Cefepim - Instructions For The Use Of An Antibiotic, Price, Analogues, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Cefepim

Cefepim: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. Drug interactions
13. 13. Analogs
14. 14. Terms and conditions of storage
15. 15. Terms of dispensing from pharmacies
16. 16. Reviews
17. 17. Price in pharmacies

Latin name: Cefepime

ATX code: J01DE01

Active substance: cefepime

Producer: Brown Laboratories Limited (India), Biosynthesis (Russia), Kraspharma (Russia)

Description and photo update: 2018-04-07

Prices in pharmacies: from 85 rubles.

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Cefepim is a cephalosporin, an antibacterial drug.

Release form and composition

Dosage forms of Cefepime:

• powder for preparation of a solution for intramuscular (i / m) administration: from white to white with a yellow tint [0.5 g or 1 g each in vials: in a cardboard box 10 or 50 vials (for hospital); in a cardboard box 1 bottle; in a cardboard box 1 bottle complete with a solvent (1 glass ampoule of 3.5 ml with lidocaine solution for injection 10 mg / ml); in a cardboard box 1 bottle complete with a solvent (1 glass ampoule of 3.5 ml with lidocaine solution for injection 10 mg / ml and 1 ampoule of 5 ml with water for injection); 1 g in vials, in a cardboard box 5 or 30 vials];
• powder for preparation of a solution for intravenous (i / v) and intramuscular (i / m) administration: white with a yellow tint [0.5 g in a vial, 1 vial in a cardboard box; in a cardboard box 10, 50, 270 or 300 bottles (for hospital); 0.5 g or 1 g in vials, in blisters 1 or 5 vials, in a cardboard box 1 pack complete with 1 or 5 glass ampoules with a solvent (water for injection); 1 g in vials, in a cardboard box 1 bottle; in a cardboard box of 10, 14, 25, 50, 270, 300 or 1000 bottles (for hospital); 2 g in a bottle, in a cardboard box 1 bottle; in a cardboard box 50 or 300 bottles (for hospital)].

1 vial of powder for i / m administration contains:

• active substance: cefepime hydrochloride monohydrate in terms of cefepime - 0.5 g or 1 g;
• auxiliary component: arginine.

1 bottle of powder for i / v and i / m administration contains:

• active substance: cefepime hydrochloride in terms of cefepime - 0.5 g, 1 g or 2 g;
• auxiliary component: arginine.

Pharmacological properties

Pharmacodynamics

Cefepim belongs to the group of IV generation cephalosporins. Its broad spectrum of antibacterial action is directed against bacteria (gram-positive and gram-negative) and strains that are resistant to aminoglycosides and / or third generation cephalosporins. The mechanism of bactericidal action is to disrupt the synthesis of the cell wall of microorganisms. Shows high resistance to hydrolysis of the predominant amount of beta-lactamases. It quickly penetrates into gram-negative bacterial cells; inside the cell, its molecular activity is directed to penicillin-binding proteins.

The following microorganisms are sensitive to Cefepime in vitro:

• gram-positive aerobes: Staphylococcus hominis, Staphylococcus epidermidis and Staphylococcus aureus (including strains producing beta-lactamase), Staphylococcus saprophyticus, other strains of Staphylococcus speciales Bsp., Streptococcus speciales (spp.), Streptococcus spp. (groups C, G and F), Streptococcus viridans, Streptococcus bovis (group D), Streptococcus pyogenes (group A);
• gram-negative aerobes: Pseudomonas aeruginosa, Pseudomonas stutzeri, Pseudomonas putida and other Pseudomonas spp., Escherichia coli, Enterobacter aerogenes, Enterobacter cloacae, Enterobacter agglomerans, Enterobacter sakazakii and others. Enterobacter opp. spp., Enterobacter sakazakii and others., Acinetobacter calcoaceticus, Proteus vulgaris, Proteus mirabilis and others Proteus spp., Aeromonas hydrophila, Citrobacter freundii, Citrobacter diversus and other Citrobacter spp., Capnocytophaga spp., Gardnerella vaginalis, Campylobacter jejuni-producing strains, Haemopheta Legionella spp., Haemophilus parainfluenzae, Haemophilus ducreyi, Hafnia alvei, Morganella morganii, Neisseria gonorrhoeae (including beta-lactamase producing strains),Moraxella catarrhalis (including beta-lactamase-producing strains), Neisseria meningitides, Salmonella spp., Providencia stuartii, Providencia rettgeri and others Providencia spp., Serratia liquefaciens, Serratia marcescens and others Serratia spp., Yersinia enterella spp., Yersinia enterella
• anaerobes: Clostridium perfringens, Prevotella melaninogenicus and other Prevotella spp., Fusobacterium spp., Peptostreptococcus spp., Mobiluncus spp., Bacteroides melaninogenicus and other Bacteroides spp. oral cavity, Veillonella spp.

