Active substanceCefuroximeCefuroxime
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  • Dosage form: & nbspPowder for the preparation of solution for intravenous and intramuscular injection.
    Composition:Cefuroxime sodium (in terms of cefuroxime) - 750 mg.
    Description:Powder from white to light yellow color.
    Pharmacotherapeutic group:Antibiotic-cephalosporin.
    ATX: & nbsp

    J.01.D.C.02   Cefuroxime

    Pharmacodynamics:
    Cephalosporin antibiotic II generation for parenteral use. It acts bactericidal (it breaks the synthesis of the bacterial cell wall). Has a wide spectrum of antimicrobial action.
    Highly active against Gram-positive microorganisms, including strains resistant to penicillins (with the exception of strains resistant to methicillin), Staphylococcus aureus, Streptococcus pyogenes (and others beta-hemolytic streptococci), Streptococcus pneumoniae, Streptococcus group B (Streptococcus agalactiae), Streptococcus mitis (viridans group), most Clostridium spp.);
    Gram-negative microorganisms (Escherichia coli, Klebsiella spp., Proteus mirabilis, Providencia spp., Proteus rettgeri, Bordetella pertussis, Haemophilus influenzae, including strains,resistant to ampicillin; Haemophilus para influenzae, including strains resistant to ampicillin; Moraxella catarrhal is, Neisseria gonorrhoeae, including strains producing and not producing penicillinase, Neisseria meningitidis, Salmonella spp, Borrelia burgdorferi.;
    Gram-positive (Peptococcus spp., Peptostreptococcus, spp.) and gram-negative anaerobes (Fusobacterium spp., Propionibacterium spp.).
    To cefuroxime are not sensitive: Clostridium difficile, Pseudomonas spp., Campylobacter spp., Acinetobacter calcoaceticus, Listeria monocytogenes, methicillin-resistant strains Staphylococcus aureus, Staphylococcus epidermidis, Legionella spp., Streptococcus (Enterococcus) faecalis, Morganella morganii, Proteus vulgaris, Hnterobacter spp ., Citrobacter spp., Serratia spp., Bacteroides fragilis.
    Pharmacokinetics:
    Parenteral administration: after intramuscular injection of 0.75 g the maximum concentration is reached after 15-60 minutes and is 27 μg / ml. With intravenous administration of 0.75 g and 1.5 g, the maximum concentration after 15 minutes is 50 and 100 μg / ml, respectively. The therapeutic concentration remains 5.3 and 8 hours, respectively.
    The half-life for intravenous and intramuscular injection is 1.3-1.5 h, for newborns it is 2-2.5 h.
    The connection with plasma proteins is 33-50%.
    It is not metabolized in the liver.
    It is excreted by the kidneys by glomerular filtration and tubular secretion 85-90% unchanged for 8 hours (most of the drug is excreted within the first 6 hours, while creating high concentrations in the urine); after 24 hours it is completely removed (50% by tubular secretion, 50% by glomerular filtration).
    Therapeutic concentrations are recorded in the pleural fluid, bile, sputum, myocardium, skin and soft tissues. Concentrations of cefuroxime exceeding the minimum inhibitory concentration for most microorganisms can be achieved in bone tissue, synovial and intraocular fluid. When meningitis penetrates the blood-brain barrier. Passes through the placenta and penetrates into breast milk.
    Indications:Bacterial infections caused by susceptible organisms: respiratory diseases (bronchitis, pneumonia, lung abscess, empyema), LOP-bodies (sinusitis, tonsillitis, pharyngitis, otitis media), urinary tract infection (pyelonephritis, cystitis, asymptomatic bacteriuria, gonorrhea), skin, and soft tissues (erysipelas, pyoderma, impetigo, furunculosis, abscess, cellulitis, wound infection, pseudoerysipelas), bones and joints (osteomyelitis, septic arthritis), pelvic organs (endometritis, adnexitis, cervicitis), sepsis, meningitis, A disease ayma (borreliosis), prevention of infectious complications in operations on the organs of the chest, abdominal cavity, small pelvis, joints, (incl.at operations on lungs, heart, an esophagus, in vascular surgery at a high degree of risk of infectious complications, at orthopedic operations).
    Contraindications:Hypersensitivity (including to other cephalosporins, penicillins and carbapenems).
    Carefully:Newborn period, prematurity, chronic renal insufficiency, bleeding and gastrointestinal tract diseases (including history, ulcerative colitis), weakened and emaciated patients, pregnancy, lactation.
    Dosing and Administration:
    Intravenous, intramuscular.

    Intravenous and intramuscularly, adults are prescribed 0.75 g three times a day; with infections of severe course - the dose is increased to 1.5 g 3-4 times a day (if necessary, the interval between administrations can be reduced to 6 h). The average daily dose is 3-6 g.

    Children older than 3 months are prescribed 30-100 mg / kg / day in 3-4 sessions. In most infections, the optimal dose is 60 mg / kg / day. Newborns and children under 3 months are prescribed 30 mg / kg / day in 2-3 doses.

    With gonorrhea - intramuscularly, 1.5 g once (or in the form of 2 injections of 0.75 g with the introduction into different areas, for example, in both gluteal muscles).

