Active substanceCefuroximeCefuroxime
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  • Dosage form: & nbsppowder for solution for intravenous administration
    Composition:
    1 bottle contains active substance - cefuroxime sodium, in terms of cefuroxime 1.5 g.
    Description:The powder is white or almost white with a yellowish tinge.
    Pharmacotherapeutic group:Antibiotic-cephalosporin
    ATX: & nbsp

    J.01.D.C.02   Cefuroxime

    Pharmacodynamics:

    Cephalosporin antibiotic II generation for parenteral use. 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), most of Clostridium spp .; Gram-negative microorganisms (Escherichia coli, Bordetella pertussis, Klebsiella spp., Proteus mirabilis, Providencia spp., Providencia 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 (Peptococcus spp., Peptostreptococcus spp.) and Gram-negative anaerobes (Fusobacterium spp., Proprionibacterium spp.).

    Cefuroxime is insensitive: Clostridium difficile, Pseudomonas spp., Campylobacter spp., Acinetobacter calcoaceticus, Listeria monocytogenes, methicillin-resistant strains of Staphylococcus aureus and Staphylococcus epidermidis, Legionella spp., Enterococcus faecialis, Morganella morganii, Proteus vulgaris, Enterobacter spp., Citrobacter spp ., Serratia spp., Bacteroides fragilis.

    Pharmacokinetics:Parenteral administration: with intravenous administration of 0.75 and 1.5 g, the maximum concentration 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 administration is 1.3-1.5 hours, for newborns it is 2-2.5 hours. The connection with plasma proteins is 33-50%. It is not metabolized in the liver. It is excreted 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 microorganisms can be achieved in bone tissue, synovial 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, abscess of the lungs, empyema of the pleura), LOP-organs (sinusitis, tonsillitis, pharyngitis, otitis), urinary tract (pyelonephritis, cystitis, asymptomatic bacteriuria), skin and soft tissue (rye, pyoderma, impetigo, furunculosis, phlegmon, wound infection, erysipeloid), bones and joints (osteomyelitis, septic arthritis), pelvic organs (endometritis, adnexitis, cervicitis), sepsis, meningitis, Lyme disease (borreliosis), gonorrhea; preventive maintenance of infectious complications at operations on bodies of a chest, an abdominal cavity, a small basin, joints (including at 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 others.cephalosporins, penicillins, carbapenems), chronic renal failure in children.
    Carefully:In newborns, including premature babies; during pregnancy and lactation; with chronic renal failure; in weakened and depleted patients; with bleeding and diseases of the gastrointestinal tract in the anamnesis, incl. with nonspecific ulcerative colitis.
    Dosing and Administration:

    Intravenously.

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

    Children up to 3 months old appoint 30 mg / kg / day 2-3 times a day.

    With bacterial meningitis - adults - 3 g every 8 hours; children younger and older - 150-250 mg / kg / day 3-4 times a day, the newborn - 100 mg / kg / day 2-3 times a day.

    At operations on heart, lungs, an esophagus, vessels, an abdominal cavity, organs of a small basin and at orthopedic operations - 1500 mg with the induction of anesthesia.When the joint is fully replaced, 1500 mg of the powder is dry mixed with each polymer methyl methacrylate cement pack before adding the liquid monomer.

    With pneumonia appoint 1500 mg 2-3 times a day.

    With an exacerbation of chronic bronchitis appoint 750 mg 2-3 times a day.

    In chronic renal failure correction of the dosing regimen is necessary; when creatinine is cleared, 10-20 ml / min is prescribed 750 mg twice a day, with creatinine clearance 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; for patients on low-speed haemofiltration, doses recommended for renal impairment are prescribed.

    Preparation of solution for injection:

    Solution for intravenous bolus administration: Dissolve 1.5 g of the drug in 15 ml of water for injection.

    Solution for intravenous infusion introduction:

    For intravenous infusions, 1.5 g of the drug is dissolved in 15 ml of water for injection, the resulting solution is added to 50-100 ml of a compatible infusion solution.

    When mixing a solution of cefuroxime (1.5 g in 15 ml of water for injection) and metronidazole (50 mg / 100 ml), both components remain active for up to 24 hours at 4 ° C or 6 hours at a temperature below 25 ° C.

    Cefuroxime is compatible with the most commonly used liquid for intravenous administration:

    - 0.9% solution of sodium chloride;

    - 5% solution of dextrose;

    - Ringer's solution;

    - Hartmann solution.

    Cefuroxime is compatible with solutions:

    - 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. Cefuroxime remains stable in a 0.9% solution of sodium chloride and in a 5% solution of dextrose in the presence of hydrocortisone sodium phosphate.

    Side effects:

    Allergic reactions: chills, rash, itching, urticaria, rarely - erythema multiforme (including Stevens-Johnson syndrome), bronchospasm, anaphylactic shock.

    Local reactions: phlebitis, thrombophlebitis.

    From the central nervous system: convulsions.

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

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

    From the sense organs: hearing loss.

    From the hematopoiesis: eosinophilia, leukopenia, neutropenia, thrombocytopenia, agranulocytosis, hemolytic anemia.

    Laboratory indicators: increased activity of "hepatic" enzymes, alkaline phosphatase, lactate dehydrogenase, hyperbilirubinemia.

    Overdose:

    Symptoms: CNS excitation, convulsions.

    Treatment: the appointment of anticonvulsant drugs, monitoring and maintenance of vital body functions, hemodialysis and peritoneal dialysis.

    Interaction:

    Simultaneous administration of "loop" diuretics slows tubular secretion, reduces renal clearance, increases plasma concentration, and increases the half-life of cefuroxime.

    Cefuroxime should not be mixed in the same syringe with antibiotics from the group of aminoglycosides.

    When used simultaneously with aminoglycosides and diuretics, the risk of nephrotoxic effects increases.

    Pharmaceutically incompatible with solutions of sodium bicarbonate 4% and 5%.

    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 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 possible 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.
    Form release / dosage:
    Powder for solution for intravenous administration 1.5 g.
    Packaging:

    1,5 g of active substance in bottles of transparent, colorless glass with a capacity of 10 ml, sealed with rubber stoppers, crimped with aluminum caps and covered with plastic caps. Each bottle is placed in a cardboard box with instructions for use.

    For 50 bottles, together with 5 instructions for use, they are placed in a box with dividing partitions made of cardboardboxed, (for hospitals). 10 boxes are placed in a box of cardboard box, (for hospitals).

    Storage conditions:List B. Store 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 the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-005423/10
    Date of registration:10.06.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:Laboratorios Atral SALaboratorios Atral SA Portugal
    Manufacturer: & nbsp
    Representation: & nbspESCO PHARMA, LLCESCO PHARMA, LLC
    Information update date: & nbsp06.09.2017
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