Cefepime resistance is shown by Clostridium difficile, methicillin-resistant staphylococci, Bacteroides fragilis, penicillin-resistant pneumococci, certain strains of Xanthomonas maltophilia, Enterococcus faecalis and most other enterococcal strains.

Pharmacokinetics

Bioavailability of cefepime is 100%.

The maximum concentration (C _max) of the drug in the blood plasma with a single intravenous drip of 1000 mg of cefepime for 0.5 hour is 0.0787 mg / ml 0.5 hours after the end of the infusion. After 12 hours, the content of the drug in the blood plasma averages 0.0006 mg / ml. The total concentration (AUC) of the drug in the blood plasma within an hour is 0.1485 mg / ml.

After i / m administration, cefepime is completely absorbed. C _max with i / m injection of 1000 mg of the drug reaches 0.0263 mg / ml after 2 hours. AUC - 0.137 mg / ml / h.

The volume of distribution on average in adults is 0.25 l / kg, in children - 0.33 l / kg.

About 20% of the administered dose binds to plasma proteins.

Cefepime in high concentrations is determined in peritoneal fluid, urine, bile, gallbladder, sputum, bronchial mucosa, blister exudate, prostate gland and appendix.

The half-life is 2 hours, with hemodialysis - 13 hours, with continuous peritoneal dialysis - 19 hours.

Approximately 15% of the dose is metabolized in the liver and kidneys, and approximately 85% is excreted unchanged in the urine.

Indications for use

Powder for preparation of solution for intramuscular injection

The use of the antibiotic Cefepim is indicated for mild and moderate severity of uncomplicated and complicated infectious diseases of the urinary tract, which are caused by Escherichia coli.

Powder for preparation of solution for intravenous and intramuscular administration

• moderate and severe pneumonia caused by Pseudomonas aeruginosa, Streptococcus pneumoniae (including cases associated with concomitant bacteremia), Klebsiella pneumoniae, Enterobacter spp.;
• pyelonephritis and other uncomplicated and complicated infectious pathologies of the urinary tract caused by Klebsiella pneumoniae, Escherichia coli, Proteus mirabilis;
• febrile neutropenia - empiric treatment;
• intra-abdominal infections of complicated genesis, which are caused by Enterobacter spp., Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis - as part of a combination therapy with metronidazole;
• infectious diseases of the skin and soft tissues of uncomplicated etiology caused by Streptococcus pyogenes, methicillin-sensitive strains of Staphylococcus aureus.

Contraindications

• breast-feeding;
• individual intolerance to beta-lactam antibiotics, including cephalosporins, penicillins, carbapenems, monobactams;
• hypersensitivity to the components of the drug.

Powder for preparation of solution for intramuscular injection

Cefepim should not be prescribed to children under the age of 12 years.

It is recommended to use with caution in chronic renal failure, the following pathologies of the gastrointestinal tract (including anamnesis): ulcerative colitis, pseudomembranous enterocolitis, regional enteritis (Crohn's disease), antibiotic-associated colitis.

During pregnancy, it is possible to use Cefepim only on strict indications, when the expected benefit from therapy for the mother significantly outweighs the potential harm to the fetus.

Powder for preparation of solution for intravenous and intramuscular administration

• I trimester of pregnancy;
• age up to 2 months.

According to the instructions, Cefepime should be used with caution in case of impaired renal function, ulcerative colitis (including history), children under 12 years of age, in the II – III trimesters of pregnancy.

Instructions for the use of Cefepim: method and dosage

Powder for preparation of solution for intramuscular injection

Ready solution of Cefepim is intended only for intramuscular injection.

