Tinidazole-Acry® (Tinidazol-Akri®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTinidazoleTinidazole
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    AKRIKHIN HFK, JSC     Russia
    • Dosage form: & nbspfilm coated tablets
    Composition:
    active substance: tinidazrl - 500 mg
    auxiliary substances: pregelatinized starch, sorbitol, potato starch, talc, stearic acid.
    shell composition: hypromellose (hydroxypropylmethyl cellulose), Macrogol (polyethylene glycol 6000), glycerol (glycerine), - titanium dioxide, talc

    Description:
    The tablets covered with a film cover, white or white with a cream or grayish shade of color, round, biconcave. At the break of the tablet white with a yellowish or yellowish-greenish tint of color.

    Pharmacotherapeutic group:antimicrobial and antiprotozoal agent
    ATX: & nbsp

    P.01.A.B.02   Tinidazole

    P.01.A.B   Nitroimidazole derivatives

    Pharmacodynamics:
    Antiprotozoal preparation with antimicrobial action. It is active against Trichomonas vaginalis, Entamoeba histolytica, Lamblia. It has bactericidal activity against anaerobic microorganisms following: Bacteroides spp, (including B. fragilis, B. melaninogenicus), Clostridium spp, Eubacterium spp, Fusobacterium spp, Peptococcus spp, Peptostreptococc.us spip,...... Veillonella spp. The mechanism of action is due to the inhibition of synthesis and damage to the DNA structure of pathogens.

    Pharmacokinetics:
    Absorption is high, bioavailability is about 100%. Connection with plasma proteins - 12%. The maximum concentration in blood plasma is achieved after oral administration of 2 g - 40-51 μg / ml, after 24 hours - 11-19 μg / ml, after 72 hours - 1 μg / ml; The maximum concentration is achieved after 2 hours. The volume of distribution is 50 liters. Penetrates through the blood-brain barrier, the placenta. It is excreted in breast milk for 72 hours after ingestion. It is metabolized in the liver with the formation of pharmacologically active hydroxylated derivatives, which suppress the growth of anaerobic microorganisms and can enhance the action of tinidazole. The half-life is 12-14 hours. It is excreted with bile - 50%, kidneys - 25% (unchanged) and 12% (in the form of metabolites) due to reverse absorption in the renal tubules.

    Indications:
    trichomoniasis (colpitis, endometritis, ovarian and tubovarial abscesses); -lambliasis;
    amoebiasis (including intestinal and hepatic forms);
    infections caused by anaerobic bargorfia (with pneumonia, pleural empyema, lung abscess, skin and soft tissue infection, with acute ulcerative gingivitis);
    mixed aerobic-anaerobic infections (in combination with antibiotics);
    eradication of Helicobacter pylori (in combination with bismuth preparations and antibiotics).The drug is used to prevent postoperative infectious complications caused by anaerobes.

    Contraindications:
    Hypersensitivity to the drug or other derivatives of 5-nitroimidazole, organic diseases of the central nervous system, hematopoiesis, I trimester of pregnancy, lactation period, children's age (up to 12 years).

    Pregnancy and lactation:
    The drug is contraindicated in the first trimester of pregnancy. Use in the II and III trimesters is only possible if the intended benefit to the mother exceeds the potential risk to the fetus.
    If necessary, the application of drugs to the lactation period should be resolved-the question of stopping breastfeeding. It should be borne in mind that tinidazole is determined in breast milk for 72 hours after ingestion.

    Dosing and Administration:
    Tablets are taken orally during or after a meal.
    With trichomoniasis and giardiasis, the drug is prescribed once for adults, 2 g / day; children at the rate of 50-75 mg / kg of body weight per day. If necessary, the preparation can be repeated in the same dose. .
    With intestinal amebiasis, the daily dose for adults is 2 g, the drug takes 2-3 days. Children tinidazole appoint at the rate of 50-60 mg / kg / day; course of treatment - 3 days. In hepatic amebiasis, adults are prescribed the drug at an initial dose of 1.5-2 g / day. The course of treatment is 3 days, if necessary, the duration of therapy can be increased to 6 days. The course dose depending on the severity of infection is 4.5-12 g. Children tinidazole prescribe in doses at the rate of 50-60 mg / kg / day; duration of therapy - 5 days.
    In the treatment of infections caused by anaerobes, adults on the first day of treatment are prescribed 2 g / day in 1 dose, then 1 g / day. Treatment continues for 5-6 days. ~
    For occupational diseases of postoperative complications, adults are prescribed 2 g once every 12 hours before surgery.
    The safety and effectiveness of the drug for the treatment and prevention of anaerobic infections in children younger than 12 years have not been established.

    Side effects:
    From the gastrointestinal tract: possible anorexia, dryness and unpleasant taste in the mouth, nausea, vomiting, diarrhea.
    From the side of the central nervous system, headache, dizziness, ataxia, peripheral neuropathy; rarely convulsions.
    Allergic reactions: urticaria, skin itch, skin rash, angioedema.Other: rarely - transient leukopenia, weakness.

    Overdose:Treatment is symptomatic. There is no specific antidote. Tinidazole is displayed during dialysis.
    Interaction:
    Strengthens the effect of indirect anticoagulants (to reduce the risk of bleeding the dose is reduced by 50%) and the effect of ethanol (disulfiram-like effect). Compatible with sulfonamides and antibiotics (aminoglycosides, erythromycin, rifampicin, cephalosporins).
    It is not recommended to administer with ethionamide. Phenobarbital accelerates metabolism.

    Special instructions:
    In the treatment of trichomoniasis, simultaneous treatment of both partners should be carried out.
    During treatment, one should refrain from using ethanol (the possibility of developing disulfiram-like reactions).
    Causes dark staining of urine.
    With therapy for more than 6 days, monitoring of the peripheral blood pattern is necessary.
    During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
    Effect on the ability to drive transp. cf. and fur:During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:
    Tablets, film-coated, 500 mg.
    4 tablets in a planar cell package.
    1 contour pack together with instructions for use in a pack of cardboard.
    Packaging:
    Tablets, film-coated, 500 mg.
    4 tablets in a planar cell package.
    1 contour pack together with instructions for use in a pack of cardboard.
    Storage conditions:
    List B. In a dry, the 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 N001858 / 01
    Date of registration:18.09.2008
    The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia
    Manufacturer: & nbsp
    Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia
    Information update date: & nbsp05.09.2015
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