Ornidazole - Instructions For The Use Of Tablets, Price, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Ornidazole

Ornidazole: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. Use in the elderly
12. 12. Drug interactions
13. 13. Analogs
14. 14. Terms and conditions of storage
15. 15. Terms of dispensing from pharmacies
16. 16. Reviews
17. 17. Price in pharmacies

Latin name: Ornidazole

ATX code: G.01. AF06

Active ingredient: ornidazole (ornidazole)

Manufacturer: VERTEX, JSC (Russia)

Description and photo update: 2018-21-11

Prices in pharmacies: from 62 rubles.

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Ornidazole is an antiprotozoal drug.

Release form and composition

Ornidazole is available in two dosage forms:

• film-coated tablets: white or white with a yellowish tinge, biconvex, round (in blister packs of 3 or 5 pcs., in cans of 3 or 10 pcs.; in a cardboard box 1 pack of 3 pcs., 2 packs of 5 pcs. Or 1 can);
• vaginal tablets: white or white with a yellowish tinge, oblong, flat, with possible marbling (in blisters of 3 pcs., in cans of 3 or 6 pcs.; in a cardboard box 1 or 2 packages or 1 can).

Composition of 1 film-coated tablet:

• active substance: ornidazole - 0.5 g;
• auxiliary components: sodium lauryl sulfate - 0.004 g; calcium stearate - 0.007 g; colloidal silicon dioxide - 0.007 g; povidone K-30 - 0.014 g; croscarmellose sodium - 0.025 g; microcrystalline cellulose - 0.042 g; lactose monohydrate - 0.101 g;
• shell: dry mixture for film coating (contains hypromellose - 60%, talc - 20%, titanium dioxide - 11%, macrogol 4000 / polyethylene glycol 4000 - 9%) - 0.025 g or macrogol 4000 / polyethylene glycol 4000 - 0.002 25 g; titanium dioxide - 0.002 75 g; talc - 0.005 g; hypromellose - 0.015 g.

Composition of 1 vaginal tablet:

• active substance: ornidazole - 0.5 g;
• auxiliary components: calcium stearate, croscarmellose sodium (primellose), citric acid, calcium phosphate dihydrate, microcrystalline cellulose, milk sugar (lactose).

Pharmacological properties

Pharmacodynamics

Ornidazole, a derivative of 5-nitroimidazole, is an antiprotozoal and antimicrobial agent. Its mechanism of action consists in the biochemical reduction of the 5-nitro group by intracellular transport proteins of protozoa and anaerobic microorganisms. The reduced 5-nitro group interacts with the DNA cells of microorganisms, inhibits the synthesis of their nucleic acids, resulting in the death of bacteria.

The drug is active against the following microorganisms:

• anaerobic cocci: Peptococcus spp., Peptostreptococcus spp.;
• obligate anaerobes: Clostridium spp., Fusobacterium spp., Bacteroides spp. (including Bacteroides vulgatus, Bacteroides thetaiotaomicron, Bacteroides ovatus, Bacteroides distasonis, Bacteroides fragilis);
• Entamoeba histolytica, Giardia lamblia (Giardia intestinalis), Trichomonas vaginalis.

Aerobic microorganisms are not sensitive to ornidazole.

Pharmacokinetics

Ornidazole characteristic:

• absorption: rapidly absorbed in the gastrointestinal tract after oral administration; on average, absorption is 90%; With _max (maximum concentration in blood plasma) is achieved after 3 hours after administration;
• distribution: the connection with proteins is approximately 13%; passes through the placenta and blood-brain barrier, enters the cerebrospinal fluid, most tissues, breast milk and other body fluids; plasma concentrations vary from 6 to 36 mg per liter; the cumulation coefficient after repeated use of 0.5 or 1 g of the agent in healthy volunteers every 12 hours was 1.5–2.5;
• metabolism: metabolized in the liver by glucuronidation, oxidation and hydroxylation to form α-hydroxymethylmetabolites and 2-hydroxymethylmetabolites (mainly); both metabolites show less activity against anaerobic bacteria and Trichomonas vaginalis than unchanged ornidazole;
• Excretion: T _1/2 (half-life) varies from 12 to 14 hours; with cirrhosis of the liver, T _1/2 increases to 22 hours; after a single dose, 85% of the dose is excreted during the first 5 days, mostly in the form of metabolites: 20–25% - through the intestines and 60–70% - by the kidneys; 4% is excreted by the kidneys unchanged; cumulates; during hemodialysis, it is excreted, and therefore, before the start of the procedure, an additional 50% of the prescribed dose of the drug is taken.

