Active substanceMetronidazoleMetronidazole
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  • Dosage form: & nbspFROMvaginal suppositories.
    Composition:For one suppository:

    Active substance: metronidazole - 0.5 g;

    Basis for suppositories: fat solid - sufficient amount to obtain a suppository weighing 2.4 g.

    Description:

    Suppositories white with yellowish or white with a greenish tint of color, torpedo-shaped.

    Pharmacotherapeutic group:antimicrobial and antiprotozoal agent
    ATX: & nbsp

    P.01.A.B   Nitroimidazole derivatives

    P.01.A.B.01   Metronidazole

    Pharmacodynamics:

    Metronidazole refers to nitro-5-imidazoles and is a DNA-tropic preparation with a bactericidal type of action.

    The mechanism of action of metronidazole is the biochemical reduction of the 5-nitro group of metronidazole by intracellular transport proteins of anaerobic microorganisms and protozoa. The restored 5-nitro group of metronidazole interacts with the DNA of a cell of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of microorganisms.

    Metronidazole is an effective antimicrobial and antiprotozoal means of a wide spectrum of action.

    The drug shows a high activity in relation to Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia intestinalis, Balantidium coli, Blastocystis hominis, Helicobacter pylori; in respect of obligate anaerobes and (sporo- and nonspore-forming) - Bacteroides spp. (V. fragilis, B. ovatus, B. distasonis, B. thetaiotaomicron, B. vulgatus), Fusobacterium spp., Clostridium spp., Peptostreptococcus spp., Peptococcus spp., sensitive strains Eubacterium).

    Metronidazole is active against an optional anaerobic bacterium: Gardnerella vaginalis.

    Pharmacokinetics:

    Metronidazole is well absorbed by intravaginal injection.The active ingredient is metabolized in the liver. Is allocated to 40-70% (about 20% in unchanged form) through the kidneys.

    Indications:Local treatment of trichomonas and nonspecific vaginitis, bacterial vaginosis.
    Contraindications:

    Hypersensitivity to metronidazole or other nitroimidazole derivatives; pregnancy (first trimester), blood diseases, leukopenia (including in anamnesis); violation of coordination of movements, organic lesions of the central nervous system (including epilepsy); hepatic failure (in the case of the appointment of large doses).

    Pregnancy and lactation:

    The drug is used with caution from the second trimester of pregnancy.

    Metronidazole penetrates into breast milk. Breastfeeding during the period of taking the drug should be canceled. Renew breastfeeding should be no earlier than 48 hours after the end of the drug.

    Dosing and Administration:

    - Trichomonal vaginitis: 1 suppository per day for 7-10 days in combination with taking the drug metronidazole in tablets.

    - Nonspecific vaginitis, bacterial vaginosis: 1 suppository per day for 7 days, if necessary in combination with taking the drug metronidazole in tablets.

    Treatment with metronidazole should not last more than 10 days and should be repeated more than 2-3 times a year.

    Side effects:

    With local use, the following side effects may occur:

    - itching, burning, pain and irritation in the vagina; thick, white, mucous discharge from the vagina (odorless or with a faint smell), frequent urination; after drug cancellation - development of candidiasis of the vagina;

    - sensation of burning or irritation of the penis in the sexual partner;

    - from the gastrointestinal tract: nausea, taste changes, metallic taste in the mouth, dry mouth, decreased appetite, abdominal cramps, nausea, vomiting, constipation or diarrhea;

    - allergic reactions: urticaria, itching of the skin, rash;

    - headache, dizziness;

    - leukopenia or leukocytosis.

    In rare cases, the color of urine can be observed in the red-brown color, due to the presence of a water-soluble pigment formed as a result of metronidazole metabolism.

    Interaction:

    Compatible with sulfonamides and antibiotics.

    When treating metronidazole, avoid taking alcohol (similarly disulfiram causes alcohol intolerance).

    Do not combine metronidazole from disulfiram and appoint metronidazole patients who took disulfiram during the last 2 weeks, since the interaction of these drugs may inhibit consciousness, the development of mental disorders.

    When used simultaneously with warfarin and other indirect anticoagulants metronidazole intensifies their action, which leads to an increase in prothrombin time.

    It is not recommended to combine with nondepolarizing muscle relaxants (vecuronium bromide).

    Influenced barbiturates it is possible to reduce the effect of metronidazole, since it accelerates its inactivation in the liver.

    Cimetidine oppresses the metabolism of metronidazole, which can lead to an increase in its concentration in the blood serum and an increased risk of developing adverse reactions.

    With simultaneous reception with drugs lithium may increase the concentration of the latter in the plasma.

    Special instructions:

    In the case of trichomoniasis, simultaneous treatment of the sexual partner with metronidazole is recommended, regardless of whether he has manifestations of the disease.

    During treatment with the drug it is recommended to abstain from sexual intercourse.

    If you have a history of changes in the composition of peripheral blood, as well as when using the drug in high doses and / or with its long-term use, it is necessary control of general analysis blood.

    Metronidazole can immobilize treponema, which leads to a false positive TPI test (Nelson's test).

    Since simultaneous administration of the drug with alcohol (ethanol) can have an effect similar to the effect of disulfiram (a feeling of heat, vomiting, tachycardia), one should not drink alcoholic beverages or drugs containing alcohol.

    Treatment with metronidazole should not last more than 10 days and should be repeated more than 2-3 times a year.

    It should be borne in mind that with prolonged use, treatment should be controlled by hematologic indicators and adverse reactions, such as peripheral or central neuropathy, manifested by paresthesia, ataxia, dizziness, convulsions, in the event of which treatment should be discontinued.

    Treatment during menstruation does not stop.

    After therapy with trichomoniasis, control tests should be performed for 3 consecutive cycles before and after menstruation.

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

    Consideration should be given to the potential for the development of side effects such as dizziness, convulsions. When these undesirable phenomena appear, one should refrain from transport management or engage in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Vaginal suppositories, 500 mg.

    Packaging:

    5 suppositories are placed in a contour mesh package.

    2 contour packs together with instructions for use are placed in a pack of cardboard.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-002039/08
    Date of registration:21.03.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia
    Manufacturer: & nbsp
    Representation: & nbspBIOSINTEZ JSC BIOSINTEZ JSC Russia
    Information update date: & nbsp19.09.2016
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