    With bacterial meningitis - intravenously, 3 g every 8 hours; children younger and older - 150-250 mg / kg / day in 3-4 hours, the newborn - 100 mg / kg / day in 2-3 hours.

    In operations on the abdominal cavity, pelvic organs and orthopedic operations - intravenously, 1.5 g with induction of anesthesia, then additionally - intramuscularly, 0.75 g, 8 and 16 hours after the operation.

    At operations on heart, lungs, an esophagus and vessels - intravenously, 1.5 g at an induction of anesthesia, then - intramuscularly, on 0.75 g 3 times a day during the next 24-48 hours.

    When the joint is completely replaced, 1.5 g of cefuroxime powder is mixed with the polymer packet with methyl methacrylate cement before adding the liquid polymer.

    With pneumonia - intramuscularly or intravenously, 1.5 g 2-3 times a day for 7-10 days.

    With exacerbation of chronic bronchitis, intramuscularly or intravenously, 0.75 g 2-3 times a day for 5-10 days.

    In chronic renal failure, correction of the dosing regimen is necessary: ​​with creatinine clearance of 10-20 ml / min, intravenously or intramuscularly, 0.75 g 2 times a day, with creatinine clearance less than 10 ml / min - 0.75 g once a day.

    Patients on continuous hemodialysis using an arteriovenous shunt or high-velocity haemofiltration inintensive care units, appoint 0.75 g 2 times a day; for patients on low-velocity haemofiltration, doses recommended for renal impairment are prescribed.

    Preparation of solutions for injection:

    For intramuscular administration, 3.0 ml of water for injections is added to 750 mg of the preparation. Gently shake until a slurry forms.

    For intravenous bolus administration, 750 mg of the drug is dissolved in 6 or more ml of water for injection.

    For intravenous infusion, 750 mg of the drug is dissolved in 6 ml of water for injection, then the resulting solution is added to 50-100 ml of the infusion solution (compatibility of solutions, see "Interaction with other drugs"). These solutions can be injected directly into the vein or into the tube of the infusion system.
    Side effects:

    Allergic reactions: chills, rash, itching, urticaria, rarely - multiforme exudative erythema (including Stevens-Johnson syndrome), bronchospasm, anaphylactic shock.

    Local reactions: irritation, infiltration and pain at the injection site, phlebitis.

    From the genitourinary system: itching in the perineum, vaginitis.

    From the central nervous system: convulsions.

    From the urinary system: impaired renal function, dysuria.

    From the digestive system: diarrhea, nausea, vomiting, spasms and pain in the abdomen, ulceration of the oral mucosa, candidiasis of the oral mucosa, rarely - pseudomembranous enterocolitis.

    From the sense organs: hearing loss.

    From the hematopoiesis: hemolytic anemia.

    Laboratory indicators: increased activity of "hepatic" enzymes, alkaline phosphatase, lactate dehydrogenase, hyperbilirubinemia.

    Overdose:
    Symptoms: excitation of the central nervous system, convulsions.
    Treatment: symptomatic, hemodialysis and peritoneal dialysis.
    Interaction:
    Simultaneous administration of "loop" diuretics slows tubular secretion, reduces renal clearance, increases plasma concentration, and increases the half-life of cefuroxime.
    When used simultaneously with aminoglycosides and diuretics, the risk of nephrotoxic effects increases.
    Pharmaceutically compatible with metronidazole, azlocillin, xylitol,with aqueous solutions containing up to 1% lidocaine hydrochloride, 0.9% sodium chloride solution, 5 and 10% dextrose solution, 0.18% sodium chloride solution and 4% dextrose solution, 5% dextrose solution and 0.9% sodium chloride solution, Ringer's solution, solution sodium lactate, Hartman's solution, heparin (10 U / ml and 50 U / ml) in a 0.9% solution of sodium chloride.
    Pharmaceutically incompatible with aminoglycosides, sodium hydro carbonate solution 2.74%.
    Special instructions:
    Patients who had a history of allergic reactions to penicillins, may have a hypersensitivity to cephalosporin antibiotics. In the process of treatment, control of kidney function is necessary, especially in patients receiving the drug in high doses. Treatment continues for 48-72 hours after the disappearance of symptoms, in the case of infections caused by Streptococcus pyogenes, treatment course - at least 7-10 days.
    During treatment, a false positive Coombs reaction and a false positive urine reaction to glucose are possible.
    In patients receiving cefuroxime, when determining the concentration of glucose in the blood, it is recommended to use tests with glucose oxidase or hexokinase.
    Form release / dosage:
    Powder for the preparation of solution for intravenous and intramuscular administration 750 mg.


    Packaging:
    750 mg of active substance per bottle from a glass tube with a capacity of 10 ml.
    1 a bottle with instructions for use in a cardboard box.
    50 bottles with instructions for use in the amount of 10 pieces in a cardboard box (for hospitals).
    Storage conditions:List B. 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:LSR-000002/10
    Date of registration:11.01.2010
    The owner of the registration certificate:Company DEKO, LLC Company DEKO, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp29.11.2015
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