Indications for use

Film-coated tablets

• giardiasis;
• amebiasis: intestinal and extraintestinal amebiasis, including amoebic liver abscess, amoebic dysentery;
• trichomoniasis;
• infections caused by anaerobic bacteria, colon surgery, in gynecology (for prevention).

Vaginal pills

• urogenital trichomoniasis;
• nonspecific vaginitis of various origins, confirmed by microbiological and clinical data;
• infections caused by anaerobic bacteria, colon surgery, in gynecology (for prevention).

Contraindications

Film-coated tablets

Absolute:

• organic pathologies of the central nervous system;
• glucose-galactose malabsorption, galactose intolerance, lactase deficiency;
• blood cell abnormalities, pathological changes in the blood;
• age under 3 years old and body weight less than 20 kg;
• I trimester of pregnancy and lactation;
• individual intolerance to the components of the drug.

Relative (diseases / conditions in the presence of which the appointment of Ornidazole requires caution):

• liver dysfunction;
• alcoholism;
• elderly age;
• II and III trimesters of pregnancy.

Vaginal pills

Absolute:

• I trimester of pregnancy;
• lactation period;
• individual intolerance to the components of the drug.

Relative (diseases / conditions in the presence of which the appointment of Ornidazole requires caution):

• a history of leukopenia;
• II and III trimesters of pregnancy.

Instructions for use of Ornidazole: method and dosage

Film-coated tablets

Ornidazole tablets are taken orally, after meals, with a small amount of water.

With the frequency of administration twice a day, the tablets are taken in the morning and evening, with the frequency of administration once a day - in the evening.

Recommended dosage regimen:

• trichomoniasis: adults and children weighing> 35 kg - 1 pc. 2 times a day. In order to eliminate re-infection, the sexual partner must undergo the same course of therapy; the dose for children weighing from 20 to 35 kg is determined based on the calculation - 0.025 g per 1 kg of body weight per day. Duration of treatment - 5 days;
• intestinal amebiasis: adults and children weighing> 35 kg - 3 pcs. in a day; weighing> 60 kg - once 4 pcs. per day at one time; the dose for children aged 3 years and older and weighing from 20 to 35 kg is set on the basis of 0.04 g per 1 kg of body weight per day at a time. Duration of treatment is 3 days;
• extraintestinal amebiasis: adults and children over the age of 12 years - 1 pc. 2 times a day; the dose for children aged 3 years and older and weighing from 20 to 35 kg is determined on the basis of 0.04 g per 1 kg of body weight 1 time per day. The duration of treatment varies from 5 to 10 days;
• giardiasis: adults and children weighing> 35 kg - once 3 pcs. in a day; the dose for children aged 3 years and older and weighing from 20 to 35 kg is set on the basis of 0.04 g per 1 kg of body weight once a day. Duration of treatment is 1–2 days;
• prevention of anaerobic infection during operations: 1–2 pcs. 1–2 hours before surgery and 1 pc. 2 times a day for 3-5 days after it.

Vaginal pills

Ornidazole tablets, after hygienic treatment of the external genital organs, are administered intravaginally, deep into the vagina.

Recommended dosage regimen:

• trichomoniasis: 1 pc. daily at bedtime for 5 days in combination with Ornidazole in the form of film-coated tablets;
• nonspecific vaginitis: 1 pc. daily before going to bed for 6-7 days;
• sanitation of the vagina before endoscopic operations: 1 pc. daily at bedtime for 6 days.

