Cefomax
Cefomax: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Cefomax
ATX code: J01DE01
Active ingredient: cefepime (Cefepime)
Manufacturer: Protech Biosystems Pvt. Ltd. (Protek Biosystems Pvt. Ltd.) (India)
Description and photo update: 2019-09-07
Prices in pharmacies: from 173 rubles.
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Cefomax is a cephalosporin antibiotic.
Release form and composition
The drug is produced in the form of a powder for the preparation of a solution for intravenous (i / v) and intramuscular (i / m) administration: white, white with a yellowish tint or light yellow (0.5; 1 and 2 g each in colorless glass vials, in a cardboard box 1 bottle and instructions for the use of Cefomax).
Powder composition in 1 bottle:
- active substance: cefepime (in the form of monohydrate hydrochloride) - 0.5; 1 or 2 g;
- auxiliary component: L-Arginine.
Pharmacological properties
Pharmacodynamics
Cefepime - the active substance of Cefomax - is a IV generation cephalosporin antibiotic with a broad spectrum of action against gram-negative and gram-positive microorganisms resistant to aminoglycosides and cephalosporin antibiotics of the third generation.
Cefepime is highly resistant to hydrolysis by most beta-lactamases. It has low affinity for beta-lactamases, which are encoded by chromosomal genes. It quickly penetrates into gram-negative bacterial cells.
In vivo and in vitro, the drug is active against the following microorganisms:
- gram-positive aerobes: Streptococcus viridans, Streptococcus pyogenes (group A), Streptococcus pneumoniae, methicillin-susceptible strains of Staphylococcus aureus;
- gram-negative aerobes: Klebsiella pneumoniae, Escherichia coli, Proteus mirabilis, Enterobacter spp., Pseudomonas aeruginosa.
In vitro, cefepime is effective (but of unknown clinical significance) against the following microorganisms:
- gram-positive aerobes: Streptococcus agalactiae (group B), Staphylococcus saprophyticus, methicillin-susceptible strains of Staphylococcus epidermidis;
- gram-negative aerobes: Klebsiella oxytoca, Hafnia alvei, Providencia rettgeri, Proteus vulgaris, Providencia stuartii, Acinetobacter lwoffii, Enterobacter agglomerans, Citrobacter diversus, Serratia marcescens, Morganella morganii, Citrobacter freunda lactamase-producing strains including beta-lactamase producing strains).
Most strains of Enterococcus spp. Are resistant to cefepime, including Enterococcus faecalis, Clostridium difficile, Stenotrophomonas maltophilia (formerly known as Xanthomonas maltophilia and Pseudomonas maltophilia), methicillin-resistant staphylococcus.
Pharmacokinetics
Cefepime is characterized by absolute bioavailability - 100%. After intravenous administration of a dose of 0.5 g, the maximum concentration (C max) is reached by the end of the infusion, after intramuscular administration - after 1-2 hours.
C max is: after a single 3-minute intravenous infusion in doses of 0.5; 1 and 2 g - 39, 82 and 164 μg / ml, respectively, after i / m administration of the same doses - 14, 30 and 57 μg / ml, respectively. The average therapeutic plasma concentration is reached within 12 hours and is 0.7 μg / ml after intravenous administration and 0.2 μg / ml after intramuscular administration.
The volume of distribution in adults is 0.25 l / kg, in children from 2 months to 16 years old - 0.33 l / kg. The connection with plasma proteins is up to 20%, regardless of the plasma concentration. The total clearance is 120 ml / min.
After a single administration, cefepime in therapeutic concentrations is determined in urine, gallbladder tissues, bile, bronchial secretions, prostate gland, appendix, peritoneal fluid. Partially passes into breast milk.
It is metabolized in the liver and kidneys by 15%. It is excreted from the body mainly by the kidneys by glomerular filtration. Approximately 85% is excreted unchanged in the urine. In patients with functional impairment of the kidneys, elimination is slowed down.
The average renal clearance in young people is 110 ml / min, in older patients this indicator increases.
