Active substanceCefuroximeCefuroxime
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  • Dosage form: & nbsppowder for solution for intravenous and intramuscular administration
    Composition:
    1 bottle contains:

    Active substance:

    cefuroxime sodium in terms of cefuroxime 750 mg or 1500 mg
    Description:White, white with a yellowish tint or pale yellow powder.
    Pharmacotherapeutic group:Antibiotic-cephalosporin.
    ATX: & nbsp

    J.01.D.C.02   Cefuroxime

    Pharmacodynamics:
    Cephalosporin antibiotic II generation for oral and 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), most of Clostridium spp .;
    Gram-negative microorganisms (Escherichia coli, Klebsiella spp., Proteus mirabilis, Providencia spp., including Providencia 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, Bordetella pertussis;
    Gram-positive (Peptococcus spp., Peptostreptococcus spp., Propionibacterium spp.) and Gram-negative anaerobes (Fusobacterium spp.).
    By 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:
    After intramuscular (intramuscular) administration of 750 mg, the maximum concentration (Cmax) is reached after 15-60 minutes, with intravenous (iv) after 15 minutes. The therapeutic concentration remains about 5 and 8 hours, respectively. 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). T1 / 2 with iv and / m introduction - an average of 1.5 hours, in newborns - 2-2.5 hours.
    Therapeutic concentrations are created in the pleural fluid, bile, sputum, myocardium, skin and soft tissues.Concentrations of cefuroxime exceeding the minimum inhibitory concentration for most microorganisms are 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 susceptible microorganisms:

    (respiratory tract, bronchitis, pneumonia, lung abscess, empyema of the pleura, etc.)

    - LOP-organs (including sinusitis, tonsillitis, pharyngitis, otitis media),

    - urinary tract (including pyelonephritis, cystitis, asymptomatic bacteriuria, gonorrhea),

    -skin and soft tissues (erysipelas, pyoderma, impetigo, furunculosis, phlegmon, wound infection, erysipeloid, etc.)

    -news and joints (osteomyelitis, septic arthritis, etc.),

    -organisms of the small pelvis (endometritis, adnexitis, cervicitis),

    -sepsis, meningitis, Lyme disease (borreliosis),

    -prophylaxis of infectious complications during operations on the organs of the chest, abdominal cavity, pelvis, joints (including operations on the lungs, heart, esophagus, vascular surgery with a high risk of infectious complications, and orthopedic operations).
    Contraindications:Hypersensitivity (including to others.cephalosporins, penicillins and carbapenems).
    Carefully:Newborn period, prematurity, chronic renal failure, bleeding and gastrointestinal diseases (including history, ulcerative colitis), weakened and emaciated patients, pregnancy, lactation.
    Pregnancy and lactation:
    If it is necessary to use the drug during pregnancy, it is necessary to correlate the benefits to the mother and the risk to the fetus, as the data on the development of embryotoxic or teratogenic effects of cefuroxime are absent.
    Cefuroxime excretes in breast milk, so caution should be exercised when prescribing it to nursing mothers, correlating the benefits to the mother and the risk to the infant.
    Dosing and Administration:
    In / m, in / in.
    In / in and / m adults are prescribed 750 mg every 8 hours; with infections of severe course - the dose is increased to 1500 mg every 6-8 hours. The average daily dose is 3-6 g. The average course of treatment is 5-10 days.

    With gonorrhea - in / m 1500 mg once (or in the form of 2 injections of 750 mg with the introduction of different

    region, for example, in both gluteal muscles).

    With bacterial meningitis - IV, 3 g every 8 hours.

    With infection of bones and joints-1500 mg every 8 hours.

    In surgeries on the abdominal cavity, pelvic organs and orthopedic operations - 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 hours.

    When pneumonia - in / m or / in the 1500 mg 2-3 times a day for 48-72 hours, then go to the inside, 500 mg 2 times a day for 7-10 days.

