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
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    BIOKOM, CJSC     Russia
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    OZONE, LLC     Russia
  • Tinidazole-Acry®
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    AKRIKHIN HFK, JSC     Russia
    • Dosage form: & nbspfilm coated tablets
    Composition:
    1 tablet contains:
    active substance: tinidazole - 500 mg,
    auxiliary substances: microcrystalline cellulose, silicon dioxide colloid, magnesium stearate, hypromellose, titanium dioxide, macrogol.

    Description:
    The tablets covered with a film cover, white or white with a yellowish shade of color, round, biconcave. Insignificant surface roughness is allowed. Color of tablets on a cross-section - from white to white with grayish or with a yellowish shade.

    Pharmacotherapeutic group:Antiprotozoal and antimicrobial agent.
    ATX: & nbsp

    P.01.A.B.02   Tinidazole

    P.01.A.B   Nitroimidazole derivatives

    Pharmacodynamics:
    Tinidazole is active against Trichomonas vaginalis, Entamoeba histolytica, Lamblia spp; causative agents of anaerobic infections (Bacteroides spp., including B. fragilis, B. melaninogenicus, Clostridium spp., Eubacterium spp., Fusobacterium spp., Peptococcus spp., Peptostreptococcus spp.). Being a highly lipophilic preparation, it penetrates inside the cells of pathogens, where it is reduced by nitrodeructase, inhibits synthesis and damages the DNA structure.

    Pharmacokinetics:
    Absorption is high, bioavailability is about 100%. Connection with plasma proteins - 12%. The maximum concentration (Cmax) after oral administration of 2 g is 40-51 μg / ml, after 24 hours - 11-19 μg / ml, after 72 hours - 1 μg / ml; time to reach maximum concentration
    (TCmax) -2 hours.The volume of distribution is 50 liters. Penetrates through the blood-brain barrier (GEB), 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, giardiasis, amoebiasis (including hepatic form and amoebic dysentery); acute ulcerative gingivitis, nonspecific vaginitis, cutaneous leishmaniasis;
    infections of different locations caused by anaerobic bacteria: peritonitis, abscess, endometritis, pyosalpinx; sepsis, wound infections (including the prevention of postoperative anaerobic infections), skin and soft tissue infections, pneumonia, empyema, lung abscess;
    mixed aerobic-anaerobic infections (in combination with antibiotics);
    eradication of Helicobacter pylori (in combination with bismuth preparations and antibiotics).

    Contraindications:
    Hypersensitivity to the components of the drug, organic diseases of the central nervous system (CNS), oppression of bone marrow hematopoiesis, pregnancy (I trimester), lactation (breastfeeding), children's age (up to 12 years).

    Dosing and Administration:
    Inside, during or immediately after a meal.
    With giardiasis, adults are prescribed 2 g once; children - 50-75 mg / kg body weight (not more than 2 g). If inefficiency (presence of lamblia in the contents of the duodenum or in the feces 7-10 days after the end of therapy), the treatment is repeated in the same dose. It is recommended to treat all family members simultaneously.
    With urogenital trichomoniasis, adults are prescribed 2 g once. Children - 50-75 mg / kg body weight; if necessary, re-administration in the same dose.
    Amoebiasis of the intestine: adults - 2 g / day in 1 reception for 2-3 days.
    Children - 50-60 mg / kg once a day, for 3 days.
    Liver amebiasis: adults - 1.5-2 g / day in 1 dose for 3 days; if necessary, treatment is continued with the same doses up to 5-6 days.
    Children - 50-60 mg / kg once a day for 5 days.
    Acute ulcerative gingivitis - 2 g once.
    With nonspecific vaginitis - 2 g, once, or 2 g consistently for 2 days.
    For anaerobic infections (Bacteroides, Fusobacterium, Clostridium spp.), The course of treatment is 5-6 days; on the first day of treatment - 2 g / day, then 1 g once a day or 0.5 g 2 times a day.
    For the prevention of postoperative anaerobic infections, 2 g are prescribed for 12 hours before the operation.

    Side effects:
    On the part of the digestive system: a decrease in appetite, dryness of the oral mucosa, a "metallic" taste in the mouth, nausea, vomiting, diarrhea.
    From the nervous system: headache, dizziness, fatigue, movement coordination disorders (including locomotor ataxia), dysarthria, peripheral neuropathy, rarely - convulsions, weakness. Allergic reactions: urticaria, itchy skin, skin rash,
    angioedema.
    Other: transient leukopenia.

    Overdose:
    Treatment: symptomatic. There is no specific antidote. It is in 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 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 should refrain from drinking alcohol (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.
    Safety and efficacy in the treatment and prevention of anaerobic infections in children younger than 12 years of age have not been established.
    During the treatment period, it is necessary, to be cautious when driving vehicles and engaging in other activities that require an increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:
    Tablets, film-coated, 500 mg.
    4 tablets per contour cell pack. On 1 contour acheikova packing together with the instruction on application in a pack cardboard.

    Packaging:
    Tablets, film-coated, 500 mg.
    4 tablets per contour cell pack. On 1 contour acheikova packing together with the instruction on application in a pack cardboard.

    Storage conditions: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 expiry date printed on the package. Storage conditions

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-000859/10
    Date of registration:10.02.2010
    The owner of the registration certificate:BIOKOM, CJSC BIOKOM, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp05.09.2015
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