Ornizol

General characteristics. Structure:

Active ingredient: ornidazole;

1 tabletkasoderzhit an ornidazol of 500 mg;

excipients: cellulose microcrystallic, povidone, talc, sodium krakhmalglikolit, calcium stearate, lactose monohydrate, mix for a covering of "Opadry ΙΙ White" (contains: lactose monohydrate, etc.).

Pharmacological properties:

Pharmacodynamics. Ornidazol – antiprotozoan and antibacterial agent. Entamoeba histolytica, Giardia lamblia (Giardia intestinalis), and also some anaerobic bacteria, such as is active concerning Trichomonas vaginalis: Bacteroides, Clostridium spp., Fusobacterium spp. and anaerobic cocci.

On the action mechanism орнидазол – DNK-tropny drug with selective activity concerning the microorganisms having the fermental systems capable to recover nitrogroup and to catalyze interaction of proteins of group of ferridoksin with nitro compounds. After penetration of drug into a microbic cell the mechanism of its action is caused by recovery of nitrogroup under the influence of nitroreductases of a microorganism and activity of already recovered nitroimidazole. Products of recovery form complexes with DNA, causing its degradation, break processes of replication and a transcription of DNA. Besides, products of metabolism of drug have cytotoxic properties and break processes of cellular respiration.

Pharmacokinetics. After intake орнидазол it is quickly soaked up. The maximum concentration is reached in 3 h after reception. Less than 15% contact proteins of plasma. Bioavailability – 90%. Drug easily passes through gistogematichesky barriers, including hematoencephalic, well gets into liquids and body tissues. It is metabolized in a liver.

22% – intestines are removed preferential by kidneys in the form of metabolites (about 4% of the accepted dose are removed in not changed look). The elimination half-life makes 12 – 14 h.

Main physical and chemical properties: tablets, film coated white color, an oval form with a biconvex surface, from a tablet, risky on one party, and a text of "KMP" on other party.

Indications to use:

Trichomoniasis (the urinogenital infections at women and men caused by Trichomonas vaginalis), amebiasis (all intestinal infections caused by Entamoeba histolytica, including amoebic dysentery, all abenteric forms of an amebiasis, especially amoebic abscess of a liver); lambliasis. Prevention of the infections caused by anaerobic bacteria during surgical interventions. In schemes of an eradikation H. Pylori (in a combination with inhibitors of a proton pomp, other antibacterial agents, drugs of salts of bismuth).

Route of administration and doses:

Ornizol accept inside after food.

At trichomoniasis. On 1 tablet 2 times a day (in the morning and in the evening) for 5 days.

To eliminate a possibility of repeated infection, the sexual partner has to complete the same course of treatment.

The daily dose for children with body weight more than 20 kg makes 25 mg/kg of body weight and is appointed in one step.

Amebiasis. Schemes of treatment are possible: a 3-day course of treatment of patients with amoebic dysentery and 5 ‑ a 10-day course of treatment at all forms of an amebiasis.

Treatment duration	Daily dose
	Adults and children with body weight it is more than 35 kg	Children with body weight to 35 kg
a) amoebic dysentery 3 days	3 tablets on one reception in the evening; at body weight more than 60 kg: 4 tablets (according to 2 tab. in the morning and in the evening)	35 kg – 3 tablets on odinpriy, 25 kg – 2 tablets on odinpriy, 15 kg – 1 tablet on one reception (is calculated, how 40 mg/kg of body weight on 1 reception)

 

b) other forms of an amebiasis 5 - 10 days

2 tablets (according to 1 tab. in the morning and in the evening)

35 kg – 2 tablets on odinpriy, 25 kg – 1 tablet on odinpriy, (is calculated, how 25 mg/kg of body weight on 1 reception)

Lambliasis. To adults and children with body weight over 35 kg appoint 3 tablets disposable in the evening; children with body weight is less than 35 have some - одноразовій reception of a dose of 40 mg/kg of body weight of a nasutka. Duration of treatment makes 1 - 2 day.

Prevention of the infections caused by anaerobic bacteria. Before operation appoint 1-2 tablets of drug, after operation - on 1 tablet 2 разав days for 3-5 days.

For an eradikation of H. Pylori.Орнизол on 500 mg 2 times a day, an ingibitorprotonny pomp in a standard dose and кларитромицин 500 mg 2 разав days for 7 days or inhibitor of a proton pomp in a standard dose, Ornizol of 500 mg 3 разав days, tetracycline of 500 mg 4 times a day and drug of salts of bismuth of 120 mg 4 разав days for 7 days.

Features of use:

With care it is necessary to appoint Ornizolbolny with insufficiency of function of a liver (it is necessary to reduce a dosage), the patient with hemopoiesis disturbance (big risk of development of a leukopenia, neutropenia).

At trichomoniasis simultaneous treatment of sexual partners is recommended.

Ability to influence speed of response at control of motor transport or work with other mechanisms. Drug can influence ability to manage motor transport or other mechanisms.

Side effects:

At Ornizol's use are possible:

– from a digestive tract and a liver: metal smack, dryness in a mouth, change of hepatic functional trials, nausea, weight and an abdominal pain, diarrhea, vomiting;

– from a nervous system: drowsiness, a headache, dizziness, a tremor, rigidity, a lack of coordination of movements, a temporary loss of consciousness, fatigue, an ataxy, spasms, confusion of consciousness, symptoms of the touch or mixed peripheral neuropathy;

– allergic reactions: skin rash, itch, small tortoiseshell.

Interaction with other medicines:

Ornizolusilivayet effect of peroral anticoagulants of a coumarinic row, prolongs myorelaxation action a bromide vekuroniya.

Concentration of drug decreases at simultaneous use with inductors of microsomal enzymes (phenobarbital, rifampicin) and increases at simultaneous use with inhibitors of microsomal systems of a liver, in particular, with blockers N2retseptorov (Cimetidinum).

Contraindications:

Hypersensitivity to drug or to other derivatives of an imidazole, TsNS disease (epilepsy, damage of a brain, multiple sclerosis). Period of pregnancy, feeding by a breast.

Use during pregnancy or feeding by a breast. Not a rekomendovanolecheniye drug during pregnancy. During treatment by drug feeding by a breast should be stopped.

Children. With care appoint drug to children. Do not apply this dosage form to children up to 3 years.

Overdose:

Simptomy:depressiya, peripheral neuritis, convulsive reactions, it is very rare – epileptiform spasms.

Lecheniye:simptomaticheskoye. At emergence of spasms diazepam is shown.

Storage conditions:

Period of validity 2 years. To store in the place, unavailable to children, in original packaging, at a temperature not above 25 °C.

Issue conditions:

According to the recipe

Packaging:

On 10 tablets in the blister, 1 blister in a pack.