Composition, form of production and packaging
Tablets covered with a film shell of white or almost white color, round, biconcave, with a risk on one side; on the fracture - the core is white or almost white, surrounded by a shell of white or almost white color.
1 tab.
Ornidazole 500 mg
Auxiliary substances: starch, microcrystalline cellulose, sodium lauryl sulfate, povidone K90, talc purified, magnesium stearate, silicon colloidal dioxide, sodium carboxymethyl starch (type A), butyl methacrylate copolymer, dimethylaminoethyl methacrylate and methyl methacrylate [1: 2: 1] (eudragit E100), titanium dioxide, macrogol 6000.
10 pieces. - Strips (1) - packs of cardboard.
10 pieces. - strips (1) - packs cardboard (5) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
An antiprotozoal preparation, 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 bacteria and protozoa. The reduced 5-nitro group of ornidazole interacts 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, as well as against anaerobic bacteria 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
Suction and distribution
Absorption from the gastrointestinal tract is high. Bioavailability is 90%. The time to reach C max is 1-2 h.
Binding to plasma proteins is less than 15%. Penetrates into most tissues, passes through the BBB and the placental barrier. Excreted in breast milk.
Metabolism and excretion
Metabolized in the liver by hydroxylation, oxidation and glucuronation. T 1/2 - 12-14 hours. It is excreted as metabolites by the kidneys (60-70%) and with the calves (20-25%), about 5% of the dose is excreted unchanged.
INDICATIONS
- Trichomoniasis;
- amebiasis, amoebic dysentery, extraintestinal amoebiasis (including amoebic liver abscess);
- giardiasis;
- prevention of infections caused by anaerobic bacteria, in operations on the colon and in gynecology.
DOSING MODE
Tablets are taken orally after a meal.
For trichomoniasis, adults are prescribed 1.5 g once or 1 g in combination with intravaginal administration of 500 mg (vaginal tablets) overnight. You can treat for 5 days, appointing 500 mg orally 2 times / day (morning and evening), also with the appointment of 1 vaginal tablet at 500 mg per night. Children dose set at a rate of 25 mg / kg body weight once.
For amoebic dysentery, adults and children weighing more than 35 kg per 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 daily dose is set at the rate of 40 mg / kg body weight. The course of treatment is 3 days.
In other forms of amebiasis, adults and children over 12 years of age - 500 mg 2 times / day for 5-10 days. Children older than 3 years and weighing less than 35 kg - 25 mg / kg body weight once for 5-10 days.
With giardiasis, adults and children weighing more than 35 kg - 1.5 grams 1 time / day, children over 3 years old and weighing less than 35 kg - 40 mg / kg / day. Duration of treatment is 1-2 days.
To prevent infections caused by anaerobic bacteria , appoint 0.5-1 g before the operation and 0.5 g 2 times / day after the operation for 3-5 days.
SIDE EFFECT
From the side of the central nervous system and peripheral nervous system: drowsiness, headache, dizziness, tremor, rigidity of muscles, impaired coordination of movements, convulsions, fatigue, temporary loss of consciousness, sensory or mixed peripheral neuropathy, distortion of taste sensations.
From the digestive system: nausea, increased activity of liver enzymes.
Other: allergic reactions.
CONTRAINDICATIONS
- Children under 3 years of age (for this dosage form);
- Hypersensitivity to the components of the drug.
With caution should apply the drug for diseases of the central nervous system (including epilepsy, multiple sclerosis), liver disease, alcoholism, pregnancy and lactation.
PREGNANCY AND LACTATION
The drug is contraindicated for use in the first trimester of pregnancy and lactation (breastfeeding).
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution should be used in cases of liver disease.
APPLICATION FOR CHILDREN
Contraindication: children under 3 years (for this dosage form).
SPECIAL INSTRUCTIONS
In the treatment of trichomoniasis, simultaneous treatment of both sex partners should be carried out.
Impact on the ability to drive vehicles and manage mechanisms
Because Ornidazole has a depressing effect on the central nervous system, it should not be used during the management of vehicles or other work that requires a clear coordination of movements.
OVERDOSE
Symptoms: convulsions, depression, neuritis of peripheral nerves.
Treatment: spend symptomatic therapy, with convulsions - diazepam.
DRUG INTERACTION
When combined, ornidazole enhances the effect of indirect anticoagulants of the coumarin series, prolongs the miorelaxing 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
The drug should be stored in a dry, protected from light and out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 3 years.
