Cefepime, 1000 mg, powder for solution for intravenous and intramuscular administration, 1 pc.


CEFEPIM

Directions for use and doses

Intravenous (IV) infusion (over at least 30 minutes) or intramuscular (IM) (only for complicated or uncomplicated mild to moderate urinary tract infections caused by E. coli).
Pneumonia (moderate to severe) caused by Streptococcus pneumoniae (including with concomitant bacteremia), Pseudomonas aeruginosa, Klebsiella pneumoniae or Enterobacter spp.: 1-2 g intravenously every 12 hours for 10 days.

Febrile neutropenia (empirical therapy): 2 g IV every 8 hours for 7 days or until neutropenia resolves.

Complicated or uncomplicated urinary tract infections of mild to moderate severity caused by E. coli, Klebsiella pneumoniae, Proteus mirabilis: IV or IM (only for infections caused by E. coli) 0.5-1 g every 12 hours for 7 -10 days. Severe complicated or uncomplicated urinary tract infections (including pyelonephritis) caused by E. coli or Klebsiella pneumoniae: 2 g IV every 12 hours for 10 days.

Moderate and severe infections of the skin and soft tissues caused by Staphylococcus aureus (only methicillin-sensitive strains), Streptococcus pyogenes: 2 g intravenously 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: 2 g intravenously every 12 hours for 7-10 days.

To prevent infection during surgical interventions on the abdominal organs: 60 minutes before the start of surgery, 2 g of the drug is administered intravenously over 30 minutes. At the end of the infusion, an additional 500 mg of metronidazole intravenously. Metronidazole solutions should not be administered concomitantly with cefepime. The infusion system should be flushed before administering metronidazole. During long-term (more than 12 hours) surgical operations, 12 hours after the first dose, repeated administration of 2 g of the drug intravenously over 30 minutes is recommended, followed by 500 mg of metronidazole.

In children from 2 months

and with body weight up to
40
kg, the recommended dosage regimen for all indications (excluding febrile neutropenia) is
50
mg/kg every
12
hours IV;
for febrile neutropenia - 50
mg/kg every
8
hours. Duration of treatment is the same as for adults. The maximum dose for children should not exceed the recommended dose for adults.

In patients with impaired renal function

(creatinine clearance [CC] <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. Recommended maintenance doses of the drug are presented in the table.

Creatinine clearance (CC) (ml/min) Recommended maintenance doses
>50 2 g every 8 hours (usual dose, 2 g every 12 hours (usual dose, 1 g every 12 hours (usual dose, 500 mg every 12 hours (usual
no adjustments required) no adjustments required) no adjustments required) dose,

no adjustments required)

30-50 2 g every 8 hours 2 g every 12 hours 1 g every 12 hours 500 mg every 12 hours
11-29 1 g every 12 hours 1 g every 24 hours 500 mg every 24 hours 500 mg every 24 hours
<10 1 g every 24 hours 500 mg every 24 hours 250 mg every 24 hours 250 mg every 24 hours

For patients on hemodialysis,

on day 1, 1 g is administered, 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 administer cefepime at the same time every day.

Data on the use of the drug in children with concomitant chronic renal failure (CRF)

are absent, however, given the similarity of pharmacokinetics in children and adults, the dosage regimen (reducing the dose or increasing the interval between doses) in children with chronic renal failure is similar to the dosage regimen in adults.

To prepare a solution for intravenous administration, the drug is dissolved in 10 ml (1.0 g) of sterile water for injection, 5% dextrose solution or 0.9% sodium chloride solution. Injected intravenously over 3-5 minutes. For intravenous infusion, the prepared solution is combined with other solutions for intravenous infusion (0.9% sodium chloride solution, 5% or 10% dextrose solution, lactated Ringer's solution and 5% dextrose solution; maximum concentration 40 mg/ml) and administered over a period of less than 30 minutes.

To prepare a solution for intramuscular administration, the drug is dissolved in sterile water for injection, 0.9% sodium chloride solution, bacteriostatic water for injection with paraben or benzyl alcohol, 0.5% and 1% solution of lidocaine hydrochloride (1.0 g in 2.4 ml).

pharmachologic effect

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 spp., including Enterococcus faecalis, methicillin-resistant staphylococci, Stenotrophomonas maltophilia (formerly known as Xanthomonas maltophilia and Pseudomonas maltophilia), Clostridium difficile are not sensitive to cefepime.

