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Additional ingredients: Microcrystalline cellulose, Starch, Croscarmellose sodium, Magnesium stearate, Color Opadry Orange.
Pharmaceutical Form: Film coated tablets.
Pharmacotherapeutic group:
Antibacterial agents for system use, Nitroimidazoles derivate. Code АТС: G01A.
Pharmacological properties
Pharmacodynamics
Orgyl тм is effective against Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia (Giardia intestinalis),and against some of anaerobic bacteria, such as Gardnerella vaginalis, Bacteroides, Clostridium spp., Fusobacterium and anaerobic coccus.
Pharmacokinetics
Absorption: After the oral usage Оrnidazole is absorbed quickly. Approximately absorption is 90%. Maximum concentration is reached in the plasma for 3 hours.
Allocation: The binding of ornidazole with the proteins is approximately 13%. The active ingredient of Orgyl тм penetrates well into the cerebrospinal fluid, others fluids of the organism and tissues.
Concentrations of ornidazole in the plasma are in optimal range for the different indications for the usage of the drug: 3 36 mg/ml. Index of cumulation after the frequentative usage of the drug in dosage of 500 mg or 1000 mg by the healthy volunteers is 1,5 2,5 after every 12 hours.
Metabolism: Ornidazole is metabolised in the liver for the formation of metabolites of 2-hydroxymethyl-and α hydroxymethyl. Both of them have a less activity against Trіchomonas vagіnalіs and anaerobic bacteria then original Ornidazole.
Excretion: The period of the half life is approximately 13 hours. After the single usage of the 85% of the dose of ornidazole it is excreted during the first 5 days, mainly as metabolites. Approximately 4 % of the dose is excreted by kidney in unchanged form.
Indications: Trichomoniasis (urino-genital infections in male and female, caused by Trіchomonas vagіnalіs);
amebiasis (all of intestinal diseases, caused by Entamoeba hіstolytіca, including amebic dysentery, all of abenteric forms of the amebiasis, especially amebic abscess of the liver; lambliasis;
Prophylaxis of infections caused by anaerobic bacteria in gynecology and colon operations.
Administration and Dosage: Orgyl тм is used only after the meal.
Trichomoniasis: 1 tablet two times per day (at the morning and at the evening) - 5 days. For the avoiding of the possibility of reinfection the partner should receive the same course of the treatment in any cases.
Amebiasis: There are schemes of the treatment: 3 days for the treatment of the patients with amebic dysentery and 5 10 days for the treatment of all of other amebiasis forms.
Duration of the treatment |
Daily dosage
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Adults and children with the body weight more then 35 kg.
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Children with the body weight less then 35kg. |
а) amebic dysentery
3days |
3 tablets in one taking at the evening;
in a case of body weight
more then 60 kg: 4 tablets (in 2 tablets at the morning and at the evening). |
35 kg 3 tablets in one taking;
25 kg 2 tablets in one taking;
15 kg 1 tablet in one taking;
(it is calculated as 40 mg/kg of BW in one taking)
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b) other amebiasis forms
5 - 10 days |
2 tablets (in 1 tablet at the morning and at the evening). |
35 kg 2 tablets in one taking;
25 kg 1 tablet in one taking;
15 kg 1/2 of the tablet in one taking;
(it is calculated as 25 mg/kg of BW in one taking) |
Lambliasis:
For adults and children with the body weight more then 35 kg it is administered 3 tablets in one taking at the evening; for the children with the body weight less then 35 kg it is administered 40 mg/kg of BW per day. Duration of the treatment is 1 2 days.
The prophylactic of the infections, caused by anaerobic bacteria: Before the operation it is administered 1 2 tablets per day during 3 5 days.
Side effects:
It could be insignificant drowse, headache, gastro-intestinal disorders (nausea). In rare cases it could be CNS disorders, such as dizziness, tremor, disorders of the coordination, convulsions, weakness, temporary loss of consciousness, and signs of the sensory or mixed peripheral neuropathy. There were disorders of gustatory sense, changes of the livers functional tests, skin reactions and reactions of hypersensitivity.
Contraindications:
Hypersensitivity to the drug components. Orgyl тм is contraindicated for the patients with CNS affection, epilepsy, during the period of the pregnancy and lactation.
Overdosage: The symptoms: spasms, depression, peripheral neuritis.
The treatment
is symptomatic, the special antidote in unknown.
Special indications: During the treatment of Trichomoniasis it is necessary to treat both of the partners. Pregnansy and lactation.
There were no any controlled studies in pregnant women. During the periods of the pregnancy and lactation the drugs usage is allowed only if the expected benefit for mother is more then the fetus or baby risk.
Influence on ability to drive a car and to operate any other machines.
Orgyl can influent on the ability to drive a car or operate complicated machines, so in a case of the appearance of side effects it is necessary to stop such activity.
Drug interactions: Ornidazole intensifies the activity of the coumarin anticoagulants, that it is necessary to correct their doses accordingly. Ornidazole prolongs the relaxing activity of the vecuronium bromide.
Storage and Shelf-life: Store at the temperature not more 25 oC, in protected from light place; keep out of reach of children Shelf-life 3 years.
Conditions of supply: After prescription.
Package: 10 tablets are in the blister, in carton box.
Manufacturer:
Kusum Healthcare Pvt. Ltd, India
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