Meratin - instructions, indications, composition, method of application

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Manufacturers: Mili Healthcare

Active ingredients

• Ornidazole

Disease class

• Not indicated. See instructions

Clinical and pharmacological group

• Not indicated. See instructions

Pharmacological action

• Not indicated. See instructions

Pharmacological group

• Not indicated. See instructions

Pharmacological authorities

Pharmacodynamics

.

The mechanism of ornidazole binding to damaged DNA structure in sensitive microorganisms. Ornidazole active supplement Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia (Giardia intestinalis), Haelicobacter Pylori

, as well as certain anaerobic bacteria, such as
Bacteroides
and
Clostridium spp., Fusobacterium spp.
and anaerobic cocs.

Pharmacokinetics.

After stagnation internally, 90% of ornidazole is absorbed from the herbal tract. The maximum concentration in blood plasma is reached within 3 years. The binding of ornidazole to plasma proteins is approximately 13%. Depending on the dosing regimen, the optimal concentration of the active substance becomes 6–36 mcg/l. Ornidazole is metabolized with minimal production of cytochrome P450 in the system. The drug penetrates well into the spinal cord and other areas and tissues of the body.

The recovery period is approximately 13 years. After a one-time administration of the drug, 85% of the dose is excreted in the first 5 dB. It is important to excrete by cutting (63%) and feces (22%). Approximately 4% of the infused dose is excreted in the unchanged state. The cumulation coefficient after multiple doses of the drug at a dose of 500 mg or 1000 mg in healthy volunteers on the skin for 12 years becomes 1.5–2.5.

Meratin instructions for use

Compound

active ingredient: ornidazole;

1 tablet contains ornidazole 500 mg

excipients: microcrystalline cellulose, corn starch, sodium methylparaben (E219), sodium propylparaben (E217), magnesium stearate, talc, colloidal silicon dioxide, sodium starch (type A), hypromellose, titanium dioxide (E171), polyethylene glycol 6000

Dosage form

Film-coated tablets.

Basic physical and chemical properties:

White, round, biconvex, film-coated tablets, embossed with "500" on one side and "MERATIN" on the other side.

Pharmacological group

Medicines used for amoebiasis and other protozoal infections . Nitroimidazole derivatives. Ornidazole. ATX code P01A B03.

Pharmacological properties

Pharmacological.

The mechanism of action of ornidazole is associated with disruption of the DNA structure in microorganisms sensitive to it. 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 3:00. The binding of ornidazole to plasma proteins is 13%. Depending on the dosage regimen, the optimal concentration of the active substance is 6-36 mcg/l. Ornidazole is metabolized with minimal involvement of the cytochrome P450 system. The drug penetrates well into the cerebrospinal fluid and other fluids and tissues of the body.

The half-life is 13 hours. After a single use of the drug, 85% of the dose is eliminated within the first 5 days. Excreted primarily in urine (63%) and feces (22%). Approximately 4% of the dose is excreted unchanged by the kidneys. The accumulation coefficient after repeated use of the drug at a dose of 500 mg or 1000 mg by healthy volunteers every 12:00 is 1.5-2.5.

Indications

Trichomoniasis (genitourinary 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.

Contraindications

Hypersensitivity to the components of the drug or to other nitroimidazole derivatives. Damage to the central nervous system (epilepsy, brain damage, multiple sclerosis).

Pathological blood lesions or other hematological abnormalities.

Interaction with other drugs and other types of interactions

You should not drink alcohol during the course of treatment for at least 3 days after stopping the drug. However, ornidazole enhances the effect of oral coumarin anticoagulants and requires appropriate adjustment of their dose.

Ornidazole prolongs the muscle relaxant effect of vecuronium bromide.

The combined use of phenobarbital and other enzyme inducers reduces the circulation period of ornidazole in the blood serum, while enzyme inhibitors (for example cimetidine) increase it.

Features of application

When using high doses of the drug and when treating 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 during repeated courses of treatment.

Increased disturbances in the central or peripheral nervous system may be observed during treatment. In the case of peripheral neuropathy, impaired coordination of movements (ataxia), dizziness or clouding of consciousness should be stopped.

