Tiberal, 500 mg 10 pcs

Pharmacodynamics

Antiprotozoal, antibacterial.

Active against: Trichomonas vaginalis. Entamoeba histolytica. Giardia lamblia (Giardia intenstinalis). Some anaerobic bacteria (Bacteroides spp., Clostridium spp., Fusobacterium spp.) and anaerobic cocci.

Pharmacokinetics

Intake

After oral administration, Ornidazole is rapidly absorbed in the gastrointestinal tract. On average, absorption is 90%. Maximum plasma concentrations are reached within 3 hours.

Distribution

The binding of Ornidazole to proteins is about 13%. The active substance penetrates into the cerebrospinal fluid, other body fluids and tissues. Plasma concentrations of Ornidazole are in the range of 6-36 mg/l, which is the level considered optimal for various indications for the use of the drug. After multiple doses of 500 mg or 1000 mg in healthy volunteers every 12 hours, the cumulation factor is 1.5-2.5.

Metabolism

Ornidazole is metabolized in the liver to form mainly 2-hydroxymethyl – and α-hydroxymethylmetabolites. Both metabolites are less active against Trichomonas vaginalis and anaerobic bacteria than unchanged Ornidazole. </Excretion

The elimination half-life is about 13 hours. After a single dose, 85% of the dose is excreted within the first 5 days, mainly as metabolites. About 4% of the dose taken is excreted unchanged through the kidneys.

Indications

Trichomoniasis (genitourinary infections in women and men caused by Trichomonas vaginalis);
amebiasis (all intestinal infections caused by Entamoeba histolytica, including amoebic dysentery, and all extraintestinal forms of amebiasis, especially amoebic liver abscess).
giardiasis;
prevention of anaerobic infections during operations on the colon and gynecological interventions.

Pharmacological effect

Pharmacodynamics

Antiprotozoal, antibacterial.

Active against: Trichomonas vaginalis. Entamoeba histolytica. Giardia lamblia (Giardia intenstinalis). Some anaerobic bacteria (Bacteroides spp., Clostridium spp., Fusobacterium spp.) and anaerobic cocci.

Pharmacokinetics

Suction

After oral administration, Ornidazole is rapidly absorbed from the gastrointestinal tract. On average, absorption is 90%. Maximum plasma concentrations are achieved within 3 hours.

Distribution

Ornidazole protein binding is about 13%. The active substance penetrates into the cerebrospinal fluid, other body fluids and tissues. Ornidazole plasma concentrations are in the range of 6-36 mg/l, that is, at a level considered optimal for various indications for the use of the drug. After repeated administration of 500 mg or 1000 mg doses to healthy volunteers every 12 hours, the accumulation coefficient is 1.5-2.5.

Metabolism

Ornidazole is metabolized in the liver to form mainly 2-hydroxymethyl and α-hydroxymethyl metabolites. Both metabolites are less active against Trichomonas vaginalis and anaerobic bacteria than unchanged Ornidazole.

Removal

The half-life is approximately 13 hours. After a single dose, 85% of the dose is excreted during the first 5 days, mainly in the form of metabolites. About 4% of the dose taken is excreted unchanged through the kidneys.

Special instructions

Caution should be exercised in patients with diseases of the central nervous system, for example, epilepsy, multiple sclerosis.

There is a certain risk in patients with liver damage, brain damage, alcohol abusers, pregnant and nursing mothers and children, especially if the dose is exceeded.

Active ingredient

Ornidazole

Composition

Active ingredients:

ornidazole 500 mg.

Excipients:

kernel – corn starch,

microcrystalline cellulose,

methylhydroxyethylcellulose,

magnesium stearate;

shell – methylhydroxypropylcellulose,

talc,

titanium dioxide

Pregnancy

In the experiment, Tiberal does not have a teratogenic or toxic effect on the fetus.

Since controlled studies have not been conducted in pregnant women, Tiberal can be prescribed in early pregnancy or nursing mothers only for absolute indications, when the possible benefits of its use outweigh the potential risk to the woman and the fetus.

Contraindications

Hypersensitivity to the drug or other nitroimidazole derivatives.

Side Effects

Mild: drowsiness, headaches, gastrointestinal disorders (nausea).

In some cases – disorders of the central nervous system, such as: dizziness, tremor, muscle rigidity, lack of coordination, convulsions, fatigue, temporary loss of consciousness, signs of sensory or mixed peripheral neuropathy.

Cases have been observed: distortions of taste, changes in liver function tests, skin reactions and hypersensitivity reactions.

Interaction

Ornidazole does not inhibit aldehyde dehydrogenase and is therefore not incompatible with alcohol.

However, Ornidazole potentiates the effect of oral coumarin anticoagulants, which requires appropriate adjustment of their dose.

Ornidazole prolongs the muscle relaxant effect of vecuronium bromide.

Overdose

Symptoms: side effects develop, but in a more pronounced form.

Treatment: specific antidote is unknown, for seizures – diazepam.

Storage conditions

Store at room temperature up to 30 °C.
Keep out of the reach of children.

Shelf life

5 years.

Manufacturer

Deva Holding AS, Türkiye