The following solvents can be used to dissolve the powder: sterile water for injection, 5% glucose solution for injection, 0.9% sodium chloride solution for injection, bacteriostatic water for injection with benzyl alcohol or paraben, 0.5% or 1% lidocaine hydrochloride solution … For the introduction of 0.5 g of powder, it must be dissolved in 1.3 ml, for the introduction of 1 g - in 2.4 ml of solvent.

The doctor determines the dose and period of treatment based on clinical indications, the severity of the infection, and the functional state of the kidneys.

The recommended dosage of Cefepime: 0.5-1 g every 12 hours, the course of treatment is 7-10 days.

With impaired renal function with creatinine clearance (CC) less than 30 ml / min, patients need to adjust the dosage regimen. The usual dose of the drug is taken as the initial dose.

Powder for preparation of solution for intravenous and intramuscular administration

Ready solution of Cefepim is intended for intramuscular administration (only in the treatment of uncomplicated and complicated urinary tract infections of mild and moderate severity caused by Escherichia coli) or for jet and drip intravenous administration.

To prepare a solution for intravenous injection, add 10 ml of one of the solvents to 1 g of the drug: sterile water for injection, 5% dextrose (glucose) solution, 0.9% sodium chloride solution. The prepared solution is injected within 3-5 minutes.

To prepare a solution for intravenous drip administration, you can use one of the following solvents: 0.9% sodium chloride solution, sodium lactate solution, 5% or 10% dextrose (glucose) solution, a mixture of Ringer's lactate and 5% dextrose solution, mixture 5 % dextrose solution and 0.9% sodium chloride solution. The contents of the vial (1 g of powder) are first dissolved in 5-10 ml of one of the listed solutions, then mixed in an infusion container with the same solution, bringing it to 50 ml or 100 ml. The duration of the infusion is 30 minutes.

To prepare a solution for intramuscular injection, you can use sterile water for injection, 0.9% sodium chloride solution or 0.5-1% lidocaine hydrochloride solution. For 1 g of powder, 2.4 ml of solvent should be added to the vial. IM injection must be carried out after preliminary aspiration to avoid getting the needle into the vessel and introducing the solution into the blood (especially lidocaine)! The solution is injected deep into the muscle in the upper outer quadrant of the buttock.

No particles are allowed in each of the prepared solutions!

The finished solution can be stored at room temperature for no more than 24 hours or at 2-8 ° C in the refrigerator for 7 days. When the solution darkens, the activity of the drug does not change.

When prescribing the dose and route of administration of the drug, the doctor takes into account the localization, the nature and type of infection, the functional state of the kidneys and the age of the patient.

Recommended dosage of Cefepime for adults:

• moderate and severe pneumonia: IV - 1-2 g every 12 hours, course of treatment - 10 days;
• moderate uncomplicated and complicated infections of the urinary tract and kidneys, including pyelonephritis: intravenous or intramuscular - 0.5-1 g every 12 hours, course of treatment - 7-10 days;
• severe uncomplicated and complicated infections of the urinary tract and kidneys, including pyelonephritis: IV - 2 g every 12 hours, course of treatment - 10 days;
• complicated intra-abdominal infections (in combination with metronidazole): IV - 2 g every 12 hours, course of treatment - 7-10 days;
• moderate and severe uncomplicated infections of the skin and soft tissues: IV - 2 g every 12 hours, course of treatment - 10 days;
• neutropenic fever, life-threatening infection: IV - 2 g every 8 hours, course of treatment - 7 days.

In case of impaired liver function, correction of the dosage regimen is not required.

In case of impaired renal function, correction of the dosage regimen is required, including for patients on hemodialysis or peritoneal dialysis. Changes should be made based on the initial usual single dose prescribed for the treatment of a particular disease and taking into account the level of CC.

For patients on hemodialysis, cefepime should be administered after the end of the session, preferably at the same time.

The recommended dosage for the treatment of children from 2 months to 16 years and with a body weight of up to 40 kg: IV - at the rate of 0.05 g per 1 kg of the child's weight. The frequency of administration for all indications (except for febrile neutropenia) - every 12 hours, with febrile neutropenia - every 8 hours. Duration of treatment, taking into account indications as for adult patients.

