Trichopol tablets 250mg №10×2

Name:
Trichopolum
Description:
Tablets are white, with a yellowish tint, turn yellow under the influence of light, round, flat on both sides, with a dividing risk on one side. The main active substance Metronidazole Release formTrichopol® tablets are packed in 20 pieces in blisters of Al / PVC foil (2 blisters of 10 tablets) and placed in a lithographic carton. Dosage 250 mg Pharmacological action Metronidazole is a derivative of 5-nitroimidazole with antiprotozoal and antibacterial action. Metronidazole penetrates into unicellular organisms, protozoa and bacteria, does not penetrate into mammalian cells. The oxidoreduction potential of metronidazole is less than that of ferredoxin, a protein that transports electrons. This protein is found in anaerobic and microaerobic organisms. The potential difference leads to the reduction of the metronidazole nitro group. The reduced form of metronidazole is capable of damaging the DNA strand in these organisms. Metronidazole is active against Trichomonas vaginalis, Giardia lamblia, Entamoeba histolytica and Balantidium coli. It also has a bactericidal effect against anaerobic bacteria: gram-negative rods: Bacteroides species, including the Bacteroides fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Fusobacterium species; gram-positive rods: Eubacterium, Clostridium; Gram-positive cocci: Peptococcus species, Peptostreptococcus species. Metronidazole does not have a bactericidal effect on most aerobic and partially anaerobic bacteria, fungi and viruses. Indications for use Metronidazole is intended for use in adults and children with the following indications: treatment of infections caused by anaerobic bacteria of the genus Bacteroides, Fusobacterium, Clostridium, Eubacterium, anaerobic cocci and Gardnerella vaginalis, as well as the protozoa Trichomonas, Entamoeba histolytica, Giardia lamblia and Balantidium; prevention of postoperative infections caused by anaerobic bacteria, including Bacteroides and Streptococcus species; treatment of infections caused by anaerobic bacteria (sepsis, bacteremia, peritonitis, brain abscess, pneumonia, osteomyelitis, puerperal fever, abscess in the pelvic area, endometritis, inflammation of surgical wounds after surgical interventions); trichomonas infection of the genitourinary system in both women and men; bacterial vaginosis; amoebiasis; giardiasis; acute ulcerative gingivitis; acute periodontitis; trophic ulcers of the lower extremities and bedsores; combined therapy of peptic ulcer with simultaneous eradication of Helicobacter pylori. Consideration should be given to local formal recommendations regarding the appropriate use of antibacterial drugs. Dosage and administration Trichopol® should always be used in accordance with the doctor’s recommendations. In case of doubt, a doctor should be consulted. The following dosing is usually recommended: Prevention of infections caused by anaerobic bacteria Adults and children over 12 years of age: at the beginning of treatment, 1 g (4 tablets of 250 mg) once, then 1 tablet of 250 mg 3 times a day during or after meals, until the period of immediate preparation of the patient for surgery. Children aged 5-12 years: 125 mg every 8 hours for 2 days, a dose of 20-30 mg / kg body weight / day is prescribed once 1-2 hours before surgery. Children from 3 to 5 years old: dose at the rate of 5 mg/kg of body weight every 8 hours for 2 days. Treatment of infections caused by anaerobic bacteria Metronidazole is used as a single drug or in combination with other antibacterial agents. Usually the course of treatment does not exceed 7 days. Adults and children over 12 years old: 1-2 tablets of 250 mg are prescribed 3 times a day during or after meals. Children from 3 to 12 years old: a dose of 7.5 mg/kg of body weight is prescribed 3 times a day during or after meals. Trichomoniasis Adults and children over 10 years: 2000 mg once, or 250 mg 3 times a day for 7 days, or 500 mg 2 times a day for 5-7 days. Note: simultaneous treatment of both sexual partners is carried out. Children under 10 years old: dose at the rate of 40 mg / kg orally, once or at the rate of 15-30 mg / kg of body weight / day in 2-3 doses for 7 days. A single dose should not exceed 2000 mg. Bacterial vaginosis Adults: 500 mg (2 x 250 mg tablets) morning and evening for 7 days or 2000 mg once. Amoebiasis Adults: 750 mg (3 x 250 mg tablets) 3 times a day for 5-10 