Tinidazole (Tinidazol)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTinidazoleTinidazole
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  • Tinidazole
    pills inwards 
    BIOKOM, CJSC     Russia
  • Tinidazole
    pills inwards 
    OZONE, LLC     Russia
  • Tinidazole-Acry®
    pills inwards 
    AKRIKHIN HFK, JSC     Russia
    • Dosage form: & nbspfilm coated tablets
    Composition:
    1 tablet contains:
    active substance: tinidazole 500 mg
    Excipients:
    core: microcrystalline cellulose - 80.0 mg,
    potato starch - 17.0 mg,
    Povidone (polyvinylpyrrolidone) - 32.0 mg,
    croscarmellose sodium - 15.0 mg,
    magnesium stearate 6.0 mg;
    shell: hypromellose - 12.0 mg,
    Macrogol 2.5 mg, titanium dioxide -0.5 mg,
    talc (magnesium hydrosilicate) - 0.5 mg.

    Description:
    Tablets are cylindrical, biconvex, coated with a white or white film cover with a cream-colored hue. On a broken white with a cream-gray shade 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 spp. It has bactericidal action against the following anaerobic microorganisms: Bacteroides spp., (Including Bacteroides fragilis, Bacteroides melaninogenicus), Clostridium spp., Eubacterium spp., Fusobacterium spp., Peptococcus spp., Peptostreptococcus 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 (Stach) 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. Time to reach a maximum concentration of 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. Metabolised in the liver with the formation of pharmacologically active hydroxylated derivatives that inhibit the growth of anaerobic microorganisms and can enhance the action of tinidazole. The half-life period (T1 / 2) is 12-14 hours. It is excreted with bile - 50%, kidneys - 25% (unchanged) and 12% (in the form of metabolites). It is reversed in the renal tubules.
    Indications:
    - trichomoniasis (colpitis, endometritis, ovarian and tubovarial abscesses);
    - giardiasis;
    - amebiasis (including intestinal and hepatic form);
    - infections caused by anaerobic bacteria (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 derivative of 5-nitroimidazole, organic diseases of the central nervous system, oppression of bone marrow 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 you need to use the drug during lactation, you should decide whether to stop 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 administered once to adults by 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; the duration of therapy is 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.
    To prevent 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: hives, skin itching, skin rash,
    angioedema.
    Other: rarely - transient leukopenia, weakness.

    Overdose:
    Treatment is symptomatic. There is no specific antidote. Tinidazole is displayed during dialysis.

    Interaction:
    Enhances the effect of indirect anticoagulants (to reduce the risk of bleeding dose reduced by 50%) and the action of ethanol
    (disulfiram-like reactions). 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 genital trichomoniasis, simultaneous treatment of sexual 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.
    At appointment more than 6 days the control of a picture of peripheric blood is necessary.
    During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Effect on the ability to drive transp. cf. and fur:
    During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:
    Tablets, film-coated 500 mg.
    For 4, 10 tablets are placed in a contour mesh box made of a polyvinylchloride film and aluminum foil printed lacquered.
    At 4, 10, 16, 20, 30 or 50 tablets are placed in a polymer container for medicinal products. One container or 1, 2, 3, 4 or 5 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

    Packaging:
    Tablets, film-coated 500 mg.
    For 4, 10 tablets are placed in a contour mesh box made of a polyvinylchloride film and aluminum foil printed lacquered.
    At 4, 10, 16, 20, 30 or 50 tablets are placed in a polymer container for medicinal products. One container or 1, 2, 3, 4 or 5 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

    Storage conditions:
    List B. Store in a dry, protected from light 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:LSR-008613/09
    Date of registration:28.10.2009
    The owner of the registration certificate:OZONE, LLC OZONE, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspOZONE LLC OZONE LLC Russia
    Information update date: & nbsp05.09.2015
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