Active substanceOrnidazoleOrnidazole
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  • Dosage form: & nbspfilm-coated tablets
    Composition:

    Each tablet contains:

    Active substances: Ornidazole - 500.0 mg

    Excipients:starch, microcrystalline cellulose, sodium lauryl sulfate, povidone-K90, talc purified, magnesium stearate, silicon dioxide colloid,sodium carboxymethyl starch (type A), butyl methacrylate,

    dimethylaminoethyl methacrylate and methyl methacrylate copolymer [1: 2: 1] (Eudragit E 100), titanium dioxide, macrogol-6000.

    Description:

    Round, biconvex tablets, covered with a film shell of white or almost white color, having a risk on one side.

    View of the break: The core is white or almost white, surrounded by a white or almost white shell.

    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 in the biochemical reduction of 5-nitro ornidazole intracellular transport proteins of anaerobic bacteria and protozoa. The recovered 5-nitro ornidazole interacts with DNA microbial cells by inhibiting synthesis of nucleic acids, which leads to the death of the bacteria.

    Active with respect to Trichomonas vaginalis, Giardia lamblia, Entamoeba histolytica, as well as anaerobes Bacteroides spp. (incl. Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Clostridium spp. Orniferous microorganisms are not sensitive to ornidazole.

    Pharmacokinetics:

    Absorption from the gastrointestinal tract is high. Bioavailability is 90%.Time to reach the maximum concentration (TCmax) - 1-2 hours Link with plasma proteins - less than 15%. Metabolized in the liver by hydroxylation, oxidation and glucuronation. T1 / 2 - 12-14 hours Penetrates into breast milk and most tissues, passes through the blood-brain barrier and the placenta. The half-life (T1 / 2) is about 13 hours. It is excreted as metabolites by the kidneys (60-70%) and with the calves (20-25%), about 5% of the dose is excreted unchanged.

    Indications:

    Trichomoniasis, amoebiasis, amoebae dysenteryeamoebiasis (including afungal abscess liver); giardiasis; prevention of infections caused by anaerobic bacteria, in operations on the colon and in gynecology.

    Contraindications:

    Hypersensitivity. Children up to 3 years (for this dosage form).

    Carefully:

    Diseases of the central nervous system (including epilepsy, multiple sclerosis), liver disease, alcoholism, pregnancy, lactation.

    Dosing and Administration:

    Tablets are taken orally after eating.

    When trichomoniasis: adults - 1.5 g once or 1 g in combination with intravaginal injection of 500 mg (vaginal tablets) at night. You can treat for 5 days, appointing 500 mg orally 2 times a day (morning and evening), also with the appointment of 1 vaginal tablet of 500 mg per night.Children - in a single dose, at a rate of 25 mg / kg.

    With amoebic dysentery adults and children weighing over 35 kg - 1.5 g once a day, with a body weight of over 60 kg - 2 g / day. Children older than 3 years and with a body weight of less than 35 kg-40 mg / kg / day. Course - 3 days.

    For the treatment of other forms of amoebiasis: adults and children over 12 years - 0.5 g 2 times a day for 5-10 days. Children older than 3 years and weighing less than 35 kg - 25 mg / kg once for 5-10 days.

    With giardiasis: adults and children weighing over 35 kg - 1.5 g once a day; children over 3 years old and weighing less than 35 kg - 40 mg / kg / day. Duration of treatment is 1-2 days.

    Preventing infections caused by anaerobic bacteria - 0.5-1 g before surgery, after surgery - 0.5 g 2 times a day for 3-5 days.

    Side effects:

    Drowsiness, headache, dysfunction of the gastrointestinal tract (including nausea), dizziness, tremor, rigidity of muscles, impaired coordination of movements, convulsions, fatigue, temporary loss of consciousness, sensory or mixed peripheral neuropathy, perversion of taste sensations, increase activity of "liver" enzymes, allergic reactions.

    Overdose:

    Symptoms: convulsions, depression, peripheral neuritis.

    Treatment: symptomatic (diazepam - with convulsions).

    Interaction:

    Strengthens the effect of indirect anticoagulants coumarinic series, prolongs the miorelaksiruyuschee effect of vecuronium bromide. Compatible with ethanol (does not inhibit acetaldehyde dehydrogenase), unlike other imidazole derivatives (metronidazole).

    Special instructions:

    In the treatment of trichomoniasis, simultaneous treatment of both sex partners should be carried out.

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

    As ornidazole has a depressing effect on the central nervous system, it should not be used during the management of vehicles or other work that requires a clear coordination of movements.

    Form release / dosage:Tablets, film-coated, 0.5 g.
    Packaging:

    10 tablets per strip, made of aluminum foil. 1 strip with instructions by the application is placed in a cardboard box; 5 cardboard packs are placed in a cardboard box.

    Storage conditions:

    Store in a dry, dark place at a temperature of no higher than + 25 ° C.

    Keep out of the reach of children.

    Shelf life:3 years. Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:P N 015785/01
    Date of registration:25.05.2009
    Expiration Date:Unlimited
    The owner of the registration certificate:San Pharmaceutical Industries Co., Ltd.San Pharmaceutical Industries Co., Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspSAN PHARMACEUTICAL INDUSTRIES LTD. SAN PHARMACEUTICAL INDUSTRIES LTD. India
    Information update date: & nbsp17.03.2017
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