Composition
Active ingredient: Â ornidazole 500 mg;
Excipients:
lactose (milk sugar),
microcrystalline cellulose,
povidone (polyvinylpyrrolidone),
sodium lauryl sulfate,
calcium stearate,
colloidal silicon dioxide (aerosil),
primellose (sodium croscarmellose),
hypromellose (hydroxypropylmethylcellulose),
macrogol 4000 (polyethylene glycol 4000),
talc,
titanium dioxide
Pharmacological action
Ornidazole is an antiprotozoal and antimicrobial drug, a derivative of 5-nitroimidazole. The mechanism of action consists in 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 interacts with the DNA cells of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria.
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 (P. bivia, P. buccae, P. disiens), and some Gram-positive microorganisms (Eubacterium spp., Clostridium). Aerobic 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%.
It is metabolized in the liver by hydroxylation, oxidation, and glucuronidation. T1 / 2 – 12-14 hours.
Penetrates into breast milk and most tissues, passes through the BBB and placenta. It is excreted as metabolites by the kidneys (60-70%) and with feces (20-25%), about 5% of the dose is excreted unchanged.
Indications
- trichomoniasis;
- amoebiasis: amoebic dysentery, extra-intestinal amoebiasis (including amoebic liver abscess);
- giardiasis;
- prevention of infections caused by anaerobic bacteria during operations on the colon and in gynecology.
Contraindications
- hypersensitivity;
- pregnancy (I trimester);
- lactation period;
- due to the indivisibility of the dosage form, do not prescribe to children with a body weight of less than 12 kg.
With caution: Â diseases of the central nervous system (including epilepsy, multiple sclerosis), liver diseases, alcoholism, pregnancy, lactation.
Side effects
Drowsiness, headache, gastrointestinal disorders (including nausea), dizziness, tremor, muscle rigidity, impaired coordination of movement, convulsions, fatigue, temporary loss of consciousness, sensory or mixed peripheral neuropathy, perversion of taste sensations, changes in the activity of “liver” enzymes, allergic reactions.
Interaction
Enhances the effect of coumarin-type anticoagulants, prolongs the muscle-relaxing effect of vecuronium bromide.
It is compatible with ethanol (does not inhibit acetaldehyde dehydrogenase), unlike other imidazole derivatives (metronidazole).
How to take, course of use and dosage
Ornidazole is prescribed orally after a meal.
With trichomoniasis: Â inside 1.5 g once or 1 g in combination with intravaginal use of 500 mg (vaginal tablets) at night. You can carry out treatment for 5 days, prescribing 1 tablet (500 mg) inside 2 times a day (morning and evening), also with the appointment of 1 vaginal tablet of 500 mg at night.
For amoebic dysentery: Â adults and children with a body weight of more than 35 kg – 1.5 g 1 time 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. The course lasts for 3 days.
For the treatment of other forms of amoebiasis: Â adults and children over 12 years of age – 0.5 g orally in the morning and evening for 5-10 days.
With giardiasis: Â adults and children with a body weight over 35 kg – 1.5 g 1 time a day; children with a body weight of 12-35 kg-40 mg / kg / day. The duration of treatment is 1-2 days.
Prevention of infections caused by anaerobic bacteria: Â 0.5-1 g before surgery, after surgery-0.5 g 2 times a day for 3-5 days.
Overdose
Symptoms: Â epileptiform seizures, depression, peripheral neuritis.
Treatment: Â symptomatic (diazepam – for convulsions).
Composition
Tablet Form of production
Storage conditions
Store in a dry place, protected from light, at a temperature not exceeding 25 °C
Shelf life
2 years
Active ingredient
Ornidazole
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
Description
For adults as prescribed by a doctor, for children as prescribed by a doctor
Indications
Trichomoniasis, Amoebiasis and giardiasis, Intestinal infections
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