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Active ingredients
Metronidazole
Release form
Pills
Composition
Excipients: propylene glycol - 40 g, vaseline - 12.5 g, vaseline oil - 7.5 g, emulsion wax - 5 g, macrogol (polyethylene oxide 1500) - 1 g, purified water - up to 100 g
Pharmacological effect
Anti-protozoan drug with antibacterial activity, a derivative of 5-nitroimidazole. 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 restored 5-nitro group of metronidazole interacts with the microbial cell DNA, 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 .; as well as 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 positive microorganisms (Eubacterium spp., Clostridium spp., Peptococcus spp., Peptostreptococcus spp.). The MIC for these strains is 0.125-6.25 mcg / ml. In combination with amoxicillin, it is active against Helicobacter pylori (amoxicillin inhibits the development of metronidazole resistance). Metronidazole has no bactericidal action against most bacteria and facultative anaerobes, fungi and viruses. In the presence of mixed flora (aerobes and anaerobes), metronidazole is synergistic with antibiotics that are effective against conventional aerobes. Metronidazole increases the sensitivity of tumors to radiation, causes sensitization to ethanol (disulfiram-like action), stimulates reparative processes.
Indications
trichomoniasis; bacterial vaginosis; all forms of amebiasis (diseases of the intestinal and extra-intestinal localization, including amebic liver abscess, amoebic dysentery, as well as asymptomatic amebiasis); giardiasis; 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 Helicobacter pylori infections in gastric or duodenal ulcers in combination with bismuth preparations and an antibiotic, for example, amoxicillin; prophylactic appointment before surgery on the gastrointestinal tract and reproductive organs.
Contraindications
leukopenia (including in history); organic lesions of the central nervous system (includingepilepsy); liver failure (in the case of the appointment of the drug in high doses); I trimester of pregnancy; lactation period (breastfeeding); children up to 3 years; hypersensitivity to metronidazole or other derivatives of nitroimidazole, as well as to any other components of the drug. Precautions should be prescribed the drug to patients with renal and / or liver failure, in the II and III trimesters of pregnancy.
Use during pregnancy and lactation
Trichopolum is 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 outweighs the potential risk to the fetus. If necessary, use Trichopolum during lactation breastfeeding should be discontinued.
Dosage and administration
The drug is prescribed inside, during or after a meal, pills are taken without chewing. Trichomoniasis Adults and children over 10 years old are prescribed 250 mg (1 tab.) 3 times / day or 500 mg (2 tab.) 2 times / day for 7 days. Women should also be prescribed metronidazole in the form of vaginal suppositories or pills. If necessary, you can repeat the treatment. Between courses, you should take a break of 3-4 weeks with repeated laboratory tests. An alternative treatment regimen is the administration 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 with both sexual partners. Children aged 3 to 7 years, appoint 125 mg (1/2 tab.) 2 times / day; at the age of 7 to 10 years - 125 mg (1/2 tab.) 3 times / day. The course of treatment is 7 days. Bacterial vaginosis 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. Amebiasis In invasive forms of intestinal amebiasis in susceptible patients (including those with amoebic dysentery), 750 mg (3 pills) are prescribed to adults and children over 10 years of age 3 times / day. Children aged 3 to 7 years - 250 mg (1 tab.) 4 times / day; at the age of 7 to 10 years old - at 375 mg (1.5 tab.) 3 times / day. The course of treatment is usually 5 days. In intestinal amebiasis in less susceptible patients and in chronic amoebic hepatitis, adults and children over 10 years old are prescribed 375 mg (1.5 tab.) 3 times / day.Children aged 3 to 7 years old - 125 mg each (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. In amoebic abscess of the liver and other forms of extraintestinal amebiasis, adults and children over 10 years old 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 each (1 tab.) 3 times / day. The course of treatment is 5 days. For asymptomatic cysts carriage, adults and children over 10 years old are prescribed 375-750 mg (1.5-3 pills) 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 each (1 tab.) 3 times / day. Duration of treatment is 5-10 days. Giardiasis Adults and children over 10 years old are prescribed 500 mg (2 pills) 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 each (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. Periodontal infections In acute ulcerative gingivitis, adults and children over 10 years old 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 each (1 tab.) 3 times / day. Duration of treatment is 3 days. In acute odontogenic infections, adults and children over 10 years old 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 IV infusions. As soon as it becomes possible, treatment should be continued with metronidazole in the form of pills. Adults and children over 10 years old are prescribed 500 mg (2 tab.) 3-4 times / day. The duration of treatment should not exceed 7 days. Children under 10 years old when treating anaerobic infections are advised to use metronidazole in the form of infusion solutions. 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 surgery on the abdomen, in gynecology and obstetrics) Adults and children over 12 years old are prescribed 250-500 mg (1-2 pills) 3 times / day for 3-4 days before surgery. 1-2 days after the operation (when oral administration is already permitted), 250 mg (1 tab.) Are prescribed 3 times / day for 7 days.In case of severe renal failure (CC less than 10 ml / min), the daily dose of Trichopol should be reduced by 2 times.
