Active ingredient

Metronidazole

Release form, composition and packaging

Solution for infusion transparent, colorless or slightly greenish or greenish-yellow, without mechanical inclusions.

Excipients: sodium dihydrogen phosphate dihydrate, sodium hydrogen phosphate dodecahydrate, water for injection.

100 ml - glass bottles (1) - cardboard packs.

Pharmacological action

Antiprotozoal and antimicrobial drug, a 5-nitroimidazole derivative. The mechanism of action is the biochemical reduction of the 5-nitro group by intracellular transport proteins anaerobic microorganisms and protozoa. The reduced 5-nitro group of metronidazole interacts with the DNA of microbial cells, inhibiting the synthesis of nucleic acids, which leads to the death of microorganisms.

Active regarding Trichomonas vaginalis, Entamoeba hystolitica, Gardnerella vaginalis, Giardia intestinalis, as well as obligate anaerobes Bacteroides spp. (including Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides distasonis, Bacteroides vulgatus), Fusobacterium spp., Veillonella spp., Prevotella (Prevotella bivia, Prevotella buccae, Prevotella disiens) and some gram-positive microorganisms (Eubacterium spp., Clostridium spp., Peptococcus spp., Peptostreptococcus spp.). The MIC for these strains is 0.125-6.25 μg/ml. In combination with it is active in regarding Helicobacter pylori (amoxicillin suppresses the development of resistance to metronidazole).

Aerobic microorganisms are insensitive to metronidazole and facultative anaerobes, but in the presence mixed flora(aerobes and anaerobes) Metronidazole acts synergistically with antibiotics effective against common aerobes.

Increases the sensitivity of tumors to radiation, causes disulfiram-like reactions, and stimulates reparative processes.

Pharmacokinetics

Distribution

It has high penetrating ability, reaching bactericidal concentrations in most tissues and body fluids, incl. in the lungs, kidneys, liver, skin, cerebrospinal fluid, brain, bile, saliva, amniotic fluid, abscess cavity, vaginal secretion, seminal fluid, breast milk, penetrates the BBB and placental barrier.

Vd for adults is approximately 0.55 l/kg, for newborns 0.54-0.81 l/kg. C max ranges from 6 to 40 mcg/ml depending on the dose. Protein binding - 10-20%. With intravenous administration of 500 mg over 20 minutes, Cmax in blood serum after 1 hour is 35.2 μg/ml. The concentration of metronidazole in the blood serum after 4 hours is 33.9 mcg/ml, after 8 hours - 25.7 mcg/ml; C min upon subsequent administration - 18 μg/ml. Tmax - 30-60 minutes, therapeutic concentration is maintained for 6-8 hours. With normal bile formation, the concentration of metronidazole in bile after intravenous administration can significantly exceed the concentration in plasma.

Metabolism

Removal

T 1/2 at normal function liver - 8 hours (from 6 to 12 hours). 60-80% is excreted by the kidneys (20% unchanged), 6-15% is excreted through the intestines.

Pharmacokinetics in special clinical situations

T1/2 for alcoholic liver damage is 18 hours (from 10 to 29 hours), in newborns born at 28-30 weeks of pregnancy. - approximately 75 hours, at 32-35 weeks. - 35 hours, at 36-40 weeks. - 25 hours

With severe renal impairment (creatinine clearance less than 10 ml/min), patients may experience accumulation of metronidazole in the blood serum after reintroduction drug. In this case, the dose of the drug must be halved.

Metronidazole and its main metabolites are quickly removed from the blood during hemodialysis (T 1/2 is reduced to 2.6 hours). During peritoneal dialysis, it is excreted in small quantities.

Indications

— protozoal infections: extraintestinal amebiasis, incl. amoebic liver abscess, intestinal amebiasis (amebic dysentery), trichomoniasis (incl. trichomonas vaginitis, Trichomonas urethritis), balantidiasis, giardiasis, cutaneous leishmaniasis;

— infections caused by Bacteroides spp. (including Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides distasonis, Bacteroides vulgatus): bone and joint infections, central nervous system infections (including meningitis, brain abscess), bacterial endocarditis, pneumonia, empyema and lung abscess , sepsis;

— infections caused by Clostridium spp., Peptococcus spp., Peptostreptococcus spp.: infections abdominal cavity(peritonitis, liver abscess), pelvic infections (endometritis, abscess of the fallopian tubes and ovaries, vaginal vault infections), skin and soft tissue infections;

- pseudomembranous colitis (associated with the use of antibiotics);

- gastritis or peptic ulcer duodenum, associated with Helicobacter pylori;

- prevention postoperative complications(especially after interventions on colon, perirectal area, appendectomy, and also after gynecological operations).

