Ornidazol-OBL
Producer: CJSC FP OBOLENSKOYE Russia
Code of automatic telephone exchange: G01AF06
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredient: 500 mg of an ornidazol in 1 tablet.
Excipients: lactose (sugar milk), magnesium stearate, silicon dioxide colloid (aerosil), cellulose microcrystallic, povidone (коллидон 30), sodium of a kroskarmeloz (primelloz), talc, sodium lauryl sulfate, gipromelloza (gidroksipropil-methyl cellulose), polyethyleneglycol 6000 (macrogoal), titanium dioxide.
Pharmacological properties:
Pharmacodynamics. Ornidazol is active concerning Trichomonas vaginalis, Gardnerella vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia spp., some anaerobic microorganisms (Bacteroides spp., Fusobacterium spp., Clostridium spp. and anaerobic cocci).
Pharmacokinetics. Absorption from digestive tract high. Bioavailability - 90%.
Time of achievement of the maximum concentration (TCmax) of-1-2 h. Communication with proteins of plasma - not less than 15%. Gets through a blood-brain barrier. An elimination half-life (T1/2) - about 13 h. It is removed in the form of metabolites by kidneys (60-65%) and with fecal masses of 20-22%), about 5% of a dose are removed in not changed look.
Indications to use:
Trichomoniasis; amebiasis, amoebic dysentery, abenteric amebiasis (including amoebic abscess of a liver); lambliasis; prevention of the postoperative infectious complications caused by anaerobic bacteria at surgical intervention on a large intestine and gynecologic operations.
Route of administration and doses:
At trichomoniasis: adult-500 mg 2 times a day within 5 days.
To children - in a single dose, at the rate of 25 mg/kg of body weight a day.
At amoebic dysentery to adults and children with body weight over 35 kg - 1,5 g of 1 times a day, at body weight over 60 kg - 2 g a day.
To children with body weight less than 35 kg - 40 mg/kg/days. Treatment duration - 3 days.
For treatment of other forms of an amebiasis: to adults and children with body weight more than 35 kg - on 500 mg inside, 2 times a day in the morning and in the evening, weighing up to 35 kg - 25 mg/kg/days once within 5-10 days.
At a lambliasis: to adults and children with body weight over 35 kg - inside, on 1,5 g of 1 times a day; to children with body weight to 35 kg - on 40 mg/kg/days. Treatment duration - 1-2 days.
Prevention of the postoperative infectious complications caused by anaerobic bacteria - 500 mg before operation, then each 12 hours on 500 mg, within 3-5 days.
Features of use:
Pregnancy and lactation. Contraindicated.
At treatment of trichomoniasis it is necessary to carry out simultaneous treatment of both partners.
Side effects:
Headache, dizziness, drowsiness, fatigue, disturbance or temporary loss of consciousness, tremor, muscle tension, diskoordination of movements, spasms, the touch or mixed peripheral neuropathy, perversion of flavoring feelings, nausea, change of activity of "liver enzymes", allergic reactions, dispepsichesky frustration.
Interaction with other medicines:
Strengthens effect of anticoagulants of a coumarinic row, the bromide vekuroniya prolongs miorelak-siruyushchy action.
Let's combine with ethanol (does not inhibit an atsetaldegiddegidrogenaza), unlike other imidazolovy derivatives (metronidazole).
Contraindications:
Гиперчувствителыюсть, pregnancy (I trimester), lactation period, organic diseases of the central nervous system.
Children's age up to 3 years (for this dosage form).
Overdose:
Symptoms: epileptiform spasms, depression, peripheral neuritis.
Treatment: symptomatic.
Storage conditions:
List B. In the dry place protected from light at a temperature not above 25 °C. To store in the place, unavailable to children. A period of validity - 2 years. Not to use after the period of validity specified on packaging.
Issue conditions:
According to the recipe
Packaging:
Tablets, film coated on 500 mg. Packaging: on 3 or 10 tablets in a blister strip packaging from a film of the polyvinyl chloride and printing aluminum foil varnished. On 1, 2, 3, 4 or 5 blister strip packagings together with the application instruction in a pack from a cardboard.