Active substanceNimorazoleNimorazole
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  • Naxojin®
    pills inwards 
  • Dosage form: & nbsppills
    Composition:

    Each tablet contains:

    Active component: niromazole - 500 mg.

    Auxiliary components: microcrystalline cellulose -101.2 mg, corn starch - 40.0 mg, methylcellulose 400 - 2.8 mg, stearic acid - 6.0 mg.

    Description:Round, convex, white or slightly yellowish tablets with a fault line on one side.
    Pharmacotherapeutic group:Antiprotozoal agent
    ATX: & nbsp

    P.01.A.B   Nitroimidazole derivatives

    P.01.A.B.06   Nimorazole

    Pharmacodynamics:

    Naxojin® is a chemotherapeutic drug that is active against Trichomonas vaginalis g of other protozoa (including Giardia intestinalis and Entamoeba histolytica), as well as for anaerobic bacteria, namely Bacteroides fragilis and Gardnerella vaginalis.

    The minimum trichomonaside concentration ranges from 0.3 to 3 μg / ml.
    Pharmacokinetics:

    Nimorazole is well absorbed after oral administration. After three times taking the drug at a dose of 1 g every 12 hours, the concentration of nimorazole in the blood reaches 16 μg / ml 3 hours after the first dose, 28 μg / ml - to 25ohm h and 7.5 μg / ml after the last administration.

    Nimorazole is excreted from the body, mainly through the kidneys; The concentration of nimorazole and its active metabolites in urine and vaginal secretion is much higher than trichomonocidal concentrations.After a three-time intake of nimorazole in a dose of 1 g every 12 hours, the concentration of nimorazole in the vaginal secretion, measured at 24.48 and 72 hours, was 129 μg / g, 95 μg / g and 4 μg / g, respectively.

    Indications:Infections caused by Trichomonas vaginalis, lambliasis, amoebiasis, vaginitis caused by Gardnerella vaginalis, acute ulcerative-necrotic gingivitis (gingivitis of Vincent).
    Contraindications:

    Hypersensitivity to any component of the drug, severe diseases of the central nervous system and blood, severe renal and hepatic insufficiency, children's age (up to 3 years).

    Carefully:

    Acute neurological diseases.

    During treatment with Naxogine®, it is not recommended to drink alcoholic beverages (at least 48 hours after taking the drug).
    Pregnancy and lactation:The use of Naxojin® during pregnancy (especially in the first three months) and lactation should be avoided because of the possible manifestation of mutagenic properties.
    Dosing and Administration:

    Inside, after eating.

    Trichomoniasis:

    Treatment is carried out according to one of the schemes listed below:

    Adults:

    a) 2 g once after eating;

    b) 3 times 1 g every 12 hours;

    at) 250 mg three times a day for 5-7 days.

    Children:

    15 mg / kg / day, divided into three doses, for 5-7 days.

    Amebiasis:

    Adults:

    500 mg twice daily for 5-10 days;

    Children:

    20 mg / kg / day, divided into two doses, for 5-10 days.

    Lambliasis:

    Adults:

    500 mg twice daily for 5-7 days; -

    Children:

    15 mg / kg / day, divided into two doses, for 5-7 days.

    Infections caused by Gardnerella vaginalis:

    Adults:

    a) 500 mg twice a day, for 7 days;

    b) 2 g once.

    Acute ulcerative-necrotic gingivitis (gingivitis of Vincent):

    Adults:

    500 mg twice daily for 2 days.

    Side effects:

    Usually Naxojin® is well tolerated. Side effects are mild or moderate and do not require drug withdrawal. Possible side effects include: heartburn, nausea, sometimes vomiting (taking the drug after meals can minimize these effects), skin rash, dizziness, drowsiness, diarrhea, a "metallic" taste and dry mouth, tongue lagging, glossitis and stomatitis, transient moderately expressed leukopenia, dysuria and dark color of urine.

    Overdose:

    Symptoms: gastrointestinal discomfort (heartburn, nausea, vomiting, diarrhea), dizziness, neurologic symptoms (stupor, tingling, paresthesia and convulsions) are also possible.

    Treatment: gastric lavage and symptomatic treatment.

    Interaction:With simultaneous use with alcohol, niromazole can provoke disulfiram-like reactions. Nimorazole can enhance the anticoagulant effect of warfarin and reduce the clearance of phenytoin and lithium. Phenobarbital can reduce, and cimetidine - Increase plasma concentrations of nimorazole.
    Special instructions:

    Treatment of patients with acute neurologic diseases should be carried out under the strict supervision of a physician.

    When treating trichomoniasis in order to avoid reinfection, it is recommended to treat both sex partners simultaneously, even if one of them has no symptoms of the disease.

    Effect on the ability to drive transp. cf. and fur:In connection with the possibility of dizziness and other side effects associated with taking the drug, it is recommended to refrain from management car, other mechanisms and perform work that requires increased concentration of attention.
    Form release / dosage:Tablets 0.5 g.
    Packaging:For 6 tablets in a vial of dark glass; 1 bottle together with the application is placed in a cardboard box.
    Storage conditions:

    At a temperature not higher than 25 ° C in a place inaccessible to children.

    Shelf life:

    5 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N011956 / 01
    Date of registration:28.10.2011 / 11.03.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:Pfizer Italy Sr.L.Pfizer Italy Sr.L. Italy
    Manufacturer: & nbsp
    Representation: & nbspPfizer LtdPfizer LtdUSA
    Information update date: & nbsp23.05.2018
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