Klion D 100 pills vaginal 10 pieces
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Active ingredients
Metronidazole + Miconazole
Release form
Pills
Composition
Active ingredient: metronidazole 100 mg, miconazole nitrate 100 mg. Excipients: sodium lauryl sulfate - 0. 5 mg, colloidal silicon dioxide - 7 mg, magnesium stearate - 13 mg, povidone - 26 mg, sodium bicarbonate - 90 mg, tartaric acid - 100 mg, carboxymethyl starch sodium (type A) - 100 mg , crospovidone - 100 mg, hypromellose - 190 mg, lactose monohydrate - 473. 5 mg. Concentration of active ingredient (mg): 200 mg.
Pharmacological effect
Metronidazole, enters the microorganism by passive diffusion. Inside the bacterial cell, it is restored and the biologically active cytotoxic metabolite infects DNA. The enzyme that restores the nitro group of metronidazole, nitro-reductase, is ineffective in the presence of oxygen, which explains the fact that metronidazole acts only under anaerobic conditions. Metronidazole is effective in infecting some protozoa (Trichomonas vaginalis, Entamoeba hystolitica and Giardia lamblia) and obligate anaerobic microorganisms. Spectrum of action: In vitro is effective against all obligate anaerobes (with the exception of Propionibacteria and Actinomycetes). Goam-negative chopsticks: Bacteroides species, including the Bacteroides fragilis group (B. fragilis, B. ovatus, B. thetaiotaomicron), Fusobacterium species. Goam-positive sticks: Clostridium species, Eubacterium species. Goam positive cocci: Peptococcus species and Peptostreptococcus species. The drug is effective against some facultative anaerobes (Gardnerella vaginalis, Helicobacter pylori) and against some spirochaetes.
Pharmacokinetics
The half-life of healthy volunteers from the body is an average of 8 hours. 60-80% of metronidazole and its metabolites are excreted by the kidneys, 6–15% of the administered dose is excreted through the intestine. Tests conducted on healthy volunteers and patients, proved that metronidazole quickly penetrates the cerebrospinal fluid, and reaches a therapeutic concentration in the abscess of the brain or lung. Metronidazole has a large volume of distribution and less than 20% “binds to blood proteins. Metronidazole penetrates the biliary tract and reaches the same concentration as in plasma. The concentration of the drug in the blood plasma is linearly dependent on the dose administered. The solution injected to healthy volunteers in a dose of 100-4000 mg (for eight hours) gave a linearly increasing peak plasma concentration. A single injected solution containing 500 mg of metronidazole gave an average concentration of 11.718 μg / ml of plasma.In patients with impaired hepatic function, a decrease in the clearance of metronidazole was observed. Reduced renal function has no significant effect on the pharmacokinetics of metronidazole. The toxicity of metronidazole during its long-term administration varies between breeds of mice and between different species of animals. For example, the neurological abnormalities described in dogs were not noted on other animal species. High oral doses of the drug in one of the laboratory lines of mice and rats caused a decrease in body weight and atrophy of the testes, but intravenous administration did not affect the weight of the rats and did not cause significant blood pressure deviations, and deviations in hematological and biochemical parameters. High doses of the drug in monkeys caused structural abnormalities of the liver, without deviating the activity of the liver enzymes. A 5-week course of drug administration to mice, at a dose of 1 mg per kg of body weight, did not cause a fatal outcome. In one of the tests, an increase in the incidence of lung and malignant lymphoma tumors was described, but other researchers could not confirm this in Sprague-Dawley rats or hamsters. In vitro metronidazole turned out to be mutagenic on a number of microorganisms, but in vivo tests failed to prove the danger of genetic damage.
Indications
Topical treatment of vaginitis of mixed etiology caused simultaneously by Trichomonas spp. and Candida spp.
Contraindications
Leukopenia (including in history). Organic lesions of the central nervous system (including epilepsy). Liver failure. Pregnancy (I trimester). Lactation period (breastfeeding). Children's age up to 12 years. Hypersensitivity to the drug. Hypersensitivity to other azoles. Precautions should be prescribed the drug for diabetes, microcirculation disorders.