days. Adolescents and children over 10 years old: 500-750 mg 3 times a day for 5-10 days. Children aged 7 to 10 years: 250 mg 3 times a day for 5 to 10 days. Alternatively, the dose may be expressed in milligrams per kg of body weight: 35-50 mg/kg of body weight per day in 3 doses for 5-10 days, not exceeding a dose of 2400 mg/day. Giardiasis (giardiasis) Adults: 250 mg 3 times a day for 5-7 days or 2000 mg once a day for 3 days. Adolescents and children over 10 years of age: 2000 mg once daily for 3 days or 500 mg twice daily for 7 to 10 days. Children aged 7 to 10 years: 1000 mg once daily for 3 days. Children aged 3 to 7 years: 750 mg once daily for 3 days. Alternatively, the dose may be expressed in milligrams per kg body weight: 15-40 mg/kg body weight/day in 2-3 divided doses. Eradication of Helicobacter pylori Metronidazole should be taken for at least 7 days in combination with other drugs for the eradication of Helicobacter pylori. Adults: appoint 500 mg (2 tablets of 250 mg) in 2-3 doses per day for 7-14 days. Children and adolescents: as combination therapy, 20 mg/kg body weight/day not exceeding 500 mg twice daily for 7-14 days. Please read these Therapy Requirements before starting treatment. Acute ulcerative gingivitis Adults: 250 mg 2-3 times a day for 3 days. Children: 35-50 mg/kg body weight/day in 3 divided doses for 3 days. Acute periodontitis Adults: 250 mg 2-3 times a day for 3-7 days. Trophic ulcers of the lower extremities and bedsores Adults: 500 mg 2 times a day for 7 days. Use in children under 3 years of age This dosage form is indicated for children from 3 years of age. Use in patients with hepatic insufficiency Metronidazole is biotransformed mainly by oxidation in the liver. In patients with severe hepatic insufficiency, metronidazole is biotransformed slowly, which can lead to accumulation of metronidazole and its metabolites in the body. The drug can accumulate to a large extent in patients with hepatic encephalopathy, and high plasma concentrations of metronidazole can cause encephalopathy. The daily dose, which can be administered once, should be reduced to ⅓. Use in patients with renal insufficiency In renal insufficiency, the biological half-life of metronidazole does not change. Reducing the dose of the drug in this case is not necessary. In patients on hemodialysis, metronidazole and its metabolites are removed within 8 hours. Immediately after dialysis, metronidazole should be re-administered to the patient. In patients on fractional peritoneal dialysis or continuous dialysis, there is no need for dose modification. Use in elderly patients The drug should be used with caution in elderly patients, especially when taking high doses. How to use: ATTENTION! Tablets can be crushed for ease of use in children. The drug can be used regardless of the meal. Missing a dose of the drug If you miss a dose of the drug, it should be taken as soon as possible. Do not take a double dose to make up for a missed dose. Use during pregnancy and lactation Before using any medicine, you should consult your doctor. Pregnancy There are no well-controlled studies of the use of metronidazole in pregnant women. Metronidazole crosses the placental barrier. Metronidazole is contraindicated in the first trimester of pregnancy. In the second and third trimester of pregnancy, the drug should be taken only if the potential benefit of using the drug in a pregnant woman outweighs the risk of adverse effects on the fetus. Breastfeeding Metronidazole is excreted in breast milk reaching concentrations comparable to plasma levels of the drug. During breastfeeding, the drug should not be taken. If treatment is necessary, breastfeeding should be discontinued. Precautions Metronidazole has no direct effect on aerobic and facultative anaerobic bacteria. There is a possibility of persistence of gonococcal infection after elimination of Trichomonas vaginalis. Patients should be warned that metronidazole may darken the urine. Due to insufficient data on mutagenic risk in humans, caution should be exercised in the use of metronidazole for longer treatment than is usually required. When using metronidazole, cases of severe, sometimes fatal, bullous skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, have been reported (see “Side Effects”). Most reported cases of SDS occurred within 7 weeks of starting metronidazole treatment. If symptoms of SDS or TEN are present (eg, flu-like