Tiberal
Tiberal: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. For violations of liver function
- 12. Drug interactions
- 13. Analogs
- 14. Terms and conditions of storage
- 15. Terms of dispensing from pharmacies
- 16. Reviews
- 17. Price in pharmacies
Latin name: Tiberal
ATX code: G01AF06
Active ingredient: ornidazole (ornidazole)
Producer: Sandoz Grup Saglik Urunleri Ilaclari Sanayi ve Ticaret AS (Turkey), F. Hoffmann-La Roche, Ltd. (Switzerland)
Description and photo updated: 2019-27-08
Prices in pharmacies: from 671 rubles.
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Tiberal is an antimicrobial drug with an antiprotozoal effect.
Release form and composition
The drug is produced in the form of film-coated tablets: round, biconvex, DEVA engraved on one side; the core in cross section and the film sheath - from white to yellowish-white (10 pcs. in blisters made of PVC / Al film, in a cardboard box 1 blister and instructions for use of Tiberal).
Composition of 1 tablet:
- active ingredient: ornidazole - 0.5 g;
- excipients: microcrystalline cellulose, corn starch, magnesium stearate, hypromellose;
- film shell: talc, titanium dioxide, hypromellose.
Pharmacological properties
Pharmacodynamics
The active substance of Tiberal, ornidazole, has antimicrobial and antiprotozoal properties.
The drug is effective against Entamoeba histolytica, Trichomonas vaginalis, Giardia lamblia (Giardia intestinalis), as well as some anaerobic bacteria (Clostridium spp., Bacteroides spp., Fusobacterium spp.) And anaerobic cocci (Peptococcus spp.)
Pharmacokinetics
Ornidazole after oral administration is rapidly absorbed in the gastrointestinal tract. The average absorption is 90%. Maximum plasma concentrations are reached within 3 hours.
The binding of the substance to proteins is approximately 13%. Ornidazole penetrates into the cerebrospinal fluid, breast milk, most tissues, and other body fluids, passes through the blood-brain barrier and the placenta. Plasma concentrations of the substance are 6–36 mg / l, that is, they are at a level that is considered optimal for various indications for the use of Tiberal. After repeated administration of ornidazole at a dose of 500 or 1000 mg to healthy volunteers every 12 hours, the cumulation coefficient ranged from 1.5 to 2.5.
Ornidazole metabolism occurs in the liver with the formation of mainly 2-hydroxymethyl- and α-hydroxy-methylmetabolites. These metabolites are less active against Trichomonas vaginalis and anaerobic bacteria than the unchanged substance.
The half-life of ornidazole is approximately 13 hours. After a single dose, 85% of the dose is excreted by the kidneys during the first 5 days, mainly in the form of metabolites. Approximately 4% of the dose taken is excreted by the kidneys as unchanged substance. From 20 to 25% of the dose is excreted by the intestines; cumulates.
Indications for use
- Trichomoniasis (male and female genitourinary infections caused by Trichomonas vaginalis);
- amebiasis (intestinal infections caused by Entamoeba histolytica, including amoebic dysentery, all extraintestinal forms of amebiasis, especially amoebic liver abscess);
- giardiasis (protozoal invasion of the digestive tract caused by infection with Lamblia intestinalis).
For surgical interventions on the colon and gynecological operations, Tiberal tablets are used to prevent anaerobic infections.
Contraindications
Absolute:
- children under 3 years old;
- child's body weight <35 kg;
- hypersensitivity to ornidazole / nitroimidazole derivatives / auxiliary components in the drug.
Tiberal is used with caution during pregnancy and lactation (breastfeeding), diseases of the central nervous system (central nervous system), including epilepsy and multiple sclerosis, liver pathologies, alcoholism.
Tiberal, instructions for use: method and dosage
Tiberal tablets are taken orally, always after meals, with plenty of water.
- trichomoniasis: adult patients take 1 pc. twice a day, in the morning and in the evening; the duration of the course is 5 days (the sexual partner must undergo the same course of therapy in order to avoid reinfection). For children, the daily dose is 25 mg / kg at a time;
- giardiasis: adult patients and children weighing> 35 kg take 3 pcs. once, in the evening. For children weighing <35 kg - 40 mg / kg per day, once. Course duration - 1–2 days;
- amebiasis (amoebic dysentery): adult patients and children: with a body weight> 35 kg - take 3 pcs. once, in the evening; with a body weight> 60 kg - take 4 pcs. per day (2 pcs. in the morning and evening). For children weighing <35 kg - 40 mg / kg per day, once. Course duration - 3 days;
- amebiasis (all forms): adults and children weighing> 35 kg take 2 pcs. per day (1 piece in the morning and evening). For children weighing <35 kg - 25 mg / kg per day, once. Duration of the course - 5-10 days;
- perioperative prevention of anaerobic infection: 1–2 pcs. 1-2 hours before surgery, after - 1 pc. 2 times a day for 3-5 days.
Side effects
When using Tiberal, the following adverse reactions may develop:
- digestive system: heartburn, nausea, skin rash;
- nervous system: dizziness, headache, impaired consciousness, muscle stiffness, convulsions, tremors, impaired coordination of movements, peripheral neuropathy (sensory or mixed), nausea / vomiting, diarrhea.
Overdose symptoms are all of the above conditions (side effects) in a more pronounced form. The specific antidote for ornidazole is unknown; for seizures, diazepam is recommended.
Overdose
The main symptoms are: increased dose-dependent side effects.
Therapy: symptomatic, diazepam is indicated for convulsions. The specific antidote is unknown.
special instructions
Influence on the ability to drive vehicles and complex mechanisms
It is not recommended during the period of therapy to engage in potentially hazardous activities that require speed of psychomotor reactions and increased concentration of attention, including driving vehicles.
Application during pregnancy and lactation
Tiberal during pregnancy / lactation can only be used in cases where the expected benefit outweighs the possible risk.
During the research, it was found that ornidazole has no toxic or teratogenic effect on the fetus.
Pediatric use
For patients under 3 years old and weighing up to 35 kg, the drug is not prescribed.
For violations of liver function
In the presence of liver disease, Tiberal should be administered with caution.
Drug interactions
Ornidazole, unlike other nitroimidazole derivatives, does not inhibit acetaldehyde dehydrogenase, therefore Tiberal is compatible with alcohol.
The effect of indirect coumarin anticoagulants is enhanced when combined with ornidazole, which may require an appropriate dose adjustment.
The use of Tiberal with vecuronium bromide helps to lengthen the muscle relaxant effect of the latter.
Analogs
Tiberal's analogues are: Gairo, Lornisol, Ornidazole, Dazolic, Ornidazol-Vero, Ornisid forte, Ornisid, etc.
Terms and conditions of storage
Store at room temperature out of the reach of children.
The shelf life is 5 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Tiberal
Reviews about Tiberal are mostly positive. Indicate the high efficiency of the drug, the possibility of its use during pregnancy and lactation. The disadvantages include the high cost and development of side effects, most often in the form of drowsiness and loss of appetite.
The price of Tiberal in pharmacies
The approximate price for Tiberal (10 tablets) is 619–759 rubles.
Tiberal: prices in online pharmacies
Drug name Price Pharmacy |
Tiberal 500 mg film-coated tablets 10 pcs. RUB 671 Buy |
Tiberal tablets p.o. 500mg 10 pcs. 715 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, 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!