Trichopol, tablets 250 mg 20 pcs

An antiprotozoal drug with antibacterial activity, a derivative of 5-nitroimidazole. Mechanism of action consists in biochemical reduction of 5-nitrogroup of metronidazole by intracellular transport proteins of anaerobic microorganisms and protozoa. The reduced 5-nitrogroup of metronidazole interacts with the DNA of the microbial cell, inhibiting the synthesis of their nucleic acids, which leads to the death of the microorganisms.

Metronidazole is active against Trichomonas vaginalis, Entamoeba histolytica, Gardnerella vaginalis, Giardia intestinalis, Lamblia spp.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 MPC for these strains is 0.125-6.25 µg/ml.

In combination with amoxicillin it shows activity against Helicobacter pylori (amoxicillin suppresses the development of resistance to metronidazole).

Metronidazole has no bactericidal effect against most bacteria and facultative anaerobes, fungi and viruses. In the presence of mixed flora (aerobes and anaerobes) metronidazole shows synergism with antibiotics effective against common aerobes.

Metronidazole increases the sensitivity of tumors to radiation, causes sensitization to ethanol (disulfiram-like action), stimulates reparative processes.

Indications

Active ingredient

Composition

1 tablet:

– metronidazole 250 mg;

excipients:

potato starch,

gelatin,

molasses starch,

magnesium stearate.

How to take, the dosage

The drug is prescribed orally, with or after meals, the tablets are taken without chewing.

Trichomoniasis

Adults and children over 10 years of age are prescribed 250 mg (1 tablet) 3 times daily or 500 mg (2 tablets) 2 times daily for 7 days. Women should additionally be prescribed metronidazole in the form of vaginal suppositories or tablets. If necessary, the course of treatment may be repeated. Between courses of treatment a break of 3-4 weeks should be taken with repeated laboratory tests.

An alternative therapy regimen is to prescribe 750 mg (3 tablets) in the morning and 1250 mg (5 tablets) in the evening or 2000 mg (8 tablets)/day once. The duration of treatment is 2 days. The treatment is carried out simultaneously in both sexual partners.

Children aged 3 to 7 years are prescribed 125 mg (1/2 tablet) 2 times/day; aged 7 to 10 years, 125 mg (1/2 tablet) 3 times/day. The course of treatment is 7 days.

Bacterial vaginosis

Adults are prescribed 500 mg (2 tablets) 2 times/day for 7 days or 2000 mg (8 tablets)/day once. Simultaneous treatment of the sexual partner is not required.

Amoebiasis

In invasive forms of intestinal amoebiasis in susceptible patients (including amoebic dysentery), adults and children over 10 years of age are prescribed 750 mg (3 tablets) 3 times daily. Children aged 3 to 7 years are prescribed 250 mg (1 tablet) 4 times daily; children aged 7 to 10 years are prescribed 375 mg (1.5 tablets) 3 times daily. The course of treatment is usually 5 days.

In intestinal amebiasis in less susceptible patients and in chronic amebic hepatitis, adults and children over 10 years of age are given 375 mg (1.5 tablets) 3 times daily. For children aged 3 to 7 years old – 125 mg (1/2 tablet) 4 times per day; for children aged 7 to 10 years old – 250 mg (1 tablet) 3 times per day. The duration of treatment course is 5-10 days.

In amebic liver abscess and other forms of extraintestinal amoebiasis, adults and children over 10 years of age are prescribed 375 mg (1.5 tablets) 3 times/day. For children aged 3 to 7 years old – 125 mg (1/2 tablet) 4 times daily; for children aged 7 to 10 years old – 250 mg (1 tablet) 3 times daily. The course of treatment is 5 days.

In asymptomatic cyst carriers, adults and children over 10 years of age are given 375-750 mg (1.5-3 tablets) 3 times daily. For children aged 3 to 7 years old – 125 mg (1/2 tablet) 4 times daily; for children aged 7 to 10 years old – 250 mg (1 tablet) 3 times daily. The course of treatment is 5-10 days.

Lambliosis

Adults and children over 10 years of age are prescribed 500 mg (2 tablets) 2 times/day for 5 to 7 days; or 2000 mg (8 tablets) 1 time/day for 3 days.

In children aged 3 to 7 years, 250-375 mg (1-1.5 tablets) once daily for 5 days, or 500-750 mg (2-3 tablets) once daily for 3 days. For children 7 to 10 years old, 250 mg (1 tablet) 2 times a day for 5 days, or 1000 mg (4 tablets) 1 time a day for 3 days.

Periodontal infections

In acute ulcerative gingivitis, adults and children over 10 years of age are prescribed 250 mg (1 tablet) 3 times daily. For children aged 3 to 7 years old – 125 mg (1/2 tablet) 2 times a day; for children aged 7 to 10 years old – 125 mg (1 tablet) 3 times a day. The duration of the course of treatment is 3 days.

In acute odontogenic infections in adults and children over 10 years of age it is indicated for 250 mg (1 tablet) 3 times daily for 3-7 days.

Infections caused by anaerobic bacteria

The treatment of anaerobic infections usually begins with IV 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 tablets) 3-4 times daily. The duration of treatment should not exceed 7 days.

