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

Active ingredient

Composition

Active substances:

Ornidazole 500 mg.

Associates:

The core is corn starch,

microcrystalline cellulose,

methylhydroxyethylcellulose,

magnesium stearate;

coating – methylhydroxypropylcellulose,

talc,

titanium dioxide.

How to take, the dosage

Tiberal is taken orally after a meal with a small amount of water.

In trichomoniasis

1 tablet in the morning and evening for 5 days. Children are prescribed, once, 25 mg/kg body weight per day.

In amebic dysentery

The course of treatment is 3 days. Adults and children with body weight over 35 kg are prescribed 3 tablets, once in the evening. Adults with body weight over 60 kg 2 tablets in the morning and in the evening. For children with body weight less than 35 kg 40 mg/kg of body weight once a day.

In all forms of amebiasis

The course of treatment is 5-10 days. Adults and children with body weight over 35 kg – 1 tablet in the morning and in the evening. For children with body weight less than 35 kg – 25 mg/kg of body weight once.

In giardiasis

The course of treatment – 1-2 days. Adults and children with body weight over 35 kg – 3 tablets, once in the evening. For children with a body weight of up to 35 kg – 40 mg/kg, once.

Interaction

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

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

Ornidazole prolongs the myorelaxant effect of vecuronium bromide.

Special Instructions

Caution should be exercised in patients with CNS disorders, e.g., epilepsy, multiple sclerosis.

There is some risk in patients with liver damage, brain damage, alcohol abuse, pregnant and lactating mothers and children, especially if the dose is exceeded.

Contraindications

Hypersensitivity to the drug or other nitroimidazole derivatives.

Side effects

Mildly expressed: somnolence, headaches, gastrointestinal disorders (nausea).

In isolated cases – CNS disorders, such as: dizziness, tremor, muscle stiffness, coordination disorders, seizures, fatigue, temporary loss of consciousness, signs of sensory or mixed peripheral neuropathy.

There have been observed cases of: perversion of the sense of taste, changes in functional liver function tests, skin reactions and hypersensitivity reactions.

Overdose

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

Treatment: specific antidote is unknown, in case of seizures – diazepam.

Pregnancy use

Tiberal has no teratogenic or toxic effects on the fetus in experiments.

Since no controlled studies have been conducted in pregnant women, Tiberal in early pregnancy or lactating women should only be prescribed for absolute indications when the possible benefits of its use exceed the potential risk to the woman and the fetus.

Similarities