Ornidazole-Vero - instructions for use, dose, side effects, contraindications

The tablets covered with a film membrane white or white with a yellowish shade of color, round, biconcave. Two layers are visible on the cross-section.

Pharmacotherapeutic group:Antiprotozoal agent

ATX: & nbsp

G.01.A.F.06 Ornidazole

Pharmacodynamics:

Antiprotozoal and antimicrobial drug, a derivative of 5-nitroimidazole. The mechanism of action is in the biochemical reduction of 5-nitro ornidazole intracellular transport proteins of anaerobic bacteria and protozoa. The reduced 5-nitro group of ornidazole interacts with DNA by microorganism cells, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria and protozoa.

Ornidazole is active against Trichomonas vaginalis, Giardia lamblia, Entamoeba histolytica, as well as anaerobes Bacteroides spp. (incl. Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Clostridium spp.

Pharmacokinetics:

Absorption from the gastrointestinal tract is high. Bioavailability is 90%. Time to reach the maximum concentration (T_C_max) - 1-2 hours. Connection with plasma proteins - not less than 15%. Penetrates through the blood-brain barrier.Half-life (T_1/2) - about 13 hours. It is excreted as metabolites by the kidneys (60-65%) and through the intestine (20-22%), about 5% of the dose is excreted unchanged. Cumulates.

Indications:

Trichomoniasis; amebiasis, amoebic dysentery, extraintestinal amoebiasis (including amoebic liver abscess); giardiasis; prevention of postoperative infectious complications caused by anaerobic bacteria, with surgery on the colon and gynecological operations.

Contraindications:

Hypersensitivity to the components of the drug; Children under 3 years old (for this dosage form).

Carefully:

Pregnancy, lactation, organic diseases of the central nervous system (including epilepsy, multiple sclerosis).

Liver disease, alcoholism.

Pregnancy and lactation:

In the experiment ornidazole did not have a teratogenic or embryotoxic effect. Since controlled studies in pregnant women have not been conducted, ornidazole during pregnancy (especially in the early stages) or nursing mothers can only be if the benefits of using it for the mother exceed the potential risk to the fetus and the baby.

Dosing and Administration:

Inside, after eating.

With trichomoniasis: adults - 0.5 g 2 times a day for 5 days. Children older than 3 years, and with a body weight of less than 35 kg - at a rate of 25 mg / kg body weight per day.

With intestinal amebiasis adults and children weighing more than 35 kg - 1.5 grams 1 time / day, with a body weight of more than 60 kg - 2 g / day. Children older than 3 years and with a body weight of less than 35 kg - 40 mg / kg / day. Duration of treatment - 3 days.

For the treatment of other forms of amoebiasis: adults and children weighing more than 35 kg - 0.5 grams orally 2 times a day, children over 3 years old and weighing less than 35 kg -25 mg / kg once for 5-10 days.

With giardiasis: adults and children with a body weight of more than 35 kg - inside, 1.5 g once a day; children over 3 years old and weighing less than 35 kg - 40 mg / kg / day. Duration of treatment is 1-2 days.

Prevention of postoperative infectious complications caused by anaerobic bacteria - 0.5 g before the operation, then every 12 hours for 0.5 g, for 3-5 days.

Side effects:

Headache, dizziness, impaired consciousness, tremor, muscle rigidity, discoordination of movements, convulsions, sensory or mixed peripheral neuropathy, dyspeptic disorders, hypersensitivity reactions, drowsiness, fatigue, temporary loss of consciousness, perversion of taste sensations, alteration of activity of "liver" enzymes.

If any of the side effects listed in the manual are aggravated or any other side effects not indicated in the instructions are noted, the doctor should be informed immediately.

Overdose:

Symptoms: epileptiform cramps, depression, peripheral neuritis.

Treatment: symptomatic.

Interaction:

Ornidazole enhances the effect of anticoagulants of the coumarin series, which requires appropriate correction of their dose, prolongs the miorelaksiruyuschee action of vecuronium bromide. Unlike other imidazole derivatives (metronidazole), it is compatible with alcohol (it does not inhibit acetaldehyde hydrogenase).

Special instructions:

When treating trichomoniasis, simultaneous treatment of sexual partners should be carried out.

Effect on the ability to drive transp. cf. and fur:

When appointing persons whose activities are associated with driving and working with machinery, the possibility of the effect of the drug on the central nervous system should be taken into account.

Form release / dosage:

Tablets, film-coated, 500 mg.

Packaging:

10 tablets per contour cell pack. 10 tablets per can of polymeric materials.

Each jar or 1 circuit cell pack together with the instruction in a pack of cardboard.

Storage conditions:At a temperature of no higher than 30 ° C. Keep out of the reach of children.

Shelf life:5 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LS-000690

Date of registration:24.08.2010 / 16.09.2015

Expiration Date:Unlimited

The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia

Manufacturer: & nbsp

VEROPHARM SA Russia

Representation: & nbspVEROPHARM, AO VEROPHARM, AO Russia

Information update date: & nbsp11.06.2017

Illustrated instructions

Instructions

Ornidazole-Vero (Ornidazole-Vero)