An exacerbation of candidiasis may occur, which will require appropriate treatment.

If recommended doses are exceeded, the risk of side effects increases 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 half-life and prescribe additional doses of the drug before or after hemodialysis.

The concentration of lithium salts, creatinine and electrolyte concentrations must be monitored when lithium therapy is used.

The effect of other medicines may be increased or decreased during treatment.

Use with caution in patients with impaired liver function.

Use during pregnancy or breastfeeding

Ornidazole does not exhibit teratogenic or toxic effects on the fetus. Since controlled studies have not been conducted in pregnant women, the drug can 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.

The ability to influence the reaction rate when driving vehicles or other mechanisms

When using ornidazole, manifestations such as drowsiness, rigidity, dizziness, tremors, convulsions, decreased coordination, and temporary loss of consciousness are possible. The possibility of such manifestations must be taken into account for patients who drive vehicles and operate other mechanisms.

Directions for use and doses

Meratin is taken orally after meals with a small amount of water.

Trichomoniasis

Recommended dosage regimens:

a) course of treatment - 1 day:

adults and children weighing more than 35 kg - 3 tablets per evening; daily dose for children weighing more than 20 kg - 25 mg of ornidazole per 1 kg of body weight in 1 dose;

b) course of treatment - 5 days:

adults and children weighing more than 35 kg - 2 tablets per day (1 tablet morning and evening). Children weighing less than 35 kg are not recommended.

To prevent re-infection, the sexual partner must undergo the same course of treatment.

amoebiasis

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:

Table 1.

Giardiasis

Adults and children weighing more than 35 kg take 3 tablets once in the evening, children weighing less than 35 kg take a single dose of 40 mg/kg body weight per day. The duration of the course of treatment is 1-2 days.

Children

The drug is used for children in accordance with the dosage recommendations specified in the section “Dosage and Administration” »

.

Overdose

Manifested by increased symptoms of adverse reactions.

Treatment:

specific antidote is unknown; If seizures occur, diazepam should be used.

Interactions with other medicinal drugs and other types of interactions

Do not drink alcohol during a course of treatment for at least 3 days after taking medication. Prote ornidazole enhances the effect of oral coumarin anticoagulants, which promotes appropriate correction of their dosage.

Ornidazole prolongs the muscle relaxant effect of vecuronium bromide.

Severe use of phenobarbital and other enzyme inducers reduces the period of circulation of ornidazole in the serum, while enzyme inhibitors (such as cimetidine) increase it.

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Features of good stagnation

When administering high doses of the drug and administering it for at least 10 days, it is recommended to conduct clinical and laboratory monitoring.

If the patient's history shows a disorder in the side of the blood, it is recommended to monitor leukocytes, especially when conducting repeated courses of treatment.

Severe damage to the side of the central or peripheral nervous system can be avoided during treatment with the drug. In cases of peripheral neuropathy, loss of coordination of the arms (ataxia), confusion or dimness of information, the following should be treated.

You can be careful not to get infected with candidiasis if you are suffering from thyroid treatment.

When the recommended doses are exceeded, there is an increased risk of side effects in children, patients with liver disease, and patients who are addicted to alcohol.

In case of hemodialysis, it is necessary to change the dosage period and take additional doses of the drug before or after hemodialysis.

The concentration of lithium salts, creatinine and electrolyte concentrations must be monitored during the induration of lithium therapy.

The effect of other medications may increase or decrease during treatment with the drug.

Use caution in patients with impaired liver function.

Suspension during pregnancy or breastfeeding.

Ornidazole does not exhibit teratogenic or toxic effects on the child. No controlled studies have been carried out on the participa- tion of vaginal patients; the drug can be prescribed in the early stages of pregnancy or during breastfeeding only if absolute indications are evident, if possible complications due to the use of the drug for the mother may exceed Potential rhizik for the fetus/child.

This is due to the fluidity of the reaction during treatment with vehicles or other mechanisms.

When taking ornidazole, symptoms such as drowsiness, rigidity, confusion, tremor, seizures, decreased coordination, and loss of speed may occur. The possibility of such manifestations must be ensured for patients who travel by motor transport or work with other mechanisms.

