Active substanceCefotaximeCefotaxime
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  • Dosage form: & nbspPPowder for solution for injection
    Composition:

    One bottle contains 0.25 g, 0.5 g or 1.0 g of Cefotaxime sodium.

    Description:

    Powder from almost white to slightly yellow.

    Pharmacotherapeutic group:Antibiotic-cephalosporin
    ATX: & nbsp

    J.01.D.D.01   Cefotaxime

    Pharmacodynamics:

    Pharmacological properties

    Cefotaxime is a third generation cephalosporin antibiotic for parenteral use. It is bactericidal. It has a wide spectrum of antimicrobial action.

    Pharmacodynamics

    Highly active against gram-negative microorganisms resistant to other antibiotics: E.coli, Citobacter, Proteus mirabilis, Proteus indole, Providencia, Klebsiella, Serratia, some strains Pseudomonas, Haemophilus influenzae. Less active against gram-positive cocci, mainly staphylococci. The drug has a high resistance to beta-lactamases gram-negative bacteria.

    Pharmacokinetics:

    Apply cefotaxime intramuscularly and intravenously. With intramuscular injection, the drug is absorbed rapidly. The peak plasma concentration is observed 30 minutes after the injection. The bactericidal concentration in the blood persists for more than 12 hours.The drug penetrates well into the tissues and body fluids; is found in effective concentrations in the pleural, peritoneal, synovial fluids. Unlike earlier cephalosporins, it penetrates the blood-brain barrier. As a result of biotransformation, an active metabolite is formed. It is excreted in significant quantities with urine in an unchanged form of about 30%) and in the form of active metabolites (about 20%). Partially excreted with bile.

    Indications:

    Apply cefotaxime in infections caused by sensitive microorganisms (mainly gram-negative): infections of respiratory and urinary tract, kidney; infections of the ear, throat, nose, septicemia, endocarditis, meningitis; infections of bones and soft tissues, abdominal cavity; with gynecological infectious diseases, gonorrhea; wound and burn infections and others.

    Contraindications:

    The drug is contraindicated in cases of hypersensitivity to cephalosporin antibiotics. A cross-allergy between penicillins and cephalosporins is possible.

    Children under 2.5 years of age should not use intramuscular injection.

    Carefully:Caution is necessary when prescribing the drug to patients with impaired renal and hepatic functions.
    Pregnancy and lactation:

    The use of the drug during pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus.

    Cefotaxime excreted in breast milk, so if you need to prescribe the drug during lactation should stop breastfeeding.

    Dosing and Administration:

    Apply cefotaxime intramuscularly and intravenously.

    For intramuscular injection dissolve 0.25 or 0.5 g of the drug in 2 ml (respectively 1 g in 4 ml) of sterile water for injection, injected deeply into the gluteal muscle. As a solvent, intramuscular injection also uses 1% lidocaine (by 0.5 g - 2 ml, for 1 g - 4 ml).

    For intravenous administration 0.5-1 g of cefotaxime is dissolved in 4 ml (2 g - 10 ml) of sterile water for injection. Enter slowly for 3-5 minutes.

    For drip introduction (within 50-60 minutes) dissolve 2 g of the drug in 100 ml of isotonic sodium chloride solution or 5% glucose solution.

    The usual dose of cefotaxime for adults and children over 12 years - 1 g every 12 hours.In severe cases, the dose is increased to 3 or 4 g per day, the drug is administered 3 or 4 times 1 g. The maximum daily dose, depending on the severity of the disease, can be increased to 12 g.

    Usual Dose for newborns and children under 12 years of age - 50-100 mg / kg of body weight per day with intervals of administration from 6 to 12 hours. For premature babies, the daily dose should not exceed 50 mg / kg.

    In the case of violations of kidney function, the dose reduce. With a creatinine clearance of 10 ml / min and a lesser daily dose of the drug is reduced by half.

    Side effects:

    When using cefotaxime, allergic reactions are possible (skin rashes, fever, anaphylactic shock), digestive disorders (dyspeptic pseudomembranous colitis (rarely), impaired functional liver tests), an increase in the number of eosinophils, leukopenia, neutropenia, agranulocytosis, hemolytic anemia, an increase in the level of alkaline phosphatase and the content of nitrogen in the urine.

    Pain, redness and swelling at the injection site.

    The body temperature may rise.

    Interaction:

    With simultaneous use of Cefotaxime with potentially nephrotoxic drugs (aminoglycoside antibiotics, furosemide) it is necessary to monitor the function of the kidneys (the risk of nephrotoxic action of the latter).

    Solutions cefotaxima incompatible with solutions of other antibiotics in a single syringe or dropper.

    Special instructions:

    Before prescribing the drug, you need to collect an allergic medical history, especially with regard to beta-lactam antibiotics. There is a cross-allergy between penicillins and cephalosporins. People who have a history of indicating allergic reactions to penicillin, the drug is used with extreme caution.

    When there are reactions of hypersensitivity (which are severe and even lead to death), the drug is canceled.

    With a duration of treatment with the drug for more than 10 days, it is necessary to monitor the picture of peripheral blood.

    Possible detection of false positive Coombs test.

    When determining glucose in the urine by a non-enzymatic method (for example, by the method of Benedict), false-positive results are possible.

    Form release / dosage:PPowder for solution for injection, 0.25 g, 0.5 g and 1 g.
    Packaging:

    For 0.25 g, 0.5 g and 1.0 g of the preparation in bottles of colorless clear glass with a capacity of 7.5 ml, 7.5 ml or 10 ml, equipped with rubber stoppers, crimped with aluminum caps.Each bottle together with instructions for use is placed in a cardboard pack.

    Solvent - "Water for injections",

    2 or 5 ml, produced by OJSC "Pharmasintez", Russia (RU No. LP-001844).

    1. One bottle with 0.25 g of the drug together with the instruction for use is placed in a cardboard pack.

    2. One bottle with 0.5 g of the drug, together with the instruction for use, is placed in a cardboard pack.

    3. One bottle with 1.0 g of the drug together from instruction by application put in a pack of cardboard

    4. One bottle with 0.25 g of preparation and one ampoule with 2 ml of solvent together from instruction by The application is placed in a cardboard pack with septa.

    5. One vial with 0.5 g of preparation and one ampoule with 2 ml of solvent together with the instruction, but the application is placed in a cardboard box with septa.

    6. One bottle with 0.5 g of preparation and one ampoule with 5 ml of solvent together with instructions for use are placed in a cardboard box with septa.

    7. One bottle with 1.0 g of preparation and one ampoule with 5 ml of solvent together with instructions for use are placed in a cardboard box with septa.

    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:3 years. Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N013793 / 01
    Date of registration:08.06.2009 / 10.07.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:FARMGID CJSCFARMGID CJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspPharmgid, OOOPharmgid, OOO
    Information update date: & nbsp11.04.2018
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