During the drip injection of Cefepim, it is recommended to suspend the administration of other solutions.

Side effects

• from the nervous system: insomnia, headache, anxiety, dizziness, confusion, convulsions, paresthesia;
• allergic reactions: pruritus, erythema, skin rash, fever, eosinophilia, exudative erythema multiforme (including Stevens-Johnson syndrome), anaphylactoid reactions; rarely - Lyell's syndrome;
• from the reproductive system: vaginitis;
• from the gastrointestinal tract: abdominal pain, nausea, vomiting, dyspepsia, diarrhea, constipation, against the background of long-term therapy - dysbiosis; extremely rare - pseudomembranous enterocolitis;
• from the urinary system: very rarely - toxic nephropathy, functional impairment of the kidneys;
• on the part of hematopoietic organs: increased bleeding, anemia, leukopenia, transient thrombocytopenia, neutropenia, hemolytic anemia, pancytopenia;
• on the part of the cardiovascular system: chest pain, tachycardia;
• from the respiratory system: shortness of breath, sore throat, cough;
• laboratory indicators: a decrease in hematocrit, an increase in the level of urea, the activity of hepatic enzymes and / or alkaline phosphatase, hypercreatininemia, hyperbilirubinemia, hypercalcemia, an increase in prothrombin time, a false-positive urine glucose test, a positive direct Coombs test;
• local reactions: with intravenous injection - phlebitis, with intramuscular injection - pain at the injection site, hyperemia;
• others: increased sweating, candidiasis, back pain, sore throat, asthenia, peripheral edema.

Overdose

Symptoms: more often occur against the background of chronic renal failure - neuromuscular agitation, convulsions, encephalopathy.

Treatment: with normal renal function - supportive therapy, careful observation. Patients with renal failure require hemodialysis.

special instructions

In case of symptoms of aerobic-anaerobic infection, an antibacterial agent active against anaerobic microorganisms should be additionally used before the pathogen is identified. Each drug must be administered separately!

If dissemination from the site of infection or meningitis is suspected, an alternative antibiotic that is effective for meningitis is required.

Since pseudomembranous colitis may develop against the background of the use of Cefepim, a thorough examination should be carried out when a patient develops diarrhea. If the diagnosis is confirmed, the drug should be discontinued. For moderate to severe pseudomembranous colitis, metronidazole or vancomycin is required.

In patients with allergic reactions to penicillins, cross-hypersensitivity may occur. In this case, the use of Cefepim should be canceled. In case of a severe reaction of an immediate type, urgent measures are indicated, including the administration of epinephrine, glucocorticosteroids.

In severe renal or hepatic impairment, the patient should be provided with regular monitoring of the concentration of cefepime in the blood.

With a course duration of more than 10 days, treatment must be accompanied by careful monitoring of blood counts and the functional state of the kidneys and liver.

The action of Cefepime may distort laboratory results.

Application during pregnancy and lactation

The use of Cefepim is possible only in exceptional cases when the expected effect of therapy for the mother significantly exceeds the potential threat to the fetus:

• in the form of a powder for i / v and i / m administration - in the II and III trimesters of pregnancy (the I trimester is an absolute contraindication for this dosage form);
• in the form of a powder for i / m administration - the entire period of pregnancy.

The use of the drug during lactation is contraindicated. In case of clinical indications requiring the appointment of Cefepime, breastfeeding should be temporarily discontinued.

Pediatric use

Powder for preparation of solution for intramuscular injection

The use of Cefepime in children under 12 years of age is contraindicated.

Powder for preparation of solution for intravenous and intramuscular administration

Cannot be used to treat children under 2 months of age.

It is recommended to prescribe the antibiotic Cefepim with caution to children under 12 years of age.

With impaired renal function

Powder for preparation of solution for intramuscular injection

In case of impaired renal function, the initial dose of Cefepime should be the same as in patients with normal renal function - 0.5 g or 1 g every 12 hours, maintenance doses are adjusted depending on creatinine clearance (CC):

• KK11-29 ml / min: 0.5 g 1 time in 24 hours;
• CC less than 10 ml / min: 0.25 g 1 time in 24 hours.