Contraindications

• Acute neurological diseases;
• Pregnancy up to 12 weeks;
• Lactation period;
• Hypersensitivity to the components of the drug or other nitroimidazole derivatives.

In experimental experiments, neither teratogenic nor embryotoxic effects of ornidazole were detected, but controlled studies on the use of Meratin by pregnant women have not been conducted. For this reason, the drug can be prescribed only if there are absolute indications and if the expected benefits outweigh the potential risks.

Meratin should be prescribed with caution to patients with diseases of the central nervous system, such as multiple sclerosis, brain lesions and epilepsy.

Method of congestion and dosage

Meratine is condensed internally after taking it with a small amount of water.

Trichomoniasis

Recommended dosage regimens for the drug:

a) treatment course – 1 day:

• older children with a body weight over 35 kg – 3 tablets per evening;
• The recommended dose for children with a body weight over 20 kg is 25 mg of ornidazole per 1 kg of body weight per

1 reception;

b) treatment course - 5 days:

• Adults and children with a body weight 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, your partner can undergo the same course of treatment.

Amoebiasis

Possible treatment schemes:

a) a three-day course of treatment of patients for amoebic dysentery;

b) 5–10-day course of treatment for all forms of amoebiasis.

Recommended dosage regimen for the drug:

Table 1.

Giardiasis

Adults and children with a body weight over 35 kg take 3 tablets once a day, children with a body weight less than 35 kg - a single dose of 40 mg/kg body weight per dose. The duration of the treatment course is 1–2 days.

Children.

The drug should be administered to children according to the dosage recommendations indicated in the section “Method of administration and dosage”»

.

Release form and composition

• Film-coated tablets: round, convex on both sides, white, embossed “MERATIN” on one side and “500” on the other (10 tablets per pack);
• Solution for infusion: transparent, colorless or light yellow, without a pronounced odor (100 ml in bottles).

1 tablet contains:

• Active ingredient: ornidazole – 500 mg;
• Auxiliary components: white gelatin, sodium lauryl sulfate, methylparaben, propylparaben, ethylcellulose, colloidal silicon dioxide, hydroxypropylmethylcellulose, microcrystalline cellulose, magnesium stearate, starch, sodium starch glycolate, propylene glycol, titanium dioxide, purified talc;
• Shell composition: PEG-6000, titanium dioxide (E171), purified talc.

100 ml of solution contains:

• Active ingredient: ornidazole – 500 mg;
• Auxiliary components: sodium chloride, injection water.

Side effects

Damage to the side of the blood and lymphatic system:

show influenza on the cerebrospinal fluid, leukopenia, neutropenia.

Damage to the side of the immune system:

hypersensitivity reactions, including anaphylactic shock, angioedema.

Damage to the side of the skin and the underside of the skin

: shkirny vysypannya, sverbizh, kropiv'yanka.

Neurological damage:

headache, fatigue, restlessness, confusion, tremor, rigidity, loss of coordination, seizures, time loss of speed, signs of sensory or mixed peripheral neuropathy, confusion, drowsiness Yes, ataxia, spatial disorientation.

Zagalni discord

: increased body temperature, chills, mild weakness, shortness of breath.

Shlunkovo-intestinal destruction:

boredom, vomiting, metal taste in the mouth, dryness in the mouth, dyspepsia, loss of taste, thick tongue, diarrhea, pain in the epigastric region, loss of appetite.

Hepatobiliary disorders:

hepatotoxicity, unknown toxicity, disruption of the biochemical indicator of liver function, increase in the level of liver enzymes.

Infections and invasions:

chronic candidiasis.

Inshi:

darkening of the color of the cut, heart-court discord, incl. decreased arterial pressure.

Side effects

When using Meratin, the following side effects may occur: rapidly transient and mild drowsiness, headache, fatigue, agitation, dry mouth; in isolated cases - dyspepsia.

When taking the drug in high doses for a long time, it is possible: rarely - hepatotoxic effect, very rarely - tremor, confusion, rigidity, incoordination of movements, convulsions, hypersensitivity reactions in the form of itching, skin rash, urticaria, angioedema;