Tiberal - instructions for use, dose, side effects, contraindications

Tablets are round, biconcave, film-coated white or white with a slightly yellowish hue of color; on one side of the tablet engraving "DEVA". On The cross-section of the nucleus is from white to white with a yellowish hue of color.

Pharmacotherapeutic group:An antiprotozoal agent.

ATX: & nbsp

G.01.A.F.06 Ornidazole

Pharmacodynamics:

Antimicrobial and antiprotozoal preparation.

Tiberal® is effective against Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia (Giardia intestinalis), as well as some anaerobic bacteria, such as Bacteroides spp. and Clostridium spp., Fusobacterium spp., and anaerobic cocci: Peptostreptococcus spp., Peptococcus spp.

Pharmacokinetics:

Suction: after oral administration ornidazole quickly absorbed in the gastrointestinal tract. On average, the absorption is 90 %. Maximum plasma concentrations are achieved within 3 hours.

Distribution: The binding of ornidazole to proteins is about 13%. The active substance penetrates into breast milk and most tissues, cerebrospinal fluid, other body fluids, passes through the blood-brain barrier and the placenta. Concentrations of ornidazole in plasma are in the range of 6-36 mg / l, that is, at a level considered optimal for different indications for the use of the drug.After repeated intake of 500 mg or 1000 mg of the drug by healthy volunteers every 12 hours, the cumulation coefficient is 1.5-2.5.

Metabolism: ornidazole metabolized in the liver with education, in mostly,

2- hydroxymethyl- and a-hydroxy-methyl metabolites. Both metabolites are less active in relation to Trichomonas vaginalis and anaerobic bacteria than unchanged ornidazole. Excretion: the half-life is about 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. About 4 % accepted dose is given through kidneys in unchanged form. It is excreted by the intestine (20-25%), cumulates.

Indications:

Trichomoniasis (genitourinary infections in women and men caused by Trichomonas vaginalis); amoebiasis (all intestinal infections caused by Entamoeba histolytica, including amoebic dysentery, and all extraintestinal forms of amoebiasis, especially amoebic liver abscess); giardiasis.

Prevention of anaerobic infections in operations on the colon and gynecological interventions.

Contraindications:

Hypersensitivity to the drug or other derivatives of nitroimidazole. Children's age with a body weight of less than 35 kg (but not younger than 3 years).

Carefully:

Diseases of the central nervous system (CNS), including epilepsy, multiple sclerosis; liver disease, alcoholism, pregnancy, lactation.

Pregnancy and lactation:In the experiment, Tiberal® does not have a teratogenic or toxic effect on the fetus. Since no controlled studies have been performed in pregnant women, use of Tiberal® in pregnancy or lactating mothers is possible only by absolute indications, and when the possible benefits of using it for the mother exceed the potential risk to the fetus and the baby.

Dosing and Administration:

Tiberal® is taken orally after eating, with a small amount of water.

Trichomoniasis

1 tablet 2 times a day (morning and evening) for 5 days.

To eliminate the possibility of re-infection, sexual partner in all cases should receive the same treatment.

Daily dose for children is 25 mg / kg body weight and is assigned in one session. Amebiasis

Possible treatment regimens: a three-day course of treatment for patients with amoebic dysentery and a 5-10-day course of treatment for all forms of amoebiasis.

Duration treatment	Daily dose
Duration treatment	Adults and children weighing more than 35 kg	Children weighing less than 35 kg
А) 3 days	3 pills in one session in the evening. With a body weight of more than 60 kg - 4 tablets (2 tablets in the morning and in the evening)	40 mg / kg body weight in one session
B) 5-10 days	2 tablets (1 tablet in the morning and in the evening)	25 mg / kg body weight in one session

Lambliasis

Adults and children weighing more than 35 kg: 3 tablets once in the evening.

Children weighing less than 35 kg: 40 mg / kg once a day. Duration of treatment is 1-2 days.

Prevention of anaerobic infection during surgery

For 0.5-1 g for 1-2 hours before surgery, after surgery - 0.5 g 2 times a day for

3- 5 days.

Side effects:

Drowsiness, headaches and gastrointestinal disorders (nausea).

Disorders from the central nervous system, such as: dizziness, tremor, muscle stiffness, impaired coordination of motion, convulsions, fatigue, temporary loss of consciousness, signs of sensory or mixed peripheral neuropathy. There have been cases of perversion of taste sensations, changes in liver functional tests, skin reactions and hypersensitivity reactions.

Overdose:

Dose-dependent symptoms, mentioned in the section "Side effect", but in a more pronounced form.

Treatment: symptomatic, specific antidote is unknown; with convulsions - diazepam.

Interaction:

Unlike other nitroimidazole derivatives, ornidazole does not inhibit acetaldehyde dehydrogenase, and is therefore not incompatible with alcohol.

but ornidazole strengthens the effect of indirect anticoagulants coumarinic series, which requires appropriate correction of their dose.

Ornidazole prolongs the miorelaksiruyuschee action of vecuronium bromide.

Special instructions:

Care should be taken in patients with CNS diseases, for example, with epilepsy, multiple sclerosis. There is a certain risk in patients with liver, brain, alcohol abuse, pregnant and lactating mothers - and children.

Effect on the ability to drive transp. cf. and fur:During the period of treatment, it is not recommended to drive vehicles and engage in other potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets, film-coated, 500 mg.

Packaging:

10 tablets in a blister of polyvinylchloride film and aluminum foil (PVC / Al).

1 blister together with instructions for use are placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 30 ° C. Keep out of the reach of children.

Shelf life:

5 years. The drug should not be used after the expiry date indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N013330 / 01

Date of registration:20.07.2011

The owner of the registration certificate:Sandoz Ilach Sanayi ve Tidjaret ASSandoz Ilach Sanayi ve Tidjaret AS Turkey

Manufacturer: & nbsp

SANDOZ ILAC SANAYI VE TICARET, A.S. Turkey

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp20.07.2011

Illustrated instructions

Instructions

Tiberal® (Tiberal®)