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

    For one tablet:

    Active substance:

    Nitroxoline

    - 50 mg

    Auxiliary substances of the core:

    lactose monohydrate (milk sugar)

    - 20 mg

    silicon dioxide colloid (aerosil)

    - 2 mg

    magnesium hydrosilicate (talc)

    - 0.5 mg

    calcium stearate monohydrate

    - 1 mg

    potato starch

    - 26.5 mg

    Shell accessories:

    sucrose (white sugar)

    - 83.71 mg

    povidone (low molecular weight polyvinylpyrrolidone)

    - 1.11 mg

    magnesium hydroxycarbonate (magnesium carbonate basic)

    - 10.151 mg

    silicon dioxide colloid (aerosil)

    - 0.39 mg

    magnesium hydrosilicate (talc)

    - 0.11 mg

    titanium dioxide (titanium dioxide)

    - 4.45 mg

    beeswax

    - 0.028 mg

    dye sunset yellow E 110

    - 0.034 mg

    paraffin wax (paraffin)

    - 0.017 mg

    Description:

    Round, biconvex tablets covered with an orange coating. Three layers are visible on the cross-section.

    Pharmacotherapeutic group:antimicrobial agent - oxyquinoline
    ATX: & nbsp

    J.01.X.X.07   Nitroxoline

    Pharmacodynamics:

    Antimicrobial agent from the group of oxyquinolines. Has a wide range of action.

    Nitroxoline selectively inhibits the synthesis of bacterial deoxyribonucleic acid (DNA), forms complexes with metal-containing enzymes of a microbial cell, causes a bacteriostatic effect.

    Active in a relationship a number of gram-positive bacteria - Staphylococcus spp. (incl. Staphylococcus aureus), Streptococcus spp. (in t.h. beta-hemolytic streptococci, Streptococcus pneumoniae, Enterococcus faecalis), Corynebacterium diphtheriae, Bacillus subtilis, Gram-negative bacteria - Escherichia coli, Proteus spp., Klebsiella spp., Salmonella spp., Shigella spp., Enterobacter spp., some other microorganisms - Mycobacterium tuberculosis, Trichomonas vaginalis and some species of mushrooms (Candida spp., dermatophytes, mold, some pathogens of deep mycoses).

    It is often effective in the resistance of microflora to other antibacterial agents.

    Pharmacokinetics:

    Quickly and well absorbed from the gastrointestinal tract. It is excreted by the kidneys unchanged, with high concentrations (100 μg / ml and more) created in the urine.

    Indications:

    Infectious-inflammatory diseases of the urinary tract caused by microorganisms sensitive to nitroxoline (incl.pyelonephritis (inflammation of the kidney and renal pelvis), cystitis (inflammation of the bladder), urethritis (inflammation of the urethra), prostatitis (inflammation of the prostate gland), epidemicgomit; infected adenoma or carcinoma of the prostate; prevention of infectious complications in diagnostic and therapeutic interventions (catheterization, cystoscopy, after kidney and urinary tract surgery).

    Contraindications:

    Hypersensitivity (including to other derivatives of 8-hydroxyquinoline).

    Nitroxoline is contraindicated in:

    - violations of kidney function, accompanied by oliguria, anuria;

    - diseases of the peripheral nervous system, as the risk of subacute myelooptic neuropathy increases;

    - with a deficiency of glucose-6-phosphate dehydrogenase due to the possibility of developing hemolytic anemia;

    - with severe renal insufficiency (creatinine clearance <20 ml / min) and with severe liver disease, tk. possible cumulation and toxic effects;

    - deficiency of lactase, lactose intolerance, glucose-galactose malabsorption;

    - deficiency of sugar / isomaltase, intolerance to fructose;

    - children under 3 years.

    Carefully:

    Carefully use nitroxoline in elderly people due to the probability of cumulation of the drug and toxic effects.

