Cefepime-Vial - instructions for use, dose, side effects, contraindications

Cephalosporin antibiotic IV generation. Has a wide spectrum of action against gram-positive and gram-negative microorganisms resistant to aminoglycosides or cephalosporin antibiotics of the third generation. Cefepim highly resistant to hydrolysis by most beta-lactamases, has a low affinity for beta-lactamases, encoded by chromosomal genes, and rapidly penetrates into Gram-negative bacterial cells.

Cefepim active at respect gram-positive (Staphylococcus aureus and methicillin-sensitive strains Staphylococcus epidermidis, Staphylococcus hominis, Staphylococcus saprophyticus, Streptococcus pneumoniae, Streptococcus pyogenes, dr. beta- hemolytic streptococci - groups FROM, G, F, Streptococcus agalactiae, Streptococcus bovis, Streptococcus viridans) and gram-negative (enterobacteria, including Enterobacter cloacae, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter sakazakii; Escherichia coli; Klebsiella, at t.h. Klebsiella pneumoniae, Klebsiella oxytoca, Klebsiella ozaenae; Proteus: Proteus mirabilis, Proteus vulgaris and dr.; pseudomonads: Pseudomonas aeruginosa, Pseudomonas putida, Pseudomonas stutzeri, Acinetobacter calcoaceticus, Aeromonas hydphila, Capnocytophaga spp., Campylobacter jejuni, Gardnerella vaginalis, Citrobacter diversus, Citrobacter freundii, Haemophilus ducreyi,' Haemophilus influenzae, including beta-lactamase-producing strains, Haemophilus parainfluenzae, Legionella spp., Hafnia alvei, Moraxella catarrhalis, at t. h. beta-lactamase-provoking strains; Morganella morganii, Neisseria meningitides, Neisseria gonorrhoeae, including beta- lactomazo-producing strains, Providencia rettgeri, Providencia stuartii, Salmonella spp., Shigella spp., Yersinia enterococolitica, Serratia marcescens) microorganisms, anaerobes (Bacteroides spp., including Bacteroides melaninogenicus and dr. bacteroides oral cavities; Clostridium perfringens, Fusobacterium spp., Mobiluncus spp., Peptostreptococcus spp., Veillonella spp.). He active at respect enterococci, listeria, legionella, some anaerobes (Bacteroides fragilis, Clostridium difficile).

Pharmacokinetics:

Bioavailability is 100%. The maximum concentration (Cmax) after a single three-minute intravenous infusion at doses of 500 mg, 1 g and 2 g is 39.1; 81.7 and 163.9 μg / ml, respectively; when intramuscularly administered the same dose C max is 13.9, 29.6 and 57.5 μg / ml and is reached after 1.5 hours. It binds to proteins up to 20%, regardless of the concentration in the blood. T 1/2 - 2 hours, total clearance - 120 ml / min. In severe renal disease, T 1/2 increases to 13-19 hours.After a single administration, therapeutic concentrations are determined in urine, bile, peritoneal fluid, bronchial secretion, gall bladder tissue, appendix, prostate gland; with inflammation of the meninges passes through the blood-brain barrier. Displayed in the kidneys by glomerular filtration, 85% of the dose is found in the urine in an unmodified form. Partially excreted in breast milk. The average renal clearance in young patients is 110 ml / min and increases in the elderly. Impaired renal function slows elimination. During a three-hour dialysis, 68% of the total amount in the body is excreted.

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:

- infections of the respiratory system (including pneumonia, bronchitis, lung abscess, empyema of the pleura);

- urinary tract infections (including pyelonephritis, pyelitis, urethritis, cystitis)

- skin and soft tissues;

- intra-abdominal infections (including peritonitis and biliary tract infections);

- septicemia;

- neutropenic fever (as an empirical therapy);

- bacterial meningitis.

Prevention of infections in the conduct of cavitary surgery.

Contraindications:Hypersensitivity to cefepime, as well as to cephalosporin antibiotics, penicillins or other beta-lactam antibiotics, L-arginine. Child age is up to 2 months.

Carefully:Pregnancy, lactation; children's age (up to 12 years - efficiency and safety not established); diseases of the gastrointestinal tract (including history) ulcerative colitis, regional enteritis or antibiotic-associated colitis, renal failure.

Pregnancy and lactation:The use of the drug during pregnancy is possible only in cases where the intended benefit to the mother exceeds the potential risk to the fetus. If you need to use the drug during lactation, you should decide whether to stop breastfeeding.

Dosing and Administration:

The drug is used intravenously (IV), intramuscularly (IM). Adults and children over 12 years of age - 2 g / day in 2 divided doses; course of treatment - 7-10 days.

With infections of the urinary tract - 0.5-1 g 2 times a day; with infections of other locations - 1 g every 12 hours.

In severe infection, 4 g / day in 2 divided doses, with an interval of 12 hours, with life-threatening infections.

Febrile neutropenia - 2 g IV every 8 hours for 7 days or until neutropenia is resolved. In children from 2 months to 16 years and with a body weight of up to 40 kg, 50 mg / kg every 12 hours.

Children (over 2 months) with uncomplicated urinary tract infections, skin and soft tissue infections, pneumonia are given a dose of 50 mg / kg every 12 hours. Patients with neutropenic fever and bacterial meningitis - every 8 hours. The maximum dose should not exceed the recommended dose for adults. . In chronic renal failure, the dose is prescribed depending on the severity of the infection and the clearance of creatinine (CC): more than 60 ml / min - 0.5-1-2 g every 12 hours or 2 g every 8 hours, KK 30-60 ml / min - 0.5, 1 g or 2 g every 24 hours or 2 g every 12 hours, with a CK of 11-29 ml / min - 0.5-1-2 every 24 hours, less than 11 ml / min - 0.25-0 , 5-1 g every 24 hours.

