens, a combination with a drug active against anaerobes is advisable. Patients in whom meningeal dissemination occurs from a distant site of infection, meningitis is suspected, or the diagnosis of meningitis is confirmed, should be prescribed an alternative antibiotic with proven clinical effectiveness for this situation.

Possible detection of a positive Coombs test, a false positive test for glucose in urine. Store the prepared solution for no more than 24 hours at room temperature or for 7 days in the refrigerator. The color change does not affect the activity of the drug.

Active ingredient

Cefepime

Composition

1 bottle contains:

active ingredient – ​​cefepime – 1 g (in the form of cefepime hydrochloride and L-arginine).

Contraindications

Hypersensitivity to Cefepime or L-arginine, as well as to cephalosporin antibiotics, penicillins or other β-lactam antibiotics. Children up to 2 months

Side Effects

Allergic reactions: skin rash (including erythematous rashes), itching, fever, anaphylactoid reactions, positive Coombs’ reaction, eosinophilia, exudative erythema multiforme (including Stevens-Johnson syndrome), rarely – toxic epidermal necrolysis (Lyell’s syndrome).

Local reactions: with intravenous administration – phlebitis, with intramuscular injection – hyperemia and pain at the injection site.

From the nervous system: headache, dizziness, insomnia, paresthesia, anxiety, confusion, convulsions.

From the genitourinary system: vaginitis.

From the urinary system: impaired renal function.

From the digestive system: diarrhea, nausea, vomiting, constipation, abdominal pain, dyspepsia, pseudomembranous colitis.

From the hematopoietic organs: anemia, thrombocytopenia, leukopenia, neutropenia, pancytopenia, hemolytic anemia, bleeding.

From the respiratory system: cough.

From the cardiovascular system: tachycardia, shortness of breath, peripheral edema.

Laboratory indicators: decreased hematocrit, increased prothrombin time, increased urea concentration, hypercreatininemia, hypercalcemia, increased activity of liver transaminases and alkaline phosphatase, hyperbilirubinemia.

Other: sore throat, chest pain, increased sweating, back pain, asthenia, development of superinfection, oropharyngeal candidiasis.

Interaction

Pharmaceutically incompatible with other antimicrobial drugs and heparin.

Incompatible with metronidazole solution (before administering metronidazole solution to prevent infections during surgical interventions, the infusion system should be flushed of cefepime solution).

Increases nephro- and ototoxicity of aminoglycosides.

Manufacturer

Borisov Medical Preparations Plant, Belarus