The half-life (T ½) - 2 hours, increases to 13-19 hours in patients with severe renal impairment.
Indications for use
Cefomax is used to treat infectious and inflammatory diseases caused by sensitive microorganisms:
- Uncomplicated skin and soft tissue infections caused by Streptococcus pyogenes or methicillin-susceptible strains of Staphylococcus aureus;
- uncomplicated and complicated urinary tract infections (including pyelonephritis) caused by Klebsiella pneumoniae, Escherichia coli, Proteus mirabilis;
- complicated intra-abdominal infections caused by Escherichia coli, Enterobacter spp., Klebsiella pneumoniae, Pseudomonas aeruginosa (in combination with metronidazole);
- febrile neutropenia (empiric therapy);
- moderate and severe pneumonia caused by Streptococcus pneumoniae (including associated with concomitant bacteremia), Enterobacter spp., Klebsiella pneumoniae, Pseudomonas aeruginosa.
For prophylactic purposes, Cefomax is prescribed to prevent infections during abdominal surgery.
Contraindications
Absolute:
- children up to 2 months - for i / v route of administration, up to 12 years for i / m route of drug administration;
- breast-feeding;
- known hypersensitivity to the components of Cefomax, penicillins, cephalosporins or other beta-lactam antibiotics.
Cefomax should be used with caution in patients with chronic renal failure and diseases of the gastrointestinal tract (including a history), such as antibiotic-associated colitis, ulcerative colitis, pseudomembranous colitis, regional enteritis.
For pregnant women, the drug is prescribed only if the intended benefit to the mother exceeds the potential risk to the fetus.
Cefomax, instructions for use: method and dosage
Cefomax is administered as an intravenous injection for 3-5 minutes or an intravenous infusion lasting at least 30 minutes. Only in complicated and uncomplicated urinary tract infections of mild and moderate severity caused by E. coli, it is possible to administer intramuscularly.
For intravenous injection, powder (1 or 2 g) is dissolved in 10 ml of sterile water for injection, 5% dextrose solution or 0.9% sodium chloride solution.
For intravenous infusion, the solution prepared as described above is combined with other infusion solutions, such as sodium chloride solution 0.9%, dextrose solution 5% or 10%, Ringer's solution with lactate and dextrose solution 5% (the maximum concentration should not exceed 40 mg / ml).
To dilute the powder for intramuscular administration, use sterile water for injection, bacteriostatic water for injection with paraben or benzyl alcohol, sodium chloride solution 0.9%, lidocaine hydrochloride solution 0.5% and 1%: for a dosage of 0.5 g - 1.3 ml, for a dosage of 1 g - 2.4 ml.
The doctor determines the optimal dose of Cefomax individually, depending on the severity of the disease, the sensitivity of the pathogen and the state of the patient's renal function.
Recommended dosage regimens of Cefomax for adults:
- moderate and severe pneumonia caused by Streptococcus pneumoniae (including associated with concomitant bacteremia), Klebsiella pneumoniae, Pseudomonas aeruginosa, Enterobacter spp.: 1-2 g 2 times a day (at intervals of 12 hours) for 10 days;
- severe infectious diseases of the urinary tract, including complicated (including pyelonephritis) caused by E. coli or Klebsiella pneumoniae: 2 g 2 times a day for 10 days;
- mild and moderate urinary tract infections (including complicated ones) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis: 0.5–1 g 2 times a day for 7–10 days;
- complicated intra-abdominal infections caused by Klebsiella pneumoniae, Escherichia coli, Enterobacter spp., Pseudomonas aeruginosa (in combination with metronidazole): 2 g 2 times a day for 7-10 days;
- moderate and severe infectious diseases of the skin and soft tissues caused by Streptococcus pyogenes or methicillin-susceptible strains of Staphylococcus aureus: 2 g 2 times a day for 10 days;
- febrile neutropenia: 2 g 3 times a day (at intervals of 8 hours) for 7 days or until neutropenia resolves;
- prevention of infections during abdominal surgery: 60 minutes before the start of the operation, 2 g of cefepime is injected within 30 minutes, at the end of the infusion, 500 mg of metronidazole is injected intravenously (these solutions cannot be administered simultaneously, the infusion system should be flushed before the administration of metronidazole). In case of prolonged surgical interventions 12 hours after the first dose of Cefomax, it is recommended to re-administer the same dose within 30 minutes, followed by the administration of metronidazole at a dose of 500 mg.
