Active substanceCefuroximeCefuroxime
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  • Dosage form: & nbsppowder for solution for intravenous and intramuscular administration
    Composition:1 bottle contains the active substance - cefuroxime sodium, equivalent to 1.5 g of cefuroxime.
    Description:Powder from white to light yellow color.
    Pharmacotherapeutic group:Antibiotic-cephalosporin
    ATX: & nbsp

    J.01.D.C.02   Cefuroxime

    Pharmacodynamics:

    Cefuroxime sodium is a semisynthetic cephalosporin antibiotic of the second generation, a broad spectrum of action. It acts bactericidal, it breaks the synthesis of the bacterial cell wall. Has a wide spectrum of antimicrobial action. It is active against a wide range of clinically significant microorganisms.

    Gram-positive microorganisms:

    Staphylococcus aureus (producing and not producing penicillinase), Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes (beta-hemolytic group streptococcus A), Streptococcus agalactiae (beta-hemolytic streptococcus group B), Streptococcus mitis (groups viridans), Clostridium spp., most other strains of beta-hemolytic streptococci.

    Gram-negative microorganisms:

    Escherichia coli, Haemophilus influenzae (including strains resistant to ampicillin), Haemophilus parainfluenzae (including strains resistant to ampicillin), Klebsiella spp., Maraxella catarrhalis, Proteus vulgaris, Proteus mirabilis, Providencia spp., Salmonella spp., Shigella spp., Pseudomonas aeruginosa, Neisseria gonorrhoeae (including strains producing and not producing penicillinase), Neisseria meningitidis, Borrelia burgdorferi, Bordetella pertussis, Yersinia enterocolitica.

    Anaerobic microorganisms

    Fusobacterium spp., Peptococcus spp., Peptostreptococcus spp., Propionibacterium spp.

    TO cefuroxime are stable strains: Clostridium difficile, Pseudomonas spp., Campylobacter spp., Acinetobacter calcoaceticus, Listeria monocytogenes, sustainable to methicillin strains Staphylococcus aureus and Staphylococcus epidermidis, Legionella spp., Streptococcus (Enterococcus) faecalis, Morganella morganii, Proteus vulgaris, Enterobacter spp., Citrobacter spp., Serratia spp., Bacteroides fragilis.

    Pharmacokinetics:
    After the / m administration of 750 mg, the maximum plasma concentration is reached after 15-60 minutes and is 27 μg / ml. With IV administration of 750 mg and 1.5 g, the maximum concentration after 15 minutes is 50 and 100 μg / ml, respectively. The therapeutic concentration is maintained at 5.3 and 8 hours, respectively. The half-life of cefuroxime for IV and IV injections is 80 minutes, in newborn infants - 3-5 times longer. 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 of 85-90% unchanged for 8 hours. Moreover, most of the drug is excreted within the first 6 hours, while creating high concentrations in the urine; after 24 hours cefuroxime is completely eliminated (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 common microorganisms can also be achieved in bone tissue, synovial fluid and intraocular fluid. When meningitis cefuroxime penetrates the blood-brain barrier. Passes through the placenta and penetrates into breast milk.
    Indications:
    Infectious-inflammatory diseases caused by susceptible to cefuroxime pathogens:
    - infections of the upper and lower respiratory tract: acute and chronic bronchitis, pneumonia, lung abscess, pleural empyema, postoperative infectious diseases of the chest, pharyngitis, sinusitis, tonsillitis, otitis, etc.
    - urinary tract infections: asymptomatic bacteriuria, cystitis, acute and chronic pyelonephritis, and others.
    - infections of the skin and soft tissues: erysipelas, pyoderma, impetigo, furunculosis, phlegmon, infected wounds, etc.
    - infection of bones and joints: septic arthritis, osteomyelitis, etc.
    - infection of the urinary tract (inflammatory diseases of the pelvic organs, endometritis, adnexitis, cervicitis, gonorrhea).
    - other infections: septicemia, meningitis, peritonin, Lyme disease (borreliosis).
    - prevention of infections after surgery.
    Contraindications:Hypersensitivity to cephalosporins, penicillins, carbapenems.
    Carefully:Newborn period, prematurity, chronic renal failure, bleeding and gastrointestinal (GI) diseases (including history, ulcerative colitis), weakened and depleted patients, pregnancy.
    Pregnancy and lactation:
    In pregnancy, use the drug only in those cases where the intended use for the mother exceeds the potential risk to the fetus.
    If it is necessary to prescribe the drug during lactation, the question of abolishing breastfeeding should be resolved.
    Dosing and Administration:

    The drug is used intramuscularly and intravenously.

