Tiberal
Producer: F. Hoffmann-La Roche Ltd., (Hoffman-la Roche Ltd) Switzerland
Code of automatic telephone exchange: G01AF06
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active agent: ornidazola of 500 mg.
Pharmacological properties:
Tiberal is effective concerning Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia (Giardia intestinalis), and also some anaerobic bacteria, such as Bacteroides and Clostridium spp., Fusobacterium spp., and anaerobic cocci.
Pharmacokinetics. Absorption. After oral administration орнидазол it is quickly soaked up. On average, absorption makes 90%. The maximum concentration in plasma are reached within 3 hours.
Distribution. Linkng of an ornidazol with proteins makes about 13%. Active agent of Tiberal very well gets into cerebrospinal fluid, other liquids of an organism and into fabrics.
Concentration of an ornidazol in plasma are in range, optimum for various indications to drug use (6-36 mg/l). The cumulation coefficient after multiple dose of doses in 500 mg or 1000 mg by healthy volunteers equals every 12 hours 1.5-2.5.
Metabolism. Ornidazol is metabolized in a liver with education, generally 2-gidroksimetil-and a - hydroxymethylmetabolites. Both metabolites are less active concerning Trichomonas vaginalis and anaerobic bacteria, than not changed орнидазол.
Removal. The elimination half-life makes about 13 hours. After a single dose of 85% of a dose it is removed during the first 5 days, mainly, in the form of metabolites. About 4% of the accepted dose are removed through kidneys in not changed look.
Indications to use:
Trichomoniasis (the urinogenital infections at women and men caused by Trichomonas vaginalis); an amebiasis (all intestinal infections caused by Entamoeba histolytica, including amoebic dysentery, and all abenteric forms of an amebiasis, especially amoebic abscess of a liver); lambliasis.
Route of administration and doses:
Tiberal always accept after food.
Trichomoniasis:
On 1 tablet 2 times a day (in the morning and in the evening) within 5 days.
To eliminate a possibility of repeated infection, the sexual partner in all cases has to receive the same course of treatment.
The daily dose for children makes 25 mg/kg of body weight and is appointed in one step.
Amebiasis:
Possible schemes of treatment: a three-day course of treatment of patients with amoebic dysentery and a 5-10-day course of treatment at all forms of an amebiasis.
Treatment duration | Daily dose | |
Adults and children with body weight more than 35 kg | Children with body weight to 35 kg | |
a) 3 days | 3 tablets in one step in the evening At body weight more than 60 kg - 4 tablets (according to 2 tab. in the morning and in the evening) |
40 mg/kg of body weight in one step |
b) 5-10 days | 2 tablets (on 1 tablet in the morning and in the evening) | 25 mg/kg of body weight in one step |
Lambliasis:
Adults and children with body weight more than 35 kg: 3 tablets once in the evening.
Children with body weight less than 35 kg: 40 mg/kg once a day.
Duration of treatment makes 1-2 days.
Features of use:
It is necessary to be careful at patients with TsNS diseases, for example, with epilepsy, damages of a brain, multiple sclerosis. At exceeding of the recommended doses the patients with damage of a liver abusing alcohol, pregnant women and nursing mothers and children have a certain risk.
Pregnancy and lactation
Comprehensive investigations on different types of animals did not reveal any teratogenic or toxic effect of drug on a fruit. The controlled researches at pregnant women were not conducted. However for all-medical reasons it is possible to appoint Tiberal on early durations of gestation or to nursing mothers only according to absolute indications.
Side effects:
Poorly expressed drowsinesses, headaches and gastrointestinal frustration (nausea). In some cases - disturbances from TsNS, such as dizziness, tremor, rigidity, lack of coordination, spasms, fatigue, temporary loss of consciousness, signs of the touch or mixed peripheral neuropathy. Cases of a perversion of flavoring feelings, changes of hepatic functional trials, skin reactions and reactions of hypersensitivity were observed.
Interaction with other medicines:
Unlike other derivatives of a nitroimidazole, орнидазол does not inhibit an aldegiddegidrogenaza and is not therefore incompatible with alcohol. However орнидазол exponentiates effect of peroral anticoagulants of a coumarinic row that demands the corresponding correction of their dose. Ornidazol extends myorelaxation action a bromide vekuroniya.
Contraindications:
Hypersensitivity to drug or other derivatives of a nitroimidazole.
Overdose:
Symptoms: the symptoms mentioned in the section "Side effect", but in more expressed form.
Treatment: the specific antidote is unknown; at spasms - diazepam.
Storage conditions:
At a temperature not above 30 °C.
To store in the place, unavailable to children.
Issue conditions:
According to the recipe
Packaging:
1 tablet, coated, contains an ornidazol of 500 mg; in the blister of 10 pieces, in a box 1 blister.