Active substanceCefazolinCefazolin
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  • Dosage form: & nbsp
    Powder for the preparation of solution for intravenous and intramuscular injection.
    Composition:
    Composition per 1 bottle: cefazolin sodium (in terms of cefazolin) - 0.5 g or 1.0 g.

    Description:
    The powder is white or white with a yellowish hue.
    Pharmacotherapeutic group:Antibiotic-cephalosporin.
    ATX: & nbsp

    J.01.D.B.04   Cefazolin

    Pharmacodynamics:
    Cephalosporin antibiotic of the first generation for parenteral use. It acts bactericidal, disrupting the synthesis of the cell wall of microorganisms. Has a wide spectrum of action, is active against Gram-positive (Staphylococcus spp., Including Staphylococcus aureus (not producing and producing penicillinase), Streptococcus pneumoniae, Corynebacterium diphtheriae, Bacillus anthracis); Enterobacter spp. and Enterococcus spp. and Gram-negative (Neisseria meningitidis, Neisseria gonorrhoeae, Shigella spp., Salmonella spp., Escherichia coli, Klebsiella spp., Treponema spp., Leptospira spp.) of microorganisms. It is active against Haemophilus influenzae, some strains of Enterobacter and Enterococcus,
    Ineffective against Pseudomonas aeruginosa, indolpositive strains of Proteus spp., Mycobacterium tuberculosis, Serratia spp., Anaerobic microorganisms, methicillin resistant strains of Staphylococcus spp.
    Pharmacokinetics:
    After intramuscular injection of the drug at a dose of 0.5 and 1 g, the maximum concentration (Cmax) is reached respectively after 2 and 1 hour and is about 38 and 64 μg / ml; after intravenous administration of 1 g, the maximum concentration (Cmax) is reached at the end of the infusion and is about 180 μg / ml.
    Penetrates into the joints, tissues of the heart and vessels, into the abdominal cavity, kidneys and urinary tracts, placenta, middle ear, respiratory tract, skin and soft tissues, in small amounts excreted in breast milk. In patients with normal bile duct function, the concentration in the gallbladder and bile tissues is significantly higher than in the serum. With obstruction of the gallbladder, the concentration in the bile is less than in the plasma.
    The volume of distribution is 0.12 l / kg. The connection with plasma proteins is 85%. The half-life for intramuscular injection is 1.8 hours, with intravenous administration -2 hours. If the renal function is impaired, the half-life period is 20-40 hours.
    It is excreted mainly by the kidneys in the unchanged form: during the first 6 hours, 60-90%, after 24 hours, 70-95%. After intramuscular injection of the drug at doses of 0.5 and 1 g, the maximum concentration in urine is 1 mg / ml and 4 mg / ml, respectively
    Indications:
    Infectious-inflammatory diseases caused by microorganisms sensitive to cefazolin: upper and lower respiratory tracts, ENT organs (including otitis media), urinary and bile ducts, pelvic organs, skin and soft tissues, bones and joints (in tons osteomyelitis), endocarditis, sepsis, peritonitis, mastitis, wound, burn and postoperative infections, syphilis, gonorrhea.
    Preventive maintenance of surgical infections in the pre- and postoperative period.
    Contraindications:Hypersensitivity to penicillins, cephalosporin group preparations and other beta-lactam antibiotics, neonatal period (up to 1 month).
    Carefully:Renal failure, pseudomembranous colitis, children under 1 year of age, intestinal diseases (including colitis in history).
    Pregnancy and lactation:In pregnancy cefazolin apply only in the case where the expected therapeutic effect for the mother exceeds the potential risk to the fetus. If it is necessary to use the drug during lactation, breastfeeding should be stopped.
    Dosing and Administration:Intramuscularly, intravenously (struyno and drip).Dosing regimen and duration of treatment are set individually, taking into account the indications, severity of the course, localization of infection and sensitivity of the pathogen.

    Average daily dose for adults - 1-4 g; the frequency of administration is 3-4 times a day. The maximum daily dose is 6 g. The average duration of treatment is 7-10 days.

    For infections of moderate severity caused by sensitive Gram-positive microorganisms, a single dose for adults is 0.25-0.5 g every 8 hours.

    With pneumococcal pneumonia - 0.5 g every 12 hours.

    In acute uncomplicated diseases of the urinary tract - 1 g every 12 hours.

    For the prevention of postoperative infection - intravenously 1 g for 30 - 60 minutes before surgery, 0.5-1 g - during surgery and 0.5-1 g - every 8 hours during the first day after surgery.

