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

    Composition:
    1 bottle contains:

    Components Dosage

    Cefazolin 500 mg 1000 mg

    (as cefazolin sodium) 524 mg 1048 mg
    Description:The powder is white or almost white. Hygroscopic.
    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 of Enterobacter spp., Enterococcus spp.
    Ineffective against Pseudomonas aeruginosa, indolpositive strains of Proteus spp., Mycobacterium tuberculosis, Serratia spp., Anaerobic microorganisms, methicillin-resistant strains of Staphylococcus spp.
    Pharmacokinetics:

    Time to reach the maximum concentration (TCmOh) with intramuscular (IM) administration at a dose of 500 and 1000 mg, respectively - 2 and 1 hour; The maximum concentration (CmOh) 38 and 64 μg / ml; after intravenous (iv) administration of 1000 mg of CmOh is achieved at the end of the infusion and is about 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 (T1/2) with the / m introduction - 1.8 h, with the / in the introduction - 2 h. In case of impaired renal function - 20-40 h.

    It is excreted mainly by the kidneys in the unmodified form: during the first 6h- 60-90%, after 24 hours - 70-95%. After i / m administration of the drug in doses of 500 mg and 1000 mg CmOh in the urine of 1000 μg / ml and 4000 μg / ml, respectively.

    Indications:Infectious-inflammatory diseases caused by microorganisms sensitive to cefazolin: upper and lower respiratory tract, JIOP-organs (incl.otitis media, urinary tract and bile ducts, pelvic organs, skin and soft tissues, bones and joints (including 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 cefazolin, cephalosporin group preparations and other (3-lactam antibiotics, neonatal period (up to 1 month).) It is not recommended simultaneous reception with anticoagulants and diuretics.
    Carefully:Renal failure, intestinal diseases (including colitis in the anamnesis), children's age from 1 month to 1 year.
    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). The dosage regimen and duration of the course 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.

    Dosing instructions for adults:

    Type of infection

    Single dose

    Multiplicity of the introduction

    Infections of the lung course caused by sensitive Gram-positive microorganisms

    0.25-0.5 g

    every 8 hours

    Pneumococcal pneumonia

    0.5 g

    every 12 hours

    Acute uncomplicated urinary tract infections

    1.0 g

    every 12 hours

    Infections of medium gravity and severe

    0.5-1 g

    After 6 to 8 hours

    Severe, life-threatening infections: endocarditis, septicemia

    1 - 1.5 g

    After 6 hours

    Prevention of postoperative infection

    The dose and frequency of administration depends on the type and duration of the operation. Intravenous or intramuscular injection of 1 g for 30 minutes - 1 hour before surgery. Dose is sufficient for minor surgical interventions of short duration.

    For prolonged surgical operations (more than 2 hours), in addition, from 0.5 g to 1 g intravenously or intramuscularly during the operation. During the day after the operation, 0.5 g-1 g every 6-8 hours.

    Use in patients with impaired renal function

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

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

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

    - with CC 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 infection.

    Use in children with normal renal function

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

    Use in children with impaired renal function

    Correction of the dosing regimen is performed depending on the values ​​of creatinine clearance (CK):

    - with SC 70-40 ml / min - 60% of the average daily dose and administered after 12 hours;

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

    - with KK 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 infection.

    Preparation of solutions:

    For intramuscular injection 500 mg of the drug is dissolved in 2 ml of water for injection, 1000 mg in 4 ml of water for injection.

    For intravenous drip the drug is dissolved in 50-100 ml of a 0.9% solution of sodium chloride or 5-10% solution of dextrose, Ringer's solution, 5% sodium bicarbonate solution. Infusion is carried out for 20 - 30 minutes (rate of administration of 60 - 80 drops per minute).

    For intravenous fluid administration 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 rashes, urticaria, itching, bronchospasm, eosinophilia, Quincke's edema, arthralgia, anaphylactic shock, multiform erythema, incl. malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis.

    From the nervous system: dizziness, 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: decreased appetite, nausea, vomiting, diarrhea, abdominal pain, pseudomembranous colitis, cholestatic jaundice, hepatitis.

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

    Laboratory indicators: positive Coombs reaction, increased activity of "liver" transaminases, hypercreatininaemia, an increase in prothrombin time. Local reactions: with the / m introduction - pain in the injection site, with / in the introduction - phlebitis.

    Other: fever, dysbacteriosis, superinfection caused by antibiotic-resistant strains, candidamycosis (including candidiasis stomatitis, candidal vaginitis).

    Overdose:
    Symptoms: increased severity of side effects, except for allergic reactions.

    Treatment: symptomatic therapy.
    Interaction:
    It is not recommended simultaneous use with anticoagulants and diuretics.With the simultaneous use of cefazolin and "loop diuretics", a blockade of its tubular secretion occurs.
    The renal clearance of cefazolin decreases with simultaneous administration of probenecid, which leads to increased and longer cefazolin concentrations in the blood. Synergism of antibacterial action is noted in combination with aminoglycoside antibiotics, vancomycin, rifampicin. Aminoglycosides increase the risk of kidney damage. Pharmaceutically incompatible with aminoglycosides (mutual inactivation).
    Cefazolin, suppressing the intestinal flora, prevents the synthesis of vitamin K. Therefore, with the simultaneous use of drugs that reduce platelet aggregation (non-steroid proizvodvolpitelnye drugs (NSAIDs), salicylates), the risk of bleeding increases. For the same reason, with simultaneous use with anticoagulants, there is an increase in anticoagulant activity. 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.
    Cefazolin can cause disulfiram-like reactions when used concomitantly with ethanol.
    Special instructions:Patients who had a history of allergic reactions to penicillins, carbapenems may have increased sensitivity to cephalosporin antibiotics. During treatment with cefazolin, positive direct and indirect Coombs probes can be obtained, as well as a false positive urine reaction to glucose. When the drug is used, there may be an exacerbation of diseases of the gastrointestinal tract, especially colitis. When there is severe diarrhea, characteristic of pseudomembranous colitis, cefazolin should be canceled and appropriate treatment prescribed. The use of drugs that inhibit intestinal peristalsis is contraindicated. During the treatment period, patients should refrain from drinking alcohol. With long-term use of the drug, control of the peripheral blood picture and kidney function is necessary.
    Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and other potentially hazardous speciesactivities that require increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:
    Powder for the preparation of solution for intravenous and intramuscular injection 500 mg, 1000 mg.


    Packaging:For 500 mg, 1000 mg of cefazolin into a bottle of colorless glass of hydrolytic class 1, sealed with a stopper of bromobutyl rubber and crimped with an aluminum cap. 1 bottle together with the instruction for use is placed in a pack of cardboard.
    Storage conditions:In a dry, the dark 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 expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-003038
    Date of registration:18.06.2015
    Date of cancellation:2020-06-18
    The owner of the registration certificate:Jodas Expo Pvt.LtdJodas Expo Pvt.Ltd India
    Manufacturer: & nbsp
    Representation: & nbspJodas Expoim, Open CompanyJodas Expoim, Open Company
    Information update date: & nbsp13.10.2015
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