    With an exacerbation of chronic bronchitis, I / m or IV is prescribed 750 mg 2-3 times a day for 48-72 hours, then go to the inside, 500 mg twice a day for 5-10 days. In chronic renal failure, correction of the dosing regimen is necessary: ​​with QC more than 20 ml / min - appoint IV or IV 750-1500 mg every 8 hours, 10-20 ml / min given IV or IV 750 mg every 12 hours, with a CC less than 10 ml / min, 750 mg every 24 hours. Patients on continuous hemodialysis using an arteriovenous shunt or high-speed haemofiltration in intensive care units are prescribed 750 mg twice daily at the end of the session hemodialysis; for patients on low-velocity haemofiltration, doses recommended for renal impairment are prescribed.Children are prescribed 30-100 mg / kg / day in 3-4 divided doses. In most infections, the optimal dose is 60 mg / kg / day. In severe and life-threatening infections, doses of 100 mg / kg / day (but not exceeding the dose in adults) can be used. In the case of bacterial meningitis, high doses of 200-240 mg / kg / day IV are used, divided into equal doses, which are administered every 6-8 hours.

    With infection of bones and joints - 150 mg / kg / day, divided into equal doses, which are administered every 8 hours.

    If the renal function is impaired, the frequency of administration should correspond to the frequency of application of the drug in adults with concomitant renal failure. Newborns and children under 3 months are prescribed 30 mg / kg / day in 2-3 sessions; at bacterial meningitis - 100 mg / kg / day.

    Rules for the preparation of a solution for intravenous administration

    750 mg of the preparation is dissolved in 8.0 ml of water for injection to obtain a solution with a concentration of about 90 mg / ml. Enter slowly for 3-5 minutes.

    For short-term infusion (up to 30 min), 1500 mg of the drug are dissolved in 50 ml of water for injection, or in one of the compatible solvents: 5% dextrose (glucose) solution, 0.9% sodium chloride solution. The resulting solutions are injected directly into the vein or into the tube of the infusion system.

    For continuous infusion, the drug solution is diluted with one of the following solutions: water for injection, 5% dextrose (glucose) injection, 10% dextrose (glucose) injection, 0.9% sodium chloride solution, 5% dextrose (glucose) solution and 0.9% sodium chloride injection, 5 % solution of dextrose (glucose) and 0.45% solution of sodium chloride for injection, sodium lactate solution for injection.

    Rules for the preparation of a solution for the / m introduction

    750 mg of the drug is diluted in 3 ml of water for injection, gently shaken until a solution is obtained. The prepared solution is injected deep into the large gluteus muscle or into the anterior surface of the thigh

    Side effects:Allergic reactions: chills, rash, itching, urticaria, multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis, bronchospasm, interstitial nephritis, angioedema, anaphylactic shock.
    From the genitourinary system: itching in the perineum, vaginitis.
    From the central nervous system: convulsions.
    From the urinary system: increased creatinine and urea nitrogen in the plasma, decreased creatinine clearance.
    On the part of the digestive system: diarrhea, nausea, vomiting, cramps and abdominal pain, ulceration of the oral mucosa, candidiasis of the oral cavity, pseudomembranous colitis.
    From the senses: a decrease in hearing.
    On the part of the organs of hematopoiesis: a decrease in hemoglobin and hematocrit, eosinophilia, transient neutropenia, and leukopenia.
    Laboratory indicators: increased activity of "liver" enzymes, incl. Alkaline phosphatase, lactate dehydrogenase, hyperbilirubinemia, false positive Coombs test. Local reactions: irritation, infiltration and pain at the injection site, thrombophlebitis.
    Overdose:
    Symptoms: excitation of the central nervous system, convulsions.
    Treatment: the introduction 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 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. Cefroxime contains sodium, which should be taken into account when prescribing the drug to patients on a diet with a lower sodium content. After dilution, the solutions of the drug can be stored at room temperature for 24 hours, in the refrigerator for 48 hours (at a temperature of 5 ° C). It is allowed to use a yellow solution during storage.
    Effect on the ability to drive transp. cf. and fur:
    Powder for the preparation of solution for intravenous and intramuscular administration 750 mg, 1500 mg.
    Form release / dosage:
    Powder for the preparation of solution for intravenous and intramuscular administration of 750 mg and 1500 mg.
    Packaging:For 750 mg and 1500 mg of active ingredient in a vial of clear glass, sealed with a plug of chlorobutyl rubber, crimped aluminum ring; 1 bottle together with instructions for use in a cardboard box.
    By 10, 25, 48 or 100 bottles with an equal number of instructions for medical use in a cardboard box (for hospitals).
    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:
    3 years. Do not use after the expiration date indicated on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-007152/10
    Date of registration:26.07.2010
    The owner of the registration certificate:JODAS EKSPOIM, LLC JODAS EKSPOIM, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspJodas Expoim, Open CompanyJodas Expoim, Open Company
    Information update date: & nbsp27.11.2015
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