Ornisid Forte 10s 500 mg coated tablets

The instruction for medical use of ORNISID® medicine forte the Trade name of Ornisid® forte the International unlicensed name Ornidazol Lekarstvennaya the Tablet form, film coated 500 mg Structure One tablet contains active agent - ornidazol 500 mg excipients: cellulose microcrystalline (Type 102), starch corn, hydroksipropilmetiltsellyuloz (E-15), magnesium stearate structure of a cover: Opadry II 85F18422 White (polyvinyl alcohol (E1203), the titan dioxide (E171), makrogol/PEG (MW 3350) (E1521), talc) the Description of the Tablet, film coated, white or yellow-white color, round shape with a biconvex surface, with risky on one party Pharmacotherapeutic group Drugs for treatment of an amebiasis and other protozoan infections. Nitroimidazole derivatives. Ornidazol the ATX P01AB03 Code the Pharmacological Ornidazol Pharmacokinetics properties is easily absorbed from digestive tract. Bioavailability – 90%. The maximum concentration in blood plasma is reached within 2 hours. After oral use of the maximum daily dose of 1.5 g the concentration of an ornidazol in blood plasma reaches 30mg/ml, on the expiration of 24 hours the plasma concentration goes down to 9 mg/ml. Linking with proteins of blood plasma makes less than 15%. Ornidazol well gets into all fabrics and liquids of an organism, including cerebrospinal liquid. Biotransformation of an ornidazol occurs in a liver. Elimination half-life of an ornidazol makes 12-14 hours. After single dose of 85% of a dose it is brought out of an organism within 5 days in the form of metabolites. Ornidazol is brought generally in the form of metabolites by kidneys (63%) and with excrement (22%). Elimination of an ornidazol is possible also in the bilious way. The pharmacodynamics Ornisid (ornidazol) possesses antibacterial and antiprotozoan action. Interacting with DNA of a microbic cell, causes disturbance of its helical structure, a rupture of threads, suppresses synthesis of nucleic acids and causes death of microbic cells and cells of protozoa. Ornisid (ornidazol) is active concerning protozoa: Trichomonas vaginalis, Entamoeba histolitica, Gardnerella vaginalis, Giardia intestinalis, Lambilia. And also concerning anaerobic cocci: Peptostrepococcus, Peptococcus. Indications - trichomoniasis at women and men: a mecotic vulvovaginitis, an urethritis, a bartholinitis, a cervicitis, prostatitis, an adnexitis - an amebiasis: amoebic dysentery, an abenteric amebiasis (including amoebic abscess of a liver) - a giardiasis - prevention of mephitic gangrenes at surgical interventions, on a large intestine and in gynecology the Route of administration and doses of the Pill are taken after a meal. At treatment of trichomoniasis at adults two schemes of combination therapy the Course of treatment 1 scheme 2 the scheme Single dose of 1.5 g are applied (the 3rd tab.) in 1 g (the 2nd tab.) inside + 1 vaginal tab. (Ornisida) before going to bed 5 days of 500 mg (1 tab.) in the morning and 500 mg (1 tab.) in the evening in 500 mg (1 tab.) in the morning and 500 mg (1 tab.) in the evening in + 1 vaginal a tab. (Ornisid) before going to bed to Children a dose is established at the rate of 25 mg/kg of body weight/days. In amoebic dysentery to adults and children with body weight higher than 35 kg are appointed inside on 1.5 g (the 3rd tab.) 1 time/days in the evening, adult with body weight more than 60 kg – 2g/days (the 2nd tab. in the morning and the 2nd tab. in the evening). To children with body weight less than 35 kg drug appoint 1 times/days from calculation 40mg/kg body weights. A course of treatment – 3 days. At other forms of an amebiasis to adults and children with body weight higher than 35 kg are appointed inside on 500 mg of 2 times/days (1 tab. in the morning and 1 tab. in the evening). A course of treatment – 5-10 days. In a giardiasis to adults and children with body weight higher than 35 kg are appointed inside on 1.5 g (the 3rd tab.) 1 time/days in the evening within 1-2 days, or on 500 mg of 2 times/days (1 tab. in the morning and 1 tab. in the evening) within 5-10 days. To children with body weight less than 35 kg drug appoint 1 times/days at the rate of 40 mg/kg of body weight at reception within 1-2 days. Prevention of the infections caused by anaerobic bacteria - 0.5-1 g before operation, after operation - 0.5 g 2 times a day within 3-5 days. The daily dose for children is established at the rate of 25 mg/kg of body weight. Side effects of Disturbance from the system of blood and lymphatic system Seldom (≥1/10,000, but & lt, 1/1000): - The Disturbance leukopenia from nervous system Very seldom (& lt, 1/10,000): - drowsiness - a headache - dizziness - a tremor - rigidity - an incoordination - a spasm - fatigue - vertigo - a temporary loss of consciousness - the touch or mixed peripheral neuropathy of Disturbance from digestive tract Infrequently (≥1/1000, but & lt, 1/100): - nausea - vomiting - diarrhea - unpleasant feeling in epigastric area - dryness in a mouth - anorexia Seldom (≥1/10,000, but & lt, 1/1000): - disturbance of taste of Disturbance from a liver and biliary tract Is unknown (it is impossible to estimate, proceeding from available data): - a bilious attack - abnormal indicators of function of a liver of Disturbance from skin and hypodermic fabrics seldom (≥1/10,000, but & lt, 1/1000) - an itching and skin reactions of the Contraindication - hypersensitivity to drug components - organic diseases of central nervous system - pregnancy and the period of a lactation - children's age up to 6 years the Medicinal interactions At combined use of Ornisid with other derivatives of the 5th nitroimidazole can be observed a peripheral neuropathy, a depression and epileptoformny spasms. Ornidazol does not inhibit an aldegiddegidrogenaza and therefore does not interact with alcohol. Simultaneous use with inductors of microsomal enzymes (barbiturates, benzodiazepines, rifampitsina, etc.) reduces a half-life period of an ornidazol in serum. Inhibitors of microsomal enzymes (Cimetidinum, macroleads, etc.) increase a half-life period of an ornidazol. Ornidazol strengthens action of anticoagulative means that demands correction of their dose. The combination of an ornisid with neurotoxic and gematotoksichny drugs is not recommended. Extends myorelaxation action a bromide vekuroniya Special instructions With care to apply in central nervous system diseases (including epilepsy, multiple sclerosis), diseases of a liver and alcoholism. In trichomoniasis it is necessary to carry out simultaneous treatment of the sexual partner in order to avoid repeated infection. Features of influence of medicine on ability to drive the car or potentially dangerous mechanisms Considering a possibility of development of side effects from central nervous system, it is necessary to be careful at control of transport and potentially dangerous mechanisms. Overdose Symptoms: strengthening of manifestations of pobochy actions. Treatment: antidote does not exist, carry out symptomatic therapy, in spasms appoint diazepam. The form of release and packing On 10 tablets place in blister strip packaging from a film of polyvinylchloride and aluminum foil. On 1 planimetric packing together with the instruction for medical use in the state and Russian languages put Storage conditions in a cardboard pack to Store in the dry, protected from light place at a temperature not over 25 of 0C. To store in places inaccessible for children! 3 years not to apply a period of storage after the expiration date specified on packing. Prescription status According to the prescription ABDI IBRAHIM Producer, Istanbul, Turkey the Owner of the registration certificate of ABDI IBRAHIM, Istanbul, Turkey