Active substanceNitroxolineNitroxoline
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  • Dosage form: & nbspTwrappers covered with shell.
    Composition:

    1 tablet contains

    Active substance:

    nitroxoline - 50 mg.

    Excipients:

    Core: lactose monohydrate (sugar milk) - 0.022 g, potato starch - 0.021 g, silicon dioxide colloid (aerosil) 0.003 g, talc 0.003 g, calcium stearate 0.001 g to obtain tablet (without casing) 0.1 g.

    Sheath: sucrose (sugar) 0.07866 g, magnesium hydroxycarbonate 0.01717 g, povidone 0.00093 g, silicon dioxide colloid (aerosil) 0.00123 g, talc 0.00015 g, titanium dioxide 0.00127 g g, dye quinoline yellow - 0.00054 g, wax - 0.0005 g until a tablet with a mass (with a coating) of 0.2 g.

    Description:

    Round, biconcave tablet form, covered with a coat, yellow or yellow with a greenish tinge. On the cross-section, two layers are visible: the outer layer is colored yellow or green-yellow, the inner layer is yellow or gray-yellow, a light green shade is permissible.

    Pharmacotherapeutic group:antimicrobial agent - oxyquinoline
    ATX: & nbsp

    J.01.X.X.07   Nitroxoline

    Pharmacodynamics:

    Antimicrobial agent of a wide spectrum of action. Nitroxoline selectively inhibits the synthesis of bacterial deoxyribonucleic acid (DNA), forms complexes with metal-containing enzymes of the microbial cell.

    Has an effect on gram-positive microorganisms: Staphylococcus spp. (including Staphylococcus aureus)," Streptococcus spp. (including beta-hemolytic streptococci, Streptococcus pneumoniae, Enterococcus faecalis), Corynebacterium diphtheriae, Bacillus spp. (including Bacillus subtilis). Has an effect on gram-negative microorganisms: Neisseria gonorrhoeae, Escherichia coli, Proteus spp., Klebsiella spp., Salmonella spp., Shigella spp., Enterobacter spp.

    Nitroxoline is active against Mycobacterium tuberculosis, Trichomonas vaginalis.

    Nitroxoline is active against certain species of fungi (Candida spp., dermatophytes, molds, some pathogens of deep mycoses).

    Pharmacokinetics:

    After oral administration, it is highly absorbed from the gastrointestinal tract. It is excreted by the kidneys unchanged. There is a high concentration in the urine (100 mg / ml and more).

    Indications:

    Infectious and inflammatory diseases of mainly the urinary tract (including pyelonephritis, cystitis, urethritis, epididymitis, infected adenoma or carcinoma of the prostate gland) caused by micro-organisms sensitive to nitroxoline.

    Prevention of infectious complications in diagnostic and therapeutic manipulations (catheterization, cystoscopy) in the postoperative period with surgical interventions on the kidneys and urinary tract.

    Contraindications:

    Hypersensitivity to nitroxoline, to other components of the drug, to quinoline preparations.

    Cataract, neuritis, polyneuritis

    Chronic renal failure (oligo-, anuria).

    Liver failure.

    Deficiency of glucose-6-phosphate dehydrogenase.

    Congenital intolerance to galactose, intolerance to fructose, Lactose lactose deficiency, or glucose-galactose malabsorption syndrome or isohalase-isomaltase deficiency.

    Carefully:Carefully prescribe with renal failure (cumulation is possible).
    Pregnancy and lactation:

    Contraindicated taking the drug during pregnancy and lactation.

    Dosing and Administration:

    The drug is taken orally during or after a meal.

    For adults The daily dose is 400-800 mg. Multiplicity 3-4 times a day with an interval of 6-8 hours. The course of treatment is 2-3 weeks.

    The maximum daily dose is 800 mg.

    With chronic infections of the urinary tract the drug can be given again for 2 weeks with a 2-week break.

    Average daily dose for children from 3 to 5 years - 0.2 g per day, divided into 4 doses; over 5 years old - 0.2-0.4 g (by 0.05-0.1 g 4 times per day).

    To prevent infections in kidney and urinary tract surgery appoint 0.1 g per reception 4 times a day for 2-3 weeks.

    Side effects:

    Nausea, vomiting, loss of appetite, skin allergic reactions, tachycardia, ataxia, headache, paresthesia, polyneuropathy, liver dysfunction.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

    Overdose:

    Data on cases of overdose are absent.

    Interaction:

    With simultaneous administration with antacid agents containing magnesium, the action of nitroxoline decreases.

    The drug worsens the absorption of nalidixic acid.

    Special instructions:

    During treatment, urine is colored in saffron-yellow color.

    When administered orally at therapeutic doses, Nitroxoline-UBF does not affect the ability to drive and perform work that requires increased concentration.

    Form release / dosage:

    Tablets, coated with a coating, 50 mg.

    Packaging:

    10 tablets per contour cell packaging made of polyvinylchloride film and aluminum foil.

    By 25, 30, 40, 50, 60, 100 tablets in cans of polymeric.

    Each jar or 1, 2, 3, 5 contour squares, together with instructions for use, are placed in a cardboard pack.

    Storage conditions:

    In a dry, the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    4 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:P N002051 / 01
    Date of registration:05.12.2008 / 30.12.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:URALBIOFARM, OJSC URALBIOFARM, OJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspURALBIOFARM, OJSCURALBIOFARM, OJSCRussia
    Information update date: & nbsp03.12.2016
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