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

Active substance: ornidazole

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

Manufacturer: ABDI IBRAHIM ILAC SAN.
VE TIC. (Turkey)
Composition, form of production and packaging
Tablets vaginal
white or almost white, oval, with pointed end, biconvex.

1 tab.

Ornidazole 500 mg

Excipients: calcium dihydrogen phosphate, lactose, citric acid anhydrous, polyvinylpyrrolidone, magnesium stearate, gelatinized starch, corn starch.

3 pcs.
- blisters (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

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

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 the DNA of a cell 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 histolytica, Lamblia spp .;
obligate anaerobic microorganisms : Bacteroides spp. (including Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Veillonela spp., Prevotella bivia, Prevotella buccae, Prevotella disiens; Gram-positive microorganisms : Eubacterium spp., Clostridium spp., Peptococcus spp., Peptostreptococcus spp., Mobiluncus spp.
The preparation is not sensitive to aerobic microorganisms.

PHARMACOKINETICS

Distribution

Penetrates into breast milk and most tissues, it penetrates the GEB and the placenta.
Binding to plasma proteins is less than 15%.
Metabolism and excretion

Metabolized in the liver by hydroxylation, oxidation and glucuronation.

It is excreted by the kidneys - 60-80% (20% unchanged), through the intestine - 10-20%.
T 1/2 is 12-14 hours.
INDICATIONS

urogenital trichomoniasis;

- nonspecific vaginitis of different etiology, confirmed by clinical and microbiological data.

DOSING MODE

When trichomoniasis is administered intravaginally, 500 mg (1 table vaginal) at night in combination with oral Orniside in the form of tablets for oral administration at a dose of 1 g 1 time / day.

Treatment can be carried out for 5 days, appointing the drug intravaginally 500 mg (1 table vaginal) at night in combination with oral Orniside in the form of oral tablets at 500 mg 2 times / day (morning and evening).

After hygienic treatment of the vulva, after releasing the vaginal tablet from the package, it should be inserted deep into the vagina.

SIDE EFFECT

From the side of the central nervous system and the peripheral nervous system: headache, dizziness, impaired consciousness, tremor, stiffness, discoordination of movements, convulsions, sensory or mixed peripheral neuropathy.

From the digestive system: nausea, vomiting, diarrhea.

CONTRAINDICATIONS

- Lakopenia;

- Violations of coordination of movements;

- organic lesions of the central nervous system (including epilepsy);

- Hepatic insufficiency (in case of appointment in high doses);

- I trimester of pregnancy;

- the period of lactation (breastfeeding);

- hypersensitivity to the components of the drug;

- hypersensitivity to nitroimidazole derivatives.

With caution should prescribe the drug in the II and III trimesters of pregnancy, leukopenia in history.

PREGNANCY AND LACTATION

The drug is contraindicated in the first trimester of pregnancy and during breastfeeding.
With caution should prescribe the drug in the II and III trimesters of pregnancy.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

The drug is contraindicated in case of liver failure (in case of appointment in high doses).

SPECIAL INSTRUCTIONS

During treatment, it is necessary to abstain from sexual intercourse.

With vaginitis caused by Trichomonas vaginalis, simultaneous treatment of sexual partners is recommended.
Treatment of the sexual partner is advisable to conduct ornidazole for oral administration.
In the case of using the drug together with ornidazole for oral administration, especially in the second course, monitoring of the peripheral blood pattern is necessary (the risk of developing leukopenia).

OVERDOSE

Symptoms: epileptiform cramps, depression, peripheral neuritis.

Treatment: conduct symptomatic therapy;
when cramps are prescribed diazepam.
DRUG INTERACTION

With simultaneous application of Ornisid enhances the effect of anticoagulants coumarinic series.

Ornisid prolongs the miorelaksiruyuschee action of vecuronium bromide.

When used simultaneously with ethanol, it does not inhibit acetaldehyde dehydrogenase.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children, dry, protected from light at a temperature of no higher than 30 ° C.
Shelf life - 2 years.
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