Active substanceCefuroximeCefuroxime
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  • Dosage form: & nbspPowder for the preparation of solution for intravenous and intramuscular injection.
    Composition:
    Cefuroxime sodium in terms of cefuroxime 0.75 g or 1.5 g.

    Description:
    White or white with a yellowish tinge powder, hygroscopic.

    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 (and others beta-hemolytic streptococci), Streptococcus pneumoniae, Streptococcus group B (Streptococcus agalactiae), Streptococcus mitis (viridans group), Bordetella pertussis, majority. 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.).
    By cefuroxime 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:Parenteral administration: after intramuscular administration of 750 mg, the maximum concentration (Cmax) is reached after 15-60 minutes and is 27 μg / ml. When administered intravenously, 0.75 and 1.5 g 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 period (T1 / 2) with IV and IM injection is 1.3-1.5 hours, in newborns 2-2.5 hours. The connection 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 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 (MIC) for most microorganisms can be achieved in bone tissue, synovial and intraocular fluid. When meningitis penetrates the blood-brain barrier (BBB). Passes through the placenta and penetrates into breast milk.
    Indications:Infectious and inflammatory diseases caused by susceptible organisms: respiratory infections (bronchitis, pneumonia, lung abscess, empyema, etc.), LOP-bodies (sinusitis, tonsillitis, pharyngitis, otitis media, and others.), Urinary tract infection (pyelonephritis, cystitis, asymptomatic bacteriuria, gonorrhea, etc..), skin and soft tissues (erysipelas, pyoderma, impetigo, furunculosis, cellulitis, wound infection, pseudoerysipelas et al.), bones and joints (osteomyelitis, septic arthritis, and others.), pelvic organs ( endometritis, adnexitis, cervicitis), sepsis, meningitis, bol zn Lyme (Borrelia); 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:In newborns, premature babies; during pregnancy and lactation; with chronic renal failure (CRF); in weakened and depleted patients; with bleeding and diseases of the gastrointestinal tract in the anamnesis, incl. with nonspecific ulcerative colitis.
    Dosing and Administration:
    In / in and / m adults are prescribed 750 mg 3 times a day; for 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 divided 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.

    With gonorrhea - in / m, 1500 mg (in the form of 2 injections of 750 mg with the introduction into different areas, for example, in both gluteal muscles).

    With bacterial meningitis - IV, 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 in orthopedic operations - IV, 1500 mg with the induction of anesthesia, then additionally - in / m, 750 mg, 8 and 16 hours after the operation.When the joint is completely replaced, 1500 mg of the powder is mixed dry with each polymer-methacrylate cement polymer packet before adding the liquid monomer.

    At operations on heart, lungs, an esophagus and vessels - in / in, 1500 mg at an induction of anesthesia, then - in / m, on 750 mg 3 times day for the next 24-48 hours. At a pneumonia - in / in, on 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 in / m or / in, 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 CRF requires correction mode: the creatinine clearance (CC) of 10-20 ml / min administered in / in or / m to 750 mg 2 times a day, with CC than 10 ml / min - 750 mg 1 time 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.

    Preparation of solution for injection:

    for IM injections:

    Add 3 ml of water for injection to 750 mg of cefuroxime. Gently shake until a slurry forms.With the / m introduction cefuroxime is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride. Cefuroxime in a dose of 1500 mg is only for IV administration.

    Solution for intravenous administration

    Dissolve

    - 750 mg cefuroxime in 6 ml or more water for injection, -1.5 g cefuroxime in 15 ml or more 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.

    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 a temperature of 4 ° C or up to 6 hours at a temperature below 25 ° C FROM.

    Cefuroxime is compatible with the most commonly used liquid for intravenous administration. The preparation is stable up to 24 hours at room temperature when mixed with the following solutions:

    - 0.9% solution of sodium chloride; -5% solution of dextrose;

    - Ringer's solution;

    - Hartman solution.

    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.

    With the following solutions cefuroxime compatible for 24 hours at room temperature:

    - 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 Do not mix in one syringe with antibiotics from the aminoglycoside group.

    A solution of sodium hydrogencarbonate 2.74% has a pH that significantly affects the color of the solution of cefuroxime, so it is not recommended to use it for dilution. If necessary, the solution of sodium hydrogen carbonate can be injected directly into the tube of the infusion system.

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

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

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

    From the central nervous system (CNS): convulsions.

    On the part of the urinary system: a violation of kidney function, dysuria.

    From the digestive system: diarrhea, nausea, vomiting, spasms and abdominal pain,

    ulceration of the oral mucosa, candidiasis of the oral cavity, rarely - pseudomembranous enterocolitis.

    From the senses: a decrease in hearing.

    From the hemopoiesis: hemolytic anemia.

    Laboratory indicators: increased activity of "hepatic" enzymes, alkaline phosphatase, lactate dehydrogenase, hyperbilirubinemia.
    Overdose:
    Symptoms: CNS excitement, convulsions.

    Treatment: the appointment of antiepileptic drugs, 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 T1 / 2 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. 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. 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 of 0.75 grams, 1.5 grams.
    Packaging:
    Powder for the preparation of a solution for intravenous and intramuscular injection of 0.75 g, 1.5 g of active substance in 10 ml and 20 ml glass vials, hermetically sealed with stoppers, crimped with aluminum caps or crimped with aluminum caps combined.
    1. Vials with a preparation of 10, 14, 25, 50 pieces are placed in boxes with an application of 3 to 5 instructions for the use of the drug (for hospitals).
    2.1 The vial of the preparation and the instruction for use is placed in a pack of cardboard.
    3. 1 bottle with 0.75 g of the preparation and 2 ampoules with a solvent, or I vial with 1.5 g of preparation and 3 ampoules with a solvent, are packed in a contour mesh box made of a polyvinylchloride film and aluminum foil, or without foil.
    One outline package with an application instruction and a knife with an ampoule or scarifier ampoule is placed in a pack of cardboard.
    Solvent
    - "Water for injection" of 5 ml in glass ampoules.
    4. 1 bottle with 0.75 g of preparation and 2 ampoules with a solvent or 1 bottle with 1.5 g of preparation and 3 ampoules with a solvent and with application instructions for use and with a vial ampoule or ampoule scapegrip placed in a pack of cardboard.
    Solvent
    - "Water for injection" of 5 ml in glass ampoules.
    Storage conditions:List B. In a dry, the dark place at a temperature of no higher than 25 ° C. In a place inaccessible to children.
    Shelf life:
    3 years.
    Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-009307/08
    Date of registration:24.11.2008
    The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp29.11.2015
    Illustrated instructions
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