    Adults: usually appointed cefuroxime in a dose of 750 mg-1.5 g every 8 hours. The course of treatment is usually from 5 to 10 days.

    Newborns - appoint IV in a dose of 30-100 mg / kg / day, divided into 2-3 doses (in the first weeks of life, the half-life of cefuroxime in the blood serum of a newborn can be 3-5 times higher than in an adult).

    Infants and children under 12 years - appoint iv 30-100 mg / kg / day every 6-8 hours. In the treatment of most infections, the optimal daily dose is 60 mg / kg.

    With pneumonia - appoint 1.5 g IV or IM 2-3 times a day for 48-72 hours, and then go to the inside (use medicinal forms for oral administration) of 500 mg 2 times a day for 7 -10 days.

    With an exacerbation of chronic bronchitis - appoint IV or IV 750 mg 2-3 times a day for 48-72 hours, then go to the inside (use medicinal forms for oral administration) 500 mg 2 times a day for 5-10 days.

    With uncomplicated urinary tract infection, skin infection, disseminated gonococcal infection, and uncomplicated pneumonia - appoint 750 mg every 8 hours. If necessary, the interval between administrations can be reduced to 6 hours and the daily dose will rise to 3-6 g. In severe or complicated infections, 1.5 g every 8 hours is prescribed.

    With bacterial meningitis - appoint IV, 3.0 g every 8 hours; children younger and older - in / in 150-250 mg / kg / day in 3-4 reception.After 3 days in case of clinical improvement, the dose can be reduced to 100 mg / kg / day. The newborn drug is administered IV in a dose of 100 mg / kg / day.

    With gonorrhea - 1,5 g in the form of IM injection once (as 2 injections of 750 mg with the introduction into different areas, for example, in both gluteal muscles).

    For the prevention of surgical interventions:

    - at operations on an abdominal cavity, bodies of a basin and at orthopedic operations - in / in, 1,5 g at an anesthesia induction, then in addition - in / m 750 mg, through 8 h and 16 h after operation;

    - at operations on heart, lungs, an esophagus, vessels and orthopedic operations - in / in, 1,5 g at an anesthesia induction, then - in / m, on 750 mg 3 times a day during the next 24-48 hours;

    - when the joint is fully replaced, 1.5 g of the preparation is dry mixed with each polymer methyl methacrylate cement pack before adding the liquid monomer.

    In chronic renal failure correction of the dosing regimen is necessary:

    - with a creatinine clearance of 10-20 ml / min is given either IV or IV 750 mg twice daily,

    - when creatinine clearance is 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 are prescribed 750 mg twice daily.Patients on low-velocity haemofiltration are given doses recommended for renal dysfunction.

    Preparation of solutions for administration:

    The solutions are prepared in aseptic conditions.

    For intramuscular injection - in a bottle containing 1.5 g of the drug, add 6 ml of water for injection and mix thoroughly.

    For intravenous administration - in a bottle containing 1.5 g, add 15 ml of water for injection and mix thoroughly.

    For short-term intravenous infusions (no more than 30 min): 1.5 g of cefuroxime is dissolved in 50-100 ml of water for injection. These solutions are injected directly into the veins or indirectly, using a system for infusion solutions.

    For slow intravenous administration additionally dissolved in 50 ml of 5% or 10% solution of dextrose for injection, 0.9% solution of sodium chloride for injection, Ringer's solution, Ringer's solution with lactate.

    In accordance with the requirements of good clinical practice, it is recommended to use only freshly prepared solutions, but the solution remains stable for 24 hours when stored in a refrigerator (2-8 ° C).

