Trichopol (Metronidazole) 250 mg tablets 20
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Active substance: metronidazole 250mg.
Excipients: potato starch, gelatin, starch molasses, magnesium stearate.
Antiprotozoal drug with antibacterial activity, 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 reduced 5-nitro group of metronidazole interacts with the DNA of the cell of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of microorganisms.
Metronidazole is active against Trichomonas vaginalis, Entamoeba histolytica, Gardnerella vaginalis, Giardia intestinalis, Lamblia spp.; and the obligate anaerobes Bacteroides spp. (including Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Veillonella spp., Prevotella spp. (Prevotella bivia, Prevotella buccae, Prevotella disiens); some gram-positive microorganisms (Eubacterium spp., Clostridium spp., Peptococcus spp., Peptostreptococcus spp.). The BMD for these strains is 0.125-6.25 μg/ml.
In combination with amoxicillin, it is active against Helicobacter pylori (amoxicillin inhibits the development of resistance to metronidazole).
Metronidazole does not have a bactericidal effect against most bacteria and facultative anaerobes, fungi and viruses. In the presence of mixed flora (aerobes and anaerobes), metronidazole shows synergy with antibiotics effective against conventional aerobes.
Metronidazole increases sensitivity tumors to irradiation, causes sensitization to ethanol (disulfiram-like action), stimulates reparative processes.
Indications for use
- bacterial vaginosis;
- all forms of amebiasis (diseases of intestinal and extraintestinal localization, including amoebic abscess of the liver, amoebic dysentery, as well as asymptomatic amebiasis);
- periodontal infections (including acute ulcerative gingivitis, acute odontogenic infections);
- anaerobic bacterial infections (gynecological and abdominal infections, CNS infections, bacteremia, sepsis, endocarditis, infections of bones and joints, skin and soft tissues, respiratory tract infections) caused by Bacteroides spp., Clostridium spp., Eubacterium spp., Peptococcus spp., Peptostreptococcus spp. and anaerobes sensitive to metronidazole;
- treatment of infections Helicobacter pylori for peptic ulcer of the stomach or duodenum in combination with bismuth preparations and an antibiotic, for example, amoxicillin;
- prophylactic appointment before surgery on the gastrointestinal tract and reproductive organs.
- leukopenia (including in the anamnesis);
- organic lesions of the central nervous system (including epilepsy);
- hepatic insufficiency (in the case of prescribing the drug in high doses);
- I trimester of pregnancy;
- lactation (breastfeeding);
- children's age up to 3 years;
- hypersensitivity to metronidazole or other derivatives of nitroimidazole, as well as to any other components of the drug.
With caution, the drug should be prescribed to patients with renal and / or hepatic insufficiency, in II and III trimesters of pregnancy.
Use in pregnancy and lactation
Metronidazole penetrates the placental barrier, so Trichopolum ® contraindicated for use in the first trimester of pregnancy. The use of the drug in the II and III trimesters is possible only in cases where the intended benefit to the mother exceeds the potential risk to the fetus.
Since metronidazole is excreted in breast milk, reaching concentrations in it close to the concentration in the blood plasma, if necessary, the use of Trichopolum during lactation, breastfeeding should be discontinued.
Use in case of impaired liver functionWith caution, Trichopolum should be prescribed ® patients with severe hepatic insufficiency, because as a result of a slowdown in metabolism, the concentration of metronidazole and its metabolites in plasma increases.
Use in renal dysfunction
With caution, the drug should be prescribed to patients with renal insufficiency.
In severe renal failure (QC less than 10 ml / min), the daily dose of Trichopolum should be reduced by 2 times.
Use in children
The drug is contraindicated in children under 3 years of age.
In combination with amoxicillin, it is not recommended to use Trichopolum ® in children and adolescents under 18 years of age.
Use in elderly patientsIn elderly patients, the excretion of metronidazole by the kidneys decreases.
With caution, Trichopolum should be prescribed ® patients with severe hepatic insufficiency, because as a result of a slowdown in metabolism, the concentration of metronidazole and its metabolites in plasma increases.
Due to the slowdown in excretion, caution is required when choosing the dose of metronidazole y patients with renal insufficiency.
Caution is required when prescribing Trichopolum to patients with oppression of bone marrow hematopoiesis and CNS functions, as well as elderly patients. The appearance of ataxia, dizziness and any other deterioration in the neurological status of patients requires discontinuation of treatment.
With long-term therapy with metronidazole (more than 10 days), the peripheral blood picture and liver function should be monitored.
