Active substanceCefuroximeCefuroxime
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  • Dosage form: & nbsp
    Powder for the preparation of solution for intravenous and intramuscular injection.

    Composition:
    Cefuroxime sodium

    in terms of active substance cefuroxime - 250 mg and 750 mg.
    Description:Powder from white to yellow. Hygroscopic.
    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 (viridans group), Bordetella pertussis, most Clostridium spp.): Gram-negative microorganisms (Escherichia coli, Klebsiella spp ., Proteus mirabilis, Providencia spp., Proteus rettgeri, Haemophilus influenzae, including ampicillin resistant strains, Haemophilus parainfluenzae, including ampicillin resistant strains, 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.). Cefuroxime is 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 plasma concentration is reached after 15-60 minutes and is 27 μg / ml. With intravenous administration of 0.75 and 1.5 g of Cmax after 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 1.3-1.5 hours, in newborns it is 2-2.5 hours. The connection with blood plasma proteins is 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:Bacterial infections caused by sensitive microorganisms: diseases of the respiratory tract (bronchitis, pneumonia, abscess of the lungs, empyema of the pleura, 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, meningitis, Lyme disease (bo relioz), 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 (including to other cephalosporins, penicillins and carbapenems).
    Carefully:Newborn period, prematurity, chronic renal insufficiency, bleeding and gastrointestinal tract diseases (including history, ulcerative colitis), weakened and emaciated patients, pregnancy, lactation.
    Dosing and Administration:
    Intravenous and intramuscular. 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 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.

    In gonorrhea - intramuscularly, 1500 mg single dose (or in the form of two injections of 750 mg with administration in different areas, for example in both gluteal muscle).

    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 abdomen, pelvis and orthopedic surgery -vnutrivenno, 1500 mg for inducing anesthesia, then further - intramuscular injection, 750 mg.at 8 and 16 h after the operation.

    At operations on heart, lungs, an esophagus and vessels - intravenously. 1500 mg with the induction of anesthesia, then intramuscularly, 750 mg 3 times a day for the next 24-48 hours. For pneumonia, intramuscularly or intravenously, 1500 mg 2-3 times a day for 48-72 hours, then pass for oral administration, 500 mg twice a day for 7-10 days. If the exacerbation of chronic bronchitis is prescribed intramuscularly or intravenously, 750 mg 2-3 times a day for 48-72 hours, then switch to oral administration, 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 high-speed haemofiltration in intensive care units are prescribed 750 mg twice daily; 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;

    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 side of the central nervous system: convulsions.

    From the sense organs: hearing loss.

    From the hematopoiesis: reduction in hemoglobin and hematocrit, anemia (aplastic or hemolytic), eosinophilia, neutropenia, leukopenia, agranulocytosis, thrombocytopenia, hypoprothrombinemia, prolongation of prothrombin time. Local reactions: irritation, infiltration and pain at the injection site, phlebitis.

    Overdose:

    Symptoms: CNS excitation, 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% solution sodium chloride, 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 Hartman, 0.9% solution of sodium chloride, 5% dextrose and hydrocortisone, heparin (10 U / ml and 50 U / ml) in 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 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 reaction urine for glucose.
    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.
    Form release / dosage:Powder for the preparation of solution for intravenous and intramuscular injection 250 mg, 750 mg.
    Packaging:250 mg, 750 mg of the active substance in 10 ml vials.
    1 bottle with instructions for use in a pack of cardboard.
    10 bottles with instructions for use in a cardboard box.
    For hospitals:
    - 50 bottles with an equal number of instructions for use in a cardboard box;
    - from 1 to 50 bottles with an equal number of instructions for use in a cardboard box.
    Storage conditions:
    In the dark place at a temperature of no higher than 25 ° C.
    Keep out of the reach of children.
    After the expiry date of the drug, unused vials should be carefully opened, the contents dissolved in a large amount of water and drained into the drain.
    Shelf life:2 years. Do not use after expiry date.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-002529/07
    Date of registration:31.08.2007
    The owner of the registration certificate:KRASFARMA, JSC KRASFARMA, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp29.11.2015
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