Active substanceCefotaximeCefotaxime
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  • Dosage form: & nbsppowder for solution for intravenous and intramuscular administration
    Composition:1 bottle contains the active substance cefotaksim sodium (in terms of cefotaxime) - 1000 mg.
    Description:PThe powder is white or white with a yellowish hue, it is sensitive to the action of light.
    Pharmacotherapeutic group:Antibiotic-cephalosporin
    ATX: & nbsp

    J.01.D.D.01   Cefotaxime

    Pharmacodynamics:

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

    It is active against gram-positive and gram-negative microorganisms resistant to other antibiotics: Staphylococcus spp. (incl. Staphylococcus aureus, including penicillinase forming strains), Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Enterococcus species, Enterobacter spp., Escherichia coli, Haemophilus influenzae (including strains that form penicillinase), Haemophilus parainfluenzae, Klebsiella spp. (incl. Kl.pneumoniae), Morganella morganii, Neisseria gonorrhoeae (including strains that form penicillinase), Acinetobacter species, Corynebacterium diphtheriae, Erysipelothrix insidiosa, Eubacterium spp., Propionibacterium spp., Bacillus subtilis, Clostridium spp. (incl. Clostridium perfringens, most strains Clostridium difficile resistant to the drug), Escherichia coli, Citrobacter spp., Proteus mirabilis, Proteus indole, Proteus vulgaris, Providencia spp. (incl. Providencia rettgeri), Serratia spp., Pseudomonas aeruginosa, Neisseria meningitidis, Bacteroides spp. (including some strains Bacteroides fragilis), Fusobacterium spp. (incl. Fusobacterium nucleatum), Peptococcus spp., Peptostreptococcus spp.

    It is resistant to most beta-lactamases of gram-positive and gram-negative microorganisms, penicillinase of staphylococci.

    Pharmacokinetics:

    After a single intravenous (iv) injection of 1000 mg of the drug, the maximum concentration (CmOh) are achieved after 5 minutes and is 101.7 μg / ml.

    After intramuscular (IM) administration of CmOh is achieved after 0.5 hours and is 21 μg / ml. The connection with plasma proteins is 25-40%.

    Creates therapeutic concentrations in most tissues (myocardium, bones, gallbladder, skin, soft tissues) and fluids (synovial, pericardial, pleural, sputum, bile, urine, cerebrospinal fluid) of the body. The volume of distribution is 0.25-0.39 l / kg.

    The half-life (T1/2) with intravenous and intramuscular injection - 1 hour. It is excreted by the kidneys - 60% -70% unchanged, the rest - in the form of metabolites (the deacetylated derivative has bactericidal activity, and the other two metabolites do not possess).

    In chronic renal failure (CRF) and in the elderly T1/2 increases by 2 times.

    T1/2 in newborns - 0.75-1.5 h, in preterm neonates increases to 4.6 hours.

    With repeated intravenous doses of 1000 mg every 6 hours for 14 days cumulation is not observed.

    Penetrates into breast milk.

    Indications:

    Bacterial infections of severe course caused by susceptible microorganisms:

    - infections of the central nervous system (including meningitis);

    - infection of the respiratory tract and ENT organs, incl. pneumonia;

    - urinary tract infection, in t.ch. acute and exacerbation of chronic pyelonephritis;

    - infections of the skin and soft tissues, incl. postoperative wound complications;

    - infection of bones and joints;

    - infection of the pelvic organs, in t.ch. acute and exacerbation of chronic adnexitis, pelvioperitonitis, endometritis;

    - uncomplicated and complicated infections of the abdominal cavity (peritonitis, postoperative abscesses of the abdominal cavity, cholecystitis, cholangitis);

    - infection of the genitourinary system, incl. chlamydia, gonorrhea;

    - endocarditis;

    - sepsis;

    - infection against the background of immunodeficiency;

    - prevention of infections after surgical operations (including urological, obstetric-gynecological, on the gastrointestinal tract).

    Contraindications:

    Hypersensitivity to cefotaxime and other cephalosporin antibiotics.

    When using lidocaine as a solvent:

    - intracardiac blockades without an established pacemaker;

    - cardiogenic shock;

    - intravenous administration;

    - children up to 2.5 years;

    - hypersensitivity to lidocaine or other local anesthetic of the amide type.

    Carefully:

    Chronic renal failure, ulcerative colitis (including in the anamnesis), allergic reactions to penicillins in the anamnesis.

    Pregnancy and lactation:

    The use of Cefabol® during pregnancy is possible in cases where the intended benefit to the mother exceeds the potential risk to the fetus.

    Cefotaxime penetrates into breast milk, so if you need to use the drug during lactation should stop breast-feeding.

    Dosing and Administration:

    Intramuscularly and intravenously (jet and drip), depending on the chosen dose, the dosage regimen and the severity of the infection.

    Adults and children over 12 years of age, or with a body weight of 50 kg or more

    When uncomplicated infections are given in / m or / in, 1 g every 12 h.

    With uncomplicated acute gonorrhea - 0.5-1 g IM once.

    For infections of moderate severity, appoint 1-2 g / m or IV every 8 hours.

    In cases where large doses of antibiotic (including for the treatment of sepsis) are required, iv is administered at a dose of 2 g with an interval of 6-8 hours. In life-threatening infections, the intervals between administrations can be reduced to 4 hours (the maximum dose is 12 g / day).

    For antimicrobial prophylaxis of postoperative purulent-septic complications, 1.0 g of Cefabol® is administered 30 min before the operation once. If necessary, the administration is repeated at 6 and 12 hours.

