Universal reference book for medicines
Name of the preparation: CEPIME ® (CEPIME)

Active substance: cefepime

Type: Cephalosporin IV generation

Producer: BIOKOM TECHNOLOGY (Republic of Belarus) produced SYNTHESIS (Russia) trademark owner BIOKOM TECHNOLOGY (Republic of Belarus)
Composition, form of production and packaging
Powder for the preparation of a solution for intravenous and /
or injection of white or white with a yellowish hue, is hygroscopic.

1 f.

cefepime (in the form of hydrochloride) 500 mg

Excipients: arginine - 0.36 g.

Vials with a capacity of 10 ml (1) - packs of cardboard.

Vials with a capacity of 10 ml (10) - packs of cardboard.

Vials with a capacity of 10 ml (50) - cardboard boxes.

Vials with a capacity of 10 ml (1) complete with a solvent (water d / or sodium chloride 0.9% - amp 5 ml 1 pc.) - packings of cellular contour (1) - packs cardboard.

Vials with a capacity of 10 ml (1) complete with a solvent (water d / or sodium chloride 0.9% - amp 5 ml 2 pcs.) - packings of cellular contour (1) - packs cardboard.

Vials with a capacity of 10 ml (5) complete with a solvent (water d / or sodium chloride 0.9% - amp 5 ml 5 pcs.) - packings, cell planimetric (2) - packs cardboard.

Powder for the preparation of a solution for intravenous and / or injection of white or white with a yellowish hue, is hygroscopic.

1 f.

cefepime (in the form of hydrochloride) 1 g

Excipients: arginine - 0.72 g.

Vials with a capacity of 10 ml (1) - packs of cardboard.

Vials with a capacity of 10 ml (10) - packs of cardboard.

Vials with a capacity of 10 ml (50) - cardboard boxes.

Vials with a capacity of 10 ml (1) complete with a solvent (water d / or sodium chloride 0.9% - amp 5 ml 1 pc.) - packings of cellular contour (1) - packs cardboard.

Vials with a capacity of 10 ml (1) complete with a solvent (water d / or sodium chloride 0.9% - amp 5 ml 2 pcs.) - packings of cellular contour (1) - packs cardboard.

Vials with a capacity of 10 ml (5) complete with a solvent (water d / or sodium chloride 0.9% - amp 5 ml 5 pcs.) - packings, cell planimetric (2) - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

Antibacterial preparation of a wide spectrum of action from group of cephalosporins of IV generation for injections.
It acts bactericidal, disrupting the synthesis of the cell wall of microorganisms. Has a wide spectrum of action against Gram-positive and Gram-negative bacteria, incl. strains resistant to aminoglycosides and / or cephalosporin antibiotics of the third generation.
Highly resistant to hydrolysis by most plasmid and chromosomal β-lactamases and rapidly penetrates into gram-negative bacterial cells.
Inside the bacterial cell, the molecular target is penicillin-binding proteins.
It is active in vivo and in vitro for gram-positive aerobes: Staphylococcus aureus (only methicillin-sensitive strains), Streptococcus pneumoniae, Streptococcus pyogenes (group A), Streptococcus viridans;
Gram-negative aerobes: Enterobacter spp., Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa.
In vitro is active 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? -lactamase), Hafnia alvei, Klebsiella oxytoca, Moraxella catarrhalis (including strains producing? -lactamases), Morganella morganii, Proteus vulgaris , Providencia rettgeri, Providencia stuartii, Serratia marcescens.
Resistant to cefepime: most strains of Enterococcus spp.
(including Enterococcus faecalis), methicillin-resistant staphylococci, Stenotrophomonas maltophilia (formerly known as Xanthomonas maltophilia), Bacteroides fragilis, Clostridium difficile.
PHARMACOKINETICS

Suction

Bioavailability is 100%.
TC max after iv administration of the drug at a dose of 0.5 g - by the end of infusion. TC max after a / m introduction at a dose of 0.5 g - 1-2 hours. C max with a / m administration of the drug in doses of 0.5 g, 1 g and 2 g - 14 μg / ml, 30 μg / ml and 57 μg / ml respectively; with iv administration in doses of 0.25 g, 0.5 g, 1 g and 2 g - 18 μg / ml, 39 μg / ml, 82 μg / ml and 164 μg / ml, respectively.
Time to reach the average therapeutic concentration in plasma - 12 h;
the average therapeutic concentration at the / m introduction is 0.2 μg / ml, with the / in the introduction - 0.7 μg / ml.
Distribution

High concentrations of cefepime are determined in urine, bile, peritoneal fluid, blister exudate, bronchial mucus secretion, sputum, prostate gland, appendix and gallbladder.
V d - 0.25 l / kg, in children from 2 months to 16 years - 0.33 l / kg. Binding to plasma proteins - 20%. It is excreted in breast milk.
Metabolism

Metabolized in the liver and kidneys by 15%.

