Tsefipim

General characteristics. Structure:

Active ingredient: 0,5 g or 1 g of a tsefepim a hydrochloride (in terms of tsefepy).

The antibiotic of group of cephalosporins possessing a broad spectrum of activity.

Pharmacological properties:

Pharmacodynamics. Drug is active concerning the majority of strains of microorganisms:

- aerobic gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis (including the strains producing beta lactamazu); other strains of stafilokokk, including Staphylococcus hominis, Staphylococcus saprophyticus; Streptococcus pyogenes (group A streptococci); Streptococcus agalactiae (group B streptococci); Streptococcus pneumoniae (including strains with average penicillin resistance — MPK from 0,1 to 0,3 mkg/ml); other beta and hemolitic streptococci (C, G groups, F), Streptococcus bovis (group D), Streptococcus viridans.

Majority of strains of enterococci, for example Enterococcus faecalis and metitsillinustoychivy stafilokokk of a rezistentna to a tsefepim.

- aerobic gram-negative bacteria: Pseudomonas spp., including P. aeruginosa, P. putida, P. stutzeri, Escherichia coli, Klebsiella spp. (including K. pneumoniae, K. oxytoca,

K. oxaenae), Enterobacter spp. (including E. cloacae, E. aerogenes, E. agglomerans, E. sakazakii), Proteus spp. (including P. mirabilis, P.vulgaris), Acinetobacter calcoaceticus (subsp. anitratus, iwofii), Aeromonas hydrophila, Capnocytophaga spp., Citrobacter spp. (including C. diversus, C. freundii), Campylobacter jejuni, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae (including the strains producing β-lactamazu), Haemophilus parainfluenzae, Hafnia alvei, Legionella spp., Morganella morganii, Moraxella catarrhalis (including the strains producing β-lactamazu), Neisseria gonorrhoeae (including the strains producing β-lactamazu), Neisseria meningitidis, Providencia spp. (including P.rettgeri, P. stuartii), Salmonella spp., Serratia (including S. marcescens, S. liquefaciens), Shigella spp., Yersinia enterocolitica.

Tsefepim is inactive concerning some strains of Xanthomonas maltpphilia (Pseudomonas maltophilia).

- anaeroby:prevotella spp. (including Prevotella melaninogenicus) Bacteroides sp., including Bacteroides melaninogenicus and other microorganisms of an oral cavity relating to Bacteroides; Clostridium perfringens; Fusobacterium sp.; Mobiluncus sp.; Peptostreptococcus sp.; Veilonella sp. Tsefepim is inactive concerning Bacterioides fragilis and Clostridium difficile.

Indications to use:

Tsefepim apply at the bacterial infections caused by sensitive microorganisms:

- respiratory infection and ENT organs (including pneumonia, bronchitis, abscess of lungs, a pleura empyema);

- the infections of urinary tract (complicated and uncomplicated, including pyelonephritis, a pyelitis, an urethritis, cystitis, gonorrhea);

- infections of biliary tract (cholangitis, cholecystitis, empyema of a gall bladder);

- infections of skin and soft tissues, bones and joints;

- intraabdominal infections (including peritonitis);

- bacterial meningitis at children;

- septicaemia;

- a febrile neutropenia, infections against the background of an immunodeficiency;

- contaminated wounds and burns;

- prevention of surgical infections in before - and the postoperative period.

Route of administration and doses:

The drug is administered to adults and children with body weight by more than 40 kg in/in (slowly within 3-5 minutes) and in oil (it is deep in a muscle). The mode of dosing is set individually taking into account weight of a course of a disease, a type of the activator and its sensitivity to a tsefepim.

At a renal failure dose adjustment is required.

Features of use:

With care apply at patients with any forms of an allergy, especially on medicines.

At emergence of allergic reaction use of drug should be stopped. When developing pseudomembranous colitis with long diarrhea to stop reception and will appoint Vancomycinum (inside) or metronidazole.

At prolonged treatment control of peripheral blood, laboratory indicators of a functional condition of kidneys and a liver is necessary.

Side effects:

From a nervous system and sense bodys: headache, dizziness, paresthesia, sleeplessness, feeling of concern, confusion of consciousness, spasm.

From cardiovascular system and blood (a hemopoiesis, a hemostasis): tachycardia, otdyshka, peripheral hypostases, anemia, thrombocytopenia, leukopenia, neutropenia, pancytopenia, hemolitic anemia.

From respiratory system: cough.

From bodies of a GIT: nausea, vomiting, abdominal pain, lock, dyspepsia, pseudomembranous coloenteritis.

From urinogenital system: vaginitis, renal failure, oliguria.

Allergic reactions: rash (including erimatozny rashes), an itch, fever, anaphylactoid reactions, an eosinophilia, a mnogoformny exudative erythema, Stephens-Johnson's syndrome, it is rare – a toxic epidermal necrolysis (Lyell's disease).

Others: reactions in an injection site: at introduction in oil — pain, consolidation and an inflammation of fabrics in an injection site; at in introduction — phlebitis; a dorsodynia and a throat, the increased sweating, development of superinfection, candidiasis.

Laboratory indicators: decrease in a hematocrit; increase in a prothrombin time, increase in concentration of urea, creatinine, bilirubin; increase in plasma level of calcium, increase in activity of hepatic transaminases (nuclear heating plant and ALT) and alkaline phosphatase.

Interaction with other medicines:

Not to mix in one syringe with other antimicrobic drugs and heparin.

In need of co-administration it is necessary to enter each antibiotic separately.

It is incompatible with metronidazole solution (before administration of solution of metronidazole for prevention of an infection at surgeries it is necessary to wash out infusional system from solution of a tsefepim).

Contraindications:

Hypersensitivity (including to penicillin, other cephalosporins, beta лактамным to antibiotics, L-arginine),

With care: pregnancy, feeding by a breast (gets into breast milk), children's age up to 12 years, digestive tract diseases (including in the anamnesis): ulcer colitis, regional enteritis or the antibiotiko-associated colitis; chronic renal failure.

Issue conditions:

According to the recipe

Packaging:

Powder for preparation of solution for injections of 0,5 g and 1,0 g in bottles in packaging No. 1, No. 40.