Active substanceMetronidazoleMetronidazole
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  • Dosage form: & nbspfromvaginal vaginal suppositories
    Composition:For one suppository:

    Active substance:

    Metronidazole - 500 mg.

    Excipient:

    Solid fat is sufficient to produce a suppository with a mass of 2.20 g.

    Description:FROMoppposition from white to white with a yellowish tint of color, torpedo shape.
    Pharmacotherapeutic group:Antimicrobial and antiprotozoal drug
    ATX: & nbsp

    P.01.A.B   Nitroimidazole derivatives

    P.01.A.B.01   Metronidazole

    Pharmacodynamics:

    Antiprotozoal and antibacterial drug, a derivative of 5-nitroimidazole. The mechanism of action 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 bacteria.

    Active in relation to:

    - protozoa - Trichomonas vaginalis, Entamoeba histolytica, Lamblia intestinalis, Balantidium coli;

    - Gram-negative anaerobes - Bacteroides spp. (in t.h. AT. fragilis, AT. distasonis, AT. ovatus, AT. thetaiotaomicron, AT. vulgatus), Fusobacterium spp.;

    - gram-positive anaerobic spore-forming sticks - Eubacterium spp., Clostridium spp.;

    - Gram-positive anaerobic cocci - Peptococcus niger, Peptostreptococcus spp.;

    - microaerophiles - Gardnerella vaginalis, Helicobacter pilory.

    The MIC for these strains is 0.125-6.25 μg / ml.

    Pharmacokinetics:

    Suction:

    After intravaginal application metronidazole is subject to systemic absorption (about 56%). Bioavailability of metronidazole for intravaginal application is 20%.

    Distribution:

    The connection with plasma proteins is less than 20%.Penetrates into breast milk and most tissues, passes through the BBB and the placenta.

    Metabolism:

    -Active, the ingredient is metabolized in the liver by hydroxylation, oxidation and glucuronation. Activity of the main metabolite (2-hydroxymethonidazole) - 30% of the activity of the starting compound.

    Excretion:

    T1/2 Metronidazole is 6-11 hours. It is isolated by 40-70% (about 20% unchanged) through the kidneys.

    Indications:

    Local treatment of trichomoniasis and nonspecific vaginitis.

    Contraindications:

    Hypersensitivity to metronidazole or other nitroimidazole derivatives; blood diseases, leukopenia (including history, decrease in the number of leukocytes in the blood); violation of coordination of movements, organic lesions of the central nervous system (including epilepsy); hepatic failure (in the case of high doses), pregnancy (I trimester), the period of breastfeeding.

    If you have any of the listed diseases, always consult a doctor before using the drug.

    Carefully:

    Pregnancy (II-III trimester), leukopenia in the anamnesis.

    Pregnancy and lactation:

    The purpose of the drug is contraindicated in the I trimester (pregnancy.In II and III trimester of pregnancy, the drug can be administered only on strict indications and under close supervision of a doctor.

    If it is necessary to prescribe the drug during lactation, breastfeeding should be discontinued, since metronidazole excreted in breast milk. Breastfeeding can be resumed 24-48 hours after the end of treatment.

    Dosing and Administration:

    Intravaginal.

    Trichomonal vaginitis: 1 suppository per day for 10 days.

    Nonspecific vaginitis: 1 suppository 2 times a day for 7 days.

    Preliminarily releasing the suppository from the contour pack using scissors (cut the film along the contour of the suppository), insert it deep into the vagina.

    Side effects:

    Local reactions: itching, burning, pain and irritation in the vagina; thick, white, mucous discharge from the vagina without smell or with a faint smell, frequent urination, after drug withdrawal; possible development of candidiasis of the vagina; feeling of burning or irritation of the penis in the sexual partner;

    From the digestive system: nausea, change in taste, metallic taste in the mouth, dry mouth, decreased appetite, abdominal cramps, nausea, vomiting, constipation, or diarrhea;

    Allergic reactions: urticaria, itching of the skin, rash;

    From the hematopoiesis: leukopenia (a decrease in the number of leukocytes in the blood) or leukocytosis (an increase in the number of leukocytes in the blood compared to the norm).

    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.

    In case of adverse reactions, it is necessary to cancel the drug and consult a doctor.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

    Overdose:

    Symptoms: nausea, vomiting, ataxia.

    Treatment: There is no specific antidote, symptomatic and maintenance therapy.

    Interaction:

    Pharmacokinetic:

    Under the influence of barbiturates, the effect of metronidazole may decrease, since its inactivation in the liver is accelerated.

    Cimetidine depresses 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 administration with lithium preparations, the concentration of the latter in plasma can increase.

    Pharmacodynamic:

    When used concomitantly 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).

    Compatible with sulfonamides and antibiotics.

    When treating metronidazole, avoid drinking alcohol (similar to disulfiram causes alcohol intolerance).

    Do not combine metronidazole with disulfiram, since the interaction of these drugs may inhibit consciousness, the development of mental disorders.
    Special instructions:

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

    In the treatment of trichomonas vaginitis in women and trichomoniasis in men, it is recommended to abstain from sexual intercourse. With vaginitis caused by Trichomonas vaginalis, simultaneous treatment of the sexual partner by the drug is recommended metronidazole for oral administration.

    In the case of using the drug in conjunction with metronidazole for oral administration, especially in the second course, monitoring of the peripheral blood picture is necessary (danger of leukopenia).

    During the period of treatment, the intake of ethanol is contraindicated (it is possible to develop a disulfiram-like reaction: spastic abdominal pain, nausea, vomiting, headache, sudden rush of blood to the face).

    The drug is not recommended for use in children.

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

    It is necessary to pay attention of patients, especially drivers of vehicles and persons operating other mechanisms, to the possibility of dizziness associated with taking the drug.

    Form release / dosage:

    Vaginal suppositories, 500 mg.

    Packaging:

    5 suppositories per contour cell package.

    Two contour packs together with the instruction for use are placed in a pack of cardboard.

    Storage conditions:

    In the dark place at a temperature of no higher than 20 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the date shown on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-000248
    Date of registration:05.05.2010 / 11.04.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:ALTAYVITAMINS, CJSC ALTAYVITAMINS, CJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspALTAYVITAMINS, CJSCALTAYVITAMINS, CJSC
    Information update date: & nbsp11.05.2018
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