On the first day, patients on hemodialysis should be administered 1 g, then - 0.5 g of the drug every 24 hours. The procedure is carried out after the end of the session, preferably at the same time.

In children with chronic renal failure over 12 years old, doses for adults are used.

Powder for preparation of solution for intravenous and intramuscular administration

The dosage regimen of Cefepim when prescribing a dose of 0.5 g every 12 hours, taking into account QC, the dose is reduced in the following order:

• CC 11-60 ml / min: 0.5 g 1 time in 24 hours;
• CC less than 11 ml / min: 0.25 g 1 time in 24 hours;
• peritoneal dialysis: 0.5 g every 48 hours.

The dosage regimen of Cefepim when prescribing a dose of 1 g every 12 hours, taking into account QC, the dose is reduced in the following order:

• CC 30-60 ml / min: 1 g 1 time in 24 hours;
• CC 11-29 ml / min: 0.5 g 1 time in 24 hours;
• CC less than 11 ml / min: 0.25 g 1 time in 24 hours;
• peritoneal dialysis: 1 g every 48 hours.

The dosage regimen of Cefepim when a dose of 2 g is prescribed every 12 hours, taking into account the CC, the dose is reduced in the following order:

• CC 30-60 ml / min: 2 g 1 time in 24 hours;
• CC 11-29 ml / min: 1 g 1 time in 24 hours;
• CC less than 11 ml / min: 0.5 g 1 time in 24 hours;
• peritoneal dialysis: 2 g every 48 hours.

The dosage regimen of Cefepim when a dose of 2 g is prescribed every 8 hours, taking into account QC, the dose is reduced in the following order:

• CC 30-60 ml / min: 2 g every 12 hours;
• CC 11-29 ml / min: 2 g 1 time in 24 hours;
• CC less than 11 ml / min: 1 g 1 time in 24 hours;
• peritoneal dialysis: 2 g every 48 hours.

Patients on hemodialysis are prescribed 1 g on the first day of hemodialysis, then 0.5 g every 24 hours.

Drug interactions

With the simultaneous use of Cefepim:

• aminoglycosides, diuretics, polymyxin B cause a decrease in tubular secretion of cefepime, an increase in the half-life and an increase in its concentration in the blood, an increase in nephrotoxicity;
• non-steroidal anti-inflammatory drugs help to slow down the elimination of cephalosporins, increase the risk of bleeding;
• macrolides, chloramphenicol, tetracyclines are antagonistic to the drug;
• aminoglycosides are synergistic.

The drug should not be mixed in the same syringe with a solution of metronidazole, gentamicin, vancomycin, tobramycin, aminophylline or netilmicin. If necessary, the simultaneous appointment of each drug should be administered separately.

Solutions of ampicillin and cefepime can be mixed in one syringe at a concentration of each of them not exceeding 40 mg per 1 ml.

Analogs

Analogues of Cefepim are: Maksipim, Ladef, Movizar, Tsepim, Efipim.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 30 ° C in a dark place.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Cefepime

There are few reviews about Cefepime, which indicate its effectiveness in the treatment of infectious diseases. It is indicated that the drug is well tolerated.

Price for Cefepim in pharmacies

The price of Cefepim (for 1 bottle containing 1 g of the drug) can range from 86 to 104 rubles.

Cefepim: prices in online pharmacies

Drug name Price Pharmacy

Cefepime 500 mg powder for preparation of solution for intravenous and intramuscular administration 1 pc. RUB 85 Buy

Cefepime 1000 mg powder for preparation of solution for intravenous and intramuscular administration 1 pc. 91 rbl. Buy

Cefepime 1 g powder for solution preparation for intravenous and intramuscular administration 1 pc. 110 RUB Buy

Cefepime 1 g powder for solution preparation for intravenous and intramuscular administration 1 pc. 115 RUB Buy

Cefepime 1000 mg powder for preparation of solution for intravenous and intramuscular administration 1 pc. 121 RUB Buy

Cefepime 1000 mg powder for preparation of a solution for intramuscular administration with a solvent 1 pc. 130 RUB Buy

Cefepim powder for prig solution for intravenous and intramuscular injection. 1g 156 r Buy

Cefepime 1 g powder for solution preparation for intravenous and intramuscular administration 1 pc. 156 r Buy

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Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!