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

Excipients (core): cellulose microcrystalline - 88.0 mg, corn starch - 42.0 mg, povidone-K25 - 42.0 mg, sodium carboxymethyl starch - 21.0 mg. magnesium stearate - 7.0 mg.

Auxiliary substances (shell): gynromellosis - 9.00 mg, macrogol-4000 - 1.90 mg, titanium dioxide - 4.10 mg.

Description:Round biconvex tablets covered with a film coat of white or white with a yellowish hue. On the crack of the tablet, two layers are visible: the core is from almost white to light yellow and the film shell.

Pharmacotherapeutic group:Antiprotozoal agent

ATX: & nbsp

G.01.A.F.06 Ornidazole

Pharmacodynamics:

Antimicrobial and antiprotozoal drug.

Ornidazole is effective against Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia (Giardia intestinalis), as well as some anaerobic bacteria, such as Bacteroides spp. and Clostridium spp., Fusobacterium spp., and anaerobic cocci: Peptostreptococcus spp.

Orniferous microorganisms are not sensitive to ornidazole.

Pharmacokinetics:

Suction

After oral administration ornidazole quickly absorbed in the gastrointestinal tract. Bioavailability of the drug reaches 90 %. Maximum plasma concentrations are achieved within 3 hours.

Distribution

The binding of ornidazole to proteins is about 13%. The active substance penetrates into breast milk and most tissues, cerebrospinal fluid, other body fluids, passes through the blood-brain barrier and the placenta.Concentrations of ornndazole in the plasma are in the range of 6-36 mg / l, that is, at a level considered optimal for different indications for the use of the drug.

Metabolism

Ornidazole is metabolized in the liver with the formation of mainly 2-hydroxymethyl- and a-hydroxymethylmetabolites. Both metabolites are less active in relation to Trichomonas vaginalis and anaerobic bacteria than unchanged ornidazole.

Excretion

The half-life is about 13 hours. After a single dose, 85% of the dose is withdrawn within the first 5 days. In the form of metabolites is excreted by the kidneys 60-80% and the intestines 20-25%. About 4% of the accepted dose is excreted through the kidneys unchanged.

Indications:

Trichomoniasis (genitourinary infections in women and men caused by Trichomonas vaginalis); amoebiasis (all intestinal infections caused by Entamoeba histolytica, including amoebic dysentery, and all extraintestinal forms of amoebiasis, especially amoebic liver abscess); giardiasis.

Prevention of anaerobic infections in operations on the colon and gynecological interventions.

Contraindications:

Hypersensitivity to ornidazole or other derivatives of iitroimidazole, the components of the drug.Children under 3 years old, and body weight less than 20 kg.

I trimester of pregnancy, the period of breastfeeding.

Organic diseases of the central nervous system.

Pathological changes in blood and abnormalities of blood cells

Carefully:

Liver disease, alcoholism, pregnancy II and III, children, over 3 years of age and body weight of more than 20 kg, elderly patients.

Pregnancy and lactation:

Ornidazole is contraindicated for use in the first trimester of pregnancy and during breastfeeding. In the experiment ornidazole does not have a teratogenic or toxic effect on the fetus. Since controlled studies in pregnant women have not been performed, ornidazole in II and III trimester of pregnancy is possible only on absolute indications, when the possible benefits of its use for the mother exceed the potential risk to the fetus.

Dosing and Administration:

Ornidazole is taken orally after a meal, with plenty of water.

Trichomoniasis

Adults and children weighing more than 35 kg 1 tablet 2 times a day (morning and evening) for 5 days.

To eliminate the possibility of re-infection, the sexual partner should in all cases receive the same treatment.

The daily dose for children weighing 20-35 kg is 25 mg / kg of body weight and is given in one session, for 5 days.

Amebiasis

Treatment regimens: a three-day course of treatment for patients with amoebic dysentery and a 5-10-day course of treatment for all forms of amoebiasis.

Duration of treatment	Daily dose
Duration of treatment	Adults and children with a body weight of more than 35 kg	Children with a body weight of 20-35 kg
a) 3 days	3 tablets in one evening. With a body weight of more than 60 kg - 4 tablets (2 tablets in the morning and in the evening)	40 mg / kg body weight in one session
b) 5-10 days	2 tablets (1 tablet in the morning and in the evening)	25 mg / kg body weight in one session

Lambliasis

Adults and children weighing more than 35 kg: 3 tablets one time in the evening.

Children with a body weight of 20-35 kg: 40 mg / kg once a day. Duration of treatment is 1-2 days.

Prevention of anaerobic infection during surgery

For 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:

Side effects of the drug are systematized relative to each of the organ systems depending on the frequency of occurrence, using the following classification:

Often (>1/10)

Often (>1/100-<1/10)

Infrequently (> 1/1000 - <1/100)

Rarely (>1/10000-<1/1000)

Very rarely (<1/10000)

Disturbances from the nervous system: often - headache, drowsiness, fatigue, dizziness; rarely - temporary loss of consciousness, tremor, rigidity of muscles, impaired coordination of motion, convulsions, sensory or mixed peripheral neuropathy; very rarely - a perversion of taste sensations.

Violations of the blood and lymphatic system: infrequently - oppression of bone marrow hematopoiesis, neutropenia.

Disorders from the digestive system: very often - nausea, vomiting, metallic taste in the mouth; rarely - diarrhea, changes in activity "hepatic"enzymes.

Immune system disorders: infrequently - hypersensitivity reactions, skin rash, itching, urticaria, and Quincke's edema.

Overdose:

The dose-related symptoms mentioned in the section "Side effect", but in a more pronounced form.

Treatment: conduct symptomatic therapy: with convulsions appoint diazepam. The specific antidote is unknown.

Interaction:

Unlike other derivatives of nitroimidazole. ornidazole does not inhibit acetaldehyde dehydrogenase, and is therefore not incompatible with alcohol.

Ornidazole enhances the effect of indirect anticoagulants of the coumarin series, which requires appropriate correction of their dose. Lengthens the miorelaxing effect of vecuronium bromide.

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

When combined use of ornidazole with inhibitors of microsomal liver enzymes (for example, cimetidine) there is an increase in the concentration of ornidazole.

Special instructions:

When treating trichomoniasis, simultaneous treatment of sexual partners should be carried out. In the course of treatment, there may be worsening of the course of diseases of the peripheral nervous system. When symptoms of peripheral neuropathy, ataxia, dizziness or confusion arise, treatment should be suspended.

In patients on hemodialysis, there is a shortened half-life period. You may need to adjust the dose of the drug.

Patients receiving lithium therapy should monitor the concentration of lithium, electrolytes and creatinine in the blood plasma during treatment with ornidazole.

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

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

Form release / dosage:

Tablets, film-coated, 500 mg.

Packaging:

By 3, 4, 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

For 10, 20, 30, 40, 50, 60 or 100 tablets in cans of polyethylene terephthalate or cans of polymeric for medicines.

One jar or 1, 2, 3, 4, 5, 6, 7 or 10 contour mesh packages together with the instruction but are placed in a cardboard package.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002883

Date of registration:27.02.2015

Expiration Date:27.02.2020

The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Representation: & nbspOZONE LLC OZONE LLC Russia

Information update date: & nbsp11.06.2017

Illustrated instructions

Instructions

Ornidazole (Ornidazole)