Tiberal^® (Tablets) Instructions for Use

Marketing Authorization Holder

Deva Holding A.S. (Turkey)

ATC Code

P01AB03 (Ornidazole)

Active Substance

Ornidazole (Rec.INN registered by WHO)

Dosage Form

Tiberal®

Film-coated tablets, 500 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or white with a slight yellowish tint, round, biconvex, with an engraving “DEVA” on one side; the core on a cross-section is from white to white with a yellowish tint.

Excipients: corn starch – 70 mg, microcrystalline cellulose – 68 mg, hypromellose – 10 mg, magnesium stearate – 2 mg.

Shell composition hypromellose – 8 mg, talc – 3 mg, titanium dioxide – 4 mg.

10 pcs. – blisters (1) – cardboard packs.

Clinical-Pharmacological Group

Antiprotozoal drug with antibacterial activity

Pharmacotherapeutic Group

Antiprotozoal agents; agents for the treatment of amoebiasis and other protozoal infections; nitroimidazole derivatives

Pharmacological Action

Antiprotozoal agent, a derivative of 5-nitroimidazole. It is believed that the mechanism of action is associated with disruption of the DNA structure of susceptible microorganisms. Active against Trichomonas vaginalis, Giardia lamblia, Entamoeba histolytica, as well as against some anaerobic bacteria (including Bacteroides spp., Clostridium spp., Fusobacterium and anaerobic cocci).

The T_1/2 of ornidazole is greater than that of metronidazole.

Pharmacokinetics

After oral administration, absorption from the gastrointestinal tract is high. The time to reach C_max is 1-2 hours.

Plasma protein binding is 15% or more. Penetrates the blood-brain barrier. T_1/2 is about 13 hours.

It is excreted by the kidneys as metabolites (60-70%) and in feces (20-25%), unchanged – about 5%.

Indications

Trichomoniasis, amoebiasis (intestinal and extraintestinal forms, including amoebic dysentery and amoebic liver abscess), giardiasis, prevention of postoperative complications (especially during operations on the colon or in gynecology).

ICD codes

Dosage Regimen

For oral administration, depending on the indications, treatment regimen and patient’s body weight, a single dose for adults varies from 500 mg to 2 g; for children weighing up to 35 kg, the daily dose is 20-40 mg/kg. The frequency of administration and duration of use are set individually.

For intravenous infusion in adults, an initial dose of 0.5-1 g is used, then the dose is set individually, depending on the indications and treatment regimen; for children – 20-30 mg/kg/day.

Adverse Reactions

From the digestive system: possible – nausea, heartburn, dizziness, drowsiness, skin rash.

From the nervous system possible – headache, dizziness, impaired consciousness, tremor, muscle rigidity, impaired coordination of movements, convulsions, sensory or mixed peripheral neuropathy, nausea, vomiting, diarrhea.

Contraindications

Diseases of the central nervous system, acute neurological diseases, first trimester of pregnancy, lactation period, hypersensitivity to ornidazole.

Use in Pregnancy and Lactation

Contraindicated in the first trimester of pregnancy, during lactation. During pregnancy, use is possible only for absolute indications, if the expected benefit to the mother outweighs the potential risk to the fetus.

Pediatric Use

Use is possible according to the dosing regimen.

Special Precautions

Does not inhibit alcohol dehydrogenase, therefore it is not incompatible with alcohol.

Drug Interactions

Potentiates the effect of indirect anticoagulants, increases the duration of action of vecuronium bromide.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.