Side effects
On the part of the digestive system: epigastric pain, nausea, vomiting, diarrhea, constipation, intestinal colic, loss of appetite, anorexia, taste disturbance, unpleasant metallic taste in the mouth, dry mouth, glossitis, stomatitis; very rarely - abnormal liver function tests, cholestatic hepatitis, jaundice, pancreatitis. From the side of the central nervous system: with prolonged use - headache, dizziness, incoordination, ataxia, peripheral neuropathy, irritability, irritability, depression, sleep disturbance, drowsiness, weakness; in some cases - confusion, hallucinations, convulsions; very rarely - encephalopathy. On the part of the urinary system: dysuria, cystitis, polyuria, urinary incontinence, urine staining in red-brown color. On the part of the reproductive system: pain in the vagina. Allergic reactions: skin rash, pruritus, urticaria, erythema multiforme, nasal congestion, fever. From the musculoskeletal system: myalgia, arthralgia. From the hemopoietic system: leukopenia; rarely - agranulocytosis, neutropenia, thrombocytopenia, pancytopenia. Other: flattening of the T wave on the ECG; extremely rarely - ototoxicity; pustular rash.
Overdose
Symptoms: increased side effects, mainly nausea, vomiting and dizziness; in more severe cases, ataxia, paresthesia and convulsions are possible. The lethal dose for humans is unknown. Treatment: symptomatic and supportive therapy. The specific antidote is absent.
Interaction with other drugs
Metronidazole enhances the action 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 Trichopol 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 plasma and an increased risk of adverse reactions. The 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 blood plasma.In patients receiving long-term treatment with lithium preparations in high doses, when taking metronidazole, it is possible to increase the concentration of lithium in the blood plasma and develop intoxication symptoms. It is not recommended to combine metronidazole with non-depolarizing muscle relaxants (vecuronium bromide). With the combined intake of metronidazole and cyclosporine, an increase in plasma concentration of cyclosporine may be observed. Metronidazole reduces the clearance of fluorouracil, which can cause an increase in the toxicity of the latter. Sulfonamides enhance the antimicrobial action of metronidazole.
special instructions
Caution should be given to Trichopolus in patients with severe liver failure, because as a result of slower metabolism, plasma concentration of metronidazole and its metabolites increases. Due to slower excretion, care must be taken when choosing a dose of metronidazole in patients with renal insufficiency. Care is required in appointing Trihopol 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 prolonged therapy with metronidazole (more than 10 days), the picture of peripheral blood and liver function should be monitored. In case of 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, which leads to a false-positive Nelson test. When treating Trichomonas vaginitis in women and Trichomonas urethritis in men, it is necessary to abstain from sex. Necessarily simultaneous treatment of sexual partners. After treatment of trichomoniasis, control tests should be carried out during three regular cycles before and after menstruation. After giardiasis treatment, if symptoms persist, after 3-4 weeks it is necessary to perform 3 stool tests at intervals of several days (for some successfully treated patients, lactose intolerance caused by invasion may persist for several weeks or months, recalling the symptoms of giardiasis).Patients should refrain from drinking alcohol during metronidazole therapy, and also for at least 48 hours after completion of treatment, due to the possibility of disulfiram-like reactions: abdominal pain of a spastic nature, nausea, vomiting, headache, a sudden rush of blood to to face. During treatment with metronidazole, urine may acquire a dark or red-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. Impact on the ability to drive vehicles and control mechanisms When taking the drug should be avoided potentially hazardous activities that require increased concentration of attention, speed of psychomotor reactions, especially driving vehicles and maintenance mechanisms.