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

Antibacterial agent from the group of cephalosporins of the IV generation. It acts bactericidal, disrupting the synthesis of the cell wall of microorganisms. Has a wide spectrum of action against Gram-positive and Gram-negative bacteria, strains resistant to aminoglycosides and / or cephalosporin antibiotics of the third generation. Cefepim highly resistant to hydrolysis by most beta-lactamases.

It is active against gram-positive aerobes: Staphylococcus aureus and Staphylococcus epidermidis (only methicillin-sensitive strains), Staphylococcus hominis, Staphylococcus saprophytics, other strains of Staphylococcus spp .; Streptococcus pyogenes (group A); Streptococcus agalactiae (group B); Streptococcus pneumoniae; other beta-hemolytic Streptococcus spp. (groups C, G, F), Streptococcus bovis (group D), Streptococcus viridans; Gram-negative aerobes: Pseudomonas spp. (including Pseudomonas aeruginosa, Pseudomonas putida and Pseudomonas stutzeri); Escherichia coli, Klebsiella spp. (including Klebsiella pneumoniae, Klebsiella oxytoca, Klebsiella oxaenae); Enterobacter spp. (including Enterobacter cloacae, Enterobacter aerogenes, Enterobacter agglomerans and Enterobacter sakazakii); Proteus spp. (including Proteus mirabilis and Proteus vulgaris); Acinetobacter calcoaceticus (Acinetobacter anitratum, Acinetobacter calcoaceticus subsp. Iwoff); Aeromonas hydrophila; Capnocytophaga spp .; Citrobacter spp. (including Citrobacter diversus, Citrobacter freundii); Campylobacter jejuni, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae (including strains producing beta-lactamases); Haemophilus parainfluenzae, Hafnia alvei, Legionella spp .; Morganella morganii; Moraxella catarrhalis (including strains producing beta-lactamases); Neisseria gonorrhoeae (including strains producing beta-lactamases); Neisseria meningitidis, Providencia spp. (including Providencia rettgeri, Providencia stuartii); Salmonella spp .; Serratia spp. (including Serratia marcescens, Serratia liquifaciens); Shigella spp .; Yersinia enterocolitica;

anaerobes: Prevotella spp. (including Prevotella melaninogenicus); Clostridium perfrin-gens; Fusobacterium spp .; Mobiluncus spp .; Peptostreptococcus spp .; Veillonella spp. Inferior to ceftazidime by activity against Pseudomonas strains. Inactive against Xanthomonas maltophilia; Bacteroides fragilis and Clostridium difficile, methicillin-resistant staphylococci, penicillin-resistant pneumococci.

Pharmacokinetics:Bioavailability of 100%. Time to reach the maximum concentration after intravenous and intramuscular injection at a dose of 500 mg - by the end of infusion and 1 -2 hours, respectively. The maximum concentration in plasma with intramuscular injection in doses of 500 mg, 1 and 2 g - 14,30 and 57 μg / ml, respectively; when administered intravenously at doses of 250 mg, 500 mg, 1 and 2 g, 18, 39, 82 and 164 μg / ml, respectively; time to reach the average therapeutic concentration in plasma - 12 h; the average therapeutic concentration for intramuscular injection is 0.2 μg / ml, for intravenous administration 0.7 μg / ml. High concentrations are determined in urine, bile, peritoneal fluid, blister exudate, bronchial mucus secretion, sputum, prostate gland, appendix and gallbladder. The volume of distribution is 0.25 l / kg, in children from 2 months to 16 years - 0.33 l / kg. Connection with plasma proteins - 20%. Metabolized in the liver and kidneys by 15%. The half-life is 2 hours, the total clearance is 120 ml / min, the renal clearance is 110 ml / min. It is excreted by the kidneys (by glomerular filtration in unchanged form - 85%), with breast milk. Half-life with hemodialysis - 13 hours, with continuous peritoneal dialysis-19 hours.

Indications:

Bacterial infections caused by susceptible microorganisms:

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

- gastrointestinal tract (GIT) (including cholangitis, cholecystitis, empyema of the gallbladder),

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

- bones and joints,

- skin and soft tissues,

- peritonitis, sepsis, meningitis,

- infected wounds and burns,

- febrile neutropenia,

- infection against the background of immunodeficiency,

- prevention of postoperative infection.

Contraindications:Hypersensitivity to cefepime (including to other cephalosporins, penicillins, other beta-lactam antibiotics), arginine. Child age (up to 12 years of effectiveness and safety not established).

Carefully:Diseases of the gastrointestinal tract (including in the history): ulcerative colitis, regional enteritis or antibiotic-associated colitis, renal failure.

