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

Excipients: cellulose microcrystalline 29 mg, corn starch 40 mg, hypromellose 5 mg, magnesium stearate 1 mg; tablet coating composition: hypromellose 7.24 mg, macrogol-4000 1.66 mg, dye dangerous white M1 7120 0.59 mg [titanium dioxide (E171) 36%, hypromellose 3%, sodium benzoate 0.1%], talc 0.51 mg.

Description:

Round white or white-yellow colored tablets covered with a film sheath with a risk on one side. On the break the tablets are white.

Pharmacotherapeutic group:Antiprotozoal agent

ATX: & nbsp

G.01.A.F.06 Ornidazole

Pharmacodynamics:

Anti-protozoal and antimicrobial. Ornidazole - 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 reacts with the DNA of a cell of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria.

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

Orniferous microorganisms are not sensitive to ornidazole.

Pharmacokinetics:

After ingestion, it is well absorbed from the gastrointestinal tract. Bioavailability is 90%. Time to reach the maximum concentration (T_C_max) - 1-2 hours.

Binding to plasma proteins is at least 15%. It penetrates into breast milk and most tissues, passes through the blood-brain barrier (GEB) and the placenta. Cumulates.

Metabolized in the liver by hydroxylation, oxidation and glucuronation.

It is excreted as metabolites by the kidneys (60-80 %) and the intestines (20-25%). Around 5 % is displayed unchanged. Half-life (T_1/2) is about 13 hours.

Indications:

- Trichomoniasis;

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

- giardiasis;

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

Contraindications:

- Organic diseases of the central nervous system;

- I trimester of pregnancy;

- lactation period (breastfeeding);

- hypersensitivity to the components of the drug;

- increased sensitivity to nitroimidazole derivatives;

- Children under 3 years old (for this dosage form).

Carefully:

With liver diseases, alcoholism.

Pregnancy and lactation:

The drug is contraindicated in the first trimester of pregnancy and during breastfeeding. Information on the use of the drug in the II and III trimesters of pregnancy is absent.

Dosing and Administration:

Inside. The drug should be taken after meals.

With trichomoniasis: adults are treated for 5 days, appointing 500 mg twice 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 g / day. Children older than 3 years and with a body weight of less than 35 kg-40 mg / kg per day, once. 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 with a body weight of less than 35 kg - 40 mg / kg per day, once; 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, once a night; children older than 3 years and with a body weight of less than 35 kg - 40 mg / kg per day once. Duration of treatment is 1-2 days.

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

Side effects:

From the nervous system: headache, drowsiness, fatigue, dizziness, temporary loss of consciousness, tremor, muscle stiffness, impaired coordination of motion, convulsions, sensory or mixed peripheral neuropathy, perversion of taste sensations.

From the digestive system: change in the activity of "liver" enzymes, nausea, vomiting, diarrhea.

Other: allergic reactions.

Overdose:

Symptoms: epileptiform cramps, depression, peripheral neuritis.

Treatment: conduct symptomatic therapy; with convulsions appointed diazepam.

Interaction:

Ornidazole enhances the effect of anticoagulants coumarinic series, prolongs the miorelaxing effect of vecuronium bromide.

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

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

Special instructions:

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

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, film-coated 250 mg.

Packaging:For 10 tablets in a blister of polyvinylchloride film and aluminum foil. 2 blisters with instructions for use in cardboard pack.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of reach of children in the original packaging.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N016099 / 01

Date of registration:11.09.2012 / 15.08.2013

Expiration Date:Unlimited

The owner of the registration certificate:Abdi Ibrahim Ilyach Sanayi ve Tidzh A.Sh.Abdi Ibrahim Ilyach Sanayi ve Tidzh A.Sh. Turkey

Manufacturer: & nbsp

ABDI IBRAHIM ILAC SAN. VE TIC., A.S. Turkey

Information update date: & nbsp11.06.2017

Illustrated instructions

Instructions

Ornisid (Ornisid)