Orniside Forte - instructions for use, dose, side effects, contraindications

Excipients: hypromellose 10 mg, corn starch 70 mg, microcrystalline cellulose 58 mg, magnesium stearate 2 mg; tablet coating composition: hypromellose 14,456 mg, macrogol-4000 3,3 mg, dye dangerous white M1 7120 1.171 mg [titanium dioxide (E171) 36 %, hypromellose 3%, sodium benzoate 0.1%], talc 1.072 mg.

Description:

Round, biconvex, coated with a white or almost white colored tablet, with a risk on one side.

Pharmacotherapeutic group:Antiprotozoal agent

ATX: & nbsp

G.01.A.F.06 Ornidazole

Pharmacodynamics:

Anti-protozoal and antimicrobial. Ornidazole - a 5-nitroimidazole derivative. The mechanism of action is biochemical reduction of 5-nitro group of ornidazole by 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 distansonis, 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 - 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 and the placenta. Cumulates.

Metabolized in the liver by hydroxylation, oxidation and glucuronation.

It is excreted in the form of metabolites with urine (60-80%) and feces (20-25%). About 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:

Liver disease, alcoholism.

Pregnancy and lactation:

The drug is contraindicated in the first trimester of pregnancy and during breastfeeding. In the II and III trimesters of pregnancy, the drug is used only in the case,if the intended use for the mother exceeds the potential risk to the fetus.

Dosing and Administration:

Inside. The drug should be taken after meals.

With trichomoniasis: treatment is carried out for 5 days, appointing 500 mg

2 once a day (morning and evening). Children older than 3 years - 25 mg / kg once a day 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 / day. The course of treatment is 3 days.

With extraintestinal amebiasis: adults and children over 12 years - 500 mg in the morning and in the evening for 5-10 days. Single doses for children: at the age of 7-12 years - 375 mg (for reception of such dose the preparation Ornisidum is used, the tablets covered with a film cover of 250 mg - 1,5 tablets); 3-6 years - 250 mg; frequency of admission - 2 times a day (morning and evening); the duration of treatment is 5-10 days.

With giardiasis: adults and children with a body weight of more than 35 kg - 1.5 g per 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 infections caused by anaerobic bacteria: from 500 mg to 1 g before the operation; after the operation - 500 mg twice a day for 3-5 days.

Side effects:

From the nervous system: headache, drowsiness, fatigue, dizziness, temporary loss of consciousness, tremor, rigidity of muscles, 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 convulsions, 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 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.

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 treatment period, care must be taken when driving vehicles and when engaging in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets, film-coated 500 mg.

Packaging:For 10 tablets in a blister of polyvinylchloride film and aluminum foil. One blister along with the instructions for use are placed in a cardboard box.

Storage conditions:

When temperature not higher than 25 ° C in a place inaccessible to children.

Shelf life:

3 of the year. Not use after the date indicated on the packaging.

Terms of leave from pharmacies:On prescription

Registration number:LS-000234

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

Representation: & nbspTRIFARMA division of the company Abdi Ibrahim Pharmaceutical TRIFARMA division of the company Abdi Ibrahim Pharmaceutical Turkey

Information update date: & nbsp12.06.2017

Illustrated instructions

Instructions

Orniside Forte (Ornisid forte)