Each film coated tablet contains: Ornidazole 500 mg.
Excipients/Inactive Ingredients: Microcrystalline cellulose PH102, maize starch, croscarmellose sodium, magnesium stearate, opadry 03B53217 orange and purified water.
Pharmacotherapeutic group: Agents against amoebiasis and other protozoal diseases. Nitroimidazole derivatives. ATC code: P01AB03.
Pharmacology: Pharmacodynamics: Orgyl contains ornidazole which is a 5-nitroimidazole derivative, antiprotozoal drug. It is extremely active against protozoa and bacterial infections. The drug is effective against Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia (Giardia intestinalis), and also some anaerobic bacteria such as Bacteroides spp., and Clostridium spp., Fusobacterium spp., and anaerobic cocci.
Pharmacokinetics: Following oral administration Ornidazole is easily and rapidly absorbed. Bioavailability is 90%. Peak plasma concentrations are reached within three hours after administration. Plasma protein binding of Ornidazole is about 13%. It penetrates into the cerebrospinal fluid, other body fluids and tissues very effectively. Ornidazole is metabolised in the liver. The half-life is about 13 hours. 63% of the dose is excreted with urine, and 22% is excreted with feces.
Orgyl is indicated for the following: trichomoniasis (trichomonas vulvovaginitis, urethritis, bartholinitis, cervicitis, prostatitis, adnexitis); amoebiasis (amoebic dysentery, extraintestinal amoebiasis, including hepatic amoebiasis); giardiasis; infection prevention after surgical and gynaecological interventions.
Trichomoniasis: 500 mg (1 tablet) 2 times a day (morning and evening) for 5 days or 1.5 g (3 tablets) once in the evening. For antibacterial effect it is recommended to administer vaginal tablets concomitantly.
Sexual partner should also undergo treatment to avoid reinfection.
Intestinal amoebiasis: 1.5 g (3 tablets) once a day, if body weight is more than 60 kg - 2 g/day (4 tablets: 2 tablets in the morning and 2 tablets in the evening). Course of treatment - 3 days.
Extraintestinal amoebiasis: 0.5 g (1 tablet) orally, in the morning and evening for 5-10 days.
Giardiasis: 1.5 g/day (3 tablets). Course of treatment - 1-2 days.
Prevention of infections caused by anaerobic bacteria: 0.5-1 g (1-2 tablets) before surgery, 1 tablet twice a day for 3-5 days after surgery.
Method of administration: The tablets must always be taken orally after meal.
Symptoms: Seizures, depressive reactions, peripheral neuritis.
Treatment: No antidote is known. The administration of diazepam is recommended if seizure occur.
Hypersensitivity to the medicine; central nervous system diseases (epilepsy, brain lesion, multiple sclerosis); pregnancy and lactation; children under 18.
In the treatment of trichomoniasis it is recommended to treat both partners.
In patients with severe renal insufficiency and elderly patients due to age related renal insufficiency, doses of the drug should be decreased.
Caution is advised to patients with central nervous system diseases (organic diseases and predisposition to seizures) and diseases of the hematopoietic system.
Effects on Ability to Drive and Use Machines: It is advised to consider the possibility of decreased speed of reaction while driving or operating machines which require precision and quick reaction capability.
Dyspepsia, gastrointestinal disturbances (nausea), dysgeusia; allergic reactions (rash, pruritus).
Rare: polyuria (as it can partially block angiotensin II-receptors); somnolence, headache, dizziness, fatigue, temporary loss of consciousness, disturbances of the CNS (ataxia, dysarthria, tremor, seizures) and peripheral nerves (burning sensation, sleeping limbs, paresthesia); inhibition of leucopoiesis; abnormal liver function, allergic reactions.
Adverse Drug Reaction: Inform doctors about unexpected reactions after using drugs.
Orgyl potentiates effect of coumarin-type anticoagulants. It prolongs the muscle-relaxant effect of vecuronium bromide. Concomitant administration with other 5-nitroimidazole derivatives may lead to peripheral neuropathy, depression, epileptiform seizures.
Ornidazole does not inhibit aldehyde dehydrogenase. Hence it does not interact with alcohol.
Concomitant intake with other microsomal enzyme inducers (barbiturate, benzodiazepines, rifampicins, etc.) decreases half-life of ornidazole in serum. Microsomal enzyme inducers (cimetidine, macrolides, etc.) increase half-life of ornidazole.
Orgyl is not recommended in combination with neurotoxic and hematoxic drugs.
Store below 30°C.
Shelf Life: 36 months.
P01AB03 - ornidazole ; Belongs to the class of nitroimidazole derivatives antiprotozoals. Used in the treatment amoebiasis and other protozoal diseases.
FC tab 500 mg (orange colored, round shaped, plain on both sides) x 10 x 10's.
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