Instructions Ornidazole-KV film-coated tablets 0.5 g blister No. 10
Composition
active ingredient: 1 tablet contains ornidazole 500 mg;
excipients: corn starch, microcrystalline cellulose, magnesium stearate, hydroxypropylmethylcellulose;
shell: Opadry II White film coating mixture (hydroxypropylmethylcellulose, lactose monohydrate, polyethylene glycol, titanium dioxide (E 171), triacetin).
Dosage form
Film-coated tablets.
Main physicochemical properties: round tablets with a biconvex surface, coated with a white or almost white film coating.
Pharmacotherapeutic group
Agents used in amebiasis and other protozoal infections. Nitroimidazole derivatives. Ornidazole. ATX code P01A B03.
Pharmacological properties
Pharmacodynamics.
Ornidazole is an antiprotozoal and antibacterial agent, a 5-nitroimidazole derivative. It is active against Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia (Gardia intestinalis), as well as some anaerobic bacteria, such as Bacteroides, Clostridium spp., Fusobacterium spp. and anaerobic cocci.
By the mechanism of action, ornidazole is a DNA-tropic drug with selective activity against microorganisms that have enzyme systems capable of reducing the nitro group and catalyzing the interaction of ferridoxine group proteins with nitro compounds. After the drug penetrates the microbial cell, its mechanism of action is due to the reduction of the nitro group under the influence of nitroreductases of the microorganism and the activity of the already reduced nitroimidazole. The reduction products form complexes with DNA, causing its degradation, disrupting the processes of DNA replication and transcription. In addition, the products of the drug's metabolism have cytotoxic properties and disrupt the processes of cellular respiration.
Pharmacokinetics.
Absorption. After oral administration, ornidazole is rapidly absorbed from the gastrointestinal tract. On average, absorption is 90%. Maximum plasma concentration is reached within 3 hours.
Distribution: The binding of ornidazole to plasma proteins is approximately 13%. The active substance penetrates into the cerebrospinal fluid, other body fluids and tissues.
The concentration of ornidazole in blood plasma is in the range of 6-36 mg/l, i.e. at a level considered optimal for various indications for the use of the drug. After multiple doses of 500 mg and 1000 mg to healthy volunteers every 12 hours, the cumulation coefficient is 1.5-2.5.
Metabolism: Ornidazole is metabolized in the liver to form mainly 2-hydroxymethyl and α-hydroxymethyl metabolites. Both metabolites are less active against Trichomonas vaginalis and anaerobic bacteria than unchanged ornidazole.
Elimination: The elimination half-life is approximately 13 hours. After a single dose, 85% of the dose is excreted within the first 5 days, mainly as metabolites. About 4% of the dose is excreted unchanged by the kidneys.
Features of pharmacokinetics in certain disorders of the functioning of organs and systems.
Hepatic impairment. The half-life of the active substance in cirrhosis increases to 22 hours, clearance decreases (35 versus 51 mL/min) compared to healthy individuals.
Renal impairment. The pharmacokinetics of ornidazole do not change in renal impairment, therefore the dose of the drug does not need to be changed.
Ornidazole is removed by hemodialysis. Before starting hemodialysis, an additional 500 mg of ornidazole should be administered if the daily dose is 2 g per day, or an additional 250 mg of ornidazole if the daily dose is 1 g per day.
Children: The pharmacokinetics of ornidazole in children (including neonates) are similar to those in adults.
Indication
Trichomoniasis (urinary tract infections in women and men caused by Trichomonas vaginalis).
Amebiasis (all intestinal infections caused by Entamoeba histolytica, including amoebic dysentery, all extraintestinal forms of amebiasis, especially amoebic liver abscess).
Giardiasis.
Prevention of infections caused by anaerobic bacteria after colon surgery and gynecological procedures.
Contraindication
Hypersensitivity to the components of the drug or to other nitroimidazole derivatives. Patients with central nervous system damage (epilepsy, brain damage, multiple sclerosis); pathological blood lesions or other hematological abnormalities.
Interaction with other medicinal products and other types of interactions
You should not drink alcohol during the course of treatment and for at least 3 days after stopping the medication.
However, ornidazole enhances the effect of oral coumarin anticoagulants, which requires appropriate correction of their dosage.
Ornidazole prolongs the muscle relaxant effect of vecuronium bromide.
Concomitant use of phenobarbital and other enzyme inducers reduces the circulation period of ornidazole in the blood serum, while enzyme inhibitors (e.g. cimetidine) increase it.
Application features
In individuals with a history of blood disorders, monitoring of leukocytes is recommended, especially during repeated courses of treatment.
Aggravation of central or peripheral nervous system disorders may occur during treatment with the drug. In the event of peripheral neuropathy, impaired coordination of movements (ataxia), dizziness or confusion, treatment should be discontinued.
Exacerbation of candidiasis may occur, which will require appropriate treatment.
In the case of hemodialysis, it is necessary to take into account the reduction in half-life and prescribe additional doses of the drug before or after hemodialysis.
Lithium salt concentrations, creatinine and electrolyte concentrations should be monitored during lithium therapy.
