Active substanceCefuroximeCefuroxime
Similar drugsTo uncover
  • Aksetin®
    powder w / m in / in 
    Medocemi Co., Ltd.     Cyprus
  • Aksetin®
    powder w / m in / in 
    Medocemi Co., Ltd.     Cyprus
  • Axosafe®
    powdersolution w / m in / in 
  • Axosafe®
    pills inwards 
  • Antibioksim
    powder in / in 
    Laboratorios Atral SA     Portugal
  • ACCENOVER®
    powder w / m in / in 
  • Zinacef®
    powder w / m in / in 
  • Zinnat®
    granules inwards 
  • Zinnat®
    pills inwards 
  • Ksorim
    powder w / m in / in 
    Sandoz GmbH     Austria
  • Supero
    powdersolution w / m in / in 
    Layfarma SpA     Italy
  • Cetil Lupine
    pills inwards 
    Lupine Co., Ltd.     India
  • Cefroxime J
    powdersolution w / m in / in 
    JODAS EKSPOIM, LLC     Russia
  • Cefuabral®
    powdersolution w / m in / in 
    PREBAND PFC, LLC     Russia
  • Cefurozin®
    powdersolution w / m in / in 
    SPC ELFA, CJSC     Russia
  • Cefuroxime
    powdersolution w / m in / in 
    Company DEKO, LLC     Russia
  • Cefuroxime
    powdersolution w / m in / in 
    BIOSINTEZ, PAO     Russia
  • Cefuroxime
    powdersolution w / m in / in 
    KRASFARMA, JSC     Russia
  • Cefuroxime
    powdersolution w / m 
    KRASFARMA, JSC     Russia
  • Cefuroxime
    powdersolution w / m in / in 
    PROTEK-SVM, LLC     Russia
  • Cefuroxime
    powder w / m in / in 
    KRASFARMA, JSC     Russia
  • Cefurotek
    pills w / m in / in 
    M.Biotek Limited     United Kingdom
  • Cefurus®
    powdersolution w / m in / in 
    SYNTHESIS, OJSC     Russia
  • Dosage form: & nbspPowder for the preparation of solution for intravenous and intramuscular injection.
    Composition:
    Active substance: cefuroxime sodium (in terms of cefuroxime) - 0.75 g or 1.5 g

    Description:White or white with a yellowish tint powder.
    Pharmacotherapeutic group:Antibiotic-cephalosporin.
    ATX: & nbsp

    J.01.D.C.02   Cefuroxime

    Pharmacodynamics:
    Cefuroxime belongs to the second generation cephalosporin antibiotics.
    Cefuroxime is active against a wide range of pathogens, including strains producing β-lactamases.
    The bactericidal action of cefuroxime is associated with the suppression of bacterial cell wall synthesis.
    Cefuroxime is active in vitro against the following microorganisms:
    Gram-negative aerobics:
    Haemophilus influenzae (including ampicillin-resistant strains);
    Haemophilus parainfluenzae (including ampicillin-resistant strains);
    Moraxella catarrhalis;
    Escherichia coli;
    Klebsiella spp .;
    Proteus mirabilis;
    Providencia spp .;
    Providencia rettgeri;
    Neisseria gonorrhoeae (including penicillinase-producing and non-penicillinase-producing strains);
    Neisseria meningitidis;
    Salmonella spp .;
    Bordetella pertussis.
    Aerobics gram positive:

    Staphylococcus aureus, Staphylococcus epidermidis (including strains, sustainable to penalties- cillines and behind exclusion strains, resistant to methicillin);

    Streptococcus pneumoniae;

    Streptococcus pyogenes (and others β-hemolytic streptococci);

    Streptococcus groups AT (Streptococcus agalactiae);

    Streptococcus mitis (groups viridans).

    Anaerobes:

    Gram-positive and Gram-negative cocci (including Peptococcus and Peptostreptococcus species);

    Gram-positive bacilli (including species Clostridium spp.);

    gram-negative bacilli (including Bacteroides spp. and Fusobacterium spp.); Propionibacterium spp.

