Active substanceCefotaximeCefotaxime
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  • Dosage form: & nbspPA solution for intravenous and intramuscular administration.
    Composition:

    One bottle contains 250 mg, 500 mg or 1 g of sodium salt cefotaxime (in terms of cefotaxime).

    Description:The powder is white or slightly yellow.
    Pharmacotherapeutic group:antibiotic cephalosporin
    ATX: & nbsp

    J.01.D.D.01   Cefotaxime

    Pharmacodynamics:

    Pharmacological properties

    Cefotaxime is a cephalosporin antibiotic III generation 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, Citrobacter, 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 betalactamases of gram-positive and 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 amounts with urine unchanged (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 the respiratory and urinary tract, kidneys; infections of the ear, throat, nose, septicemia, endocarditis, meningitis; infections of bones and soft tissues, abdominal cavity; with infectious and inflammatory diseases of the pelvic organs, 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:

    Application of the drug at the period of 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 (for 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 administration (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 is 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 dose reduced. With a creatinine clearance of 10 mp / min or less, the daily dose of the drug is halved.

    Side effects:

    With the use of cefotaxime, allergic reactions are possible (skin rash, fever, anaphylactic shock), digestive disorders (dyspeptic phenomena, pseudomembranous colitis (rarely), impaired functional liver tests), an increase in the number of eosinophils, leukopenia, neutropenia, agranulocytosis, hemolytic anemia, increased alkaline levels 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:Powder for the preparation of solution for intravenous and intramuscular injection, 250 mg, 500 mg and 1 g.
    Packaging:

    250 mg, 500 mg or 1 g of cefotaxime in a bottle of clear, colorless, neutral glass (class I), sealed with a rubber stopper under an aluminum roll, and covered with a protective plastic cover.

    One bottle with instructions for use is placed in a cardboard box.

    Storage conditions:

    Store in a dry, dark place at a temperature below 25 ° C.

    The reconstituted solution should be used within 5 hours after preparation if stored at a temperature below 25 ° C or for 48 hours if stored at a temperature of 2 ° C to 10 ° 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:П N013805 / 01-2002
    Date of registration:29.08.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:Ipka Laboratories Ltd.Ipka Laboratories Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspIPKA LABORATORIES LTD. IPKA LABORATORIES LTD. India
    Information update date: & nbsp28.12.2016
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