Instructions Meratin film-coated tablets 500 mg blister No. 10
Composition
active ingredient: ornidazole;
1 tablet contains ornidazole 500 mg;
excipients: microcrystalline cellulose, corn starch, sodium methylparaben (E219), sodium propylparaben (E217), magnesium stearate, talc, colloidal anhydrous silica, sodium starch glycolate (type A), hypromellose, titanium dioxide (E171), polyethylene glycol 6000
Dosage form
Film-coated tablets.
Main physicochemical properties: white, round, biconvex, film-coated tablets, embossed with “500” on one side and “MERATIN” on the other side.
Pharmacotherapeutic group
Agents used in the treatment of amebiasis and other protozoal infections. Nitroimidazole derivatives. Ornidazole. ATC code P01A B03.
Pharmacological properties
Pharmacodynamics.
The mechanism of action of ornidazole is associated with disruption of the DNA structure of sensitive microorganisms. Ornidazole is active against Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia (Giardia intestinalis), Haelicobacter Pylori, as well as some anaerobic bacteria, such as Bacteroides and Clostridium spp., Fusobacterium spp. and anaerobic cocci.
Pharmacokinetics. After oral administration, 90% of ornidazole is absorbed from the digestive tract. The maximum concentration in blood plasma is reached within 3 hours. The binding of ornidazole to blood plasma proteins is approximately 13%. Depending on the dosage regimen, the optimal concentration of the active substance is 6–36 μg/l. Ornidazole is metabolized with minimal involvement of the cytochrome P450 system. The drug penetrates well into the cerebrospinal fluid and other body fluids and tissues.
The elimination half-life is approximately 13 hours. After a single dose of the drug, 85% of the dose is excreted within the first 5 days. It is excreted mainly in the urine (63%) and feces (22%). Approximately 4% of the administered dose is excreted unchanged by the kidneys. The accumulation coefficient after repeated administration of the drug at a dose of 500 mg or 1000 mg by healthy volunteers every 12 hours is 1.5–2.5.
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.
Contraindication
Hypersensitivity to any component of the drug or to other nitroimidazole derivatives. 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
Alcohol should not be consumed during the course of treatment and for at least 3 days after stopping the drug. However, ornidazole enhances the effect of oral coumarin anticoagulants, which requires appropriate dosage adjustment.
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
When using high doses of the drug and in case of treatment for more than 10 days, clinical and laboratory monitoring is recommended.
If the patient has a history of blood disorders, monitoring of leukocytes is recommended, especially when conducting 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.
Exceeding the recommended doses increases the risk of side effects in children, patients with liver damage, and patients who abuse alcohol.
In the case of hemodialysis, it is necessary to take into account the reduction in the 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.
Use during pregnancy or breastfeeding
Ornidazole does not show teratogenic or toxic effects on the fetus. Since controlled studies in pregnant women have not been conducted, the drug should be prescribed in early pregnancy or during breastfeeding 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.
Ability to influence reaction speed when driving vehicles or other mechanisms
When using ornidazole, such manifestations as drowsiness, rigidity, dizziness, tremor, convulsions, impaired coordination, temporary loss of consciousness are possible. The possibility of such manifestations must be taken into account for patients who drive vehicles or work with other mechanisms.
Method of administration and doses
Meratin is taken orally after meals, washed down 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 taken in the evening;
daily dose for children weighing more than 20 kg – 25 mg of ornidazole per 1 kg of body weight per
1 reception;
b) course of treatment - 5 days:
adults and children weighing over 35 kg – 2 tablets per day (1 tablet in the morning and evening).
Not recommended for children weighing less than 35 kg.
To prevent re-infection, the sexual partner must undergo the same course of treatment.
Amebiasis
Possible treatment regimens:
a) a three-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 weighing more than 35 kg | Children weighing 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 are prescribed 3 tablets once in the evening, children weighing less than 35 kg - a single dose of 40 mg/kg of body weight per day. The duration of the course of treatment is 1–2 days.
Children.
The drug is used in children according to the dosage recommendations specified in the section "Method of administration and doses".
Overdose
Manifested by increased symptoms of adverse reactions.
Treatment: no specific antidote is known; in case of convulsions, diazepam should be used. Treatment is symptomatic.
Side effects
Blood and lymphatic system disorders: bone marrow effects, leukopenia, neutropenia.
Immune system disorders: hypersensitivity reactions, including anaphylactic shock, angioedema.
Skin and subcutaneous tissue disorders: skin rash, itching, urticaria.
Neurological disorders: headache, fatigue, agitation, confusion, tremor, rigidity, impaired coordination, convulsions, temporary loss of consciousness, signs of sensory or mixed peripheral neuropathy, dizziness, drowsiness, ataxia, spatial disorientation.
General disorders: fever, chills, general weakness, shortness of breath.
Gastrointestinal disorders: nausea, vomiting, metallic taste in the mouth, dry mouth, dyspepsia, taste disturbance, coated tongue, diarrhea, epigastric pain, loss of appetite.
Hepatobiliary disorders: hepatotoxicity, not known - jaundice, abnormal biochemical liver function tests, increased liver enzymes.
Infections and infestations: exacerbation of candidiasis.
Others: darkening of urine color, cardiovascular disorders, including decreased blood pressure.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 ºС in the original packaging, out of the reach of children.
Packaging
10 tablets in a blister. 1 blister in a cardboard box.
Vacation category
According to the recipe.
Producer
Mepro Pharmaceuticals Private Limited.
Location of the manufacturer and its business address.
Unit II, Q-Road, Phase IV, GIDC, Wadhwan, Surendranagar, Gujarat, 363 035, India.
Applicant
Milli Healthcare Limited.
Location of the applicant.
2nd Floor, Office Space, 4 Chartfield House, Castle Street, Taunton, Somerset, England,
TA1 4AS, United Kingdom.