    Other microorganisms: Borrelia burgdorferi.

    The following microorganisms are not sensitive to cefuroxime:

    Clostridium difficile;

    Pseudomonas spp .;

    Campylobacter spp .;

    Acinetobacter calcoaceticus;

    Listeria monocytogenes;

    methicillin-resistant strains Staphylococcus aureus and Staphylococcus epidermidis,

    Legionella spp .;

    Enterococcus faecalis;

    Morganella morganii;

    Proteus vulgaris;

    Enterobacter spp .;

    Citrobacter spp .;

    Serratia spp .;

    Bacteroides fragilis.

    Pharmacokinetics:
    Parenteral administration: after intramuscular administration of 0.75 g, the maximum concentration (C max) 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 is maintained at 5.3 and 8 hours, respectively.
    The half-life (T1 / 2) for intravenous and intramuscular injection is 1.3-1.5 hours, in newborns it is 2-2.5 hours. The connection with plasma proteins is 33-50%.
    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 fluid and intraocular fluid. When meningitis penetrates the blood-brain barrier. Passes through the placenta and penetrates into breast milk. 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).
    Indications:
    Bacterial infections caused by microorganisms that are susceptible to cefuroxime:

    - diseases of the respiratory tract (bronchitis, pneumonia, abscess of the lungs, empyema of the pleura);

    - LOP-organs (sinusitis, tonsillitis, pharyngitis, otitis media);

    - urinary tract (pyelonephritis, cystitis, asymptomatic bacteriuria);

    - skin and soft tissues (erysipelas, pyoderma, impetigo, furunculosis, phlegmon, wound infection, erysipelitis);

    - bones and joints (osteomyelitis, septic arthritis);

    - small pelvis organs (endometritis, adnexitis, cervicitis);

    - sepsis;

    - meningitis;

    - gonorrhea;

    - Lyme disease (borreliosis);

    - prevention of infectious complications during thoracic operations organs, abdomen, pelvis, joints (including the operations in the lung, heart, esophagus, in vascular surgery at high risk of infectious complications, orthopedic surgery).
    Contraindications:Hypersensitivity to cefuroxime (including to other cephalosporins, penicillins and carbapenems).
    Carefully:Newborn period, prematurity, chronic renal failure, bleeding and gastrointestinal tract diseases (including history, ulcerative colitis), weakened and depleted patients, pregnancy, lactation, simultaneous use with aminoglycosides, loop diuretics.
    Pregnancy and lactation:
    The use of the drug during pregnancy and during breastfeeding is possible if the expected benefit for the mother exceeds the potential risk to the fetus and the baby.
    Dosing and Administration:

    Intramuscularly, intravenously.

    Intravenous and intramuscular adults appoint 0.75 g 3 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 betweenintroductions can be reduced to 6 hours). The average daily dose is 3-6 g.

    Children older than 3 months appoint 30-100 mg / kg / day in 3-4 injections. In most infections, the optimal dose is 60 mg / kg / day.

    Newborns and children under 3 months appoint 30 mg / kg / day in 2-3 introduction.

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

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

    For the prevention of postoperative complications:

    - at operations on heart, lungs, an esophagus and vessels - intravenously, 1.5 g for 0,5 - 1 hour before operation and on 0.7 g intravenously or intramuscularly every 8 hours at prolonged operations for the next 24 to 48 hours (for open heart operations, the total dose to 6 g);

    - with 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;

    -if a complete replacement of the joint - 1.5 g of the powder are mixed in dry form with each polymer methyl methacrylate cement packet before adding the liquid monomer.

    With pneumonia - intramuscularly or intravenously, 1.5 g 2-3 times a day for 48-72 hours, then switch to oral administration (use medicinal forms for ingestion) 0.5 g 2 times a day for 7-10 days.

    With an exacerbation of chronic bronchitis administered intramuscularly or intravenously, by 0.75 g 2-3 times a day for 48-72 h, then switch to ingestion (use dosage forms for oral administration) 0.5 g 2 times a day for 5-10 days.

