Active substanceCefuroximeCefuroxime
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  • Dosage form: & nbsp
    Film-coated tablets.

    Composition:

    one tablet, film-coated, contains active substance: cefuroxime axetil 300.72 mg and 601.44 mg in terms of cefuroxime 250 mg, 500 mg;


    Excipients: pregelatinized starch 62.50 mg and 125.00 mg, crospovidone 62.50 mg and 125.00 mg, croscarmellose sodium 10.00 mg and 20.00 mg, sodium lauryl sulfate 4.50 mg and 9.00 mg, magnesium stearate 8.50 mg and 17.00 mg, silicon dioxide colloidal 1.28 mg and 2.56 mg;

    film sheath: hypromelose 8.45 mg and 16.9 mg, titanium dioxide 3.49 mg and 6.98 mg, giprolose 0.06 mg and 0.12 mg.

    Description:
    White, film-coated, oblong flat-plate pills, with a risk on one side and a NOBEL inscription on the other.

    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:
    After oral administration of cefuroxime, the auxetil is absorbed in the intestine, hydrolyzed in its mucosa and enters the systemic bloodstream as cefuroxime, distributed in the extracellular fluid. The optimal level of absorption is noted when taken immediately after meals.The maximum concentration of cefuroxime in the blood plasma, about 4-6 mg / L for a dose of 250 mg and 5-8 mg / L for a dose of 500 mg, is observed approximately 2-3 hours after taking the drug. Therapeutic concentrations are recorded in the pleural fluid, bile, sputum, myocardium, skin and soft tissues. Concentrations of cefuroxime exceeding the MIC (minimum inhibitory concentration) for most microorganisms can be achieved in bone tissue, synovial and intraocular fluid. Passes through the placenta and penetrates into breast milk.
    The half-life (T1 / 2) is approximately 1.2 hours. If the kidney function is impaired, T1 / 2 is prolonged.
    The connection with plasma proteins is 33-50%.
    It is not metabolized in the liver.
    It is excreted by the kidneys through glomerular filtration and tubular secretion.
    Indications:
    Infectious-inflammatory diseases caused by microorganisms sensitive to cefuroxime:

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

    - lower respiratory tract (pneumonia, exacerbation of chronic bronchitis);

    - urinary system (pyelonephritis, cystitis and urethritis);

    - skin and soft tissues (furunculosis, pyoderma and impetigo);

    - gonorrhea (incl.acute uncomplicated gonococcal urethritis and cervicitis);

    - early manifestations of Lyme disease and the subsequent prevention of late manifestations of Lyme disease in adults and children over the age of 12 years.
    Contraindications:Hypersensitivity to cefuroxime or to any of the components of the drug (including cephalosporins, penicillins and carbapenems), children up to 3 years.
    Carefully:Chronic renal failure, bleeding and gastrointestinal diseases (including in history, ulcerative colitis), weakened and emaciated patients, pregnancy, lactation.
    Pregnancy and lactation:There are no experimental data on embryotoxic or teratogenic effects of cefuroxime, however, in pregnancy, it should be administered with caution, correlating the benefits to the mother and the risk to the fetus. Cefuroxime is excreted in breast milk, so during breast-feeding the drug is used with caution.
    Dosing and Administration:

    Inside, after eating. The standard course of therapy is from 5 to 10 days. Adults and children over 12 years of age:

    Most infections

    250 mg twice a day.

    Urinary tract infection, pyelonefrit

    250 mg twice a day.

    Infections of the respiratory tract of mild and moderate course

    250 mg twice a day.

    Severe respiratory tract infections (or suspected pneumonia)

    500 mg twice a day.

    Uncomplicated gonorrhea

    1 g once.

    Early manifestations of Lyme disease and subsequent prevention of late manifestations of Lyme disease in adults and children over the age of 12

    500 mg twice a day for 20 days.

    Children from 3 to 12 years:

    For most infections and infections of the lower respiratory tract of mild and moderate severity, the recommended dose is 125 mg twice a day (maximum daily dose of 250 mg). With average otitis media and more severe lower respiratory infections, the recommended dose is 250 mg twice daily (maximum daily dose of 500 mg).

    Side effects:

    The following side effects are classified by organs and systems and by frequency-appearance: very often (>1/10); often (>1/100 and <1/10); infrequently (>1/1000 and <1/100); rarely - (>1/10 000 and <1/1000); very rarely (<1/10 000).

    Other: often excessive growth Candida after long-term use.

    On the part of the blood and lymphatic system

    Often - eosinophilia.

    Infrequently - false positive Coombs test, thrombocytopenia, leukopenia.

    Very rarely - hemolytic anemia.

    Allergic reactions

    Hypersensitivity reactions, including: infrequently - skin rash; rarely - hives, itching; very rarely - drug fever, serum sickness, bronchospasm, anaphylactic shock, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

    From the nervous system

    Often - a headache, dizziness.

    From the digestive system

    Often - gastroenterological disorders, including diarrhea, nausea, abdominal pain.

    Infrequent - vomiting.

    Rarely, pseudomembranous colitis.

    From the hepatobiliary system

    Often - a transient increase in the activity of "hepatic" enzymes: alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase (ALT, ASAT, LDH).

    Very rarely - jaundice (mostly cholestatic), hepatitis.

    From the sense organs

    Rarely, hearing loss.

    From the genitourinary system

    Rarely, itching in the perineum, vaginitis.

    Overdose:
    Symptoms: excitation of the central nervous system, convulsions.
    Treatment: the appointment of anticonvulsant 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 cefurok-sima.
    When used simultaneously with aminoglycosides and diuretics, the risk of nephrotoxic effects increases.
    Drugs that reduce the acidity of gastric juice, reduce the absorption of cefuroxime and its bioavailability.
    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 case of infections caused by Streptococcus pyogenes, the course of treatment is not less than 10 days.
    During treatment, a false positive Coombs reaction and a false positive urine reaction to glucose are possible. In patients receiving cefuroxime, when determining the concentration of glucose in the blood, it is recommended to use tests with glucose oxidase or hexokinase.
    Effect on the ability to drive transp. cf. and fur:Since the drug may cause dizziness, the patient should be warned that it is necessary to operate the vehicles and work with the mechanisms with care.
    Form release / dosage:
    Tablets, film-coated 250 mg and 500 mg.


    Packaging:7 or 10 tablets in the film blister (PVC - thermoplastic - PVDC) and aluminum foil. 1 blister for 10 tablets or 2 blisters for 7 or 10 tablets together with instructions for use are placed in a cardboard box.
    Storage conditions:
    At a temperature of no higher than 25 ° C.
    Keep out of the reach of children.
    Shelf life:3 years. Do not use after expiry date.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-001198
    Date of registration:11.11.2011
    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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