Permanent ambulatory peritoneal dialysis - 0.5-1-2 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 desirable to enter cefepime every day at the same time.

Data on the use of the drug in children with concomitant chronic renal failure are not available, but given the similar pharmacokinetics in children and adults,dosing regimen (dose reduction or increase in the interval between administrations) in children with chronic renal failure is similar to the dosing regimen in adults.

For IV 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, administered for 3-5 minutes; for intravenous infusion, the prepared solution is combined with other solutions for intravenous infusions (0.9% sodium chloride solution, 5% or 10% dextrose solution, Ringer's solution with lactate and 5% dextrose solution, maximum concentration 40 mg / ml) and administered for not less than 30 minutes;

For intravenous administration, the drug is dissolved in sterile water for injection, 0.9% solution of sodium chloride, bacteriostatic water for injection with paraben or benzyl alcohol, in 0.5% and 1% solution of lidocaine hydrochloride (1.0 g-2, 4 ml).

Side effects:

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

From the nervous system: headache, dizziness, insomnia, paresthesia, anxiety, confusion, convulsions, encephalopathy (in the absence of dose adjustment in patients with impaired renal function).

From the genitourinary system: vaginitis.

From the urinary system: impaired renal function.

From the gastrointestinal tract: diarrhea, nausea, vomiting, constipation or diarrhea,

abdominal pain, dyspepsia, pseudomembranous enterocolitis.

From the hematopoiesis: anemia, thrombocytopenia, leukopenia, neutropenia, pancytopenia, hemolytic anemia, bleeding.

From the respiratory system: cough, chest pain.

From the cardiovascular system: tachycardia, dyspnea, peripheral edema. Laboratory indicators: decrease in hematocrit, increase in prothrombin time, increased urea concentration, hypercreatininaemia, hypercalcemia, increased activity of "liver" transaminases and alkaline phosphatase, hyperbilirubinemia, Coombs positive test (without hemolysis).

Local reactions: at intravenous introduction - phlebitis, at intramuscular - a hyperemia and morbidity in a place of introduction.

Other: pain in the throat, thoracology, increased sweating, back pain, asthenia, development of superinfection, oropharyngeal candidiasis.

Overdose:Symptoms (often occur in patients with chronic renal failure): convulsions, encephalopathy, neuromuscular excitation. Treatment: hemodialysis and maintenance therapy.

Interaction:

Pharmaceutically incompatible with other antimicrobial drugs and heparin.

Diuretics, aminoglycosides, polymyxin B reduce the tubular secretion of cefepime and increase its serum concentration, extend T1 / 2, increase nephrotoxicity (increases the risk of developing nephronecrosis). Cefepim increases the ototoxicity of aminoglycosides.

Nonsteroidal anti-inflammatory drugs, slowing the excretion of cephalosporins, increase the risk of bleeding. With the simultaneous administration of bactericidal antibiotics (aminoglycosides), synergism appears with bacteriostatic (macrolides, chloramphenicol, tetracyclines) - antagonism. Incompatible with the solution of metronidazole (before the administration of the solution of metronidazole for the prevention of infections during surgical interventions, the infusion system should be rinsed from the solution of cefepime).To avoid possible drug interactions with other drugs, cefepime solutions (as well as most other beta-lactam antibiotics) should not be administered concomitantly with solutions of vancomycin, gentamicin, tobramycin, netilmicin. When prescribing cefepime with the listed drugs, each antibiotic should be administered separately.

Special instructions:

If pseudomembranous colitis occurs with prolonged diarrhea, cefepime cease and appoint vancomycin (inside) or metronidazole.

Cefepime is prescribed with caution to patients with any form of allergy, especially with allergic reactions to medications in the anamnesis. When allergic reactions occur, the drug should be discarded. Serious hypersensitivity reactions of immediate type may require the use of epinephrine (epinephrine) and other forms of maintenance treatment.

In severe renal and hepatic insufficiency should regularly determine the concentration of the drug in the plasma (dose adjustment is performed depending on the US). With prolonged treatment, regular monitoring of peripheral blood, indicators of the functional state of the liver and kidneys is necessary.

With a mixed aerobic-anaerobic infection before identifying pathogens, a combination with drugs active against anaerobes is appropriate.

Patients who have a meningeal dissemination from a distant foci of infection, suspicions of meningitis or a diagnosis of meningitis are confirmed, an alternative antibiotic with confirmed clinical efficacy should be prescribed.

It is possible to detect a false positive glucose test in the urine.

When using cefepime (as well as other antibiotics), it is possible to develop superinfection, which requires the withdrawal of the drug and the appointment of appropriate treatment.

Form release / dosage:

Powder for solution for intravenous and intramuscular injection, 1.0 g.

Packaging:1 g of active substance in a bottle of colorless transparent glass, sealed with a rubber stopper and an aluminum cap with a protective plastic cover. 1 bottle in a cardboard box together with instructions for use.

Storage conditions:Store at a temperature of no higher than 30 ° C, in a place protected from light. The prepared solution is stable for 7 days when stored in a refrigerator (2-8 ° C). Keep out of the reach of children.

Shelf life:2 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-006747/08

Date of registration:18.08.2008

The owner of the registration certificate:North China Pharmaceutical Corporation Co., Ltd.North China Pharmaceutical Corporation Co., Ltd. China

Manufacturer: & nbsp

NORTH CHINA PHARMACEUTICAL CORPORATION China

Representation: & nbspVIAL, LLCVIAL, LLC

Information update date: & nbsp22.10.2015

Illustrated instructions

Instructions

Cefepime-Vial (Cefepime-Vial)