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

    1 the tablet contains:

    active substance: Ornidazole - 500 mg?

    Excipientslactose (sugar milk), magnesium stearate, silicon dioxide colloid (aerosil), microcrystalline cellulose, povidone (kollidon 30), sodium croscarmellose (impellose), talc, sodium lauryl sulfate,hypromellose (hydroxypropylmethylcellulose), polyethylene glycol 6000 (macrogol), titanium dioxide.

    Description:

    Tablets covered with a film coat of white or almost white color, biconvex, oblong with rounded ends, with a risk.

    On the cross section, the inner layer is white or almost white.

    Pharmacotherapeutic group:An antiprotozoal agent.
    ATX: & nbsp

    G.01.A.F.06   Ornidazole

    Pharmacodynamics:

    Ornidazole is active against Trichomonas vaginalis, Gardnerella vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia spp., some anaerobic microorganisms (Bacteroides spp., Fusobacterium spp., Clostridium spp. and anaerobic cocci).

    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 - at least 15 %. Penetrates through the blood-brain barrier. Half-life (T1/2) - about 13 hours. It is excreted as metabolites by the kidneys (60-65%) and with a caloric mass of 20-22%), about 5 % dose is displayed unchanged.

    Indications:
    Trichomoniasis; amebiasis, amoebic dysentery, extraintestinal amoebiasis (including amoebic liver abscess); giardiasis; prevention of postoperative infectious complications caused by anaerobic bacteria, with surgery on the colon and gynecological operations.

    Contraindications:

    Hypersensitivity, pregnancy (I trimester), lactation period, organic diseases of the central nervous system.

    Children under 3 years (for this dosage form).

    Pregnancy and lactation:Contraindicated.
    Dosing and Administration:

    Inside after eating.

    With trichomoniasis: adults -500 mg 2 times a day for 5 days.

    Children - in a single dose, at the rate of 25 mg / kg of body weight per day.

    With amoebic dysentery adults and children weighing over 35 kg - 1.5 grams once a day, with a body weight of more than 60 kg - 2 grams per day.

    Children with a body weight of less than 35 kg - 40 mg / kg / day. Duration of treatment - 3 days.

    For the treatment of other forms of amoebiasis: adults and children weighing more than 35 kg - 500 mg orally, twice a day in the morning and in the evening, with a weight of up to 35 kg - 25 mg / kg / day once for 5-10 days.

    With giardiasis: adults and children weighing over 35 kg - inside, 1.5 grams 1 time per day; Children with body weight up to 35 kg - 40 mg / kg / day. Duration of treatment is 1-2 days. Prevention of postoperative infectious complications caused by anaerobic bacteria - 500 mg before surgery, then every 12 hours for 500 mg, for 3-5 days.

    Side effects:

    Headache, dizziness, drowsiness, fatigue, impairment or temporary loss of consciousness, tremor, muscle stiffness,discoordination of movements, convulsions, sensory or mixed peripheral neuropathy, perversion of taste sensations, nausea, changes in the activity of "liver enzymes," allergic reactions, dyspeptic disorders.

    Overdose:

    Symptoms: epileptiform cramps, depression, peripheral neuritis.

    Treatment: symptomatic.

    Interaction:

    Strengthens the effect of anticoagulants of the coumarin series, prolongs the miorelaxing action 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 partners should be carried out.
    Form release / dosage:

    Tablets coated with a film coating of 500 mg.

    Packaging:

    For 3 or 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

    By 1,2, 3,4 or 5 contour mesh packages together with instructions for use in a pack of cardboard.
    Storage conditions:

    List B. In dry the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:

    2 of the year.

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

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-010222/08
    Date of registration:19.12.2008 / 11.09.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCRussia
    Information update date: & nbsp11.06.2017
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