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

    Composition:
    A sterile, pyrogen-free vial containing the drug contains cefuroxime sodium in terms of cefuroxime 250 mg, 750 mg. Solvent: water for injection - 2ml, 6ml.

    Description:
    White or almost white powder. Slightly hygroscopic. Solvent: Clear, colorless, odorless liquid.

    Pharmacotherapeutic group:Antibiotic-cephalosporin.
    ATX: & nbsp

    J.01.D.C.02   Cefuroxime

    Pharmacodynamics:

    Cephalosporin antibiotic II generation for oral administration. It acts bactericidal (it breaks the synthesis of the bacterial cell wall). Has a wide spectrum of antimicrobial action. Highly active in vivo and in vitro in a relationship:

    gram positive microorganisms, including strains resistant to penicillins (with the exception of strains resistant to methicillin), Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes and others beta-hemolytic streptococci, Streptococcus pneumoni­ae, Streptococcus group B (Streptococcus agalactiae);

    Gram-negative microorganisms: Escherichia coli, Klebsiella spp, Proteus mirabilis, Providencia spp., Providencia rettgerri, Haemophilus influenzae, (including strains resistant to ampicillin), Haemophilus parainfluenzae, Moraxella catarrhalis, Neisseria gonorrhoeae, (including strains producing and not producing penicillinase);

    gram-positive and gram-negative anaerobes, including Peptococcus spp., Peptostreptococcus spp., Propionibacterium spp., most Clostridium spp., Bacteroides spp., Fusobacterium spp.

    other microorganisms: Borrelia burgdorferi

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

    Pharmacokinetics:
    Parenteral administration: after the / m administration of 750 mg, the maximum concentration (C max) is reached after 15-60 minutes and is 27 μg / ml. With the intravenous injection of 0.75 and 1.5 g of C max in 15 minutes is 50 and 100 μg / ml, respectively. The therapeutic concentration is 5, 3 and 8 hours, respectively.
    The half-life period (T1 / 2) for iv and in / m administration is -1.3-1.5 h, in newborns it is 2-2.5 h. 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 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:Bacterial infections caused by microorganisms susceptible to cefuroxime: infectious diseases of the respiratory tract (bronchitis, pneumonia, lung abscess, pleural empyema) of the ENT - organs (sinusitis, tonsillitis, pharyngitis, otitis), urinary tract (pyelonephritis, cystitis, symptomatic bacteriuria, gonorrhea) skin and soft tissues (erysipelas, pyoderma, impetigo, furunculosis, wound infection, erysipeloid), bones and joints (osteomyelitis, septic arthritis), pelvic organs (in obstetrics and gynecology), septicemia, meningitis, Lyme disease (bo relioz), prevention of infectious complications during thoracic operations organs, abdominal, pelvic, joint, (includingat operations on lungs, heart, an esophagus, in vascular surgery at a high degree of risk of infectious complications, at orthopedic operations).
    Contraindications:Hypersensitivity to cefuroxime (including to other cephalosporins, penicillins and carbapenems).
    Carefully:With caution, the drug is used in newborns and prematurity; during pregnancy and lactation; in weakened and depleted patients; with chronic renal failure, hemorrhages and gastrointestinal tract diseases (including in anamnesis, ulcerative colitis), with simultaneous application to loop diuretics and aminoglycosides.
    Pregnancy and lactation:There is no data on the development of embryotoxic or teratogenic effects of cefuroxime, but caution should be exercised when prescribing it during pregnancy. The application is possible if the potential benefit to the mother exceeds the potential risk to the fetus and the baby. Cefuroxime excreted in breast milk, so caution should be exercised when prescribing it to nursing mothers.
    Dosing and Administration:

    In / in and / m adults are prescribed 750 mg 3 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.

    With gonorrhea - in / m, 1500 mg, once (or as 2 injections of 750 mg with 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 surgeries 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.

    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 a day during the subsequent 24-48 ch.

    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. When pneumonia - in / m or / in, 1,500 mg 2-3 times a day for 48-72 h, then go to the inside, 500 mg 2 times 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. 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 up to 3 months. appoint 30 mg / kg / day in 2-3 hours.