Contraindications

— organic lesions Central nervous system (including epilepsy);

— liver failure(if the drug is prescribed in high doses);

— leukopenia (including history);

— I trimester of pregnancy;

- lactation period ( breastfeeding);

— increased sensitivity to metronidazole or other nitroimidazoles.

With caution: II and III trimesters of pregnancy, renal/liver failure.

Dosage

IV drip. The injection rate is 5 ml/min.

If the patient's condition improves, the drug should be switched to oral administration.

Infections caused by anaerobic microorganisms

Adults (weighing approximately 70 kg) and children over 12 years of age: The initial dose is 15 mg/kg (3 ml/kg). The maintenance dose is 7.5 mg/kg (1.5 ml/kg) every 6 hours for 3 days. Further in the same dose - every 12 hours. Maximum daily dose- 4 years

The average duration of therapy is 7-10 days, but for treatment more than severe infections may take 2-3 weeks.

Children under 12 years of age: the initial dose is 7.5 mg/kg (1.5 ml/kg) every 8 hours for 3 days. Further in the same dose - every 12 hours.

To prevent postoperative complications

Adults (body weight about 70 kg) and children over 12 years of age: IV drip at a dose of 15 mg/kg (3 ml/kg) for 30-60 minutes. Administration of the drug must be stopped 1 hour before the start of surgery. If necessary, 6-8 hours or even 12-16 hours after surgery, the drug can be administered at a dose of 7.5 mg/kg (1.5 ml/kg).

Children under 12 years of age: the drug administration regimen is the same as above, but the single intravenous dose is 7.5 mg/kg (1.5 ml/kg).

Renal dysfunction does not have a significant effect on the pharmacokinetic parameters of the drug, so the dose of Klion does not need to be changed. U patients with severely impaired renal function who are not on hemodialysis, with CC<10 мл/мин The daily dose of the drug should be reduced by 2 times.

Metronidazole and its metabolites are readily excreted by hemodialysis. Because during hemodialysis, T1/2 decreases sharply (up to approximately 3 hours); in some cases, additional administration of the drug may be necessary.

At severe liver diseases Metronidazole is metabolized more slowly. As a result, metronidazole and its metabolites may accumulate in the blood plasma. In these cases, the dose and intervals between administrations of the drug are set depending on the degree of liver damage.

U elderly patients The pharmacokinetics of metronidazole may change, so monitoring the concentration of metronidazole in the blood serum may be necessary.

Side effects

From the digestive system: nausea, vomiting, loss of appetite, coated tongue, bitter, metallic taste in the mouth, dry mouth, glossitis, cramping pain in the lower abdomen, diarrhea, constipation, pancreatitis.

From the hepatobiliary system: increased activity of liver enzymes, cholestasis, jaundice.

From the hematopoietic system: reversible neutropenia (leukopenia).

From the nervous system: peripheral neuropathy (a feeling of numbness in the extremities), rarely and only with long-term use, headaches, convulsions, drowsiness, dizziness, impaired coordination of movements, ataxia, confusion, depression, increased excitability, weakness, insomnia, hallucinations occur.

Allergic reactions: skin rash, urticaria, pruritus, erythema multiforme, angioedema and anaphylactic reaction.

Local reactions: thrombophlebitis at the injection site is possible.

From the urinary system: dysuria, cystitis, polyuria, urinary incontinence, candidiasis, red-brown coloring of urine (due to the content of a metronidazole metabolite, has no clinical significance).

Other: increase in body temperature, decrease in the amplitude of the T wave on the ECG.

Overdose

Symptoms: nausea, vomiting, ataxia.

