Cefepime powder 1g, No. 1
Expiration Date: 05/2027
Russian Pharmacy name:
Цефепим порошок 1г, №1
Individual, depending on the sensitivity of the pathogen, the severity of the infection, as well as the state of renal function, IV route of administration is preferable for patients with severe or life-threatening infections, especially with the threat of shock. with a body weight of more than 40 kg with normal renal function, a single dose is 0.5-1 g, the interval between injections is 12 hours. In severe infections, intravenous injection is administered at a dose of 2 g every 12 hours. in combination with metronidazole according to the scheme.For children aged 2 months, the maximum dose should not exceed the recommended dose for adults. The average dose for children weighing up to 40 kg with complicated or uncomplicated urinary tract infections (including pyelonephritis), uncomplicated infections of the skin and soft tissues,pneumonia, empiric treatment of neutropenic fever is 50 mg / kg every 12 hours Patients with neutropenic fever and bacterial meningitis - 50 mg / kg every 8 hours The average duration of therapy is 7-10 days. In severe infections, a longer treatment may be required. In case of impaired renal function (CC less than 30 ml / min), a dosage regimen must be adjusted. The starting dose of cefepime should be the same as for patients with normal renal function. Maintenance doses are determined depending on the CC values ??or serum creatinine concentration. During hemodialysis, approximately 68% of the total amount of cefepime is removed from the body in 3 hours. At the end of each session, it is necessary to enter a repeated dose equal to the initial dose. In patients on continuous ambulatory peritoneal dialysis,cefepime can be used at the average recommended doses, i.e. 500 mg, 1 g or 2 g, depending on the severity of the infection, with an interval between injections of a single dose of 48 hours For children with impaired renal function, the same changes in the dosage regimen are recommended as for adults, since the pharmacokinetics of cefepime in adults and children is similar.
active substance: cefepime
Hypersensitivity to cefepime or L-arginine, as well as to cephalosporin antibiotics, penicillins, or other beta-lactam antibiotics.
pharmachologic effect
IV generation cephalosporin antibiotic for parenteral use. It has a bactericidal effect, disrupting the synthesis of the cell wall of microorganisms. Active against most gram-negative bacteria, incl. producing ?-lactamases, including Pseudomonas aeruginosa. More active than III generation cephalosporins against gram-positive cocci. Not active against Enterococcus spp., Listeria spp., Legionella spp., Some anaerobic bacteria (Bacteroides fragilis, Clostridium difficile). Cefepime is characterized by high stability against various plasmid and chromosomal ?-lactamases.
Pharmacokinetics
Plasma protein binding is less than 19% and does not depend on the concentration of cefepime in the blood serum. Therapeutic concentrations of cefepime are found in urine, bile, peritoneal fluid, blister exudate, bronchial mucosa, sputum, prostate tissue, appendix and gallbladder, cerebrospinal fluid in meningitis. In healthy people, with intravenous administration of cefepime at a dose of 2 g with an interval of 8 hours for 9 days, no cumulation was observed in the body. The average T1 / 2 from the body is on average about 2 hours, the average total clearance is 120 ml / min. Cefepime is excreted by the kidneys, mainly by glomerular filtration (average renal clearance is 110 ml / min). In urine, approximately 85% of the administered cefepime is found unchanged.In patients aged 65 years or older with normal renal function, the value of renal clearance is less than in younger patients. In patients with impaired renal function, T1 / 2 increases. In patients with severe renal impairment, in which hemodialysis is required, T1 / 2 averages 13 hours, peritoneal dialysis - 19 hours. Cefepime pharmacokinetics in patients with liver dysfunction, cystic fibrosis is not changed. The age and sex of the patients did not significantly affect the total body clearance and Vd, taking into account the correction for the body weight of each. When cefepime was administered at a dose of 50 mg / kg every 12 hours, no cumulation was observed, and when administered at the same dose every 8 hours at steady state, Cmax, AUC and T1 / 2 increased by about 15%.In patients with impaired renal function, T1 / 2 increases. In patients with severe renal impairment, in which hemodialysis is required, T1 / 2 averages 13 hours, peritoneal dialysis - 19 hours. Cefepime pharmacokinetics in patients with liver dysfunction, cystic fibrosis is not changed. The age and sex of the patients did not significantly affect the total body clearance and Vd, taking into account the correction for the body weight of each. When cefepime was administered at a dose of 50 mg / kg every 12 hours, no cumulation was observed, and when administered at the same dose every 8 hours at steady state, Cmax, AUC and T1 / 2 increased by about 15%.In patients with impaired renal function, T1 / 2 increases. In patients with severe renal impairment, in which hemodialysis is required, T1 / 2 averages 13 hours, peritoneal dialysis - 19 hours. Cefepime pharmacokinetics in patients with liver dysfunction, cystic fibrosis is not changed. The age and sex of the patients did not significantly affect the total body clearance and Vd, taking into account the correction for the body weight of each. When cefepime was administered at a dose of 50 mg / kg every 12 hours, cumulation was not observed, and when administered at the same dose every 8 hours in an equilibrium state, Cmax, AUC and T1 / 2 increased by about 15%.The pharmacokinetics of cefepime in patients with impaired liver function, cystic fibrosis is not changed. The age and sex of the patients did not significantly affect the total body clearance and Vd, taking into account the correction for the body weight of each. When cefepime was administered at a dose of 50 mg / kg every 12 hours, no cumulation was observed, and when administered at the same dose every 8 hours at steady state, Cmax, AUC and T1 / 2 increased by about 15%.The pharmacokinetics of cefepime in patients with impaired liver function, cystic fibrosis is not changed. The age and sex of the patients did not significantly affect the total body clearance and Vd, taking into account the correction for the body weight of each. When cefepime was administered at a dose of 50 mg / kg every 12 hours, no cumulation was observed, and when administered at the same dose every 8 hours at steady state, Cmax, AUC and T1 / 2 increased by about 15%.
