Ornidazole-OBL 500mg N10 Coated Tablets
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Active ingredients
Ornidazole
Release form
Pills
Composition
Active ingredient: Ornidazole Concentration of the active substance (mg): 500 mg
Pharmacological effect
Antiprotozoal drug, a derivative of 5-nitroimidazole. The mechanism of action consists in the biochemical reduction of the 5-nitro group of ornidazole with intracellular transport proteins of anaerobic bacteria and protozoa. The restored 5-nitro group of ornidazole interacts with the DNA of microorganism cells, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria. It is active against Trichomonas vaginalis, Giardia lamblia, Entamoeba histolytica, and also against anaerobic bacteria Bacteroides spp. (including Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Clostridium spp. Aerobic microorganisms are not sensitive to ornidazole.
Pharmacokinetics
Absorption and distribution Absorption from the gastrointestinal tract is high. Bioavailability - 90%. The time to reach Cmax is 1-2 hours. Binding to plasma proteins is less than 15%. It penetrates into most tissues, passes through the BBB and placental barrier. It is excreted in breast milk. Metabolism and excretion Metabolized in the liver by hydroxylation, oxidation and glucuronidation. T1 / 2 - 12-14 hours. It is excreted as metabolites by the kidneys (60-70%) and with feces (20-25%), about 5% of the dose is excreted unchanged.
Indications
Trichomoniasis, amebiasis, amebic dysentery, extraintestinal amebiasis (including amebic abscess of the liver); giardiasis; prevention of infections caused by anaerobic bacteria during operations on the colon and in gynecology.
Contraindications
Hypersensitivity, pregnancy (I term), lactation, organic diseases of the central nervous system.
Precautionary measures
Do not exceed the recommended dose. With caution, you should use the drug for diseases of the central nervous system (including epilepsy, multiple sclerosis), liver disease, alcoholism, during pregnancy and lactation.
Use during pregnancy and lactation
The drug is contraindicated for use in the first trimester of pregnancy and lactation (breastfeeding).
Dosage and administration
For trichomoniasis: adults - 0.5 g 2 times a day for 5 days. Children - in a single dose, at the rate of 25 mg / kg. In amebic dysentery in adults and children weighing more than 35 kg - 1.5 g 1 time / day, with a body over 100 kg - 2 g / day.Children weighing less than 35 kg - 40 mg / kg / day. Course - 3 days. For the treatment of other forms of amebiasis: adults and children over 12 years old - 0.5 g orally, morning and evening for 5-10 days. Single doses for children: at the age of 7-12 years - 0.375g; 1-6 years old - 0.25 g; up to 1 year - 0.125 g; frequency of appointment - 2 times a day (in the morning and in the evening); the duration of treatment is 5-10 days. With giardiasis: adults and children weighing more than 35 kg - inside, 1.5 g 1 time per day; children weighing up to 35 kg - 40 mg / kg / day. Duration of treatment is 1-2 days. Prevention of infections caused by anaerobic bacteria - 0.5-1 g before surgery, after surgery - 0.5 g 2 times a day for 3-5 days.
Side effects
Headache, dizziness, impaired consciousness, tremor, stiffness, discoordination of movements, convulsions, sensory or mixed peripheral neuropathy, nausea, vomiting, diarrhea.
Overdose
Symptoms: convulsions, depression, neuritis of peripheral nerves. Treatment: symptomatic therapy is carried out, with convulsions - diazepam.
Interaction with other drugs
When used together, ornidazole enhances the effect of indirect anticoagulants of the coumarin series, prolongs the muscle relaxant effect of vecuronium bromide. Compatible with ethanol (does not inhibit acetaldehyde dehydrogenase) unlike other imidazole derivatives (metronidazole).
special instructions
In the treatment of trichomoniasis should be the simultaneous treatment of both sexual partners. The effect on the ability to drive vehicles and control mechanisms. Ornidazole has a depressant effect on the central nervous system, then it should not be used during driving or other work requiring precise coordination of movements.