Universal reference book for medicines
Product name: ORNIONA (ORNIONA)

Active substance: ornidazole

Type: The drug with antiprotozoal and antibacterial action for topical application in gynecology

Manufacturer: ВЕРТЕКС (Russia)
Composition, form of production and packaging
Tablets vaginal
1 tab.

Ornidazole 500 mg

3 pcs.
- packings of cellular contour (1) - 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 by intracellular transport proteins of anaerobic microorganisms and protozoa. The reduced 5-nitro group of ornidazole reacts with DNA cells of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria.
It is active against Trichomonas vaginalis, Gardnerella vaginalis, Giardia intestinalis, Entamoeba histolitica, Lamblia spp., And obligate anaerobes Bacteroides spp.(including Bacteroides fraglis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Veillonela spp., Prevotella spp.
(P.bivia, P.buccae, P.disiens) and some Gram-positive microorganisms (Eubacterium spp., Clostridium spp.). Orniferous microorganisms are not sensitive to ornidazole.
PHARMACOKINETICS

Absorption from the gastrointestinal tract is high, bioavailability is 90%.
Binding to plasma proteins is less than 15%.
Metabolized in the liver by hydroxylation, oxidation and glucuronation.
T 1/2 - 12-14 hours.
Penetrates into breast milk and most tissues, passes through the BBB and the placenta.
It is excreted in the form of metabolites by the kidneys (60-70%) and with fecal masses (20-25%), about 5% of the dose is excreted unchanged.
INDICATIONS

- Trichomoniasis;

- Amoebiasis: amoebic dysentery, extra-intestinal amebiasis (including amoebic liver abscess);

- giardiasis;

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

DOSING MODE

The drug is administered orally after a meal.

For trichomoniasis : inside 1.5 g once or 1 g in combination with intravaginal injection of 500 mg (vaginal tablets) overnight.

You can carry out treatment for 5 days, appointing 1 tab.
(500 mg) orally 2 times / day (morning and evening), also with the appointment of 1 vaginal tablet of 500 mg per night.
When amoebic dysentery adults and children weighing over 35 kg - 1.5 grams once a day, with a body weight of more than 60 kg - 2 g / day, children with a body weight of 12-35 kg - 40 mg / kg / day.
Course - 3 days.
For the treatment of other forms of amoebiasis: adults and children over 12 years of age - 500 mg orally in the morning and evening for 5-10 days.

With giardiasis: adults and children weighing over 35 kg - 1.5 grams 1 time / day;
children with a body weight of 12-35 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 / day for 3-5 days.

SIDE EFFECT

Drowsiness, headache, abnormal gastrointestinal function (including nausea), dizziness, tremor, rigidity of muscles, impaired coordination of motion, convulsions, fatigue, temporary loss of consciousness, sensory or mixed peripheral neuropathy, perversion of taste sensations, changes in hepatic enzyme activity , allergic reactions.

CONTRAINDICATIONS

- Pregnancy (I trimester);

- lactation period;

- in connection with the indivisibility of the dosage form, children with body weight less than 12 kg are not prescribed.

With caution

Diseases of the central nervous system (including epilepsy, multiple sclerosis), liver disease, alcoholism, pregnancy, lactation.

PREGNANCY AND LACTATION

Contraindicated in the first trimester of pregnancy and lactation.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution in liver diseases.

APPLICATION FOR CHILDREN

Due to the indivisibility of the dosage form, children weighing less than 12 kg are not prescribed.

SPECIAL INSTRUCTIONS

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

OVERDOSE

Symptoms: epileptiform cramps, depression, peripheral neuritis.

Treatment: symptomatic (diazepam - with convulsions).

DRUG INTERACTION

Strengthens the effect of anticoagulants coumarinic series, prolongs the miorelaksiruyuschee effect of vecuronium bromide.

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

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. In a dry place inaccessible to children, protected from light at a temperature of no higher than 25 ° C.
Shelf life - 2 years. Do not use after the expiration date.
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