    Patients with impaired renal function require a change in the dosage regimen in accordance with the values ​​of creatinine clearance:

    - with a creatinine clearance of 55 ml / min or more, or with a creatinine concentration in plasma of 1.5 mg% or less, a full dose can be administered;

    - with a creatinine clearance of 54-35 ml / min or with a plasma creatinine concentration of 3-1.6 mg% - a full dose can be administered, but the intervals between injections can be increased to 8 hours;

    with clearance of creatinine 34-11 ml / min or at a concentration of creatinine in plasma of 4.5-3.1 mg% 1/2 doses at intervals of 12 h;

    - with a creatinine clearance of 10 ml / min or less, or with a plasma creatinine concentration of 4.6 mg% or more - 1 /2 average dose every 18-24 hours.

    All recommended doses are administered after the initial dose corresponding to the severity of the flow.

    Average daily dose for children 1 month and older - 25-50 mg / kg; at a heavy current of an infection the dose can be increased up to 100 mg / kg / sut. Multiplicity of administration - 3-4 times a day.

    In children with impaired renal function, the dosage regimen is adjusted depending on the values ​​of creatinine clearance:

    - with creatinine clearance of 70-40 ml / min - 60% of the average daily dose and injected every 12 hours;

    - at the clearance of creatinine 40-20 ml / min - 25% of the average daily dose with an interval of 12 hours;

    - - with creatinine clearance of 5-20 ml / min - 10% of the average daily dose every 24 hours.

    All recommended doses are administered after the initial "shock" dose corresponding to the severity of the flow.

    Preparation of solutions:

    For intramuscular injection: 0.5 g of the drug is dissolved in 2 ml of water for injection, 1 g in 4 ml of water for injection.

    For intravenous drip the preparation is dissolved in 50-100 ml of 0.9% sodium chloride solution, 5-10% dextrose solution, Ringer's solution, 5% sodium bicarbonate solution.

    For intravenous bolus introduction of a single dose of the drug is diluted in 10 ml of water for injection and injected slowly for 3-5 minutes.

    During the dilution, the vials are vigorously shaken until completely dissolved.

    Side effects:

    Allergic reactions: hyperthermia, skin rash, urticaria, skin itching, bronchospasm, eosinophilia, angioedema, arthralgia, anaphylactic shock, multiforme exudative erythema (including Stevens-Johnson syndrome).

    From the nervous system: convulsions.

    From the urinary system: in patients with kidney disease in the treatment of large doses (6 g) - a violation of kidney function (in these cases, the dose is reduced and treatment is controlled by the dynamics of the content of urea nitrogen and creatinine in the blood).

    From the digestive system: nausea, vomiting, diarrhea, abdominal pain, pseudomembranous colitis, cholestatic jaundice, hepatitis.

    From the hematopoiesis: leukopenia, neutropenia, thrombocytopenia, thrombocytosis, hemolytic anemia.

    With long-term treatment - dysbacteriosis, superinfection caused by antibiotic-resistant strains, candidiasis (including candidiasis stomatitis).

    Laboratory indicators: false-positive Coombs reaction, increased activity of "hepatic" transaminases, hypercreatininaemia, increased prothrombin time.

    Local reactions: when administered intramuscularly - soreness at the injection site, with intravenous injection - phlebitis.

    Overdose:Symptoms: increased severity of side effects, except for allergic reactions. Treatment: symptomatic therapy.
    Interaction:
    It is not recommended simultaneous reception with anticoagulants and diuretics. With the simultaneous use of cefazolin and "loop diuretics", a blockade of its tubular secretion occurs.
    Aminoglycosides increase the risk of kidney damage. Pharmaceutically incompatible with aminoglycosides (mutual inactivation).
    Drugs that block tubular secretion, increase concentration in the blood, slow down excretion and increase the risk of developing toxic reactions.
    Do not use cefazolin together with antibacterial drugs that have a bacteriostatic mechanism of action (tetracyclines, sulfonamides, erythromycin, chloramphenicol), since in vitro studies have shown that antagonism exists between them.
    Special instructions:
    Patients who had a history of allergic reactions to penicillins, carbapenems, may have increased sensitivity to cephalosporin antibiotics.
    During treatment with cefazolinum, false positive and indirect Coombs probes can be obtained, as well as a false positive urine reaction to glucose.
    When prescribing the drug may exacerbate diseases of the gastrointestinal tract, especially colitis.
    Effect on the ability to drive transp. cf. and fur:During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.
    Form release / dosage:
    Powder for solution for intravenous and intramuscular injection 0.5 g and 1.0 g.


    Packaging:0.5 g or 1.0 g of active substance (cefazolin) into 10 ml vials, hermetically sealed with rubber stoppers and crimped with aluminum or combined caps.
    1 bottle with the instruction for use is placed in an individual pack of cardboard,
    50 bottles with an equal number of instructions for use are placed in a box of cardboard (for hospitals).
    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 after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-000926
    Date of registration:27.02.2012
    The owner of the registration certificate:Company DEKO, LLC Company DEKO, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp13.10.2015
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