For children from 2 months and weighing up to 40 kg, Cefomax is prescribed intravenously at 50 mg / kg: for febrile neutropenia - 3 times a day, for all other indications - 2 times a day. The maximum dose for children should not exceed that for adults. The course of therapy is 7-10 days.
Correction of the therapy regimen for renal failure
For adults with chronic renal failure, the dose of Cefomax is determined by the doctor, taking into account not only the severity of the course of the infectious process, but also the creatinine clearance rates (CC, ml / min):
- > 60 - 0.5-1-2 g 2 times a day or 2 g 3 times a day;
- 30-60 - 0.5-1-2 g 1 time per day or 2 g 2 times a day;
- 11-29 - 0.5-1-2 g once a day;
- <10 - 0.25-0.5-1 g 1 time per day.
For patients receiving continuous peritoneal dialysis, Cefomax is prescribed 0.5–1–2 g every 2 days (at intervals of 48 hours). Patients on hemodialysis are given a dose of 1 g on the first day, then 1 g 1 time per day in the case of febrile neutropenia, 0.5 g 1 time per day in all other cases. On the day of hemodialysis, the drug should be administered after the end of the session. It is advisable to inject Cefomax at the same time of day.
There is no information on the treatment of children with concomitant renal failure with the drug. Given the similarity of the pharmacokinetic profile of cefepime in adults and children, a similar change in the dosage regimen is recommended: a decrease in the dose or an increase in the interval between injections.
Side effects
- local reactions: with intravenous administration - phlebitis; with intramuscular - soreness and hyperemia at the injection site;
- laboratory parameters: hyperbilirubinemia, hypercalcemia, hypercreatininemia, an increase in prothrombin time or partial thromboplastin time, a decrease in hematocrit, a false-positive Coombs test (without hemolysis), an increase in the activity of hepatic transaminases, urea and alkaline phosphatase concentrations;
- allergic reactions: fever, itching, skin rash (including erythematous rash), eosinophilia, anaphylactic shock, anaphylactoid reactions, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis;
- from the hematopoietic system: bleeding, bleeding, pancytopenia, leukopenia, thrombocytopenia, neutropenia, anemia (including aplastic and hemolytic);
- from the nervous system: anxiety, insomnia, dizziness, headache, confusion, paresthesia, convulsions, encephalopathy (in patients with impaired renal function in the absence of dose adjustment);
- from the urinary system: functional impairment of the kidneys, toxic nephropathy;
- from the genitourinary system: vaginitis, genital itching;
- on the part of the cardiovascular system: peripheral edema, shortness of breath, tachycardia;
- from the respiratory system: chest pain, shortness of breath, cough;
- from the digestive tract: abdominal pain, constipation or diarrhea, nausea, vomiting, dyspeptic disorders, pseudomembranous colitis;
- others: increased sweating, change in taste, sore throat, asthenia, candidiasis (including oropharyngeal), development of superinfection, back pain.
Overdose
Overdose symptoms more often occur in patients with chronic renal failure: neuromuscular agitation, convulsions, encephalopathy.
Treatment is symptomatic. To remove the drug from the body, hemodialysis is performed.
special instructions
In patients with renal / hepatic insufficiency during treatment, the plasma concentration of cefepime should be periodically determined and, if necessary, the dose of Cefomax should be adjusted. With prolonged therapy, regular monitoring of peripheral blood parameters, the functional state of the kidneys and liver is shown.