Treatment: carrying out symptomatic therapy. There is no specific antidote. Metronidazole and its metabolites are readily eliminated by hemodialysis.

Drug interactions

Metronidazole can enhance the effect of oral medications. Prothrombin time may increase, so dose adjustment of oral anticoagulants is necessary.

Cimetidine inhibits the metabolism of metronidazole, which may lead to an increase in its concentration in the blood serum and an increased risk of adverse reactions.

Inducers of liver microsomal oxidation enzymes (for example, phenytoin, phenobarbital) can accelerate the elimination of metronidazole, which leads to a decrease in its concentration in the blood plasma.

Simultaneous use of alcohol causes reactions similar to reactions to the administration of disulfiram (cramping abdominal pain, nausea, vomiting, headache, skin flushing). Concomitant use with disulfiram is unacceptable (additive effects, may cause confusion).

During treatment with metronidazole, it is possible to increase the concentration of lithium in the blood, therefore, before starting to use the drug Klion, it is necessary to reduce the dose of lithium drugs or stop taking them for the duration of treatment.

Concomitant administration of cyclosporine with metronidazole may lead to an increase in plasma concentrations of cyclosporine, which requires monitoring of cyclosporine plasma concentrations.

Metronidazole reduces the clearance of fluorouracil, and therefore increases the toxicity of the latter.

In laboratory tests while taking the drug, it may be difficult to determine the activity of ALT, AST, LDH and triglyceride levels.

Simultaneous administration of the drug with other solutions containing sodium salts may lead to sodium retention in the body.

Special instructions

IV administration of Klion solution is indicated for patients in whom oral administration of the drug is impossible. For mixed infections, Klion solution can be used in combination with parenteral antibiotics, without mixing the drugs with each other.

When administered intravenously, Klion should not be mixed with other drugs.

If the course of treatment lasts more than 10 days, careful monitoring of the patient’s condition and regular monitoring of laboratory blood parameters are necessary. If a longer course of treatment is necessary due to the presence of chronic diseases, the balance between the expected benefit and the potential risk of complications should be carefully weighed.

When using the drug Klion, an exacerbation of candidiasis is possible.

Drinking alcohol during treatment with Klion is strictly prohibited.

When using the drug Klion, slight leukopenia may be observed, so it is advisable to monitor the general blood count (the number of leukocytes) at the beginning and at the end of therapy.

Impact on the ability to drive vehicles and operate machinery

If side effects from the central nervous system occur, you should refrain from driving vehicles and working with potentially dangerous mechanisms.

Pregnancy and lactation

Metronidazole is contraindicated for use in the first trimester of pregnancy. Prescribing the drug in the second and third trimesters of pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

The drug should be stored out of the reach of children, protected from light at a temperature of 15° to 30°C. Shelf life - 3 years. Do not use after expiration date.

Instructions for the drug Klion, contraindications and methods of use, side effects and reviews about this drug. Doctors' opinions and the opportunity to discuss on the forum.

Instructions for use

Directions for use and dosage Klion

• KLION Tablets

The tablets are taken during or after meals, without chewing, with a small amount of water.

At trichomoniasis sexual partners of the patient are also considered sick. The desired effect of therapy can be obtained only with their simultaneous treatment. There are two treatment regimens:

1. 500 mg/day (1 tablet 2 times/day) for 10 days. (For women, use 1 vaginal suppository per day). If necessary, the course of treatment can be repeated, the daily dose can be increased to 750-1000 mg (3-4 tablets). (Between courses of treatment, it is advisable to take a 3-4 week break with repeated control laboratory tests).

2. A single dose of 2 g of Klion (8 tablets) in the evening, before bed. (This regimen is contraindicated during the entire period of pregnancy, since in this case there is a high concentration of the drug).

At giardiasis:

For adults 1 g/day (2 tablets, 2 times/day) for 5-7 days.

Children under 1 year of age 125 mg/day (1/2 tablet), children aged 2 to 4 years 250 mg/day (1 tablet), children aged 5 to 8 years 375 mg/day (1 1/2 tablets), children over 8 years old 500 mg/day (1 tablet 2 times/day) after meals for 5 days.