Side effects

Film-coated tablets

• nervous system: headache, fatigue, drowsiness, dizziness, symptoms of neuropathy (sensory or mixed peripheral), temporary loss of consciousness, convulsions, impaired coordination of movements, muscle stiffness, tremor;
• digestive system: changes in the activity of liver enzymes, dysfunction of the gastrointestinal tract, including diarrhea, vomiting, nausea, metallic taste in the mouth, perversion of taste sensations;
• hematopoietic organs: neutropenia, oppression of bone marrow hematopoiesis;
• urinary system: polyuria;
• allergic reactions: development of hypersensitivity reactions and skin reactions (angioedema, urticaria, itching, rash).

Vaginal pills

During the period of application of Ornidazole, local reactions may develop: rarely - vaginal dryness (especially at the beginning of therapy), local irritation, burning sensation. In some cases, allergic reactions may occur.

Overdose

Film-coated tablets

The main symptoms: dyspeptic disorders, convulsions, tremors, dizziness, headache, loss of consciousness, the development of side effects in a more pronounced form.

Therapy: symptomatic treatment, gastric lavage or hemodialysis; with the development of seizures - the introduction of diazepam intravenously.

Vaginal pills

Main symptoms: peripheral neuritis, depression, epileptiform seizures.

Therapy: symptomatic treatment; with the development of seizures - the appointment of diazepam.

special instructions

Film-coated tablets

During the period of taking the pills, the course of pathologies of the peripheral nervous system may worsen. The drug therapy is suspended with the development of confusion, dizziness, ataxia, and symptoms of peripheral neuropathy.

With the combined administration of lithium preparations, the concentration of lithium, creatinine and electrolytes in the blood plasma is controlled.

There is a certain risk in alcohol abuse patients with brain or liver damage.

Ornidazole can increase or decrease the effects of other drugs.

Vaginal pills

When treating trichomoniasis, both sexual partners must be treated at the same time.

Influence on the ability to drive vehicles and complex mechanisms

Patients during the period of use of Ornidazole should refrain from driving vehicles and conducting potentially hazardous activities.

Application during pregnancy and lactation

Ornidazole is contraindicated in the first trimester of pregnancy and lactation. Its use in the II and III trimesters is possible only with absolute indications after carefully balancing the potential benefits to the mother with the expected risks to the fetus.

Pediatric use

Film-coated tablets are not prescribed for patients under 3 years of age.

Use in the elderly

According to the instructions, Ornidazole in the form of film-coated tablets is prescribed to elderly patients with caution.

Drug interactions

With the combined use of ornidazole with certain drugs / substances, the following effects may develop:

• coumarin anticoagulants: enhancement of their effect (correction of their dose is required);
• vecuronium bromide: lengthening its muscle relaxant action;
• inhibitors of microsomal liver enzymes (for example, cimetidine): an increase in its T _1/2 from blood plasma;
• phenobarbital and other inducers of hepatic enzymes: a decrease in its T _1/2 from blood plasma.

Ornidazole, unlike other imidazole derivatives (metronidazole), does not inhibit acetaldehyde dehydrogenase, making it compatible with alcohol.

Analogs

Ornidazole analogues are: Tiberal, Ornisid Forte, Ornidazol, Quinisol, Dazolik, Gayro.

Terms and conditions of storage

Store in a place protected from light and moisture at temperatures up to 25 ° C. Keep out of the reach of children.

The shelf life of film-coated tablets is 3 years, vaginal tablets - 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Ornidazole

According to reviews, Ornidazole is a convenient, affordable and effective drug for the treatment of giardiasis and trichomoniasis. Among the disadvantages, the development of side effects during the treatment period is noted.

The price of Ornidazole in pharmacies

The approximate price of Ornidazole film-coated tablets (10 pieces per pack) is 183 rubles.

Ornidazole: prices in online pharmacies

Drug name Price Pharmacy

Ornidazole 500 mg film-coated tablets 10 pcs. RUB 62 Buy

Ornidazole 500 mg film-coated tablets 10 pcs. 93 rbl. Buy

Ornidazole tablets p.o. 500mg 10 pcs. RUB 100 Buy

Ornidazole 500 mg film-coated tablets 10 pcs. 174 r Buy

Ornidazole tablets p.o. 500mg 10 pcs. 235 RUB Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!