Active substanceCefazolinCefazolin
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  • Dosage form: & nbsp
    Powder for the preparation of solution for intravenous and intramuscular injection.

    Composition:
    One bottle contains: active substance: cefazolin sodium (in terms of cefazolin) - 500 mg or 1000 mg.

    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) 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
    Enterobacter spp. and Enterococcus. spp. Ineffective against Pseudomonas aeruginosa, indolpositive strains Proteus spp.,.Mycobacterium tuberculosis, Serratia spp., Anaerobic microorganisms, methicillin-resistant strains of Staphylococcus spp.
    Pharmacokinetics:
    Time to reach the maximum concentration in the serum with intramuscular injection at a dose of 500 and 1000 mg, respectively - 2 and 1 hour; the maximum concentration is 38 and 64 μg / ml; after intravenous administration, the time to reach the maximum concentration in the serum - at the end of the infusion, after intravenous administration of 1000 mg the maximum concentration is 180 μg / ml. Penetrates into the joints, tissues of the heart and blood 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. Concentration in the tissue of the gallbladder and bile is much 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 elimination half-life is 20-40 hours. It is mainly excreted by the kidneys in the unchanged form: during the first 6 hours, 60-90%, after 24 hours - 70-95%. After intramuscular administration at doses of 500 and 1000 mg, the maximum concentration in urine is 1 mg / ml and 4 mg / ml, respectively.
    Indications:
    Infectious and inflammatory diseases caused by microorganisms sensitive to cefazolin: upper and lower respiratory tracts, ENT organs (including otitis media), urinary and bile ducts, pelvic organs (including gonorrhea), skin and soft tissues, bones and joints (including osteomyelitis), endocarditis, sepsis, peritonitis, mastitis, wound, burn and postoperative infections, syphilis. Preventive maintenance of surgical infections in the pre- and postoperative period.
    Contraindications:Hypersensitivity, simultaneous reception with anticoagulants and diuretics, the period of newborns (up to 1 month).
    Carefully:Renal failure, intestinal diseases (including colitis in the anamnesis), children's age 1-12 months.
    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 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, the severity of the course, the localization of the infection and the sensitivity of the pathogen.

    The average daily intake for adults is 1000-4000 mg; the frequency of administration is 3-4 times a day. The maximum daily dose is 6000 mg. The average duration of treatment is 7-10 days.

    For the prevention of postoperative infection - intravenously, 1000 mg 0.5-1 h before the operation, 500-1000 mg - during the operation and 500-1000 mg - every 8 hours during the first day after the operation.

    Patients with impaired renal function a change in the dosage regimen is required in accordance with the values ​​of creatinine clearance: with creatinine clearance of 55 ml / min or more, or with a plasma creatinine concentration of 1.5 mg% or less, a full dose can be administered; with a creatinine clearance of 54-35 ml / min or a plasma creatinine concentration of 3-1.6 mg%, a full dose can be administered, but the intervals between injections should be increased to 8 hours; with a creatinine clearance of 34-11 ml / min or a creatinine concentration in the plasma of 4.5-3.1 mg% - 1/2 dose at intervals of 12 hours; with a creatinine clearance of 10 ml / min or less, or with a plasma creatinine concentration of 4.6 mg% or more - 1/2 the usual dose every 18-24 hours.

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

    Children 1 month and older - 25-50 mg / kg / day; In severe infection, the dose can be increased to 100 mg / kg / day. Multiplicity of administration - 3-4 times a day.

    In children with impaired renal function correction of the dosing regimen is carried out depending on the values ​​of creatinine clearance: at creatinine clearance of 70-40 ml / min - 60% of the average daily dose is administered every 12 hours; at a creatinine clearance of 40-20 ml / min - 25% of the average daily dose with an interval of 12 hours; with a creatinine clearance of 5-20 ml / min - 10% of the average daily dose every 24 hours. All recommended doses are administered after the initial dose corresponding to the severity of the flow.

    For infections of moderate severity caused by sensitive Gram-positive microorganisms, single dose for adults - 250-500 mg every 8 hours.

    With pneumococcal pneumonia - 500 mg every 12 hours, with acute uncomplicated urinary tract diseases -1000 mg every 12 hours.

    Preparation of solutions for injection and infusion: 500 mg of the drug are dissolved in 2 ml of water for injection, 1000 mg in 4 ml of water for injection.

    For intravenous bolus administration, the resulting solution is diluted with 5 ml of water for injection, then injected slowly, for 3-5 minutes.

    For intravenous drip, 50-100 ml of a 5-10% solution of dextrose, 0.9% sodium chloride solution, Ringer's solution,5% solution of sodium bicarbonate. During the dilution, vials should be vigorously shaken until completely dissolved.

    Side effects:

    Allergic reactions: hyperthermia, skin rash, urticaria, pruritus, 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 (6000 mg) - a violation of kidney function (in these cases, the dose is reduced and treatment is controlled by the dynamics of the concentration 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 resistant to antibiotic strains, candidamycosis (including candidal stomatitis).

    Laboratory indicators: false positive test of Coombs, increased activity "hepatic" transaminases, hypercreatininaemia, an increase in prothrombin time.

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

    Overdose:
    When an overdose of cefazolin or its cumulation in patients with chronic renal failure may occur neurotoxic phenomena, with increased convulsive readiness, generalized clonic-tonic convulsions, vomiting, tachycardia.
    The drug is excreted from the body during hemodialysis; peritoneal dialysis is less effective.
    Interaction: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.
    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.
    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:When using the drug may occur: convulsions, nausea, vomiting, abdominal pain, therefore, during treatment should refrain from driving or potentially dangerous mechanisms.
    Form release / dosage:Powder for the preparation of solution for intravenous and intramuscular injection of 500 mg and 1000 mg.
    Packaging:For 500 mg and 1000 mg in bottles with a capacity of 10 ml. Each bottle, together with the instructions for use, is placed in a pack of cardboard.Packaging for hospitals: 20 or 40 bottles with an equal number of instructions for use are placed in a cardboard box.
    Storage conditions:In the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.
    Shelf life:3 years. Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N010948 / 01
    Date of registration:27.07.2010
    The owner of the registration certificate:OMELA, LTD. OMELA, LTD. Russia
    Manufacturer: & nbsp
    BELMEDPREPARATY, RUP Republic of Belarus
    Information update date: & nbsp14.10.2015
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