Nitroxoline (Nitroxoline)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceNitroxolineNitroxoline
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    • Dosage form: & nbspTwrappers covered with shell.
    Composition:

    1 tablet, coated, contains:

    Active substance: nitroxoline - 50 mg.

    Excipients: lactose monohydrate 23 mg, potato starch 21 mg, silicon dioxide colloid (aerosil) 3 mg, talc 2 mg, calcium stearate 1 mg.

    Shell accessories: sucrose - 67.158 mg, magnesium carbonate basic - 29.681 mg, povidone (low molecular weight polyvinylpyrrolidone, plastidone K-17) 0.174 mg, silicon dioxide colloid (aerosil) 1.826 mg, talc 0.037 mg, titanium dioxide 0.761 mg, orange orange (sunset yellow, orange-yellow S) E 110 - 0.289 mg, beeswax - 0.074 mg.

    Description:

    The tablets covered with a cover, from orange to brownish-orange color, round, biconcave form. Marble is allowed. Three layers are visible on the cross-section.

    Pharmacotherapeutic group:antimicrobial agent - oxyquinoline
    ATX: & nbsp

    J.01.X.X.07   Nitroxoline

    Pharmacodynamics:

    Nitroxoline selectively inhibits the synthesis of bacterial DNA and has an effect on both gram-positive microorganisms: Staphylococcus spp. (incl. S. aureus), Streptococcus spp. (including beta-hemolytic streptococci, Streptococcus pneumoniae, Enterococcus faecalis), Corynebacterium diphtheria, Bacillus subtilis; and on gram-negative microorganisms: N.gonorrhoeae, E.coli, Proteus spp., Klebsiella spp., Salmonella spp., Shigella spp., Enterobacter spp.

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

    Pharmacokinetics:

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

    Indications:

    Infectious and inflammatory diseases mainly of the genitourinary tract (including pyelonephritis, cystitis, urethritis, epididymitis, infected adenoma or carcinoma of the prostate, etc.) 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 kidney and urinary tract.

    Contraindications:

    - Hypersensitivity to nitroxoline or other components of the drug,

    - hypersensitivity to quinoline drugs,

    - cataract,

    - severe renal failure (creatinine clearance below 20 ml / min),

    - severe hepatic impairment,

    - neuritis, polyneuritis,

    - pregnancy and lactation,

    - deficiency of glucose-6-phosphate dehydrogenase,

    - lactose intolerance, fructose, lactase deficiency, sucrose / isomaltase, glucose-galactose malabsorption,

    - Children under 3 years old (for this dosage form).

    Dosing and Administration:

    Inside, during or after a meal, 0.1 g (2 tablets) 4 times a day, for 2-3 weeks.

    If necessary, the reception can be continued by an intermittent schedule - 2 weeks per month.

    The maximum daily dose is 0.8 g (16 tablets).

    Average dose for school-age children is 0.2-0.4 g / day (4-8 tablets).

    Children from 3 to 5 years old prescribe a dose of 0.2 g / day (4 tablets), divided into 4 doses.

    For the prevention of infections in kidney and urinary tract surgery - 0.1 g (2 tablets) 4 times a day for 2-3 weeks.

    Side effects:

    From the digestive system: nausea, vomiting (can be prevented by taking the drug while eating).

    Allergic reactions: skin rash.

    Other: tachycardia, ataxia, headache, paresthesia, polyneuropathy.

    Laboratory indicators: thrombocytopenia, increased levels of "liver" transaminases and uric acid in the serum.

    Overdose:

    Increased severity of side effects.

    Recommendations: discontinue use of the drug, consult a doctor.

    Interaction:

    Nitroxoline should not be administered simultaneously with drugs containing hydroxyquinolines and their derivatives.

    Special instructions:

    In patients with impaired renal function, cumulation of the drug may occur, so they should take the drug under the supervision of a doctor.

    Do not prescribe courses of treatment for more than 4 weeks without additional examination of the liver and kidney function.

    Against the background of treatment with nitroxoline, urine is colored in an intense yellow-red color.

    Effect on the ability to drive transp. cf. and fur:Data on the effect of the drug on the ability to drive a car or machinery there.
    Form release / dosage:

    Tablets, coated with a coating, 50 mg.

    Packaging:

    10 tablets per contour cell pack.

    1, 2, 3, 4 or 5 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

    Storage conditions:

    AT protected from light, 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 expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-009313/08
    Date of registration:25.11.2008 / 29.05.2014
    Expiration Date:Unlimited
    The owner of the registration certificate:TATHIMFARMPREPARATY, JSC TATHIMFARMPREPARATY, JSC Russia
    Manufacturer: & nbsp
    Representation: & nbspTATHIMFARM PREPARATIONS OJSC TATHIMFARM PREPARATIONS OJSC Russia
    Information update date: & nbsp03.12.2016
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