    Pregnancy and lactation:

    In connection with the lack of reliable information on the safety of nitroxoline is not recommended for pregnant and lactating women.

    Dosing and Administration:

    Inside, during meals or after meals.

    Adults - 100 mg 4 times a day, the maximum daily dose - 800 mg.

    Average dose for children from 3 to 5 years - 50 mg each, 5 years and over - 50-100 mg 4 times a day.

    The duration of treatment depends on the nature and severity of the disease.

    In most cases, the course of treatment is 2-3 weeks.

    Repeated courses (if necessary) are conducted with a 2-week break.

    With chronic recurrent processes, the course of treatment is several months.

    For the prevention of infections in kidney and urinary tract surgery - 100 mg 4 times a day for 2-3 weeks.

    Correction of dose with renal failure: for patients with moderate renal failure (creatinine clearance above 20 ml / min), the usual dose should be divided in half (1 tablet 4 times a day). In severe renal failure (creatinine clearance <20 ml / min), treatment with the drug is contraindicated.

    Correction of dose with hepatic insufficiency: the usual dose should be divided in half (1 tablet 4 times a day).

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

    Correction of dose in old age: the usual dose should be divided in half (1 tablet 4 times a day).

    Side effects:

    The drug is usually well tolerated.

    Nervous system: headache, dizziness, paresthesia, polyneuropathy. Perhaps the development of subacute myelooptic neuropathy (the so-called SMON-syndrome), which initially manifests with abdominal pain and diarrhea, and then develops severe peripheral polyneuritis and optic nerve atrophy. Sometimes it is combined with cerebral disorders: retardation, retrograde amnesia.

    Gastrointestinal tract: nausea, vomiting, loss of appetite, indigestion.

    Liver: increased activity of transaminases, liver dysfunction.

    Allergic reactions: a rash, itching, hives.

    The cardiovascular system: tachycardia.

    Overdose:

    The phenomenon of possible accumulation of the drug manifests itself in the form of nausea, vomiting, general weakness, which, usually, independently pass after drug withdrawal.

    In case of an overdose, dose-dependent side effects may be increased. In the event of any undesirable effects, it is necessary to temporarily suspend the use of the drug and urgently seek medical attention.

    Interaction:

    Nitroxoline should not be used concomitantly with preparations containing hydroxyquinolines or their derivatives.

    Special instructions:

    During treatment with nitroxoline, it is possible to stain the tongue, urine and feces in a yellow-red color.

    Care must be taken in patients with impaired renal function due to possible cumulation of the drug.

    With prolonged or repeated treatment with high doses of halogenated hydroxyquinoline, the cases of development of peripheral neuritis and damage to the optic nerve are described.

    Attention! Before using the drug Nitroxoline you should consult a doctor, as well as if the improvement does not occur within a few days or new symptoms appear.

    Strictly adhere to the regimen and treatment regimen during the entire course of therapy, do not skip the dose and take it at regular intervals. If a dose is missed, take it as soon as possible; not to accept,if it's almost time for the next dose; do not double the dose.

    Effect on the ability to drive transp. cf. and fur:

    Given the presence of side effects from the nervous system (headache, dizziness) during the period of treatment, care must be taken when driving vehicles and engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Tablets, coated with a coating, 50 mg.

    Packaging:

    10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil or paper with polyethylene coating.

    20, 50 tablets in a polymer can of BP type or in a can of orange glass of BTS type, sealed with a lid tightened with a sealing element.

    Each jar or 1, 2, 3 or 5 contour squares, together with the instruction for use, is placed in a pack of cardboard.

    Storage conditions:

    In 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:LS-001647
    Date of registration:12.07.2011 / 25.06.2014
    Expiration Date:Unlimited
    The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia
    Manufacturer: & nbsp
    Representation: & nbspBIOSINTEZ JSC BIOSINTEZ JSC Russia
    Information update date: & nbsp03.12.2016
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