In children under 10 years of age in the treatment of anaerobic infections it is recommended to use metronidazole in the form of infusion solutions.

Eradication of Helicobacter pylori

Prescribe 500 mg (2 tablets) 3 times daily for 7 days (in combination therapy, for example, with amoxicillin 2.25 g/day).

Prophylaxis of infections caused by anaerobic bacteria (before surgical operations on abdominal cavity, in gynecology and obstetrics)

Adults and children over 12 years are prescribed on 250-500 mg (1-2 tablets) 3 times/day 3-4 days before surgery. 1-2 days after surgery (when oral administration is already allowed) it is prescribed 250 mg (1 tablet) 3 times a day for 7 days.

In severe renal failure (CKR less than 10 ml/min) the daily dose of Trichopolol should be reduced by half.

Interaction

Metronidazole increases the effects of warfarin and other coumarin anticoagulants (doses of both drugs must be reduced with this combination).

Similar to disulfiram, metronidazole causes ethanol intolerance. Simultaneous use of Trichopol with disulfiram may lead to the development of various neurological symptoms (the interval between the use of these drugs should be at least 2 weeks).

Cimetidine inhibits metabolism of metronidazole, which may increase its plasma concentrations and increase the risk of adverse reactions.

The concomitant administration of drugs that stimulate hepatic microsomal enzyme activity (phenobarbital, phenytoin) may accelerate elimination of metronidazole, which leads to decreased plasma concentrations.

In patients receiving long-term treatment with high-dose lithium medications, metronidazole may increase plasma lithium concentrations and develop intoxication symptoms.

It is not recommended to combine metronidazole with nondepolarizing myorelaxants (vecuronium bromide).

When combined use of metronidazole and cyclosporine, increased plasma concentrations of cyclosporine may be observed.

Metronidazole decreases clearance of fluorouracil, which may increase the toxicity of the latter.

Sulfonamides increase the antimicrobial effects of metronidazole.

Special Instructions

Caution should be exercised when prescribing Trichopol® to patients with severe hepatic impairment because metronidazole and its metabolites increase in plasma concentrations due to delayed metabolism.

Because of the delayed excretion, caution is required in choosing a dose of metronidazole in patients with renal impairment.

Caution is required when prescribing Trichopol in patients with suppression of medullary hematopoiesis and CNS functions as well as elderly patients. Appearance of ataxia, dizziness and any other deterioration of the neurological status of patients requires discontinuation of treatment.

When long-term therapy with metronidazole (more than 10 days) the peripheral blood count and liver function should be monitored.

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

The use of metronidazole should be avoided in patients with porphyria.

Trichopol® may cause immobilization of treponemes, resulting in a false positive Nelson’s test.

The treatment of trichomonas vaginitis in women and trichomonas urethritis in men requires abstinence from sexual activity. The simultaneous treatment of sexual partners is mandatory. After the therapy of trichomoniasis, control tests should be performed for three consecutive cycles before and after menstruation.

After treatment of giardiasis, if the symptoms persist, three stool tests should be carried out after 3-4 weeks, with an interval of several days (some successfully treated patients may have lactose intolerance caused by the infestation for weeks or months, resembling the symptoms of giardiasis).

Patients should refrain from drinking alcohol during therapy with metronidazole, and for at least 48 hours after treatment completion, because of the possibility of developing disulfiram-like reactions: spastic abdominal pain, nausea, vomiting, headache, sudden rush of blood to the face.

During treatment with metronidazole, urine may become dark or red-brown due to the presence of water-soluble dyes.

Pediatric use

Trichopol® is not recommended in combination with amoxicillin in children and adolescents under 18 years of age.

Impact on driving and operating machinery

When taking the drug, avoid potentially hazardous activities requiring increased concentration and quick psychomotor reactions, especially driving vehicles and operating machinery.

Contraindications

Side effects

Digestive system disorders: epigastric pain, nausea, vomiting, diarrhea, constipation, intestinal colic, decreased appetite, anorexia, taste disorders, unpleasant metallic taste in the mouth, dry mouth, glossitis, stomatitis; very rarely – abnormal liver function tests, cholestatic hepatitis, jaundice, pancreatitis.

CNS disorders: with long-term use – headache, dizziness, movement coordination disorders, ataxia, peripheral neuropathy, hyperexcitability, irritability, depression, sleep disturbance, somnolence, weakness; in single cases – mental confusion, hallucinations, seizures; very rare – encephalopathy.

Urinary system disorders: dysuria, cystitis, polyuria, urinary incontinence, staining of urine red-brown.

In the genital system: pain in the vagina.

Allergic reactions: skin rash, itching, urticaria, erythema multiforme, nasal congestion, fever.

Muscular system disorders: myalgia, arthralgia.

Hematopoietic system: leukopenia; rarely agranulocytosis, neutropenia, thrombocytopenia, pancytopenia.

Others: flattening of the T wave on ECG; very rarely ototoxicity; pustular rash.

Overdose

Symptoms: increased side effects, mainly nausea, vomiting and dizziness; in more severe cases ataxia, paresthesias and seizures are possible. The lethal dose in humans is unknown.

Treatment: conduct symptomatic and supportive therapy. There is no specific antidote.

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