Precautionary measures
With extreme caution prescribed to patients with chronic diseases, abnormal liver function (required dose reduction). With a decrease in Cl creatinine less than 10 ml / min, the daily dose is halved. Prolonged treatment (more than 10 days) requires regular monitoring of clinical and laboratory parameters. It is forbidden to drink alcohol during therapy, since the blockade of acetaldehyde dehydrogenase leads to the development of a disulfiram-like reaction.May reduce the content of glutamyl oxaloacetic transaminase in serum.
Use during pregnancy and lactation
Group: Metronidazole penetrates the hemato-placental barrier. Tests were conducted on rats, in which it was determined that with the administration of a fivefold dose to rats, no adverse effect of the drug was observed either on the fertility of adult rats or on the fetus. With the introduction of the usual dose recommended for the treatment of humans, intraperitoneally pregnant mice, an increase in fetotoxicity was noted, but with the introduction of the same dose orally, no abnormalities were found. Despite this, studies on pregnant women have not been conducted. A meta-analysis of studies with the administration of metronidazole was conducted in the first three months of pregnancy and concluded that there was no increase in negative effects on the fetus. Despite this, metronidazole during pregnancy, especially in the first trimester of pregnancy, can be prescribed only after a careful assessment of the expected benefits and negative aspects of using the drug. Breastfeeding: Metronidazole is found in breast milk at a concentration equal to its concentration in plasma. It can give the milk a bitter taste. In order to avoid a negative effect of the drug on the child, it is necessary to stop either breastfeeding during the treatment and after stopping the course for another 1-2 days, or using the drug, depending on how important the course of therapy is for the mother.
Dosage and administration
Intravaginally. On 1 vaginal tablet (previously having moistened with water) enter deeply into a vagina in the evening before going to bed for 10 days in combination with taking the drug metronidazole inside.
Side effects
Local reactions: burning, itching, pain and irritation of the vaginal mucosa. thick, white, mucous discharge from the vagina without odor or with a faint odor. burning sensation or irritation of the penis of the partner. On the part of the digestive system: nausea, vomiting, change in taste, metallic taste in the mouth, loss of appetite, abdominal pain, spastic character, constipation or diarrhea. From the side of the central nervous system: headache, dizziness. From the hemopoietic system: leukopenia or leukocytosis.Allergic reactions: urticaria, itchy skin, rash. On the part of the urinary system: urine staining in red-brown color due to the presence of water-soluble pigment (metronidazole metabolite - 2 oxymetronidazole), resulting from the metabolism of metronidazole.
Overdose
When overdose symptoms appear (nausea, vomiting, ataxia), symptomatic therapy is performed (gastric lavage, administration of activated carbon, hemodialysis), as metronidazole does not have a specific antidote. Metronidazole and its metabolites are well eliminated by hemodialysis.
Interaction with other drugs
Enhances the action of oral anticoagulants, which leads to an increase in prothrombin time. Similar to disulfiram, it causes intolerance to ethanol. Simultaneous use with disulfiram can lead to the development of various neurological symptoms (the interval between administration is at least 2 weeks). Cimetidine inhibits the metabolism of metronidazole, which can lead to an increase in its concentration in serum and an increase in the risk of adverse reactions. The inducers of enzymes of microsomal oxidation of the liver (phenytoin, phenobarbital) are able to accelerate the elimination of metronidazole, which leads to a decrease in its concentration in blood plasma. When taken simultaneously with lithium preparations, it is possible to increase the concentration of the latter in plasma and the development of symptoms of intoxication. Not recommended in combination with non-depolarizing muscle relaxants (vecuronium bromide). Sulfonamides enhance the antimicrobial action of metronidazole.
special instructions
During treatment, alcohol is contraindicated (a disulfiram-like reaction may develop: spastic abdominal pain, nausea, vomiting, headache, sudden flushing). With prolonged therapy, it is necessary to control the blood picture. In case of 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. Metronidazole is able to immobilize treponemas, which leads to a false Nelson test.When treating Trichomonas vaginitis in women and Trichomonas urethritis in men, patients should refrain from sex. Necessarily simultaneous treatment of sexual partners. The treatment does not stop during menstruation. 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 to perform 3 feces analyzes at intervals of several days (in some successfully treated patients, lactose intolerance caused by invasion may persist for several weeks or months, recalling the symptoms of giardiasis). It paints urine in a dark color. Use in pediatrics. In combination with amoxicillin is not recommended for use in children and adolescents under 18 years of age.