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

    Each tablet contains:

    Active substance: nitroxoline - 50 mg.

    Excipients: corn starch, lactose, talc, calcium stearate.

    Sheath: hypromellose, propylene glycol, macrogol, talc, tropeolin 0, titanium dioxide.
    Description:

    The tablets covered with a cover, biconcave, round form, yellow or yellow with a greenish shade of color.

    Pharmacotherapeutic group:antimicrobial agent - oxyquinoline
    ATX: & nbsp

    J.01.X.X.07   Nitroxoline

    Pharmacodynamics:

    A broad-spectrum antimicrobial agent that includes most microorganisms that cause urinary tract infections.

    Nitroxoline selectively inhibits the synthesis of bacterial DNA and has an effect as on Gram-positive microorganisms: Streptococcus spp. (including beta-hemolytic streptococci, Streptococcus pneumoniae, Enterococcus faecalis), Corynebacterium diphtheriae, Bacillus subtilis; and on gram-negative microorganisms: E. coli, N.gonorrhoeae, Salmonella spp., Shigella spp., and Ureaplasma urealyticum, Mycoplasma hominis.

    Nitroxoline is also active in relation to Mycobacterium tuberculosis, Trichomonas vaginalis, some species of fungi (Candida spp., dermatophytes, molds, some pathogens of deep mycoses).

    Unstable sensitivity to nitroxoline have: Proteus spp., Staphylococcus spp.

    Resistant to nitroxoline: Pseudomonas spp., Providencia spp., Klebsiella spp., Enterobacter spp., Serratia spp., anaerobic bacteria.

    Pharmacokinetics:

    Absorption is high. It is excreted by the kidneys unchanged, with a high concentration in the urine (100 μg / ml and more).

    Indications:

    Acute, chronic and recurrent infectious-inflammatory diseases of the urogenital tract caused by pathogens sensitive to nitroxoline: pyelonephritis, cystitis, urethritis, epididymitis; infected adenoma or carcinoma of the prostate.

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

    Prevention of recurrent urinary tract infections.

    Contraindications:

    Children up to 3 years.

    Renal function disorders accompanied by oligo- or anuria (creatinine clearance below 20 ml / min.); severe hepatic impairment; cataract; deficiency of glucose-6-phosphate dehydrogenase; pregnancy, lactation.

    Hypersensitivity to nitroxoline or other quinoline preparations.

    Dosing and Administration:

    Inside. Nitroxoline should be taken before eating and washed down with a full glass of water.

    For adults The daily dose is 400-800 mg. Multiplicity of admission 3-4 times a day with an interval of 6-8 hours. The course of treatment is 2-3 weeks. The average dose is 400 mg per day. Take the drug for 100 mg (2 tablets, coated), 4 times daily before meals.

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

    Children from 3 to 5 years - 200 mg per day, divided into 4 doses. For children over 5 years the average daily dose is 200-400 mg (50-100 mg 4 times a day).

    To prevent infections in kidney and urinary tract surgery appoint 100 mg per reception 4 times a day for 2-3 weeks.

    Doses in renal failure: for patients with moderate renal failure (creatinine clearance above 20 ml / min), the usual dose should be divided in half (50 mg 4 times per day).

    Doses for liver failure: the usual dose should be divided in half (50 mg 4 times per day).

    Side effects:Sometimes nausea, vomiting, loss of appetite, very rarely skin allergic reactions are possible.
    In rare cases - tachycardia, ataxia, headache, paresthesia, polyneuropathy, liver dysfunction.
    With prolonged use, the case of the development of neuritis of the optic nerve is described.
    Interaction:

    Not marked.

    Special instructions:During treatment, the tongue, urine and feces can be painted in saffron-yellow color.
    Form release / dosage:Tablets, coated with a coating, 50 mg.
    Packaging:

    For 50 tablets in cans of polymer, 10 tablets in a planar cell package.

    Each jar or 1, 2 or 5 contour squares with instruction for use is placed in a cardboard package.

    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:

    2 years.

    Do not use after the expiration date indicated on the label.

    Terms of leave from pharmacies:On prescription
    Registration number:P N001588 / 01
    Date of registration:10.06.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspSYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products SYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products Russia
    Information update date: & nbsp04.12.2016
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