The effect of other medicines may be increased or decreased during treatment with the drug.
Use with caution in patients with impaired liver function.
The medicinal product contains lactose, therefore it should not be used in patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.
Use during pregnancy or breastfeeding
It is known that in the experiment ornidazole did not show any teratogenic or toxic effects on the fetus.
Since controlled studies in pregnant women have not been conducted, the drug is contraindicated in the first trimester of pregnancy. In the second and third trimesters of pregnancy, the drug should be taken only if there are absolute indications, when the possible benefits of using the drug for the mother outweigh the potential risk to the fetus/child.
If necessary, use of the drug should stop breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
When using ornidazole, symptoms such as drowsiness, muscle rigidity, dizziness, tremors, seizures, decreased coordination, and temporary loss of consciousness are possible.
The possibility of such manifestations must be considered for patients who drive vehicles or work with other mechanisms.
Method of administration and doses
Ornidazole-KV should be taken orally after meals, with a small amount of water.
Trichomoniasis
Recommended dosage regimens of the drug:
a) treatment course – 1 day:
adults and children weighing over 35 kg – 3 tablets per dose in the evening;
The daily dose for children weighing more than 20 kg is 25 mg of ornidazole per 1 kg of body weight per dose.
b) course of treatment – 5 days:
adults and children weighing over 35 kg – 2 tablets (1 tablet in the morning and evening).
Not recommended for children weighing less than 35 kg.
To eliminate the possibility of re-infection, the sexual partner must undergo the same course of treatment.
Amebiasis
Possible treatment regimens:
a) 3-day course of treatment for patients with amoebic dysentery;
b) 5-10-day course of treatment for all forms of amebiasis.
Recommended dosage regimen of the drug:
Table 1
| Duration of treatment | Daily dose |
Adults and children with body weight over 35 kg | Children with mass body weight up to 35 kg |
a) amoebic dysentery 3 days | 3 tablets to be taken in the evening. With a body weight of more than 60 kg: 4 tablets (2 tablets in the morning and 2 tablets in the evening) | 35 kg – 3 tablets per dose 25 kg – 2 tablets per dose 13 kg – 1 tablet per dose (calculated as 40 mg of ornidazole per 1 kg of body weight per dose) |
b) other forms of amebiasis 5-10 days | 2 tablets (1 tablet in the morning and evening) | 35 kg – 2 tablets per dose 20 kg – 1 tablet per dose (calculated as 25 mg of ornidazole per 1 kg of body weight per dose) |
Giardiasis
Adults and children weighing more than 35 kg should be prescribed 3 tablets once in the evening, children weighing less than 35 kg - a single dose of 40 mg/kg body weight per day. The duration of treatment is 1-2 days.
Prevention of infections caused by anaerobic bacteria.
The duration of postoperative therapy is usually 5-10 days, but it should be determined based on the clinical data of the operated patient. Ornidazole-KV tablets should be prescribed after the patient's condition has stabilized and it is possible to independently use tableted medications. Prescribe 1 tablet every 12 hours.
For children, the daily dose is 20 mg per 1 kg of body weight in 2 doses for 5-10 days.
To prevent mixed infections, Ornidazole-KV should be used in combination with aminoglycosides, penicillin and cephalosporin antibiotics.
Medicines should be used separately.
Children.
Contraindicated for children under 3 years of age.
Children should use the medicine according to the dosage recommendations specified in the "Method of administration and doses" section.
Overdose
Symptoms: overdose may cause loss of consciousness, headache, dizziness, tremors, convulsions, dyspeptic disorders or increased manifestations of other adverse reactions.
Gastric lavage or hemodialysis is recommended to remove ornidazole from the body.
In case of convulsions, intravenous administration of diazepam is recommended.
Side effects
Side effects of ornidazole are dose-dependent.
From the blood and lymphatic system: suppression of bone marrow hematopoiesis, neutropenia, leukopenia.
On the part of the immune system: hypersensitivity reactions, including manifestations of skin allergic reactions, anaphylactic shock.
Skin and subcutaneous tissue disorders: skin rash, skin hyperemia, angioedema, itching, urticaria.
Nervous system: headache, fatigue, agitation, confusion, tremor, rigidity, impaired coordination, ataxia, convulsions, spatial disorientation, temporary loss of consciousness, signs of sensory or mixed peripheral neuropathy, dizziness, drowsiness.
Gastrointestinal: nausea, vomiting, metallic taste in the mouth, loss of appetite, dry mouth, coated tongue, changes in taste sensations, epigastric pain, dyspepsia, diarrhea.
From the hepatobiliary system: jaundice, hepatotoxicity, changes in liver function tests.
General disorders: fever, chills, general weakness, shortness of breath.
Infections and infestations: exacerbation of candidiasis.
Others: darkening of urine color, cardiovascular disorders, including decreased blood pressure.
Expiration date
5 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in a blister; 1 blister in a pack.
Leave category. By prescription.
Vacation category
According to the recipe.
Producer
JSC "KYIV VITAMIN FACTORY".
Address
04073, Ukraine, Kyiv, Kopylivska St., 38.
Website: www.vitamin.com.ua.
