Active substanceMetronidazoleMetronidazole
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  • Dosage form: & nbsptabscesses
    Composition:

    Each tablet contains:

    active substance: metronidazole 250 mg;

    Excipients: potato starch - 45.0 mg, povidone (low molecular weight polyvinylpyrrolidone) 2.0 mg, stearic acid 3.0 mg.

    Description:

    Tablets are white or white with a yellowish or yellowish-greenish hue,flat-cylindrical, with a risk and a facet.

    Pharmacotherapeutic group:Antimicrobial and antiprotozoal drug
    ATX: & nbsp

    P.01.A.B   Nitroimidazole derivatives

    P.01.A.B.01   Metronidazole

    Pharmacodynamics:

    Metronidazole is a 5-nitroimidazole and has a broad spectrum of action against anaerobic microorganisms Peptostreptococcus species, Clostridium spp., Bacteroides spp., Fusobacterium spp., Veillonella spp., Prevotella (Prevotella bivia, Prevotella buccae, Prevotella disiens). Suppress the development of protozoa - Trichomonas vaginalis, Giardia intestinalis (Lamblia intestinalis), Entamoeba histolytica.

    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 reduced 5-nitro group of metronidazole reacts with the deoxyribonucleic acid of the cells, inhibiting the synthesis of their nucleic acids, which leads to the death of microorganisms.

    Pharmacokinetics:

    Ingestion Metronidazole quickly and fully absorbed from the gastrointestinal tract. Eating does not affect the absorption of the drug. Binding to blood proteins is insignificant and does not exceed 10-20%. The drug quickly penetrates into tissues and organs, is found in almost all tissues and body fluids, penetrates into breast milk and passes through the placental and blood-brain barrier.

    Metronidazole is metabolized by oxidation in the liver and binding to glucuronic acid. Half-life with normal liver function - 8 hours (6 to 12 hours), with alcohol damage of the liver - 18 hours (10 to 29 hours). Removal of the drug is carried out at 40-70% through the kidneys (in unchanged form - about 20% of the dose) and with feces. In patients with hepatic insufficiency, the half-life period remains unchanged.

    Kidney clearance - 10.2 ml / min. In patients with impaired renal function after repeated administration of metronidazole cumulation in serum can be observed (hence patients with severe renal impairment receiving frequency to be reduced).

    Metronidazole and the major metabolites are rapidly removed from. blood during hemodialysis (the half-life is reduced to 2.6 hours). When peritoneal dialysis is withdrawn in small quantities.

    Indications:

    Trichomonas vaginitis and urethritis in women, trichomoniasis urethritis in men, giardiasis, amoebic dysentery; Anaerobic infections caused by microorganisms that are sensitive to the drug.

    Combined therapy of severe mixed aerobic-anaerobic infections.

    Prevention of anaerobic infection during surgical interventions (especially on the organs of the abdominal cavity, urinary tract).

    In combination with amoxicillin: chronic gastritis in the exacerbation phase, peptic ulcer of the stomach and duodenum in the acute phase, associated with Helicobacter pylori.

    Contraindications:

    - Hypersensitivity to any of the components of the drug and imidazoles;

    - organic lesions, central nervous system (including epilepsy);

    - pregnancy and the period of breastfeeding;

    - blood diseases, leukopenia (including in the anamnesis);

    - Children's age under 3 years (for this dosage form).

    Carefully:

    Renal and / or hepatic insufficiency.

    Dosing and Administration:

    Inside, during or after a meal (or squeezed milk), without chewing.

    With amebiasis Metronidazole is used for 7 days to 0.25-0.5 g 3 times a day (adults) and 30-40 mg / kg per day also in three doses (children).

    With giardiasis the drug is prescribed for 5 days - adults 0.25-0.5 g 2-3 times a day (maximum 1.0 g / day), children aged 3-5 years at 0.25 g per day, children 6 -10 years for 0.375 g and children 11-15 years at 0.50 g per day. Take the drug 2-3 times a day.

    With trichomoniasis in men (urethritis) and in women (urethritis and vaginitis) metronidazole administered once at a dose of 2 g or a course of treatment for 10 days: 1 tablet (0.25 g), 2 times a day. To exclude possible re-infection, it is necessary to simultaneously treat sexual partners. The course of treatment is repeated if necessary in 4-6 weeks.

    With nonspecific vaginitis apply 0.5 g of the drug 2 times a day for 7 days.

    In the treatment of anaerobic infections adults are appointed Metronidazole 1.0-1.5 g per day, children - at a rate of 20-30 mg / kg per day.

    For eradication of Helicobacter pylori - 500 mg 3 times a day for 7 days (as part of a combination therapy).