Excretion

T 1/2 - 2 hours, total clearance - 120 ml / min, renal clearance - 110 ml / min.
It is excreted by the kidneys, by glomerular filtration in unchanged form - 85%. T 1/2 for hemodialysis - 13 hours, with continuous peritoneal dialysis - 19 hours.
INDICATIONS

Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:

- pneumonia (moderate to severe) caused by Streptococcus pneumoniae (including association with concomitant bacteremia), Pseudomonas aeruginosa, Klebsiella pneumoniae or Enterobacter spp .;

- febrile neutropenia (empirical therapy);

- Complicated and uncomplicated urinary tract infections (including pyelonephritis) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis;

- uncomplicated skin and soft tissue infections caused by Staphylococcus aureus (only methicillin-sensitive strains), Streptococcus pyogenes;

Complicated intra-abdominal infections (in combination with metronidazole) caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Enterobacter spp., Bacteroides fragilis.

Prevention of infections in the conduct of cavitary surgery.

DOSING MODE

Assign IV (spray and drip) and less often - in / m (only with complicated or uncomplicated infections of urinary tract of mild and moderate severity caused by Escherichia coli).

Doses and the route of administration of the drug vary depending on the sensitivity of the microorganisms of the pathogens, the severity of the infection, as well as the state of kidney function in the patient.

Pneumonia (moderate to severe) caused by Streptococcus pneumoniae (including cases of association with concomitant bacteremia), Pseudomonas aeruginosa, Klebsiella pneumoniae or Enterobacter spp.
- in / in 1-2 g every 12 hours for 10 days.
Febrile neutropenia (empiric therapy) - iv 2 g every 8 hours for 7 days or until neutropenia is resolved.

Complicated or uncomplicated urinary tract infections of mild to moderate severity caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis - iv or IM (for infections caused by Escherichia coli) 0.5-1 g every 12 hours for 7-10 days.

Severe complicated or uncomplicated urinary tract infections ( including pyelonephritis) caused by Escherichia coli or Klebsiella pneumoniae - iv 2 g every 12 hours for 10 days.

Severe and severe skin and soft tissue infections caused by Staphylococcus aureus (methicillin-sensitive strains only), Streptococcus pyogenes - iv 2 g every 12 hours for 10 days.

Complicated intra-abdominal infections (in combination with metronidazole) caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Enterobacter spp., Bacteroides fragilis - iv 2 g every 12 hours for 7-10 days.

To prevent infection during surgical interventions on the abdominal organs - 60 minutes before the onset of the surgical procedure, 2 g of the drug is injected within 30 minutes.
At the end of the infusion, 500 mg of metronidazole is additionally administered intravenously. Metronidazole solutions should not be administered concomitantly with cefepime. Infusion system before the introduction of metronidazole should be washed.
During prolonged (more than 12 hours) surgical operations 12 hours after the first dose, repeated iv injection of 2 g is recommended for 30 minutes, followed by administration of 500 mg of metronidazole.

In children from 2 months to 16 years and with a body weight of up to 40 kg, the recommended dosing regimen for all indications (excluding febrile neutropenia) is 50 mg / kg every 12 hours IV;
with febrile neutropenia - 50 mg / kg every 8 hours. The duration of treatment is the same as in adults (7-10 days).
In patients with impaired renal function (CK <30 mL / min), the dose of the drug should be adjusted.
The initial dose of cefepime should be the same as for patients with normal renal function. The recommended maintenance doses of the drug are shown in the table.
KK (ml / min) Recommended maintenance doses

> 50 2 g every 8 hours (normal dose, no correction needed) 2 g every 12 hours (regular dose, no correction required) 1 g every 12 hours (regular dose, no correction required) 500 mg every 12 hours (regular dose, correction is not required)

