Active substanceCefuroximeCefuroxime
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  • Dosage form: & nbsp
    Powder for the preparation of solution for intramuscular injection.
    Composition:
    Active substance: cefuroxime sodium (in terms of cefuroxime) - 250 mg and 750 mg

    Description:The powder is white or yellowish white. Hygroscopic.
    Pharmacotherapeutic group:Antibiotic-cephalosporin.
    ATX: & nbsp

    J.01.D.C.02   Cefuroxime

    Pharmacodynamics:
    Cephaloeporine antibiotic of the second generation. 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 (viridarts group), Bordetella pertussis, most Clostridium spp.); Gram-negative microorganisms (Escherichia coli, Klebsiella spp., Proteus mirabilis, Providencia spp., Proteus rettgeri, Haemophilus influenzae, including strains,resistant to ampicillin; Haemophilus parainfluenzae, including strains resistant to ampicillin; Moraxella catarrhalis, Neisseria gonorrhoeae, including strains producing and not producing penicillinase, Neisseria meningitidis, Salmonella spp., Borrelia burgdorferi; Gram-positive and Gram-negative anaerobes (Peptococcus spp., Peptostreptococcus spp., Fusobacterium spp., Propionibacterium spp.). By cefuroxime insensitive: Clostridium difficile, Pseudomonas spp, Campylobacter spp, Acinetobacter calcoaceticus, Listeria monocytogenes, methicillin-resistant strains of Staphylococcus aureus, Staphylococcus epidermidis, Legionella spp, Streptococcus (Enterococcus) faecalis, Morganella morganii, Proteus vulgaris, Enterobacter spp.... , Citrobacter spp., Serratia spp., Bacteroides fragilis.
    Pharmacokinetics:
    After intramuscular injection of 750 mg, the maximum plasma concentration is reached after 15-60 minutes and is 27 μg / ml. Therapeutic concentration is maintained for 5 hours.
    Half-life with intramuscular injection of the drug is 1.3-1.5 h, in newborns it is 2-2.5 h.
    Communication with blood plasma proteins - 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 concentrations for most microorganisms can be achieved in bone tissue, synovial and intraocular fluid. When meningitis penetrates the hemato-encephalic barrier. Passes through the placenta and penetrates into breast milk.
    Indications:Bacterial infections caused by sensitive microorganisms: diseases of the lower respiratory tract (bronchitis, pneumonia, abscess of the lungs, pleural empyema, etc.), LOP-organs (sinusitis, tonsillitis, pharyngitis, otitis, etc.), urinary tract (pyelonephritis, cystitis, asymptomatic bacteriuria, gonorrhea, etc.), skin and soft tissues (erysipelas, pyoderma, impetigo, furunculosis, phlegmon, wound infection, erysipeloid, etc.), bones and joints (osteomyelitis, septic arthritis, etc.), pelvic organs (endometritis , adnexitis, cervicitis), sepsis, Lyme disease (Borre lyosis).
    Contraindications:Hypersensitivity (including to other cephalosporins, penicillins and carbapenems).
    Carefully:The period of newborns, prematurity, chronic renal failure (CRF), bleeding and diseases of the gastrointestinal tract (incl.in anamnesis, ulcerative colitis), weakened and emaciated patients, pregnancy, lactation.
    Dosing and Administration:
    Intramuscularly. Adults appoint 750 mg three times a day; with infections of severe course - the dose is increased to 1500 mg 3-4 times a day (if necessary, the interval between administrations can be reduced to 6 hours). The average daily dose is 3-6 g.

    Children are prescribed 30-100 mg / kg / day in 3-4 divided doses. 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 1500 mg once (or in the form of 2 injections of 750 mg with the introduction into different areas, for example, in both gluteal muscles).

    With exacerbation of chronic bronchitis, intramuscularly administered 750 mg 2-3 times a day for 48-72 hours, then go to the inside, 500 mg twice 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, 750 mg is prescribed twice a day, with creatinine clearance less than 10 ml / min 750 mg once a day. Patients on continuous hemodialysis using an arteriovenous shunt or high-speed haemofiltration in intensive care units,appoint 750 mg twice a day; for patients on low-velocity haemofiltration, doses recommended for renal impairment are prescribed.
    Side effects:

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

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

    From the urinary system: impaired renal function, dysuria, itching in the perineum, vaginitis.

    FROMabout the central nervous system: convulsions.

    On the part of the organs of the gastrointestinal tract and the hepatobiliary system: nausea, vomiting, constipation, flatulence, cramps and abdominal pain, ulceration of the oral mucosa, candidiasis of the oral cavity, rarely - pseudomembranous enterocolitis, laboratory indicators: increased activity of "hepatic" enzymes: aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase, hyperbilirubinemia.

    From the sense organs: hearing loss.

    From the hematopoiesis: decrease in hemoglobin and hematocrit, anemia (aplastic or hemolytic), eosinophilia, neutropenia, leukopenia, agranulocytosis, thrombocytopenia, hypothrombinemia, prolongation of prothrombin time.

    Overdose:

    Symptoms: excitation of the central nervous system, convulsions. Treatment: the appointment of antiepileptic drugs, the control and maintenance of vital body functions, hemodialysis and peritoneal dialysis.

    Interaction:
    Simultaneous oral administration of "loop" diuretics slows down the 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 aqueous solutions containing up to 1% lidocaine hydrochloride, 4%, 5% and 10% dextrose solutions, 0.18%, 0.45%, 0.9% solutions of sodium chloride and dextrose solution 5%, Ringer's solution, Hartman solution, sodium lactate solution, heparin (10 U / ml and 50 U / ml) in a 0.9% solution of sodium chloride.

    Pharmaceutically incompatible with aminoglycosides, sodium bicarbonate 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 direct Coombs reaction and a false-positive reaction of urine to glucose are possible.

    The ready-to-use solution can be stored at room temperature for 7 hours, in the refrigerator for 48 hours. It is allowed to use a yellow solution during storage. During treatment can not be used ethanol. Against the background of treatment of meningitis in children, hearing loss is 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. When switching from parenteral to ingestion, the severity of the infection, the sensitivity of the microorganisms and the general condition of the patient should be considered.If 72 hours after taking cefuroxime inside, there is no improvement, it is necessary to continue parenteral administration.
    Form release / dosage:Powder for the preparation of solution for intramuscular injection of 250 mg and 750 mg.
    Packaging:Powder for the preparation of solution for intramuscular administration of 250 mg and 750 mg in glass bottles. The bottle with instructions for use is placed in a pack. 10 bottles with instructions for use in a cardboard box.
    For hospital: 50 bottles per box of cardboard with the application of 5 instructions for use.
    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 expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-002181/07
    Date of registration:15.08.2007
    The owner of the registration certificate:KRASFARMA, JSC KRASFARMA, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp29.11.2015
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