symptoms, progressive skin rash, often with blistering or mucosal lesions), treatment should be discontinued. Metronidazole should be used with caution in patients with active or chronic disease of the central or peripheral nervous system due to the risk of exacerbation of neurological symptoms. Patients who have neurological disorders (numbness, crawling or convulsions) during the treatment period can take the drug only if the benefit of its use outweighs the possible risk of complications. The drug should be used with caution in patients with severe hepatic insufficiency and hepatic encephalopathy (see “Method of application and dosage”). The drug should be used with caution in patients with severe renal insufficiency (see “Method of application and dosage”). Metronidazole should be used with caution in patients treated with corticosteroids and prone to edema. Patients who have changes in the blood picture before and after treatment with metronidazole, if necessary, re-use of metronidazole should be under medical supervision. During treatment, the blood picture should be monitored. If the drug is used for more than 10 days, such control is mandatory. After the use of metronidazole, candidiasis of the oral cavity, vagina and gastrointestinal tract may develop, which requires appropriate treatment. During treatment with metronidazole and at least 48 hours after the end of therapy, alcohol should not be taken due to the risk of developing a disulfiram reaction (see also “Interaction with other drugs and other forms of interaction”). Metronidazole may change some laboratory parameters (ALT, ACT, lactate dehydrogenase, triglycerides, glucose). Given the glucose content of the drug, patients with glucose-galactose malabsorption should not take this drug. Influence on the ability to drive vehicles and maintain mechanisms Patients who develop side effects from the central nervous system (drowsiness, dizziness, confusion, hallucinations, convulsions, visual impairment) should not drive a vehicle and work with dangerous mechanisms. Interaction with other drugs Metronidazole enhances the toxic effect of alcohol. Taking alcoholic beverages during treatment with the drug can cause unwanted reactions, such as a feeling of heat, sweating, headache, nausea, vomiting, epigastric pain. You should refrain from drinking alcohol during treatment with metronidazole and for at least 48 hours after treatment due to the possibility of developing a disulfiram-like (antabuse effect) reaction. When using metronidazole in conjunction with oral anticoagulants of the warfarin group, some potentiation of the effect of anticoagulant therapy was noted. A dose reduction of the anticoagulant may be required. It is necessary to observe the indicator of prothrombin time in dynamics. Interaction with heparin was not observed. Drugs that activate liver microsomal enzymes, such as phenytoin and phenobarbital, accelerate the elimination of metronidazole, reducing the half-life to approximately 3 hours, resulting in a decrease in the serum concentration of the drug, while drugs that reduce the activity of liver enzymes (eg, cimetidine) may increase the half-life of metronidazole. In patients who simultaneously received lithium preparations and metronidazole, lithium retention was noted, accompanied by signs of possible kidney damage. Before using metronidazole, you should reduce the dose of lithium preparations taken or completely stop taking the latter. In patients receiving concomitant lithium preparations and metronidazole, monitoring of the concentrations of lithium, creatinine and electrolytes in plasma in dynamics should be carried out. Metronidazole can cause undesirable effects on the part of the circulatory system when interacting with terfenadine and astemizole (on the ECG, QT interval prolongation, arrhythmia). Simultaneous administration of metronidazole and disulfiram can sometimes cause acute psychosis and disorientation. Treatment with metronidazole can be started 2 weeks after the end of treatment with disulfiram. Metronidazole can increase the plasma levels of busulfan, which can lead to the development of severe toxic effects of busulfan. Metronidazole belongs to inhibitors of cytochrome P450 3A4 (CYP3A4) and, therefore, can slow down the biotransformation of drugs that are metabolized with the participation of this enzyme. By decreasing the clearance of 5-fluorouracil, metronidazole may increase its toxicity. Patients