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

    In chronic renal failure in children, the dosing regimen should be changed in accordance with the recommendations for adults.

    Patients on continuous hemodialysis using arteriovenousshunt or high-velocity haemofiltration in intensive care units, appoint 0.75 g 2 times a day; for patients on hemofiltration low speed, prescribe doses, recommended for violation of kidney function.

    Preparation of suspension for intramuscular administration:

    0.75 g (10 ml vial) is dissolved in 3 ml of water for injection.

    1.5 g (20 ml vial) is dissolved in 6 ml of water for injection.

    Gently shake until a slurry forms.

    Preparation of a solution for intravenous administration:

    0.75 g (10 ml vial) is dissolved in 9 ml of water for injection.

    1.5 g (20 ml vial) dissolve in 14 ml of water for injection.

    Solution for intravenous infusion.

    In the case of short-term intravenous infusions (eg, up to 30 min), 1.5 g is dissolved in 50 ml of water for injection. These solutions can be injected directly into a vein or dropper if the patient is given parenteral fluid.

    Side effects:

    Allergic reactions: chills, rash, itching, urticaria, multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (blue Dr Lyell), bronchospasm, drug fever, serum sickness, anaphylactic shock, cutaneous vasculitis.

    Local reactions: when administered intramuscularly - pain, irritation and infiltration at the injection site, with intravenous injection - phlebitis, thrombophlebitis.

    From the nervous system: convulsions.

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

    From the urinary system: impaired renal function (with increased creatinine and / or urea nitrogen and decreased creatinine clearance), dysuria, interstitial nephritis.

    From the digestive system: diarrhea, constipation, flatulence, glossitis, nausea, vomiting, cramps and abdominal pain, ulceration of the oral mucosa, candidiasis of the oral cavity, cholestasis, pseudomembranous colitis.

    FROMabout the sides of the hematopoiesis: eosinophilia, leukopenia, neutropenia, thrombocytopenia, agranulocytosis, hemolytic anemia, decreased hemoglobin and hematocrit, hypoprothrombinemia, prolonged prothrombin time.

    From the sense organs: hearing loss.

    Laboratory indicators: increased activity of "hepatic" enzymes (alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, alkaline phosphatase), hyperbilirubinemia, false-positive Coombs test.

    Overdose:
    Symptoms: excitation of the central nervous system, convulsions.

    Treatment: symptomatic, hemodialysis, 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.
    It is pharmaceutically compatible 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 , Hartman's 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, in elderly patients with a history of kidney disease, while using with aminoglycosides and loop diuretics.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 a test with glucose oxidase or hexokinase.
    Pseudomembranous colitis is observed with a wide range of antibiotics, the possibility of its occurrence should be borne in mind in patients with severe diarrhea that occurred during or after a course of antibiotic treatment.
    During treatment can not be used ethanol.
    Against the background of treatment of meningitis in children, hearing loss is possible.
    When switching from parenteral administration to ingestion, the severity of the infection, the sensitivity of the microorganisms and the general condition of the patient should be considered. If there is no clinical effect after 72 hours from the start of treatment, the parenteral course of therapy should be continued.
    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.
    Effect on the ability to drive transp. cf. and fur:During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.
    Form release / dosage:Powder for the preparation of solution for intravenous and intramuscular injection 0.75 g and 1.5 g.
    Packaging:
    0.75 g of active substance into bottles with a capacity of 10 ml, 1.5 g of active substance in bottles with a capacity of 20 ml, hermetically sealed with stoppers rubber, crimped caps aluminum or caps combined aluminum with plastic caps.
    1, 5 or 10 bottles with instructions for use are placed in a pack of cardboard.
    50 bottles with 5 instructions for use are placed in a carton box for delivery to hospitals.
    Storage conditions: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 expiry date.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-001160
    Date of registration:30.06.2011
    The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp27.11.2015
    Illustrated instructions
      Instructions
      Up