Ozola 500 mg (10 tablets)

Instruction for medical use of medicine O. Evils Trade name of the Lake. The evils the International unlicensed name Ornidazol Lekarstvennaya the Tablet form, film coated 500 mg Structure One tablet contains active agent – an ornidazol of 500 mg, excipients: corn starch, cellulose microcrystalline, povidone, water purified, cellulose microcrystalline (Avitsel), the talc purified of sodium of starch glikolit (type A), magnesium stearate, a cover: white SC-SP-3180 dye (Spraycel) (the hydroxypropyl-methyl cellulose, polyethyleneglycol 4000, talc purified the titan dioxide (E171)), 2 propyl alcohol, methylene dichloride. The description of the Tablet, film coated white color, round shape with a biconvex surface Pharmacotherapeutic group Antibacterial drugs for system use. Other antibacterial drugs. Imidazole derivatives. Ornidazol. The ATX J01XD03 code the Pharmacological Pharmacokinetics Absorption Later properties of intake ornidazol is quickly soaked up in digestive tract. On average, absorption is 90%. The maximum concentration in plasma are reached within 3 h. Distribution distribution Volume after intravenous administration averages 1 l/kg. About 13% of an ornidazol contact proteins of plasma. Active agent of drug O. The evils very well gets into cerebrospinal liquid, other liquids of an organism and fabric. Concentration in plasma is maintained at the level which is considered optimum for various indications (6-36 mg/l). The cumulation coefficient calculated after repeated introduction of doses of 500 mg or 1000 mg to healthy volunteers each 12 h equaled 1.5-2.5. Metabolism Biotransformation of an ornidazol happens, mainly, in a liver to formation of 2-oxymethyl and a-oxymethyl metabolites. Both main metabolites are less active concerning Trichomonas vaginalis and anaerobic bacteria, than not changed ornidazol. Removal Elimination half-life makes about 13 h. After reception of a single dose of 85% it is brought during the first 5 days, generally in the form of metabolites. About 4% of a dose are removed in not changed view with urine. The pharmacokinetics in special cases Patients with an abnormal liver function – at patients with cirrhosis elimination half-life of an ornidazol is extended (22 hours instead of 14 hours) and the clearance (35 instead of 51 ml/min.) in comparison with healthy faces is reduced. The dosing interval at patients with heavy insufficiency of function of a liver has to be doubled. Patients with a renal failure – the pharmacokinetics of an ornidazol does not change at depression of function of kidneys. Dose adjustment is not necessary. Ornidazol leaves at a hemodialysis. Therefore before a hemodialysis it is necessary to give an additional dose of an ornidazol of 500 mg if a daily dose of 2 g, and 250 mg if a daily dose – 1 g. Newborns and children – pharmacokinetics of an ornidazol at newborns and children of younger age same, as at adults. Pharmacodynamics of the Lake. The evils possesses antibacterial and antiprotozoan action. Active agent of drug O. It is evil – ornidazol – interacts with DNA of a microbic cell and causes disturbance of its helical structure, a rupture of threads, suppresses synthesis of nucleic acids, causes death of microbic cells and cells of protozoa. Lake. The evils Entamoeba histolytica, Giardia lamblia (Giardia intestinalis) and also some anaerobic bacteria, such as Bacteroides and Clostridium spp., Fusobacterium spp is effective concerning Trichomonas vaginalis. and anaerobic cocci. Indications - trichomoniasis (the urinogenital infections at women and men caused by Trichomonas vaginalis) - an amebiasis (all intestinal infections, the caused Entamoeba histolytica, including amoebic dysentery and also all not intestinal forms of an amebiasis, in particular, amoebic abscess of a liver) - a giardiasis - the infections caused by anaerobic bacteria: the septicaemia, meningitis, peritonitis, postoperative wound fevers, postnatal sepsis, sepsis after an abortion, the endometritis caused by sensitive pathogens - prevention of mephitic gangrenes at surgical interventions, especially on a large intestine or bodies of a small pelvis the Route of administration and doses to use Drug strictly on doctor's orders in order to avoid complications. A pill needs to be taken always after a meal. Trichomoniasis a) Treatment by a single dose: 3 tablets (on 500 mg) in the evening. b) 5-day course of treatment: 2 tablets (on 1 tablet of 500 mg in the morning and in the evening). To eliminate a possibility of repeated infection, the sexual partner in all cases has to accept the same doses. To children