receiving cyclosporine are at risk of elevated serum levels of cyclosporine. If necessary, simultaneous use should be closely monitored for levels of serum cyclosporine and serum creatinine in dynamics. Metronidazole may interact with drugs that prolong the QT interval such as amiodarone, ciprofloxacin, levofloxacin, sparfloxacin, erythromycin, clarithromycin, mefloquine, ketoconazole, cisapride, tamoxifen, donepezil, haloperidol, pimozide, thioridazine, mesoridazine. Contraindications Hypersensitivity to the active substance or any excipient. First trimester of pregnancy. For this dosage form, the use of the drug in children under 3 years of age is not indicated. Composition One tablet contains: active ingredient: metronidazole 250 mg; excipients: potato starch, gelatin, liquid glucose, magnesium stearate. Overdose In case of taking the drug in a dose greater than recommended, you should immediately consult a doctor. Side effects Like all medicines, Trichopolum® can have side effects, although not everybody gets them. The frequency of development of reactions is defined as follows: very frequent (≥1/10), frequent (≥1/100 and <1/10), infrequent (≥1/1000 and <1/100), rare (≥1/10000 and < 1/1000), very rare (<1/10000), with unknown frequency (cannot be estimated from the available data). The frequency of cases, the type and intensity of manifestation of undesirable effects in children are the same as in adults. Severe side effects are rare with recommended treatment regimens. If the clinician wants to conduct long-term therapy in the treatment of chronic diseases, longer than recommended, should evaluate the balance of potential therapeutic benefit and risk of peripheral neuropathy. Blood and lymphatic system disorders Very rare: agranulocytosis, neutropenia, thrombocytopenia, pancytopenia. With an unknown frequency: leukopenia. Immune system disorders Rare: anaphylaxis. With an unknown frequency: angioedema, urticaria, fever. Metabolic and nutritional disorders Not known: anorexia. Psychiatric disorders Very rare: Psychiatric disorders, including confusion and hallucinations. With an unknown frequency: depression. Nervous system disorders Very rare: encephalopathy (eg, confusion, fever, headache, hallucinations, paralysis, photophobia, visual and movement disturbances, neck stiffness) and subacute cerebellar syndrome (eg, ataxia, dysarthria, gait disturbance, nystagmus and tremor), which are reversed after the abolition of metronidazole; drowsiness, dizziness, convulsions, headache. Not known: Peripheral sensory neuropathy or transient epileptic seizures, usually resolving after discontinuation of the drug or dose reduction; aseptic meningitis. On the part of the organ of vision Very rare: transient visual disturbances, including diplopia and myopia. Frequency not known: Optic neuropathy or neuritis Gastrointestinal disorders Not known: taste disturbance, stomatitis, coated tongue, nausea, vomiting, epigastric pain, diarrhea Liver and biliary tract disorders Very rare: increased levels liver enzymes (ACT, ALT, alkaline phosphatase), cholestatic or mixed hepatitis and hepatocellular liver damage, jaundice and pancreatitis, which is reversible after discontinuation of the drug. In patients treated with metronidazole in combination with other antibiotics, there have been cases of liver failure requiring liver transplantation. Skin and subcutaneous tissue disorders Very rare: rash, pustular skin rash, pruritus, skin flushing Not known: erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis. Musculoskeletal and connective tissue disorders Very rare: myalgia, arthralgia Renal and urinary disorders Very rare: dark urine due to the presence of metronidazole pigments. Genital and breast disorders Not known: Vaginal pain and candidiasis. In the event of any of the above or other undesirable effects not listed in this leaflet, you must inform your doctor or pharmacist about them. Storage conditionsStore in a place protected from moisture and light, at a temperature not exceeding 25°C. Keep out of the reach of children. Medicines must not be flushed down the drain or thrown into the wastebasket. Ask the pharmacist what to do with unused medicines. This is necessary to protect the environment. Shelf life 3 years Do not use the drug after the expiration date indicated on the package. The expiration date means the last day of the specified month. Buy Trichopol tablets 250mg No. 10x2