Description
Latin name
Ornidazole
Release form
Tablets, film-coated, white or yellowish yellow, round, biconvex at the fracture of white or yellowish-white.
Packing
5 pcs. – blister packs (2) – packs of cardboard.
Pharmacological action
Antiprotozoal and antimicrobial drug derived from 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 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., as well as 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. Aerobic microorganisms are not sensitive to ornidazole.
Pharmacokinetics
Absorption from the digestive tract is high, bioavailability is 90%. Communication with plasma proteins – less than 15%.
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 the placenta. It is excreted in the form of metabolites by the kidneys (60-70%) and with feces (20-25%), about 5% of the dose is excreted unchanged.
Indications
trichomoniasis
amoebiasis: amoebic dysentery, extraintestinal amoebiasis (including amoebic liver abscess)
giardiasis
prophylaxis of infections caused by anaerobic bacteria in cases of intestinal surgery.
Contraindications
hypersensitivity
pregnancy (I trimester)
lactation period
due to the indivisibility of the dosage form is not prescribed for children weighing less than 12 kg.
Precautions: central nervous system diseases (including epilepsy, multiple sclerosis), liver disease, alcoholism, pregnancy, lactation.
Use during pregnancy and lactation
Contraindicated in pregnancy (I trimester) and with lactation.
Composition
1 tab. contains 500 mg of ornidazole
Excipients:
lactose (milk sugar),
microcrystalline cellulose,
povidone (polyvinylpyrrolidone),
sodium lauryl sulfate, srdlkrp kiosk (sodium sulfrloid kromllopp) (hydroxypropyl methylcellulose),
macrogol 4000 (polyethylene glycol 4000),
talc,
titanium dioxide.
Dosage and administration
Ornidazole is prescribed orally after meals.
For trichomoniasis: orally, 1.5 g once or 1 g in combination with intravaginal administration of 500 mg (vaginal tablets) at night. You can treat 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 per night.
In case of amoebic dysentery: adults and children with body weight over 35 kg – 1.5 g once a day, with body weight over 60 kg – 2 g / day. Children with a body weight of 12-35 kg – 40 mg / kg / day. The course is 3 days.
For the treatment of other forms of amoebiasis: for adults and children over 12 years old – 0. 5 g orally in the morning and evening for 5-10 days.
For giardiasis: adults and children with a body weight of over 35 kg – 1.5 g once a day for 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: 0.5-1 g before surgery, after surgery – 0.5 g 2 times a day for 3-5 days.
Side effects
Drowsiness, headache, impaired gastrointestinal function (including nausea), dizziness, tremors, muscle stiffness, impaired movement coordination, cramps, fatigue, temporary loss of consciousness, sensory or mixed peripheral neuropathy, perversion of taste sensations , a change in the activity of liver enzymes, allergic reactions.
Drug Interaction
Enhances the effect of coumarin series anticoagulants, prolongs the muscle relaxant effect of vecuronium bromide.
Unlike other imidazole derivatives (metronidazole), compatible with alcohol (does not inhibit acetaldehyde dehydrogenase).
Overdose
Symptoms: epileptiform seizures, depression, peripheral neuritis.
Treatment: symptomatic.
Storage conditions
In a dry, dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.
Expiration
2 years.
Do not use after the expiry date stated on the package.
Deystvuyuschee substances
Ornidazole
dosage form
dosage form
tablets
Obolensky AF Russian