    Side effects:

    Allergic reactions: rash, urticaria, skin itching, chills, serum sickness, multiforme exudative erythema (Stevens-Johnson syndrome), bronchospasm, anaphylactic shock, vasculitis.

    From the central nervous system: convulsions.

    From the digestive system: diarrhea, nausea, vomiting or constipation, flatulence, spasms and pain in the abdomen, manifestations of the oral mucosa, candidiasis of the oral mucosa, glossitis, pseudomembranous enterocolitis, cholestasis.

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

    From the urinary system: impaired renal function, dysuria.

    From the hematopoiesis: reduction of hemoglobin and hematocrit, anemia (aplastic or hemolytic), eosinophilia, neutropenia, leukopenia, agranulocytosis, thrombocytopenia, hypoprothrombinemia.

    Laboratory Tests: transient increase in the activity of "hepatic" transaminases - aspartate aminotransferase (ACT), alanine aminotransferase (AJIT), alkaline phosphatase, lactate dehydrogenase, bilirubin in blood serum. In some patients, a false positive Coombs test is observed during treatment.

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

    Overdose:
    Symptoms: agitation, convulsions.
    Treatment: the appointment of antiepileptic drugs, ventilation and perfusion, hemodialysis and peritoneal dialysis.
    Interaction:
    Simultaneous oral administration of "loop" diuretics slows 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 metronidazole, azlocillin, xylitol, with aqueous solutions containing up to 1% lidocaine hydrochloride, 0.9% sodium chloride solution, 5% dextrose solution, 0.18% sodium chloride solution and 4% dextrose solution, 5% dextrose solution and 0.9% sodium chloride solution, 5% dextrose solution and 0.45% sodium chloride solution, 5% dextrose solution and 0.225% sodium chloride solution, 10% dextrose solution, 10% inverted sugar in water for injection, Ringer's solution, solution of sodium lactate, Hartmann solution, 5% ra Dextrose and hydrocortisone,heparin (10 U / ml and 50 U / ml) in a 0.9% solution of sodium chloride, potassium chloride (10 mEq / L and 40 mEq / L) in a 0.9% solution of sodium chloride.
    Pharmaceutically incompatible with aminoglycosides, sodium bicarbonate solution 2.74%.
    The drug has no effect on enzyme assays for glycosuria, or for creatinine, measured by the alkaline picrate method.
    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 is recommended to continue for 48-72 hours after the disappearance of symptoms, in the case of infections caused by Streptococcus pyogenes, it is recommended to continue treatment for at least 10 days.
    During treatment, a false positive Coombs reaction and a false positive urine reaction to glucose are possible.
    After dilution, it can be stored at room temperature for 7 hours, in the refrigerator for 48 hours. Yellow solution may be used during storage.
    During treatment can not be used ethanol.
    In patients receiving cefuroxime, when determining the level of glucose in the blood, it is recommended to use tests with glucose oxidase or hexokinase. Against the background of treatment of meningitis in children, hearing loss is possible.
    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 receiving cefuroxime inside there is no clinical improvement, it is necessary to continue parenteral administration.
    Caution should be exercised in appointing high doses of cephalosporins to patients receiving aminoglycosides or potent diuretics, since such combinations are likely to adversely affect kidney function.
    Effect on the ability to drive transp. cf. and fur:
    The drug does not affect the ability to drive vehicles and maintain machinery.
    Form release / dosage:
    Powder for solution for intravenous and intramuscular injection 1.5 g.
    Packaging:
    1.5 g of cefuroxime in flasks of colorless glass type I, sealed with rubber stoppers and rolled up with aluminum caps.
    For 1 bottle together with instructions for use cardboard pack.
    For 100 bottles (for hospitals), along with instructions for use in a cardboard pack.
    Storage conditions:Store in a dry, 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:LS-000023
    Date of registration:12.04.2010 / 29.12.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:Medocemi Co., Ltd.Medocemi Co., Ltd. Cyprus
    Manufacturer: & nbsp
    Representation: & nbspMEDOKEMI LTD. MEDOKEMI LTD. Cyprus
    Information update date: & nbsp03.07.2017
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