    In patients undergoing cesarean section, 1.0 g of Cefabol® is administered intravenously immediately after clamping the umbilical cord, then, if necessary, additionally 1 g at 6 and 12 hours after the first dose.

    Patients with severe impairment of function kidneys (creatinine clearance 20 ml / min / 1.73 m2) daily dose of Cefabol® is reduced by half.

    Children of the first month of life, irrespective of gestational age, use the following dosages: newborns of the first week of life are given IV dose 50 mg / kg every 12 hours; at the age of 1-4 weeks - in / in 50 mg / kg every 8 hours.

    In children from 1 month. under 12 years old, or with a body weight of less than 50 kg, the daily dose of Cefabol®, ranging from 50 to 180 mg / kg, is divided by 3-4 in / m or IV. In severe and life-threatening infections, incl.with bacterial meningitis, the dose is increased to 100-200 mg / kg / day and divided by 4-6 IV or IM. Dosages indicated for adults are used in children weighing more than 50 kg.

    Rules for the preparation of solutions

    To prepare a solution for intravenous injection, 1.0 g of dry sterile Cefabol® powder is dissolved in 3-4 ml of sterile water for injection or 1% of lidocaine solution.

    Enter deeply intramuscularly in areas of the body with a pronounced muscular layer (the upper-arm quadrant of the buttock or lateral surface of the thigh).

    It is recommended that an aspiration test be carried out to avoid undesirable introduction of the solution into the blood vessel.

    To prepare a solution for intravenous administration, 1.0 g of Cefabol® is diluted in 10 ml of sterile water for injection.

    Enter iv slowly, for 3-5 min; it is possible to administer through a special node or port for injection of a system for intravenous infusions if the patient receives fluids parenterally.

    For intravenous drip injection, 1.0 g of Cefabol® is diluted in 4-5 ml of sterile water for injection. The resulting solution is added to a vial containing 50 or 100 ml of a 5% dextrose solution or 0.9% sodium chloride solution.

    Side effects:

    Allergic reactions: urticaria, chills and fever, rash, itching, bronchospasm, eosinophilia, malignant erythema multiforme (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), angioneurotic edema, anaphylactic shock;

    From the digestive system: nausea, vomiting, diarrhea or constipation, flatulence, abdominal pain, goiter, the liver, stomatitis, glossitis, pseudomembranous enterocolitis;

    From the hematopoiesis: leukopenia, neutropenia, granulocytopenia, thrombocytopenia, hemolytic anemia, hypocoagulation;

    From the urinary system: renal dysfunction (azotemia, increased urea in the blood, oliguria, anuria, interstitial nephritis);

    From the nervous system: headache, dizziness;

    Laboratory indicators: azotemia, increasing concentrations of urea in the blood, the increase in "liver" transaminases and alkaline phosphatase hypercreatininemia, hyperbilirubinemia, false positive Coombs;

    From the cardiovascular system: potentially life-threatening arrhythmias after a rapid bolus injection into the central vein;

    Local reactions: phlebitis, soreness along the vein, soreness and infiltration at the site of the / m introduction;

    Other: Superinfection (in particular, candidal vaginitis).

    Overdose:

    Symptoms: convulsions, encephalopathy (in the case of the administration of large doses, especially in patients with renal insufficiency), tremor, increased neuromuscular excitability.

    Treatment: symptomatic therapy.

    Interaction:

    Increases the risk of bleeding when combined with antiaggregants, non-steroidal anti-inflammatory drugs.

    Does not lead to the development of disulfiram-like reactions when combined with ethanol.

    The probability of kidney damage increases with simultaneous administration with aminoglycosides, polymyxin B and "loop" diuretics.

    Drugs that block tubular secretion, increase plasma concentrations of cefotaxime and slow its elimination.

    Pharmaceutically incompatible with solutions of other antibiotics in one syringe or dropper.

    Special instructions:

    In the first weeks of treatment, pseudomembranous colitis can occur, which is manifested by severe prolonged diarrhea.At the same time, stop taking the drug and prescribe adequate therapy, including vancomycin or metronidazole.

    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.

    In persons who have a history of allergic reactions to penicillin, the drug is used with extreme caution (the possibility of developing severe anaphylactic reactions, up to a lethal outcome) should be considered.

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

    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, 1000 mg.

    Packaging:

    1000 mg active substance in bottles of glass with a capacity of 10 ml.

    Solvent - "Water for injection" in ampoules of 5 ml.

    1. 1 bottle with the drug and instructions for use are placed in a pack of cardboard.

    2. 1 bottle with the drug, 1 ampoule with a solvent and instructions for use are packed in a cardboard pack.

    3. 1 bottle with the drug and 1 ampoule with solvent are packed in a contour mesh box made of polyvinyl chloride film and foil of aluminum lacquered or without foil. One contour mesh package and instructions for use are put in a cardboard pack.

    4. Five vials of the drug are packaged in contour

    Packaging of PVC film and aluminum foil lacquered or foil-free. One outline package and instructions for use are put in a cardboard pack.

    5. Five vials of the preparation complete with 5 ampoules of the solvent are packed in contoured cell packs made of polyvinylchloride film and foil of aluminum lacquered or without foil. One outline package with the preparation, one outline package with a solvent and instructions for use are put in a cardboard pack.

    Storage conditions:

    In a dry, the dark place at a temperature of no more than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:P N001155 / 01
    Date of registration:21.04.2008 / 03.10.2014
    Expiration Date:Unlimited
    The owner of the registration certificate:PREBAND PFC, LLCPREBAND PFC, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp10.01.2017
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