Pregnancy and lactation:

Adequate and well-controlled studies of the safety of cefepime during pregnancy have not been conducted.

Application of the drug Cefepim during pregnancy is possible only if the potential benefit to the mother exceeds the possible risk to the fetus.

Cefepime is excreted in breast milk in low concentrations. However, during drug treatment Cefepim should stop breastfeeding.

Dosing and Administration:

Intravenously (intravenously) and intramuscularly (i / m)

Adults and children over 12 years of age - intravenously or intramuscularly, 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. For 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 intravenously every 8 hours for 7 days. When creatinine clearance is 30-60 ml / min, depending on the severity of the infection, 0.5, 1 g or 2 g 1-2 times a day, with KK 11-29 ml / min 0.5 g and 1 g 1 time per day , less than 11 ml / min - once.

During the hemodialysis, the initial dose is re-administered at the end of each session. With peritoneal dialysis - in the usual dose every 48 hours. For intravenous administration, dissolve in sterile water for injection, 5% dextrose solution or 0.9% solution of sodium chloride; for intramuscular injection - in sterile water for injection, in 0.5 and 1% solution of lidocaine hydrochloride.

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).

Local reactions: with intravenous injection - phlebitis; when inside muscular - hyperemia and soreness in the place of injection.

From the nervous system: headache, dizziness, insomnia, paresthesia, anxiety, confusion, convulsions.

From the genitourinary system: vaginitis.

From the side of the urinary system: a violation of kidney function.

From the digestive system: diarrhea, nausea, vomiting, constipation, abdominal pain, indigestion, pseudomembranous enterocolitis.

On the part of the organs of hematopoiesis: anemia, thrombocytopenia, leukopenia, neutropenia, pancytopenia, hemolytic anemia, bleeding.

From the respiratory system: cough.

From the cardiovascular system: tachycardia, dyspnea, peripheral edema.

Laboratory indicators: reduction of hematocrit, increase in prothrombin time, increase in urea concentration, hypercreatininemia, hypercalcemia, increased activity of "liver" transaminases and alkaline phosphatase, hyperbilirubinemia, Coombs positive reaction.

Other: sore throat, thoracalgia, increased sweating, back pain, asthenia, development of superinfection, oropharyngeal candidiasis.

Overdose:Symptoms (often occur in patients with chronic renal failure (CRF): convulsions, encephalopathy, agitation. Treatment: hemodialysis.

Interaction:

Pharmaceutically incompatible with other antimicrobial drugs and heparin.

Diuretics, aminoglycosides, polymyxin B reduce the tubular secretion of cefepime and increase its serum concentration, prolong the half-life, increase nephrotoxicity (the risk of nephronecrosis increases).

Non-steroidal anti-inflammatory drugs, slowing the excretion of cephalo-sporin, increase the risk of bleeding.

With the simultaneous administration of bactericidal antibiotics (aminoglycosides), synergism appears with bacteriostatic (macrolides, chloramphenicol, tetracyclines) - antagonism.

Special instructions:If pseudomembranous colitis occurs with prolonged diarrhea, stop taking and prescribe vancomycin (inside) or metronidazole. There is a possibility of cross-over hypersensitivity in patients with allergic reactions to penicillins. When combined severe renal and hepatic insufficiency should regularly determine the concentration of the drug in the plasma (dose adjustment is performed depending on the CK). 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 identification of pathogens, a combination with a drug 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 positive Coombs test, a false positive test for glucose in the urine. The prepared solution should not be stored for more than 24 hours at room temperature or for 7 days in a refrigerator. The color change does not affect the activity of the drug.

Form release / dosage:Powder for solution for intravenous and intramuscular injection, 1.0 g.

Packaging:Powder for solution for intravenous and intramuscular administration of 1.0 g of colorless vials of glass of hydrolytic class III capacity of 15 ml, sealed with a rubber stopper under run-aluminum caps, plastic safety cover closed blue 1 vial together instructions for use placed in a cardboard box.

Storage conditions:In a dry, protected from light place at a temperature of no higher than 25 ° C. Keep out of the reach of children!

Shelf life:

2 years. Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-004483/07

Date of registration:06.12.2007

The owner of the registration certificate:With Meditek Private LimitedWith Meditek Private Limited India

Manufacturer: & nbsp

Lincoln Parenterals HTP. Ltd. India

Representation: & nbspWith Meditek Private LimitedWith Meditek Private LimitedIndia

Information update date: & nbsp22.10.2015

Illustrated instructions

Instructions

Cefepim (Cefepime)