At amoebiasis:

For adults- a) for asymptomatic isolation of the cystic form of amoebae, 1-1.5 g/day (2 tablets 2-3 times/day) for 5-7 days; b) for chronic amebiasis (also for hepatosis) 1.5 g/day (2 tablets 3 times/day) for 5-10 days; c) for acute amoebic dysentery, 2.25 g/day (3 tablets 3 times/day) until the symptoms of the disease disappear; d) for liver abscess as part of combination therapy, 2.5 g/day (10 tablets/day) in one or 2-3 doses for 3-5 days.

Children aged 7 to 10 years a dose equal to half the dose for adults is prescribed, children aged 3 to 7 years- one third of the dose for adults, children aged 1 to 3 years- a quarter of the dose for adults.

At ulcerative stomatitis:

For adults 500 mg/day (1 tablet 2 times/day) for 3-5 days. In severe cases, it is advisable to apply local treatment for 20 minutes. For children for gangrenous stomatitis, the use of Klion is not indicated.

With a purpose prevention of anaerobic infection during surgical interventions:

For adults 750-1500 mg (1-2 tablets 3 times a day) 3-4 days before planned surgery or a single dose of 1 g (4 tablets). After surgery, in the absence of contraindications to oral administration of the drug, 750 mg/day (3 tablets/day) for 7 days.

At anaerobic infections The dosage regimen is selected individually depending on the location of the source of infection, as well as the age and severity of the patient’s condition. The daily dose should not exceed 1.5-2 g (6-8 tablets).

For treatment chronic alcoholism 500 mg/day (2 tablets/day) daily for a period of no more than 6 months.

• KLION Solution for infusion 0.5%

IV drip. The injection rate is 5 ml/min.

If the patient's condition improves, the drug should be switched to oral administration.

Infections caused by anaerobic microorganisms

Adults and children over 12 years of age: The initial dose is 15 mg/kg (3 ml/kg). The maintenance dose is 7.5 mg/kg (1.5 ml/kg) every 6 hours for three days. Further in the same dose every 12 hours.

The maximum daily dose of metronidazole should not exceed 4 g.

The average duration of therapy is 7-10 days, but more severe infections may require 2-3 weeks.

Children under 12 years of age: The initial dose is 7.5 mg/kg (1.5 ml/kg) every 8 hours for three days. Further in the same dose every 12 hours.

To prevent postoperative complications

Adults and children over 12 years old: 15 mg/kg (3 ml/kg) over 30-60 minutes.

Administration of the drug must be stopped 1 hour before the start of surgery. If necessary, after surgery, 7.5 mg/kg (1.5 ml/kg) can be administered every 6-8 or even every 12-16 hours.

Children under 12 years of age: the drug administration regimen is the same as above, but the single intravenous dose is 7.5 mg/kg (1.5 ml/kg).

Use in patients with impaired renal function: impaired renal function does not have a significant effect on the pharmacokinetic parameters of the drug, so the dose of Klion does not need to be changed. In patients with severely impaired renal function who are not on hemodialysis, with CC below 10 ml/min, the daily dose of the drug should be reduced by 2 times.

Metronidazole and its metabolites are readily excreted by hemodialysis. Since during hemodialysis T1/2 decreases sharply (up to approximately 3 hours), in some cases additional administration of the drug may be necessary.

In severe liver disease, metronidazole is metabolized more slowly. As a result, metronidazole and its metabolites may accumulate in the blood plasma. In these cases, the dose and intervals between administrations of the drug are set depending on the degree of liver damage.

In elderly patients: the pharmacokinetics of metronidazole may change, so it may be necessary to monitor metronidazole serum concentrations.

Side effects of Klion

• KLION Tablets

: mild nausea, vomiting, dry mouth, coated tongue, bitter metallic taste in the mouth, loss of appetite, diarrhea, pain in the lower abdomen.

: transient granulocytopenia, rarely - transient thrombocytopenia.

From the cardiovascular system: decreased amplitude of the T wave on the ECG.

headaches, convulsions, peripheral neuropathy, drowsiness, dizziness, loss of coordination, ataxia.

: dysuria, darkening of the color of urine (due to the high content of pigments, has no clinical significance).

Allergic reactions: urticaria, itchy skin.

