Active substanceOrnidazoleOrnidazole
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  • Dosage form: & nbspvaginal tablets
    Composition:

    Active substance: Ornidazole 500 mg;

    Excipients: calcium dihydrogen phosphate, lactose, citric acid anhydrous, polyvinylpyrrolidone, magnesium stearate, starch gelatinized, corn starch.

    Description:Oval with a pointed end biconvex tablets white or almost white.
    Pharmacotherapeutic group:Antiprotozoal agent
    ATX: & nbsp

    G.01.A.F.06   Ornidazole

    Pharmacodynamics:

    Antiprotozoal and antimicrobial drug, a derivative of 5-nitroimidazole. The mechanism of action is the biochemical reduction of the 5-nitro group of ornidazole by intracellular transport proteins of anaerobic microorganisms and protozoa. The reduced 5-nitro group of ornidazole reacts with the DNA of a cell of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria.

    Active with respect to Trichomonas vaginalis, Gardnerella vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia spp., as well as obligate anaerobes Bacteroides spp. (incl. Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Veillonela spp., Prevotella (P.bivia, P. buccae, P.disiens), and some Gram-positive microorganisms (Eubacterium spp., Clostridium Orniferous microorganisms are not sensitive to ornidazole.

    Pharmacokinetics:Penetrates into breast milk and most tissues, passes through the blood-encephalic barrier and the placenta. The connection with plasma proteins is less than 15%. Metabolized in the liver by hydroxylation, oxidation and glucuronation. It is excreted by the kidneys - 60-80% (20% of this quantity in unchanged form), intestine - 10-20%. The half-life is 12-14 hours.
    Indications:

    Urogenital trichomoniasis, nonspecific vaginitis of various etiologies, confirmed by clinical and microbiological data.

    Contraindications:

    Hypersensitivity to the drug components (including nitroimidazole derivatives), leukopenia, movement coordination disorders, organic CNS lesions (including epilepsy), hepatic insufficiency (in the case of high doses), pregnancy (I trimester), lactation period .

    Carefully:

    Pregnancy (II-III trimester), leukopenia in the anamnesis.

    Pregnancy and lactation:Contraindicated.
    Dosing and Administration:

    With trichomoniasis: adults 1.5 grams orally, once or 1.0 grams orally in combination with intravaginal administration of 500 mg per night.

    You can treat for 5 days, appointing 500 mg orally twice a day (morning and evening) also with the appointment of 1 vaginal tablet of 500 mg per night.

    After hygienic treatment of the vulva, after releasing the vaginal tablet from the package, it should be inserted deep into the vagina.

    Side effects:

    Headache, dizziness, impaired consciousness, tremor, stiffness, discoordination of movements, convulsions, sensory or mixed peripheral neuropathy, nausea, vomiting, diarrhea.

    Overdose:

    Symptoms: epileptiform cramps, depression, peripheral neuritis.

    Treatment: symptomatic (diazepam - with convulsions).

    Interaction:

    Enhances the effect of anticoagulants coumarinic series prolongs the miorelaksiruyuschee effect of vecuronium bromide. Compatible with alcohol (does not inhibit acetaldehyde dehydrogenase).

    Special instructions:

    During treatment, it is necessary to abstain from sexual intercourse. With vaginitis caused by Trichomonas vaginalis, it is recommended simultaneous treatment of sexual partners, treatment of the sexual partner is advisable to conduct ornidazole for oral administration.

    In case of application of the preparation together with ornidazole for oral administration, especially in the second course, control of the peripheral blood picture is necessary (danger of leukopenia).

    Form release / dosage:

    Vaginal tablets 500 mg.

    Packaging:

    3 tablets per blister made of polyvinylchloride film and aluminum foil.

    One blister, along with instructions for use, is placed in a cardboard box.

    Storage conditions:

    At a temperature not exceeding 30 ° C in a place inaccessible to children.

    Shelf life:

    2 years. Do not use the product after the date shown on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-000232
    Date of registration:04.08.2011 / 15.08.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:Abdi Ibrahim Ilyach Sanayi ve Tidzh A.Sh.Abdi Ibrahim Ilyach Sanayi ve Tidzh A.Sh. Turkey
    Manufacturer: & nbsp
    Representation: & nbspTRIFARMA division of the company Abdi Ibrahim Pharmaceutical TRIFARMA division of the company Abdi Ibrahim Pharmaceutical Turkey
    Information update date: & nbsp12.06.2017
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