30-50 2 g every 8 h 2 g every 12 h 1 g every 12 h 500 mg every 12 h

11-29 1 g every 12 h 1 g every 24 h 500 mg every 24 h 500 mg every 24 h

<10 1 g every 24 hours 500 mg every 24 hours 250 mg every 24 hours 250 mg every 24 hours

Patients on hemodialysis receive 1 g on the first day, then 0.5 g every 24 hours for all infections and 1 g every 24 hours for the treatment of febrile neutropenia.
On the day of hemodialysis, the drug is administered after the end of the hemodialysis session; it is advisable to inject cefepime every day at the same time.
Data on the use of the drug in children with concomitant chronic renal insufficiency are not available, however, given the similar pharmacokinetics in children and adults, the dosage regimen (dose reduction or increase in the interval between administrations) in children with chronic renal failure is similar to the dosing regimen in adults.

Rules for the preparation of solution

To prepare a solution for intravenous administration, the drug is dissolved in 5 ml (0.5 g) or 10 ml (1 g) of sterile water for injection, 5% dextrose (glucose) solution or 0.9% sodium chloride solution.
Intravenously injected intravenously for 3-5 minutes. For IV infusion, the prepared solution is mixed with other solutions for IV infusions (0.9% solution of sodium chloride, 5% or 10% dextrose (glucose) solution, Ringer's lactate solution and 5% dextrose (glucose) solution, maximum concentration of cefepime in the prepared solution - 40 mg / ml) and injected for at least 30 minutes.
To prepare a solution for intravenous administration, the preparation is dissolved in sterile water for injection, 0.9% solution of sodium chloride, bacteriostatic water for injection with paraben or benzyl alcohol, in 0.5% and 1% solution of lidocaine hydrochloride (0.5 g in 1.3 ml, 1 g in 2.4 ml).

SIDE EFFECT

Allergic reactions: skin rash (including erythematous rashes), pruritus, fever, anaphylactoid reactions, eosinophilia, multiform exudative erythema (including Stevens-Johnson syndrome);
rarely - toxic epidermal necrolysis (Lyell's syndrome).
From the side of the nervous system: headache, dizziness, insomnia, paresthesia, anxiety, confusion, convulsions, encephalopathy (in the absence of dose adjustment in patients with impaired renal function).

On the part of the reproductive system: vaginitis.

From the side of the urinary system: a violation of kidney function.

From the digestive system: oropharyngeal candidiasis, diarrhea, nausea, vomiting, constipation or diarrhea, abdominal pain, indigestion, pseudomembranous colitis, increased activity of hepatic transaminases and alkaline phosphatase, hyperbilirubinemia.

On the part of the organs of hematopoiesis : anemia, thrombocytopenia, leukopenia, neutropenia, pancytopenia, hemolytic anemia, bleeding.

On the part of the respiratory system: cough, chest pain.

From the cardiovascular system: tachycardia, dyspnea, peripheral edema.

Laboratory indicators: a decrease in hematocrit, an increase in prothrombin time, an increase in urea concentration, hypercreatininaemia, hypercalcemia, a positive Coombs test (without hemolysis).

Local reactions: with intravenous injection - phlebitis;
with a / m - hyperemia and tenderness at the injection site.
Other: sore throat, chest pain, increased sweating, back pain, asthenia, development of superinfection.

CONTRAINDICATIONS

- Children under 2 months of age (for IV) (safety and efficacy in children younger than 2 months not established);

- Children's age till 12 years (for the / m introduction);

- Hypersensitivity to the components that make up the drug (including to cephalosporins, penicillins and other beta-lactam antibiotics).

With caution : gastrointestinal diseases (including in the anamnesis) - pseudomembranous colitis, ulcerative colitis, regional enteritis or antibiotic-associated colitis;chronic renal failure.

PREGNANCY AND LACTATION

When pregnancy is used only if the intended benefit for the mother exceeds the potential risk to the fetus.

During treatment with the drug during lactation, breastfeeding should be discontinued.

