Universal reference book for medicines
Product name: CEFOMAX (CEFOMAX)

Active substance: cefepime

Type: Cephalosporin IV generation

Manufacturer: ЭЛЬФА НПЦ (Russia) produced by PROTECH BIOSYSTEMS (India)
Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..

PHARMACHOLOGIC EFFECT
Cephalosporin antibiotic IV generation for parenteral use.
It has a bactericidal effect, disrupting the synthesis of the cell wall of microorganisms.
It is active against most Gram-negative bacteria, incl.
producing beta-lactamases, including Pseudomonas aeruginosa. More active than cephalosporins of the third generation, 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 in relation to various plasmid and chromosomal β-lactamases.

PHARMACOKINETICS
The binding to plasma proteins is less than 19% and does not depend on the concentration of cefepime in serum.

Therapeutic concentrations of cefepime are found in urine, bile, peritoneal fluid, blister exudate, bronchial mucus secretion, sputum, prostate tissue, appendix and gallbladder, cerebrospinal fluid with meningitis.

In healthy people with intravenous cefepime in a dose of 2 g with an interval of 8 hours for 9 days there was no cumulation in the body.

The average T 1/2 of 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 (the average renal clearance is 110 ml / min). In urine, approximately 85% of the injected cefepime is found in unchanged form.
In patients age 65 or older with normal renal function, the magnitude of renal clearance is less than in young patients.

In patients with impaired renal function, T 1/2 increases.
In patients with severe renal dysfunction for which hemodialysis is required, T 1/2 is an average of 13 hours, peritoneal dialysis is performed for 19 hours.
The pharmacokinetics of cefepime in patients with impaired liver function, cystic fibrosis is not changed.

The age and gender of the patients did not have a significant effect on the overall clearance from the body and V d , 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 noted, and when administered at the same dose every 8 hours in the equilibrium state, C max , AUC and T 1/2 increased by approximately 15%.
INDICATIONS
Treatment of infectious and inflammatory diseases caused by microorganisms susceptible to cefepime: infections of the lower respiratory tract (including pneumonia and bronchitis), urinary tract infections (both complicated and uncomplicated), skin and soft tissue infections, intra-abdominal infections (including peritonitis and biliary infections pathways), gynecological infections, septicemia, neutropenic fever (as empirical therapy), bacterial meningitis in children.

Prevention of infections in the conduct of cavitary surgery.

DOSING MODE
Individual, depending on the sensitivity of the pathogen, the severity of the infection, as well as the state of kidney function.

The IV route is preferred for patients with severe or life-threatening infections, especially when there is a threat of shock.

With a / m or / in the introduction of adults and children with a body weight of more than 40 kg with normal kidney function, a single dose is 0.5-1 g, the interval between administrations is 12 hours. In severe infections, I / v is administered at a dose of 2 g every 12 h.

In order to prevent infections in the conduct of cavitary surgery are used 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, the empirical 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, longer treatment may be required.
For violations of kidney function (KK less than 30 ml / min), correction of the dosing regimen is necessary.
The initial dose of cefepime should be the same as for patients with normal renal function. Supportive doses are determined depending on the values ​​of CK or the serum creatinine concentration.
With hemodialysis, approximately 68% of the total amount of cefepime is removed from the body within 3 hours.
At the conclusion of each session, a repeat dose equal to the initial dose should be given. In patients who are on continuous ambulatory peritoneal dialysis, cefepime can be used in average recommended doses, i.e.500 mg, 1 g or 2 g, depending on the severity of the infection, with an interval between single dose administration of 48 hours.
Children with impaired renal function are recommended the same changes in the dosing regimen as adults, since the pharmacokinetics of cefepime in adults and children is similar.

SIDE EFFECT
From the digestive system: diarrhea, nausea, vomiting, colitis (including pseudomembranous colitis);
rarely - abdominal pain, constipation, taste change.
Allergic reactions: possible - rash, itching, hives;
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 - redness of the skin.
The most common in children is a rash.
From the hemopoietic system: anemia is possible.

From the side of the indicators of laboratory studies: may increase the activity of ALT, AST, APF, increase in total bilirubin, eosinophilia, 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 result of Coombs test without hemolysis.
Other: possible increase in body temperature, vaginitis, erythema;
rarely - genital itching, nonspecific candidiasis.
Local reactions: with IV infusion, phlebitis are possible, rarely - inflammation);
with the / m introduction possible inflammation or pain.
CONTRAINDICATIONS
Hypersensitivity to cefepime or L-arginine, as well as to cephalosporin antibiotics, penicillins or other beta-lactam antibiotics.

PREGNANCY AND LACTATION
Adequate and strictly controlled studies of the safety of cefepime during pregnancy are not conducted;
The application is only possible under the supervision of a physician.
Cefepime is excreted in breast milk in very low concentrations.
Use with caution during lactation.
In experimental studies, there was no effect on the reproductive function and fetotoxic effect of cefepime.

APPLICATION FOR FUNCTIONS OF THE LIVER
For violations of kidney function (KK less than 30 ml / min), correction of the dosing regimen is necessary.
The initial dose of cefepime should be the same as for patients with normal renal function. Supportive doses are determined depending on the values ​​of CK or the concentration of serum creatinine

APPLICATION FOR CHILDREN
Safety and effectiveness of cefepime in children under 2 months of age have not been established.
For children older than 2 months, the application is possible according to the dosing regimen. Children with impaired renal function are recommended the same changes in the dosing regimen as adults, since the pharmacokinetics of cefepime in adults and children is similar.
SPECIAL INSTRUCTIONS
When used in patients at higher risk of infection due to mixed aerobic / anaerobic microflora (including in cases where Bacteroides fragilis is one of the pathogens), it is recommended to prescribe simultaneously with cefepime a drug active against anaerobes.

Use with caution in patients at risk of developing allergic reactions, especially on drugs.

When developing allergic reactions cefepime should be discarded.

Serious reactions of immediate type hypersensitivity may require the use of epinephrine (adrenaline) and other forms of maintenance treatment.

When diarrhea appears on the background of treatment, the possibility of developing pseudomembranous colitis should be considered.
In such cases, cefepime should be immediately discontinued and, if necessary, appropriate treatment should be prescribed.
With the development of superinfection, cefepime should be immediately discontinued 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, renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, convulsions, impaired liver function including cholestasis, false positive test results on glucose of urine.

Safety and effectiveness of cefepime in children under 2 months of age have not been established.

With particular caution apply cefepime together with aminoglycosides and loop diuretics.

DRUG INTERACTION
With simultaneous administration of a solution of cefepime with solutions of metronidazole, vancomycin, gentamicin, tobramycin sulfate and netilmicin sulfate, a pharmaceutical interaction is possible.

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