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

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 recovered 5-nitro ornidazole interacts with DNA microbial cells by inhibiting synthesis of nucleic acids, which leads to the death of the bacteria.

Active with respect to Trichomonas vaginalis, Giardia lamblia, Entamoeba histolytica, as well as anaerobes Bacteroides spp. (incl. Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicronron, Bacteroides vulgatus), Fusobacterium spp., Clostridium

Orniferous microorganisms are not sensitive to ornidazole.

Pharmacokinetics:

Suction and distribution

After oral administration, the drug is well absorbed in the gastrointestinal tract. Bioavailability of the drug reaches 90%. Connection with plasma proteins - 13%.The peak concentration of the active substance in the blood plasma (T_C_max) is noted 3 hours after taking the drug.

Metabolism

Metabolized in the liver by hydroxylation, oxidation and glucuronation. Ornidazole well penetrates into all biological fluids and body tissues. Penetrates through the blood-brain and hematoplacental barrier, excreted in breast milk.

Excretion

Half-life (T_1/2) is 12-14 hours. After a single application of the drug, 85% of the dose is withdrawn within 5 days.

It is excreted in the form of metabolites (60-70%) and unchanged (4%) kidney and intestine (20-25%), cumulates.

Indications:

Ornidazole is used to treat patients with infectious diseases of various locations that are caused by microorganisms and protozoa sensitive to the action of ornidazole, including:

- trichomoniasis;

- intestinal and extra-intestinal amebiasis (including amoebic liver abscess);

- giardiasis;

- prevention of infections caused by anaerobic bacteria, in operations on the colon and in gynecology.

Contraindications:

Increased individual sensitivity to ornidazole and other components of the drug and other drugs derived from nitroimidazole;

1 trimester of pregnancy, the period of breastfeeding and children's age of 3 years (for this dosage form);

The drug is contraindicated in patients suffering from organic diseases of the central nervous system.

Carefully:The drug should be administered with caution to patients suffering from diseases of the central nervous system (including epilepsy, multiple sclerosis), liver dysfunction, hematopoiesis, pregnancy and lactation. The drug should be administered with caution to children and elderly patients. The drug should be administered with caution to patients who abuse alcohol.

Pregnancy and lactation:

Pregnancy

The drug is contraindicated in the first trimester of pregnancy.

In the II and III trimesters of pregnancy, the drug is used only with absolute indications and when the possible benefits of its use for the mother exceed the potential risk to the fetus.

Lactation

If it is necessary to use the drug during lactation, breastfeeding should be temporarily interrupted. Renewal of breastfeeding is possible no earlier than 48 hours after the last dose of the drug.

Dosing and Administration:

The drug is taken orally after eating, with plenty of water. The duration of the course of treatment and the dose of the drug is determined by the attending physician individually, depending on the nature of the disease and the personal characteristics of the patient.

With trichomoniasis: adults are treated for 5 days, appointing 500 mg 2 once a day (morning and evening). Children older than 3 years - 25 mg / kg per day, once, for 5 days.

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

With extraintestinal amebiasis: adults and children over 12 years - 0.5 grams inside, morning and evening for 5-10 days. Children older than 3 years and weighing less than 35 kg - 40 mg / kg per day, 1 time per day; the duration of treatment is 5-10 days.

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

Prevention of infections caused by anaerobic bacteria: 0.5-1 g for 1-2 hours before the operation, after the operation - 0.5 g 2 times a day for 3-5 days.

Side effects:

From the side of the central nervous system and the peripheral nervous system:

- possible drowsiness, fatigue, headache, dizziness, sensory or mixed peripheral neuropathy, impaired consciousness, tremor, rigidity of muscles, impaired coordination of motion, convulsions, temporary loss of consciousness.

From the digestive system:

- there may be a violation of the function of the gastrointestinal tract, incl. nausea, vomiting, diarrhea, a perversion of taste sensations, a change in the activity of "liver" enzymes.

Allergic reactions:

- possible skin rash, itching, urticaria, angioedema.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

Overdose:

With the use of overestimated doses of the drug, patients develop developmental disorders of consciousness, seizures, depression and peripheral neuritis.

There is no specific antidote. In case of an overdose, symptomatic therapy is indicated. In the case of seizures, diazepam is prescribed.

Interaction:

Strengthens the effect of indirect anticoagulants, prolongs the miorelaksiruyuschee effect of vecuronium bromide.

Compatible with ethanol (does not inhibit acetaldehyde dehydrogenase), unlike other imidazole derivatives (metronidazole).

Joint reception with phenobarbital or other inducers of liver enzymes reduces the half-life of ornidazole from the blood plasma.

With the combined use of ornidazole with inhibitors of microsomal liver enzymes, an increase in the concentrations of ornidazole is noted.

Special instructions:

In the treatment of trichomoniasis, simultaneous treatment of sexual partners should be conducted regardless of the results of microbiological tests.

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

During the period of treatment, it is not recommended to drive vehicles and engage in other potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets coated with a film coating of 500 mg.

Packaging:For 10 tablets in a contour mesh package, 10 or 30 tablets per can of polymer with a lid. Each jar or 1 circuit cell pack together with instructions for medical use in a pack of cardboard.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life:

2 of the year.

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-002251

Date of registration:26.09.2013

Expiration Date:26.09.2018

The owner of the registration certificate:Berezovsky Pharmaceutical Plant, ZAO Berezovsky Pharmaceutical Plant, ZAO Russia

Manufacturer: & nbsp

Berezovsky Pharmaceutical Plant, ZAO Russia

Information update date: & nbsp11.06.2017

Illustrated instructions

Instructions

Ornidazole (Ornidazole)