Active substanceCefuroximeCefuroxime
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  • Dosage form: & nbsp
    powder for solution for intravenous and intramuscular administration

    Composition:
    each vial contains:

    active substance: cefuroxime (in the form of cefuroxime sodium) - 0.75 g and 1.5 g.

    Description:Almost white or yellowish powder.
    Pharmacotherapeutic group:Antibiotic-cephalosporin.
    ATX: & nbsp

    J.01.D.C.02   Cefuroxime

    Pharmacodynamics:
    Cephalosporin 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, etc. beta-hemolytic streptococci, Streptococcus pneumoniae, Streptococcus group B (Streptococcus agalactiae), Streptococcus mitis (groups viridans), 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.).
    To cefurokeim are 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 administration of 750 mg, the maximum concentration (C max) in plasma is reached after 15-60 minutes and is 27 μg / ml. With intravenous administration of 0.75 and 1.5 grams of C max in 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 of the drug is 1.3 to 1.5 hours, in newborns it is 2 to 2.5 hours.
    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 concentration for most common 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.

    Indications:Infectious-inflammatory diseases caused by sensitive microorganisms: infections of the respiratory tract (bronchitis, pneumonia, lung abscess, pleural empyema, etc.), ENT 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, erysipelitis, etc.), bones and joints (osteomyelitis, septic arthritis, etc.), pelvic organs endometritis, adnexitis, cervicitis), sepsis, meningitis, bo ezn Lyme (Borrelia), prevention of infectious complications during thoracic operations organs, abdomen, pelvis, joints (includingat 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:period of newborns, prematurity, chronic renal failure, bleeding and gastrointestinal diseases (including ulcerative colitis in history), pregnancy and lactation, weakened and emaciated patients.
    Pregnancy and lactation:
    The use of the drug in pregnancy is possible only in those cases when the intended use for the mother exceeds the potential risk to the fetus.
    If you need to use cefuroxime during lactation, you should decide whether to stop breastfeeding.
    Dosing and Administration:
    Intravenous and intramuscular. Adults appoint 750 mg three times a day; for infections of severe course, the dose is increased to 1500 mg 3 to 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 to 100 mg / kg / day in 3 to 4 divided doses.For 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.

    In gonorrhea - intramuscularly, 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 bacterial meningitis - intravenously, 3 g every 8 hours; children younger and older - 150 - 250 mg / kg / day in 3-4 doses, newborns - 100 mg / kg / day.

    In operations on the abdominal cavity, pelvic organs and orthopedic operations - intravenously, 1500 mg with the induction of anesthesia, then additionally - intramuscularly 750 mg at 8 and 16 hours after the operation.

    In operations on the heart, lungs, esophagus and vessels - intravenously, 1500 mg with the induction of anesthesia, then - intramuscularly, 750 mg 3 times daily for the next 24 to 48 hours.

    When pneumonia - intramuscularly or intravenously, 1500 mg 2 - 3 times a day for 48-72 hours, then switch to oral administration, 500 mg twice a day for 7-10 days.

    When exacerbation of chronic bronchitis is prescribed intramuscularly or intravenously, 750 mg 2 to 3 times a day for 48-72 hours, then go to the inside, 500 mg twice a day for 5-10 days.

    When the joint is completely replaced, 1.5 g of the powder is dry mixed with each polymer-methacrylate cement polymer packet before adding the liquid monomer.

    In chronic renal failure, correction of the dosing regimen is necessary: ​​in the case of creatinine clearance (CC) 10-20 ml / min, 750 mg / day or 750 mg / day is prescribed intravenously, 750 mg / once 750 mg / kg per day.

    Patients on continuous hemodialysis using an arteriovenous shunt or on high-speed haemofiltration in intensive care units are prescribed 750 mg twice daily; for of patients on low-velocity haemofiltration, appoint doses recommended for renal dysfunction.

    Preparation of solution for injection:

    Solution for IM injections: add 3 ml of water for injection to 750 mg of the drug. Gently shake until a slurry forms. Cefuroxime is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride.

    Solution for intravenous injection: pDissolve 750 mg of the drug in 6 or more ml of water for injection, and 1.5 g in 15 or more ml of water for injection.

    For short-term intravenous infusions (up to 30 min): 1.5 g of the drug is dissolved in 50 ml of water for injection. 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, bronchospasm, malignant exudative erythema (Stevens-Johnson syndrome), anaphylactic shock.

    On the part of the organs of the gastrointestinal tract and the hepatobiliary system: diarrhea, nausea, vomiting or constipation, flatulence, cramps and abdominal pain, ulceration of the oral mucosa, candidiasis of the oral cavity, glossitis, pseudomembranous enterocolitis, impaired hepatic function (increased activity of "hepatic" enzymes in plasma aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase, bilirubin), cholestasis.

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

    From the central nervous system: convulsions.

    From the sense organs: hearing loss.

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

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

    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 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, sodium lactate solution, Hartman's solution, 0.9% sodium chloride solution, 5% dextrose solution 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%.
    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 the symptoms; In the case of infections caused by Streptococcus pyogenes, the course of treatment is at least 7-10 days.
    During treatment, a false positive Coombs reaction and a false positive urine reaction 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.
    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. When symptoms of pseudomembranous colitis appear, the drug should be discontinued.
    Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions, which is associated with a risk of side effects from the nervous system.
    Form release / dosage:
    Powder for the preparation of solution for intravenous and intramuscular injection 0.75 g and 1.5 g.


    Packaging:By 0,75 g or 1,5 g of powder in bottles of clear, colorless glass. Each bottle, along with instructions for medical use, is placed in a pack of cardboard.
    Storage conditions:Store in a 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 stated on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-000003
    Date of registration:02.03.2007
    The owner of the registration certificate:PROTEK-SVM, LLC PROTEK-SVM, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp29.11.2015
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