Expiration date: 09/2026

Release form and composition:

Tablets, coated white or white with a yellowish sheen color, round, lenticular in cross section are visible two layers.

1 tablet contains: Ornidazole 500 mg

Excipients: corn starch, microcrystalline cellulose, polyvinylpyrrolidone (povidone), sodium carboximetilkrahmal (primogel), magnesium stearate.

The composition of the shell: oksipropilmetiltselljuloza, polyvinylpyrrolidone (povidone), Polysorbate (tween-80), talc, titanium dioxide.

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Pharmacological action:

Antiprotozoal drug with antibacterial activity.

The mechanism of action consists in biochemical restoration of 5-nitro group of Ornidazole intracellular transport proteins anaerobic microorganisms and protozoa. Restored 5-nitro group of Ornidazole interacts with DNA cells of microorganisms by inhibiting the synthesis of their nucleic acids, leading to death of bacteria.

Active against Trichmnas vaginais, Gardnerea vaginais, intestinais Giardia, Entameba histytica obligate anaerobic microorganisms: Bacterides spp. (including Bacterides fragiis, Bacterides distasnis, Bacterides vatus, Bacterides thetaitamicrn, Bacterides vugatus), Fusbacterium spp. Veinea spp. Prevtea spp. (Prevtea bivia, Prevtea buccae, Prevtea disiens) gram-positive microorganisms: Eubacterium spp. Cstridium spp.

The drug is not sensitive aerobic microorganisms.

Pharmacokinetics:

Suction

Well absorbed from the gastrointestinal tract. Bioavailability is 90%. The time to reach Cmax - 1-2 hours

Distribution

Penetrates the GEB. Binding to plasma proteins - not less than 15%.

Metabolism

Metabolized in the liver by hydroxylation, oxidation and glukuronirovania.

Excretion

Excreted as metabolites in the urine (60-65%) and feces (20 to 22)%. About 5% is excreted neizmenenennom. T1/2 is 13 hours

Indications:

• trichomoniasis
  
• amoebiasis, amebic dysentery, extraintestinal amebiasis (including amebic liver abscess)
  
• giardiasis
  
• prevention of infections caused by anaerobic bacteria, during operations on the colon and gynecology.
  

Dosing regimen:

The tablets are taken orally after meals.

If trichomoniasis adults appoint 500 mg 2 times/day for 5 days. Children dose set at the rate of 25 mg/kg of body weight 1 times/day once.

In amoebic dysentery adults and children weighing more than 35 kg-1.5 g 1 times/day, with body weight over 60 kg - 2 g/day. Children weighing less than 35 kg the daily dosage is determined at the rate of 40 mg/kg of body weight. The course of treatment – 3 days.

Other forms of amebiasis adults and children weighing more than 35 kg – 500 mg 2 times/day, children weighing up to 35 kg – 25 mg/kg once daily for 5-10 days.

Giardiasis adults and children weighing more than 35 kg – 1.5 g 1 times/day, children weighing less than 35 kg – 40 mg/kg/day. The duration of therapy is 1-2 days.

For the prevention of postoperative infections caused by anaerobic bacteria, is prescribed for 500 mg, then every 12 hours 500 mg for 3-5 days.

Side effects:

CNS and peripheral nervous system: headache, dizziness, impaired consciousness, tremor, rigidity, discoordination movements, cramps, sensory or mixed peripheral neuropathy.

From the digestive system: nausea, vomiting, diarrhea.

Contraindications:

• organic diseases of the Central nervous system
  
• I trimester of pregnancy
  
• lactation (breast-feeding)
  
• improved sensitivity to the preparation components (including to nitroimidazole derivatives).
  

Pregnancy and lactation:

The drug is contraindicated in the first trimester of pregnancy and during breastfeeding.

Special instructions:

In the treatment of trichomoniasis should be conducting simultaneous treatment of both sexual partners.

Overdose:

Symptoms: epileptiformnye convulsions, depression, peripheral neuritis.

Treatment: symptomatic therapy.

Drug interactions:

While the use of Ornidazole-Vero enhances the effect of anticoagulants cumarin series, prolongs the muscle relaxant effect of vecuronium bromide.

While the use of ethanol does not inhibit acetyldihydrocodeine (unlike other imidazole derivatives.