Side effect
From the digestive system: possible diarrhea, nausea, vomiting, colitis (including pseudomembranous colitis); rarely - abdominal pain, constipation, change in taste. Allergic reactions: possible - rash, itching, urticaria; rarely - anaphylactic reactions. From the side of the central nervous system and peripheral nervous system: possible - headaches; rarely - dizziness, paresthesia; in some cases, convulsions. Dermatological reactions: rarely - skin redness. The most common rash in children. From the hematopoietic system: anemia is possible. On the part of laboratory tests: there may be an increase in the activity of ALT, AST, ALP, an increase in total bilirubin, eosinophilia, an increase in prothrombin time; rarely - a temporary increase in blood urea nitrogen and / or serum creatinine, transient thrombocytopenia, transient leukopenia and neutropenia;often a positive Coombs test without hemolysis. Others: possible increase in body temperature, vaginitis, erythema; rarely - genital itching, nonspecific candidiasis.
Local reactions: with intravenous infusion, phlebitis is possible, rarely - inflammation); with intramuscular injection, inflammation or pain is possible. Application during pregnancy and lactation
Adequate and strictly controlled studies of the safety of using cefepime during pregnancy have not been conducted; application is possible only under the supervision of a physician. Cefepime is excreted in breast milk in very low concentrations. Use with caution during lactation. In experimental studies, no effect on reproductive function and fetotoxic effects of cefepime was found.
Application for impaired renal function
In case of impaired renal function (CC less than 30 ml / min), correction of the dosage regimen is necessary. The starting dose of cefepime should be the same as for patients with normal renal function. Maintenance doses are determined depending on the CC values ??or serum creatinine concentration
Application in children
The safety and efficacy of using cefepime in children under 2 months of age have not been established. For children over 2 months of age, use is possible according to the dosage regimen. Children with impaired renal function are recommended the same changes in the dosage regimen as for adults, since the pharmacokinetics of cefepime in adults and children is similar.
special instructions
When used in patients at increased risk of infection due to mixed aerobic / anaerobic microflora (including in cases where one of the pathogens is Bacteroides fragilis), it is recommended to prescribe a drug that is active against anaerobes.
Use with caution in patients at risk of developing allergic reactions, especially to drugs. With the development of allergic reactions, cefepime should be canceled. Serious immediate hypersensitivity reactions may require the use of epinephrine (adrenaline) and other forms of supportive care. When diarrhea occurs during treatment, the possibility of developing pseudomembranous colitis should be considered. In such cases, cefepime should be discontinued immediately and, if necessary, appropriate treatment should be prescribed. If superinfection develops, cefepime should be discontinued immediately and appropriate treatment should be prescribed. With the use of other antibiotics of the cephalosporin group, urticaria, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, colitis, impaired renal function were observed,toxic nephropathy, aplastic anemia, hemolytic anemia, bleeding, seizures, liver dysfunction, including cholestasis, false positive results of urine glucose tests. The safety and efficacy of using cefepime in children under 2 months of age have not been established. Cefepime is used with extreme caution in conjunction with aminoglycosides and loop diuretics.
Drug interactions
With the simultaneous administration of a solution of cefepime with solutions of metronidazole, vancomycin, gentamicin, tobramycin sulfate and netilmicin sulfate, pharmaceutical interaction is possible.