Side effect

Allergic reactions: skin rash (including erythematous rashes), itching, fever, anaphylactoid reactions, anaphylactic shock, false-positive Coombs test, eosinophilia, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

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

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

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, increased prothrombin time or partial thromboplastin time.

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, change in taste, increased sweating, back pain, asthenia, development of superinfection, oropharyngeal candidiasis.

Overdose

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

Treatment: hemodialysis and symptomatic therapy.

Interaction with other drugs

Pharmaceutically incompatible with other antimicrobial drugs and heparin.

Diuretics reduce the tubular secretion of cefepime and increase its concentration in the blood serum, lengthen the half-life, and increase nephrotoxicity (increases the risk of nephronecrosis).

Non-steroidal anti-inflammatory drugs, by slowing down the elimination of cephalosporins, increase the risk of bleeding.

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.

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 creatinine clearance).

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 drugs 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.

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

Impact on the ability to drive vehicles and operate machinery

During the treatment period, it is necessary to refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Cefepime price, where to buy

The price of Cefepime depends on the dosage of the active substance (the average cost of 1 g bottle is 100-200 rubles).

  • Online pharmacies in RussiaRussia
  • Online pharmacies in UkraineUkraine
  • Online pharmacies in KazakhstanKazakhstan

LuxPharma* special offer

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ZdravCity

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    RUB 205 order

Pharmacy Dialogue

  • Cefepime bottle 1g IV i.m. Kraspharma OJSC

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    RUB 156 order

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    290 rub. order

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Pharmacy24

  • Cefepime 1 g No. 1 powder for the preparation of solution for injection STERIL-GEN LIFE SCIENCES (P) Ltd., India
    144 UAH.order
  • Cefepime 1000 mg No. 1 powder Nectar Lifesciences.Limited, India

    67 UAH order

  • Cefepime 1 g powder AT "Lekhim-Kharkiv", Ukraine

    60 UAH.order

PaniPharmacy

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Indications for use of Cefepime

An antibiotic is prescribed for severe and moderate pneumonia caused by streptococci, enterococci, Klebsiella and other microorganisms sensitive to the action of the drug.

Instructions for use of Cefepime contain the following indications for use of the drug: infectious lesions of the urinary tract (complicated and uncomplicated forms), febrile neutropenia , uncomplicated infectious diseases of the skin and adjacent soft tissues.

The medication is recommended for use in cases of complicated intra-abdominal infectious lesions (in combination therapy with metronidazole).

Contraindications

Hypersensitivity to cefepime, components of the drug, other cephalosporins, penicillins, other beta-lactam antibiotics, children under 2 months (for intravenous administration), children under 12 years of age (for intramuscular administration), lactation period.

Carefully

Diseases of the gastrointestinal tract (including a history), especially colitis, regional enteritis or antibiotic-associated colitis, severe chronic renal failure.

Use during pregnancy and lactation

The use of the drug during pregnancy is possible only in cases where the potential benefit to the mother outweighs the risk to the fetus.

If it is necessary to prescribe the drug during lactation, breastfeeding should be suspended.

Pharmacokinetics

Bioavailability - 100%. The time to reach maximum concentration after intravenous and intramuscular administration at a dose of 0.5 g is 1 to 2 hours by the end of the infusion, respectively. The maximum concentration for intramuscular administration in doses of 0.5, 1 and 2 g is 14, 30 and 57 mcg/ml, respectively; when administered intravenously in doses of 0.25, 0.5, 1 and 2 g - 18, 39, 82 and 164 mcg/ml, respectively; time to achieve average therapeutic concentration in plasma - 12 hours; the average therapeutic concentration for intramuscular administration is 0.2 mcg/ml, for intravenous administration is 0.7 mcg/ml. High concentrations are determined in urine, bile, peritoneal fluid, blister exudate, bronchial mucous secretion, sputum, prostate gland, appendix and gall bladder. Volume of distribution - 0.25 l/kg, in children from 2 months to 16 years - 0.33 l/kg. Communication with plasma proteins - 20%. Metabolized in the liver and kidneys by 15%. The half-life is 2 hours, the total clearance is 120 ml/min, the renal clearance is 110 ml/min. It is excreted by the kidneys (through glomerular filtration unchanged - 85%), with breast milk. The half-life for hemodialysis is 13 hours, and for continuous peritoneal dialysis it is 19 hours.

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