    For the prevention of infectious complications - 750-1500 mg / day in 3 divided doses 3-4 days before surgery or 1 g once a day after the operation. 1-2 days after the operation - 750 mg / day for 7 days.

    With severe renal dysfunction (creatinine clearance less than 10 ml / min) daily dose should be reduced by 2 times.

    Side effects:

    In rare cases, there is nausea, a metallic taste in the mouth, anorexia, epigastric pain, vomiting, diarrhea, headache, dizziness, as well as local skin reactions such as hives and itching.

    Very rarely - depression.

    With prolonged treatment with large doses, there may be leukopenia, peripheral neuropathies.

    Very rare and reversible cases of pancreatitis are described.

    It is possible to stain urine in a reddish-brown color due to the presence of pigments associated with Metronidazole metabolism.

    From the digestive system: diarrhea, decreased appetite, nausea, vomiting, intestinal colic, constipation, "metallic" taste in the mouth, dry mouth, glossitis, stomatitis, pancreatitis.

    From the nervous system: dizziness, impaired coordination of movements, ataxia, confusion, irritability, depression, increased excitability, weakness, insomnia, headache, convulsions, hallucinations, peripheral neuropathy.

    Allergic reactions: urticaria, skin rash, skin hyperemia, nasal congestion, fever, arthralgia.

    From the urinary system: dysuria, cystitis, polyuria, urinary incontinence, candidiasis, staining of urine in red-brown color.

    Other: neutropenia, leukopenia, flattening of the T wave on the electrocardiogram.

    Overdose:

    Symptoms: vomiting, diarrhea, convulsions, confusion, hallucinations.

    Therapeutic measures: removal of the drug from the body, symptomatic treatment.

    Interaction:

    Pharmacodynamic: joint oral administration of metronidazole with antibiotics-aminoglycosides (neomycin, streptomycin, gentamicin , etc.) and erythromycin depresses the pathogenic flora in the digestive tract, which reduces the likelihood of complications after operations on the colon and rectum.

    Under the influence of metronidazole, there may be an increase in the effects of indirect anticoagulants.

    Simultaneous administration of drugs stimulating enzymes of microsomal oxidation in the liver (phenobarbital, phenytoin), can accelerate the elimination of metronidazole, as a result of which its concentration in the plasma decreases.

    The spectrum of action of metronidazole expands when combined with sulfanylamides and cephalosporins.

    With the combined use of metronidazole and ethyl alcohol due to the blockade of metronidazole enzyme alcohol dehydrogenase, reddening of the face, vomiting, abdominal pain, etc.,

    Do not combine metronidazole with disulfiram (teturam), since the interaction of these drugs may inhibit consciousness,psychotic disorders (the interval between the appointment - at least 2 weeks).

    Cimetidine suppresses the metabolism of metronidazole, which can lead to an increase in its concentration in the blood serum and an increased risk of side effects.

    Together with the admission lithium drugs may increase the plasma concentration of the latter and the development of symptoms of intoxication.

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

    Pharmacokinetic: adsorbents, cholestyramine, astringent and enveloping agents reduce the absorption of metronidazole in the gastrointestinal tract.

    Special instructions:

    The use of alcoholic beverages during treatment with metronidazole is contraindicated.

    In combination with amoxicillin it is not recommended to use in patients younger than 18 years.

    With prolonged therapy, it is necessary to monitor the blood picture.

    With leukopenia, the possibility of continuing treatment depends on the risk of developing an infectious process.

    The appearance of ataxia, dizziness and any other worsening of the neurological status of patients requires discontinuation of treatment.

    Can immobilize treponema and lead to a false-positive test of Nelson.

    When treating trichomonas vaginitis in women, treatment during menstruation does not stop. After therapy with trichomoniasis, control tests should be performed for 3 consecutive cycles before and after menstruation.

    After treatment of giardiasis, if symptoms persist, 3 feces analysis should be performed at intervals of several days after 3-4 weeks (in some successfully treated patients lactose intolerance caused by invasion can persist for several weeks or months, recalling the symptoms of giardiasis.

    Form release / dosage:Tablets, 250 mg.
    Packaging:

    10 or 20 tablets in a planar cell package.

    1 or 2 contour packs with instructions for use in a pack of cardboard.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    4 years.

    After the expiration date the drug should not be used.

    Terms of leave from pharmacies:On prescription
    Registration number:P N002071 / 01
    Date of registration:14.08.2008 / 15.05.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:PHARMSTANDART-FORESTRY, OJSC PHARMSTANDART-FORESTRY, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp25.04.2018
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