Composition
Composition per tablet:
Active ingredient: Â
metronidazole – 250 mg;
excipients:
potato starch-45.0 mg,
povidone (polyvinylpyrrolidone low molecular weight medical) – 2.0 mg,
stearic acid-3.0 mg
Pharmacological action
Metronidazole belongs to 5-nitroimidazoles and has a broad spectrum of action against anaerobic microorganisms Peptostreptococcus species, Clostridium spp., Bacterioides spp., Fusobacterium spp., Veillonella spp., Prevotella (Prevotella bivia, Prevotella buccae, Prevotella disiens). Inhibits the development of protozoa-Trichomonas vaginalis, Giardia intestinalis (Lamblia intestinalis), Entamoeba histolytica. The mechanism of action consists in 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 interacts with the deoxyribonucleic acid of cells, inhibiting the synthesis of their nucleic acids, which leads to the death of microorganisms.
Indications
Trichomonas vaginitis and urethritis in women, trichomonas urethritis in men, giardiasis, amoebic dysentery; anaerobic infections caused by microorganisms sensitive to the drug. Combined therapy of severe mixed aerobic-anaerobic infections. Prevention of anaerobic infection during surgical interventions (especially on the abdominal organs, urinary tract). In combination with amoxicillin: chronic gastritis in the acute 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 of the central nervous system (including epilepsy);
pregnancy and lactation;
blood diseases, leukopenia (including in the anamnesis);
children under 3 years of age (for this dosage form). Â
WITH CAUTION
Renal and / or hepatic insufficiency.
Side effects
Allergic reactions: Â urticaria, skin rash.
Local reactions: Â burning sensation or irritation of the penis in the sexual partner, burning sensation or frequent urination, vulvitis (itching, burning pain or hyperemia of the mucous membrane in the external genitals). After discontinuation of the drug, vaginal candidiasis may develop.
Systemic reactions: Â there may be changes in taste sensations, including a metallic taste, dizziness, headache, dry mouth, nausea, vomiting, decreased appetite, abdominal cramps, constipation or diarrhea, dark urine staining, leukopenia or leukocytosis.
Interaction
When used concomitantly with antacids containing aluminum hydroxide, colestyramine slightly reduces the absorption of metronidazole from the gastrointestinal tract.
When used concomitantly, metronidazole potentiates the effect of indirect anticoagulants.
When used concomitantly with disulfiram, acute psychosis and impaired consciousness may develop.
It is impossible to exclude an increase in the concentration of carbamazepine in blood plasma and an increased risk of toxic effects when used simultaneously with metronidazole.
When used concomitantly with lansoprazole, glossitis, stomatitis and/or the appearance of dark coloration of the tongue are possible; with lithium carbonate, an increase in the concentration of lithium in blood plasma and the development of symptoms of intoxication is possible; with prednisone, the excretion of metronidazole from the body increases due to the acceleration of its metabolism in the liver under the influence of prednisone. It is possible to reduce the effectiveness of metronidazole.
When used concomitantly with rifampicin, the clearance of metronidazole from the body increases; with phenytoin, a slight increase in the concentration of phenytoin in blood plasma is possible, and a case of toxic action is described.
When used concomitantly with phenobarbital, the elimination of metronidazole from the body significantly increases, apparently due to the acceleration of its metabolism in the liver under the influence of phenobarbital. It is possible to reduce the effectiveness of metronidazole.
When used concomitantly with fluorouracil, the toxic effect increases, but not the effectiveness of fluorouracil.
A case of acute dystonia after taking a single dose of chloroquine in a patient receiving metronidazole is described.
When used concomitantly with cimetidine, it is possible to inhibit the metabolism of metronidazole in the liver, which may lead to a slowdown in its excretion and an increase in its concentration in blood plasma.
With the simultaneous use of ethanol in patients receiving metronidazole, disulfiram-like reactions may develop.
How to take, course of use and dosage
Inside, during or after a meal (or with milk), without chewing. With amoebiasis, Metronidazole is used for 7 days at 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 0.25 g per day, children 6-10 years 0.375 g and children 11-15 years 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 is prescribed once at a dose of 2 g or as a course of treatment for 10 days: 1 tablet (0.25 g) 2 times a day. To avoid possible reinfection, it is necessary to simultaneously treat sexual partners. The course of treatment is repeated if necessary after 4-6 weeks. For non-specific vaginitis,0.5 g of the drug is used 2 times a day for 7 days. In the treatment of anaerobic infections, adults are prescribed Metronidazole 1.0-1.5 g per day, children-at the 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 combination therapy). For the prevention of infectious complications – 750-1500 mg / day in 3 doses 3-4 days before surgery or once 1 g in the first day after surgery. 1-2 days after surgery-750 mg / day for 7 days. In patients with severe renal impairment (creatinine clearance less than 10 ml / min), the daily dose should be reduced by 2 times.
Overdose
Symptoms: Â nausea, vomiting, ataxia; when taken as a radiosensitizing agent – convulsions, peripheral neuropathy.
Treatment: Â there is no specific antidote, and there is no symptomatic or supportive therapy.
Special instructions
During the treatment period, taking ethanol is contraindicated (a disulfiram-like reaction may develop: spastic abdominal pain, nausea, vomiting, headache, sudden rush of blood to the face).
In combination with amoxicillin, it is not recommended for use in patients under 18 years of age.
With long-term 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 deterioration in the neurological status of patients requires discontinuation of treatment.
May immobilize treponemes and result in a false positive Nelson test.
Stains urine in a dark color.
When treating trichomonas vaginitis in women and trichomonas urethritis in men, it is necessary to refrain from sexual activity. Simultaneous treatment of sexual partners is mandatory. Treatment does not stop during menstruation. After trichomoniasis therapy, follow-up tests should be performed for three consecutive cycles before and after menstruation.
After treatment of giardiasis, if symptoms persist, perform 3 stool tests in 3-4 weeks at intervals of several days (in some successfully treated patients, lactose intolerance caused by invasion may persist for several weeks or months, resembling the symptoms of giardiasis).
During the treatment period, it is recommended to stop breastfeeding.
Storage conditions
Store at a temperature not exceeding 25 °C. Keep out of reach of children.
Shelf
life is 4 years. Do not use the product after the expiration date.
Active ingredient
Metronidazole
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
Purpose
Pregnant women in the second and third trimester as prescribed by a doctor, Children as prescribed by a doctor, Adults as prescribed by a doctor
Indications
Amoebiasis and Giardiasis, Vaginitis, Pneumonia, Gastrointestinal infections caused by Helicobacter Pylori, Urethritis, Inflammation of the female genital organs, Trichomoniasis, Urinary tract infections, Stomach and Duodenal ulcers
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