APPLICATION FOR FUNCTIONS OF THE LIVER

In patients with impaired renal function (CK <30 mL / min), the dose of the drug should be adjusted.
The initial dose of cefepime should be the same as for patients with normal renal function. The recommended maintenance doses of the drug are shown in the table.
KK (ml / min) Recommended maintenance doses

> 50 2 g every 8 hours (normal dose, no adjustment needed) 2 g every 12 hours (regular dose, no adjustment required) 1 g every 12 hours (regular dose, no adjustment required) 500 mg every 12 hours (regular dose, adjustment is not required)

30-50 2 g every 8 h 2 g every 12 h 1 g every 12 h 500 mg every 12 h

11-29 1 g every 12 h 1 g every 24 h 500 mg every 24 h 500 mg every 24 h

<10 1 g every 24 hours 500 mg every 24 hours 250 mg every 24 hours 250 mg every 24 hours

Patients on hemodialysis receive 1 g on the first day, then 0.5 g every 24 hours for all infections and 1 g every 24 hours for the treatment of febrile neutropenia.
On the day of hemodialysis, the drug is administered after the end of the hemodialysis session; it is advisable to inject cefepime every day at the same time.
Data on the use of the drug in children with concomitant chronic renal failure are not available, however, given the similar pharmacokinetics in children and adults, the dosage regimen (dose reduction or increase in the interval between administrations) in children with chronic renal insufficiency is similar to the dosing regimen in adults



APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

When combined severe renal and hepatic insufficiency should regularly determine the concentration of the drug in the plasma (dose adjustment is performed depending on the creatinine clearance).

APPLICATION FOR CHILDREN

Contraindicated in childhood to 2 months (for intravenous administration) (safety and efficacy in children younger than 2 months is not established);
in children under 12 years (for the / m introduction).
In children from 2 months to 16 years and with a body weight of up to 40 kg, the recommended dosing regimen for all indications (excluding febrile neutropenia) is 50 mg / kg every 12 hours IV;
with febrile neutropenia - 50 mg / kg every 8 hours. Duration of treatment as in adults (7-10 days).
Data on the use of the drug in children with concomitant chronic renal insufficiency are not available, however, given the similar pharmacokinetics in children and adults, the dosage regimen (dose reduction or increase in the interval between administrations) in children with chronic renal failure is similar to the dosing regimen in adults.

SPECIAL INSTRUCTIONS

When using cefepime, pseudomembranous colitis may occur.
Therefore, it is important to keep this diagnosis in mind when diarrhea occurs during treatment with the drug. Mild forms of colitis do not require special treatment, it is sufficient to stop the introduction of the drug; mild or severe cases may require special treatment.
There is a possibility of cross-over hypersensitivity in patients with allergic reactions to penicillins.

When combined severe renal and hepatic insufficiency should regularly determine the concentration of the drug in the plasma (dose adjustment is performed depending on the creatinine clearance).

With prolonged treatment, regular monitoring of peripheral blood, indicators of the functional state of the liver and kidneys is necessary.

With a mixed aerobic-anaerobic infection before identifying pathogens, a combination with drugs active against anaerobes is appropriate.

Patients who have a meningeal dissemination from a distant foci of infection, suspicions of meningitis or a diagnosis of meningitis are confirmed, an alternative antibiotic with confirmed clinical efficacy should be prescribed.

It is possible to detect a positive Coombs test, a false positive test for glucose in the urine.

OVERDOSE

Symptoms (often occur in patients with chronic renal failure): convulsions, encephalopathy, neuromuscular excitation.

Treatment: hemodialysis and maintenance therapy.

DRUG INTERACTION

Pharmaceutically incompatible with other antimicrobial drugs and heparin.

Diuretics, aminoglycosides, polymyxin B reduce the tubular secretion of cefepime and increase its concentration in serum, extend T 1/2 , increase nephrotoxicity (increases the risk of developing nephronecrosis).

Cefepime increases the ototoxicity of aminoglycosides.

NSAIDs, slowing the excretion of cephalosporins, increase the risk of bleeding.

With a simultaneous appointment with bactericidal antibiotics (aminoglycosides), synergism is manifested, with bacteriostatic (macrolides, chloramphenicol, tetracyclines) antagonism.

Incompatible with the solution of metronidazole (before the administration of the solution of metronidazole for the prevention of infections during surgical interventions, the infusion system should be rinsed from the solution of cefepime).

To avoid possible drug interactions with other drugs, cefepime solutions (as well as most other beta-lactam antibiotics) should not be administered concomitantly with solutions of vancomycin, gentamicin, tobramycin, netilmicin.
When prescribing cefepime with the listed drugs, each antibiotic should be administered separately.
TERMS AND CONDITIONS OF STORAGE

The drug should be stored in a dry, protected from light, out of reach of children at a temperature of no higher than 30 ° C.
Shelf life - 2 years.
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