appoint at the rate of 25 mg/kg of body weight a day in one step. An amebiasis a) a 3-day course of treatment for patients with amoebic dysentery: Adults and children with body weight over 35 kg – 3 tablets once in the evening in one step within three days. At body weight over 60 kg – 4 tablets (on 2 tablets in the morning and in the evening) within 3 days. Children with body weight to 35 kg: at the rate of 40 mg/kg of body weight in one step within 3 days. b) a 5-10-day course of treatment at all, including not intestinal, amebiasis forms: Adults and children with body weight over 35 kg – on 1 tablet in the morning and in the evening within 5-10 days. Children with body weight to 35 kg – at the rate of 25 mg/kg of body weight a day in one step within 5-10 days. A giardiasis Adults and children with body weight over 35 kg – 3 tablets once in the evening in one step within 1-2 days. Children with body weight to 35 kg – at the rate of 40 mg/kg of body weight in one step within 1-2 days. Mephitic gangrenes At treatment of mephitic gangrenes on a condition of the patient when translating from parenteral administration on reception of tablets – on 1 tablet each 12 hours. For children the dose makes 20 mg/kg of body weight 2 times a day within 5-10 days. Side effects Seldom - dizziness, a headache, drowsiness - gastrointestinal disorders (nausea, vomiting), disturbance of taste, metal taste in a mouth - a polyuria - trembling, rigidity, a lack of coordination of movements, spasms and disturbance of consciousness, temporary a loss of consciousness - an aberration of indicators of function of a liver - allergic reactions (skin rash, an itching) - oppression of a leukopoiesis is Very rare - symptoms of the touch or mixed peripheral neuropathy - a neutropenia, the Contraindication leukopenia - hypersensitivity to an ornidazol and other derivatives of an imidazole and also to drug components - dysfunctions of the central nervous system (CNS): epilepsy or peripheral neuropathy - liver diseases - a hemodialysis - alcohol intake - pregnancy and the period of a lactation - children's age up to 6 years Medicinal interactions Unlike other derivatives of a nitroimidazole, the Lake. The evils does not inhibit an aldegiddegidrogenaza therefore does not cause side effects, like a disulfiram. However Lake. The evils exponentiates effect of oral anticoagulants of a coumarinic row that demands the corresponding dose adjustment. Ornidazol extends myorelaxation action a bromide vekoruniya. It was reported that ornidazol increases clearance of a 5-ftoruratsil. 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 of H2 receptors (Cimetidinum). Lake. The evils cannot be combined with alcoholic beverages. It is required to appoint special instructions with care ornidazol to patients with an ataxy, dizziness and disturbance of a mental state as it was reported about cases when drug worsens a mental condition of patients with disturbances of the central and peripheral nervous systems. With care it is necessary to appoint the Lake. The evils to patients 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). In trichomoniasis the simultaneous treatment of sexual partners is recommended. In case of treatment over 10 days and at use of high doses carrying out clinical and laboratory monitoring is recommended. Features of influence on ability to run the vehicle or potentially dangerous mechanisms Considering side effects of medicine, it is necessary to be careful when driving or potentially dangerous mechanisms. Overdose Symptoms: strengthening of side effects. Treatment: symptomatic, specific antidote is unknown, in spasms diazepam is appointed. The form of release and packing On 10 tablets place in blister strip packaging from a polyvinylchloride film and aluminum printing foil. On 1 planimetric packing together with the instruction for medical use in the state and Russian languages place in a cardboard box. To Store storage conditions in the dry, protected from light place, at a temperature not above 30 °C. To store out of children's reach! A period of storage 3 years not to apply after the expiration date specified on packing Prescription status According to the prescription Lincoln Pharmaceutical Ltd Producer 10, 12, 13, Trinut Estate, Near Khatraj Chokadi, P.O. Khatraj – 382,721, India the Owner of the registration certificate of Inter Pharma, India the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of KazEvroFarm LLP 050000, Republic of Kazakhstan, Almaty, Kurmangaza St., 48a, office 9 ph./fax: +7 (727) 2615141, 2614466 e-mail:
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