The drug should be used with caution in patients with any form of allergy, especially with a history of allergic reactions to drugs. If any symptoms of a developing allergy appear, Cefomax should be canceled. Serious immediate hypersensitivity reactions may require adrenaline (epinephrine) and other supportive treatment.
In case of mixed aerobic-anaerobic infection, prior to identification of pathogens, Cefomax is recommended to be used in combination with drugs that are active against anaerobes.
If, after removal of the focus of infection, there is reason to believe that the meningeal infection has spread, or meningitis is suspected or confirmed, an alternative antibiotic with proven efficacy for the disease should be prescribed.
In the event of prolonged diarrhea, the likelihood of developing pseudomembranous colitis should be assumed. Cefomax is discontinued and vancomycin or metronidazole is prescribed.
Against the background of the use of any antibiotic, the development of superinfection is possible, which requires the termination of antimicrobial therapy and the appointment of an appropriate one.
During the period of drug treatment, patients may show false positive results of the Coombs' test and tests for glucose in the urine.
Influence on the ability to drive vehicles and complex mechanisms
It was recommended to abandon for the period of therapy from performing potentially hazardous activities that require accuracy of movements, quick reactions and increased attention.
Application during pregnancy and lactation
During pregnancy, Cefomax is prescribed only in cases where a woman needs therapy with this drug, and the expected benefit is definitely higher than the potential risks.
If treatment is absolutely necessary during lactation, it is recommended to consider stopping breastfeeding.
Pediatric use
Intramuscularly Cefomax is contraindicated for children under 12 years of age. The intravenous route of administration of the drug is recommended for children from 2 months, since the safety and efficacy of use in infants up to 2 months have not been established.
With impaired renal function
In patients with chronic renal failure, the use of Cefomax is possible only as directed by a physician, under his close supervision.
For violations of liver function
There is no information on the need to change the dose for patients with liver dysfunction.
When treating patients with hepatic insufficiency, it is necessary to periodically determine the concentration of cefepime in the blood plasma and, if necessary, adjust the dose of Cefomax.
Drug interactions
Cefepime is pharmaceutically incompatible with heparin and other antimicrobial agents. It is incompatible with metronidazole, therefore, if it is necessary to use them together, after the administration of a solution of cefepime, it is necessary to flush the infusion system.
To avoid the possible development of drug interactions, cefepime solutions should not be administered simultaneously with solutions of tobramycin, gentamicin, netilmicin, vancomycin. If combination therapy is justified, each drug should be administered separately.
Bactericidal antibiotics (aminoglycosides) in combination with cefepime exhibit synergy, bacteriostatic antibiotics (macrolides, tetracyclines, chloramphenicol) - antagonism.
Polymyxin B, diuretics and aminoglycosides reduce the tubular secretion of cefepime, increase its serum concentration and half-life, increase nephrotoxicity (increase the risk of developing nephronecrosis). In turn, cefepime enhances the ototoxic effect of aminoglycosides.
Non-steroidal anti-inflammatory drugs slow down the excretion of cephalosporins, thereby increasing the risk of bleeding.
Analogs
Analogues of Cefomax are: Azaran, Axosef, Bestum, Vicef, Doxsef, Zinforo, Intrazolin, Clafobrin, Liforan, Medaxon, Natsef, Oritax, Proxim, Super, Tornaxon, Fortum, Cezolin, Cefaktiv, Ceftriaxone, Efipim and others.
Terms and conditions of storage
Store in a dark place at a temperature not exceeding 25 ° C. Keep out of the reach of children.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Cefomax
According to reviews, Cefomax is an effective antibiotic for diseases caused by sensitive microorganisms. Patients note that improvement in the condition is noted quickly, in some cases after the first injection. Additional advantages include low cost and good tolerability of the drug.
Price for Cefomax in pharmacies
The approximate price for Cefomax for 1 bottle in a dose of 1 g is 95–110 rubles.
Cefomax: prices in online pharmacies
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Drug name Price Pharmacy |
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Cefomax 1 g powder for preparation of a solution for intravenous and intramuscular administration 1 pc. 173 r Buy |
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!
