Universal reference book for medicines
Name of the drug: ORNIDAZOL (ORNIDAZOL)

Active substance: ornidazole

Type: Antiprotozoal preparation with antibacterial activity

Manufacturer: АРС (Russia) manufactured by VMG Pharmaceuticals (India)
Composition, form of production and packaging
The tablets covered with a film membrane of
white or almost white color, round, biconcave;
The tablet is white or almost white in cross section.
1 tab.

Ornidazole 500 mg

Excipients: microcrystalline cellulose 35 mg, starch 45 mg, croscarmellose sodium 10 mg, talc 6 mg, magnesium stearate 3 mg.

Composition of the film coat: hypromellose 10.12 mg, macrogol 1.0125 mg, talc 8 mg, titanium dioxide 2 mg.

10 pieces.
- blisters made of PVC / aluminum foil (1) - packs of cardboard.
10 pieces.
- blisters from PVC / aluminum foil (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

Antiprotozoal and antimicrobial drug, a derivative of 5-nitroimidazole.
The mechanism of action is the biochemical reduction of the 5-nitro group of ornidazole and intracellular transport proteins of anaerobic bacteria and protozoa. The reduced 5-nintro group of ornidazole reacts with DNA by microorganism cells, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria. It is active against Trichomonas vaginalis, Giardia lamblia, Entamoeba histolytica, and also anaerobes Bacteroides spp. (including Bacteroides fragilis, Bactcroidcs distasonis, Bacteroides ovatus, Bactcroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Clostridium spp. Orniferous microorganisms are not sensitive to ornidazole.
PHARMACOKINETICS

Suction.
After oral administration, ornidazole is rapidly absorbed in the gastrointestinal tract (GIT). Absorption is about 90%. C max in plasma is achieved within 3 hours.
Distribution.
The association of ornidazole with proteins is about 13%. Penetrates into the cerebrospinal fluid, other body fluids and tissues.
Concentrations of ornidazole in plasma are in the range of 6-36 mg / l.

After multiple doses of 500 mg or 1000 mg every 12 hours, the cumulation factor was 1.5-2.5.

Metabolism.
Ornidazole is metabolized in the liver with the formation of mainly 2-hydroxymethyl- and? -hydroxymethyl metabolites. Both metabolites are less active against Trichomoinas vaginalis and anaerobic bacteria than unchanged ornidazole.
Excretion.
T 1/2 is about 13 hours. After a single dose, 85% of the dose is excreted within the first 5 days, mainly in the form of metabolites. About 4% of the accepted dose is excreted through the kidneys in unchanged form, and 20-25% by the intestine.
INDICATIONS

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

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

DOSING MODE

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

With trichomoniasis.
Treatment is carried out for 5 days, 500 mg orally 2 times a day (morning and evening). In order to reduce the risk of re-infection at the same time, the course treatment of the sexual partner is carried out.
Children older than 12 years - inside 25 mg / kg for 5 days.

With intestinal amebiasis.
Adults and children weighing more than 35 kg - 1.5 g once a day, with a body weight of more than 60 kg - 2 g / day. Children with a body weight of less than 35 kg - 40 mg / ct / day. The course of treatment is 3 days.
With extraintestinal amebiasis.
Adults and children over 12 years of age - 0.5 grams inside, morning and evening for 5-10 days. With giardiasis
Adults and children weighing more than 35 kg - 1.5 g / day;
Children weighing less than 35 kg - 40 mg / kg / day. Duration of treatment is 1-2 days.
Prevention of infections caused by anaerobic bacteria 0.5-1 g before surgery, after surgery - 0.5 g 2 times a day for 3-5 days.

SIDE EFFECT

Slightly drowsiness, headache and nausea.
In some cases - violations of the central nervous system, such as: dizziness, tremor, rigidity of muscles, impaired coordination, convulsions, fatigue, temporary loss of consciousness, signs of sensory or mixed peripheral neuropathy. There have been cases of distortion of taste sensations, changes in "liver" functional tests, skin reactions and hypersensitivity reactions.
CONTRAINDICATIONS

Hypersensitivity to the drug (including other nitroimidazole derivatives).
Children under 12 years (for this dosage form).
Carefully.
Diseases of the central nervous system (including epilepsy, multiple sclerosis), liver disease, alcoholism, pregnancy, lactation.
PREGNANCY AND LACTATION

In the experiment, Ornidazole had no teratogenic or embryotoxic effect.
Because no controlled studies have been conducted in pregnant women, Ornidazole may be prescribed during pregnancy (especially in the early stages) or nursing mothers only in absolute indications, when the possible benefits of using it for the mother exceed the potential risk to the fetus and the baby.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Take with caution in liver disease.

APPLICATION FOR CHILDREN

Contraindicated in childhood to 12 years (this dosage form).

SPECIAL INSTRUCTIONS

Care should be taken in patients with diseases of the central nervous system (epilepsy, multiple sclerosis).
There is a certain risk in patients with diseases of the liver, brain, alcohol abusers, pregnant and lactating mothers and children, especially when the dose is exceeded.
Influence on ability to driving and work with mechanisms.
Studies on the effect of the drug on the ability to drive and work with complex mechanisms have not been conducted, however, taking into account the possible development of side effects from the nervous system (including dizziness, impaired coordination of movements) during drug treatment should refrain from driving and from employment by other kinds of activity requiring an increased concentration of attention and speed of psychomotor reactions.
OVERDOSE

Symptoms: increased dose-related side effects.

Treatment: symptomatic, specific antidote is unknown;
with convulsions - diazepam.
DRUG INTERACTION

Unlike other derivatives of nitroimidazole, ornidazole does not inhibit aldehyde dehydrogenase and therefore is not incompatible with alcohol.
Ornidazole enhances the effect of oral anticoagulants coumarinic series, which requires appropriate correction of their dose. Ornidazole prolongs the miorelaksiruyuschee action of vecuronium bromide.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

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.
3 years. Do not use after the expiration date printed on the package.
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