Active substanceCefuroximeCefuroxime
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  • Dosage form: & nbsp
    powder for solution for intravenous and intramuscular administration
    Composition:1 bottle contains an active substance - cefuroxime sodium, equivalent to 750 mg 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. The drug is highly active against the following microorganisms:

    Gram-positive bacteria, including strains resistant to penicillins (with the exception of strains resistant to methicillin): Staphylococcus aureus, Staphylococcus epidermidis; Streptococcus pyogenes (and other beta-hemolytic streptococci), Streptococcus pneumoniae, Streptococcus group B (Streptococcus agalactiae). Streptococcus mitis (groups viridans).

    Gram-negative bacteria: Bordetella pertussis, Escherichia coli, Haemophilus influenzae (including strains resistant to ampicillin), Haemophilus parainfluenzae(including strains resistant to ampicillin), Moraxella (Branhamella) catarrhalis, Klebsiella spp., Neisseria spp,, including N. gonorrhoeae (including strains producing and not producing penicillinase), Neisseria meningitidis, Proteus mirabilis, Providencia spp., Salmonella spp., including Salmonella typhi and Salmonella typhimurium, Borrelia burgdorferi.

    Anaerobic bacteria: Peptococcus spp., Peptostreptococcus spp., Fusobacteriuim spp., Propionibacterium spp., most Clostridium 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 pEnterococcus) faecalis, Morganella morganii, Proteus vulgaris, Enterobacter spp., Citrobacter spp., Serratia spp., Bacteroides fragilis.

    Pharmacokinetics:
    After intramuscular (IM) administration of 750 mg, the maximum plasma concentration is reached after 15-60 minutes and is 27 μg / ml. When intravenous (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 in both IV and / m introduction is 80 min, in newborns - 3-5 times longer, communication 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. At the same time, 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:Bacterial infections caused by susceptible to cefuroxime pathogens:
    - infections of the respiratory tract: bronchitis, pneumonia, lung abscess, empyema of the pleura.
    - infections of the LOP-organs: pharyngitis, sinusitis, tonsillitis, otitis media.
    - urinary tract infection: asymptomatic bacteriuria, cystitis, acute and chronic pyelonephritis.
    - skin and soft tissue infections: erysipelas, pyoderma, impetigo, furunculosis, phlegmon, infected wounds.
    - infection of bones and joints: septic arthritis, osteomyelitis.
    - infections of the pelvic organs: endometritis, adnexitis, cervicitis.
    - gonorrhea.
    - Other infections: peritonitis, sepsis and meningitis, Lyme disease (borreliosis). Preventive maintenance of infectious complications at operations on organs of a chest, an abdominal cavity, a basin, joints: incl. at operations on lungs, heart, an esophagus, in vascular surgery, at orthopedic operations.
    Contraindications:Hypersensitivity to cephalosporins, penicillins, carbapenems.
    Carefully:Newborn period, prematurity, chronic renal insufficiency, bleeding and gastrointestinal tract diseases (including history, ulcerative colitis), weakened and depleted patients, if necessary simultaneously with "loop" diuretics and aminoglycosides.
    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 in / m and / in.

    Adults: in / in and in / m 750 mg-1.5 g every 8 h. In severe or complicated infections - in / in 1.5 g every 8 h.If necessary, the interval between administrations may be reduced to 6 hours and the daily dose can be from 3 to 6 g. The course of treatment is usually from 5 to 10 days.

    For children: 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.

    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 that of an adult).

    With pneumonia - appoint 1.5 g IV or IM 2-3 times a day for 48-72 hours, and then go to the reception inside (use dosage forms for intravenous administration) of 500 mg twice a day for 7 -10 days. The duration of each period (parenteral therapy and oral administration) is determined by the severity of the infection and the general condition of the patient.

    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. The duration of each period (parenteral therapy and oral administration) is determined by the severity of the infection and the general condition of the patient.

    With bacterial meningitis - adults are assigned 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 given IV / IV at 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 powder is mixed in dry form with each polymer methyl methacrylate cement pack before adding the liquid monomer.

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

    - with the clearance of creatinine 10-20 ml / min is administered IV or IV 750 mg 2 times a day,

    - 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. Patients on hemodialysis at the end of each hemodialysis session should be administered an additional dose of 750 mg.

    Preparation of solutions for administration:

    The solutions are prepared in aseptic conditions.

    For intramuscular injection - in a bottle containing 750 mg, add 3 ml of water for injection and mix thoroughly.

    For intravenous administration - in a vial containing 750 mg, add 6 ml of water for injection and mix thoroughly.

    For intravenous infusion - 1.5 g of the drug is dissolved in 50 ml of water for injection and mixed thoroughly.

    Side effects:

    Cefuroxime, as a rule, is well tolerated by patients.

    Allergic reactions: rash, urticaria, skin itching, chills, whey, multiforme exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), drug fever, bronchospasm, anaphylactic shock.

    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 colitis, cholestasis.

    Co the side of the genitourinary system: impaired renal function (decreased creatinine clearance, increased creatinine and residual urea nitrogen in the blood), dysuria, pruritus, vaginitis.

    Co sides of hemopoiesis: reduction of hemoglobin and hematocrit, anemia (aplastic or hemolytic), eosinophilia, neutropenia, leukopenia, agranulocytosis, thrombocytopenia, hypoprothrombinemia, prolongation of prothrombin time.

    From the central nervous system: convulsions.

    Other: hearing loss.

    Laboratory Tests: transient increase in the activity of "hepatic" enzymes - aspartate aminotransferase (ACT), alanine aminotransferase (ALT), alkaline phosphatase, lactate dehydrogenase; bilirubin.

    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 use 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, Ringer's solution, sodium lactate solution, Hartmann solution, 5% solution of 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 glucosuria, 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.
    When treating patients, it is necessary to take into account the risk of developing pseudomembranous colitis. With the development of colitis, drug use should be discontinued and appropriate treatment initiated.
    Prolonged use of the drug may lead to the development of secondary superinfections caused by resistant microorganisms (for example, Enterobacter spp., Clostridium difficile).
    During treatment, a false positive Coombs reaction and a false positive urine reaction to glucose are possible.
    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:
    Sometimes the use of cefuroxime is accompanied by such a side effect as convulsions, care should be taken when driving vehicles and servicing moving mechanisms.
    Form release / dosage:
    Powder for the preparation of solution for intravenous and intramuscular administration 750 mg.
    Packaging:By 750 mg of cefuroxime in glass bottles of type I (EP), sealed with rubber stoppers and coated with aluminum caps. For 1 bottle together with instructions for use cardboard pack.
    For 100 bottles (for hospitals), together with an equal number of instructions for use in a cardboard box.
    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:П N012836 / 01
    Date of registration:16.04.2012
    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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