With leukopenia, the possibility of continuing treatment depends on the risk of developing an infectious process.
Metronidazole should be avoided in patients with porphyria.
Trichopolum ® can cause immobilization of treponemas, leading to a false-positive Nelson test.
In the treatment of trichomonas vaginitis in women and trichomonas urethritis in men, it is necessary to refrain from sexual activity. Be sure to simultaneous treatment of genitals Partners. After the treatment of trichomoniasis, control tests should be carried out during the next three cycles before and after menstruation.
After treatment of giardiasis, if symptoms persist, after 3-4 weeks it is necessary to conduct 3 stool tests 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).
Patients should refrain from drinking alcohol during metronidazole therapy, as well as for at least 48 hours after the completion of treatment, because of the possibility of developing disulfiram-like reactions: abdominal pain of a spastic nature, nausea, vomiting, headache, sudden rush of blood to the face.
During treatment with metronidazole, urine may acquire a dark or reddish-brown color due to the presence of water-soluble dyes.
Use in pediatrics
In combination with amoxicillin, it is not recommended to use Trichopolum ® in children and adolescents under the age of 18 years.
Influence on the ability to drive vehicles and control mechanisms
When taking the drug, potentially dangerous activities that require increased concentration of attention, speed of psychomotor reactions, especially driving vehicles and servicing mechanisms, should be avoided.
Metronidazole enhances the effect of warfarin and other coumarin anticoagulants (this combination requires a reduction in the doses of both drugs).
Similar to disulfiram, metronidazole causes ethanol intolerance. The simultaneous use of Trichopolum with disulfiram can lead to the development of various neurological symptoms (the interval between the use of these drugs should be at least 2 weeks).
Cimetidine inhibits the metabolism of metronidazole, which can lead to an increase in its concentration in the blood plasma and an increased risk of adverse reactions.
Simultaneous administration of drugs that stimulate the activity of microsomal liver enzymes (phenobarbital, phenytoin) can accelerate the elimination of metronidazole, which leads to a decrease in its concentration in the blood plasma.
In patients receiving long-term treatment with lithium preparations in high doses, when taking metronidazole, an increase in the concentration of lithium in the blood plasma and the development of symptoms of intoxication are possible.
It is not recommended to combine metronidazole with non-depolarizing muscle relaxants (vecuronium bromide).
With the combined administration of metronidazole and cyclosporine, an increase in the concentration of cyclosporine in the blood plasma may be observed.
Metronidazole reduces the clearance of fluorouracil, which can cause an increase in the toxicity of the latter.
Sulfonamides enhance the antimicrobial effect of metronidazole.
Dosage and Administration
The drug is prescribed orally, during or after meals, tablets are taken without chewing.
Adults and children over 10 years of age are prescribed 250 mg (1 tab.) 3 times / day or 500 mg (2 tab.) 2 times / day for 7 days. Women need to additionally prescribe metronidazole in the form of vaginal suppositories or tablets. If necessary, you can repeat the course of treatment. Between courses, you should take a break of 3-4 weeks with repeated control laboratory tests.
An alternative treatment regimen is the appointment of 750 mg (3 tab.) in the morning and 1250 mg (5 tab.) in the evening or 2000 mg (8 tab.) /day once. The duration of treatment is 2 days. Treatment is carried out simultaneously in both sexual partners.
Children aged 3 to 7 years are prescribed 125 mg (1/2 tab.) 2 times / day; Age from 7 to 10 years - 125 mg (1/2 tab.) 3 times / day. The course of treatment is 7 days.
Adults are prescribed 500 mg (2 tab.) 2 times / day for 7 days or 2000 mg (8 tab.) /day once. Simultaneous treatment of the sexual partner is not required.
With invasive forms of intestinal amebiasis in susceptible patients (including amoebic dysentery), adults and children over 10 years of age are prescribed 750 mg (3 tab.) 3 times / day. Children aged 3 to 7 years - 250 mg (1 tab.) 4 times / day; at the age of 7 to 10 years - 375 mg (1.5 tab.) 3 times / day. The course of treatment is usually 5 days.
With intestinal amebiasis in less susceptible patients and with chronic amoebic hepatitis, adults and children over 10 years of age are prescribed 375 mg (1.5 tab.) 3 times / day. Children aged 3 to 7 years - 125 mg (1/2 tab.) 4 times / day; at the age of 7 to 10 years - 250 mg (1 tab.) 3 times / day. Duration of treatment is 5-10 days.