    In chronic renal failure (CRF), correction of the dosing regimen is necessary: ​​with a CC of 10-20 ml / min, IV or IV is given 750 mg twice a day, with a CC less than 10 ml / min 750 mg once a day 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:

    Solution for the / m introduction:

    Add 1 ml of water for injection to 250 mg of cefuroxime. Add 3 ml of water for injection to 750 mg of cefuroxime. Gently shake until a slurry forms.

    Solution for intravenous administration: Dissolve:

    - 250 mg of cefuroxime in 2 ml of water for injection,

    - 750 mg of cefuroxime in 6 ml of water for injection,

    For short-term intravenous infusions (up to 30 min), 750 mg of the drug is dissolved in 25 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 (750 mg in 6 ml of water for injection) and metronidazole (25 mg / 50 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.

    A solution of cefuroxime (5 mg / ml) in 5% or 10% xylitol solution can be stored for up to 24 hours at a temperature below 25 ° C.

    Cefuroxime is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride. Cefuroxime compatible with the most widely used liquid for intravenous administration. The preparation is stable up to 24 h at room temperature when mixed with the following solutions:

    - 0.9% solution of sodium chloride;

    - 5% dextrose solution;

    - Ringer's solution;

    - Hartman solution.

    Axoxef® 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, Axoxef is 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.

    Axoxef® should not be mixed in the same syringe with antibiotics from the aminoglycoside group. A solution of sodium bicarbonate 2.74% has a pH value that significantly affects the color of the solution of Cefuroxime, so it is not recommended to use it for dilution. However, if a sodium bicarbonate solution is administered to the patient, then, if necessary, it 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, malignant exudative erythema, anaphylactic shock.

    From the digestive system: diarrhea or constipation, nausea, vomiting, flatulence, cramps and abdominal pain, ulceration of the oral mucosa, candidiasis of the oral cavity, glossitis, pseudomembranous colitis, 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 (decreased creatinine clearance, increased creatinine and residual urea nitrogen in the blood), dysuria, pruritus and vaginitis.

    On the part of the organs of hematopoiesis: a decrease in Hb and hematocrit, anemia (aplastic or hemolytic), eosinophilia, neutropenia, leukopenia, agranulocytosis, thrombocytopenia, hypoprothrombinemia, lengthening of thrombin time.

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

    From the side of the central nervous system: convulsions, dizziness.

    From the sense organs: hearing loss.

    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.
    Pharmaceutically compatible with metronidazole, azlocillin, xylitol, 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 % solution of dextrose and 0.9% solution of sodium chloride, 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 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.
    In patients receiving Axoxef®, glucose oxidase or hexokinase tests are recommended when determining blood glucose. Against the background of treatment of meningitis in children, hearing loss is possible.
    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 Axoxef® inside is not marked improvement, it is necessary to continue parenteral administration.
    Effect on the ability to drive transp. cf. and fur:
    During the treatment period, care should be taken when driving a car and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.
    Becausesometimes the use of cefuroxime is accompanied by a side effect such as dizziness, which can affect the ability to drive vehicles and work with complex mechanisms.
    Form release / dosage:
    Powder for the preparation of solution for intravenous and intramuscular injection of 250 mg or 750 mg.
    Packaging:
    Powder for the preparation of solution for intravenous and intramuscular injection. Preparation: the amount of the preparation containing 250 mg or 750 mg of cefuroxime into a sterile, pyrogen-free vial of colorless hydrolytic glass type III (Hearth.Pharm), sealed with a stopper of chlorobutyl rubber, crimped with an aluminum ring.
    Solvent: 2 ml or 6 ml of solvent in a colorless glass ampoule with an orange ring (for 2 ml) and with a green ring (for 6 ml) at a break of type I (Heb.).
    1 bottle with the drug and 1 ampoule with a solvent together with instructions for use in a cardboard pack.
    Storage conditions:In a dry, protected from light place at a temperature of no higher than 25 ° C. Keep out of the reach of children.
    Shelf life:The drug is 3 years old. Solvent - 5 years. Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-001214
    Date of registration:15.11.2011
    The owner of the registration certificate:Nobel Ilach Sanayi Ve Tidjaret A.Sh.Nobel Ilach Sanayi Ve Tidjaret A.Sh. Turkey
    Manufacturer: & nbsp
    Representation: & nbspNobel Ilach Sanayi Ve Tidjaret A.Sh.Nobel Ilach Sanayi Ve Tidjaret A.Sh.Russia
    Information update date: & nbsp26.11.2015
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