With amoebic abscess of the liver and other forms of extraintestinal amebiasis, adults and children over 10 years of age are prescribed 375 mg (1.5 tab.) 3 times / day. Children aged 3 to 7 years - 125 mg (1/2 tablet) 4 times / day; at the age of 7 to 10 years - 250 mg (1 tab.) 3 times / day. The course of treatment is 5 days.
With asymptomatic carriage of cysts, adults and children over 10 years of age are prescribed 375-750 mg (1.5-3 tab.) 3 times / day. Children aged 3 to 7 years - 125 mg (1/2 tab.) 4 times / day; at the age of 7 to 10 years - 250 mg (1 tab.) 3 times / day. The duration of the course of treatment is 5-10 days.
Adults and children over 10 years of age are prescribed 500 mg (2 tab.) 2 times / day for 5 -7 days; or 2000 mg (8 tab.) 1 time / day for 3 days.
Children aged 3 to 7 years - 250-375 mg (1-1.5 tab.) 1 time / day for 5 days, or 500-750 mg (2-3 tab.) 1 time / day for 3 days. Children aged 7 to 10 years - 250 mg (1 tab.) 2 times / day for 5 days, or 1000 mg (4 tab.) 1 time / day for 3 days.
In acute ulcerative gingivitis, adults and children over 10 years of age are prescribed 250 mg (1 tab.) 3 times / day. Children aged 3 to 7 years - 125 mg (1/2 tab.) 2 times / day; at the age of 7 to 10 years - 125 mg (1 tab.) 3 times / day. The duration of the course of treatment is 3 days.
In acute odontogenic infections, adults and children over 10 years of age are prescribed 250 mg (1 tab.) 3 times / day for 3-7 days.
Infections caused by anaerobic bacteria
Treatment of anaerobic infections usually begins with intravenous infusions. As soon as possible, treatment should be continued with metronidazole in tablet form.
Adults and children over 10 years of age are prescribed 500 mg (2 tab.) 3-4 times / day. The duration of treatment should not exceed 7 days.
Children under 10 years of age in the treatment of anaerobic infections, the use of metronidazole in the form of infusion solutions is recommended.
Eradication of Helicobacter pylori
Assign 500 mg (2 tab.) 3 times / day for 7 days (as part of combination therapy, for example, with amoxicillin 2.25 g / day).
Prevention of infections caused by anaerobic bacteria (before abdominal surgery, in gynecology and obstetrics)
Adults and children over 12 years of age are prescribed 250-500 mg (1-2 tab.) 3 times / day 3-4 days before the operation. 1-2 days after the operation (when oral administration is already allowed), 250 mg (1 tab.) 3 times / day for 7 days are prescribed.
In severe renal failure (QC less than 10 ml / min), the daily dose of Trichopolum should be reduced by 2 times.
Symptoms: increased side effects, mainly nausea, vomiting and dizziness; in more severe cases ataxia, paresthesia and convulsions are possible. The lethal dose to humans is unknown.
Treatment: symptomatic and maintenance therapy. There is no specific antidote.
From the digestive system: epigastric pain, nausea, vomiting, diarrhea, constipation, intestinal colic, decreased appetite, anorexia, taste disturbance, unpleasant metallic taste in the mouth, dry mouth, glossitis, stomatitis; very rarely - a deviation from the norm of functional tests of the liver, cholestatic hepatitis, jaundice, pancreatitis.
From the side of the central nervous system: with prolonged use - headache, dizziness, impaired coordination of movements, ataxia, peripheral neuropathy, increased excitability, irritability, depression, sleep disturbance, drowsiness, weakness; in some cases - confusion, hallucinations, convulsions; very rarely - encephalopathy.
From the urinary side systems: dysuria, cystitis, polyuria, urinary incontinence, staining of urine in red-brown color.
From the reproductive system: pain in the vagina.
Allergic reactions: skin rash, itching, urticaria, erythema multiforme exudative, nasal congestion, fever.
From the musculoskeletal system: myalgia, arthralgia.
From the hematopoietic system: leukopenia; rarely - agranulocytosis, neutropenia, thrombocytopenia, pancytopenia.
Other: flattening of the T wave on the ECG; extremely rare - ototoxicity; pustular rashes.
The drug should be stored out of the reach of children, a dry, dark place at a temperature not exceeding 25 ° C.
Shelf life - 5 years.
- Polpharma SA
- Dosage form
- 250 mg
- Number of tablets
- INN Russian
- Russian title