Others: secondary fungal infections (mainly caused by Candida fungi)

These side effects disappear with cessation of therapy.

• KLION Solution for infusion 0.5%

From the digestive system: nausea, vomiting, loss of appetite, coated tongue, bitter, metallic taste in the mouth, dry mouth, glossitis, cramping pain in the lower abdomen, diarrhea, constipation, pancreatitis, increased activity of liver enzymes, cholestasis, jaundice.

From the hematopoietic system: reversible neutropenia (leukopenia).

From the central nervous system and peripheral nervous system: peripheral neuropathy (a feeling of numbness in the limbs), rarely and only with long-term use, headaches, convulsions, drowsiness, dizziness, poor coordination of movements, confusion, depression, increased excitability, weakness, insomnia, hallucinations occur.

Allergic reactions: skin rash, urticaria, pruritus, erythema multiforme, angioedema and anaphylactic reaction.

Local reactions: thrombophlebitis is possible at the injection site.

From the urinary system: dysuria, cystitis, polyuria, urinary incontinence, candidiasis, red-brown coloring of urine (due to the content of a metronidazole metabolite, no clinical significance).

Others: increase in body temperature, decrease in the amplitude of the T wave on the ECG.

Almost all medications have side effects. As a rule, this occurs when taking drugs in maximum doses, when using a drug for a long time, or when taking several drugs at once. Individual intolerance to a particular substance is also possible. This can lead to serious consequences, so if the medicine causes side effects for you, you should stop taking it and consult a doctor.

Overdose

• KLION Tablets

Symptoms: nausea, vomiting, ataxia.

There is no specific antidote. Symptomatic therapy is carried out.

• KLION Solution for infusion 0.5%

If symptoms of overdose appear (nausea, vomiting, ataxia), symptomatic therapy is carried out. There is no specific antidote.

Metronidazole and its metabolites are readily eliminated by hemodialysis.

Drug interactions

• KLION Tablets

Enhances the effect of oral anticoagulants. Prothrombin time may increase. In this case, it is necessary to adjust the dosage.

Inducers of liver enzymes (for example, phenytoin, phenobarbital) can accelerate the elimination of metronidazole and thus reduce its plasma concentration.

Enzyme inhibitors (for example, cimetidine) may increase the half-life of metronidazole.

Concomitant use with disulfiram is not permissible (possible additive effects, development of psychotic states).

• KLION Solution for infusion 0.5%

Metronidazole may enhance the effect of oral anticoagulants. Prothrombin time may increase, so dose adjustment of oral anticoagulants is necessary.

Cimetidine inhibits the metabolism of metronidazole, which leads to an increase in its concentration in the blood serum and an increased risk of side effects.

Inducers of liver microsomal oxidation enzymes (for example, phenytoin, phenobarbital) can accelerate the elimination of metronidazole, which will lead to a decrease in its concentration in the blood plasma.

Simultaneous use of alcohol causes reactions similar to reactions to the administration of disulfiram (cramping abdominal pain, nausea, headache, skin flushing).

Concomitant use with disulfiram is not permissible (additive effects, may cause confusion).

During treatment with metronidazole, the concentration of lithium in the blood may increase, therefore, before starting to use Klion, it is necessary to reduce the dose of lithium drugs or stop taking them for the duration of treatment.

Concomitant administration of cyclosporine with metronidazole may lead to an increase in plasma concentrations of cyclosporine, which requires monitoring of cyclosporine plasma concentrations.

Metronidazole reduces the clearance of fluorouracil, and therefore increases the toxicity of the latter.

In laboratory tests while taking the drug, it may be difficult to determine the activity of liver transaminases, LDH and triglyceride levels.

Simultaneous administration of the drug with other solutions containing sodium salts may lead to sodium retention in the body.

Very important information that is not always taken into account when taking medications. If you take two or more drugs, they can either weaken or strengthen each other's effects. In the first case, you will not get the expected result from the drug, and in the second, you risk causing an overdose or even poisoning.

Protozoal infections: extraintestinal amebiasis, including amoebic liver abscess, intestinal amebiasis (amebic dysentery), trichomoniasis, giardiasis, balantidiasis, giardiasis, cutaneous leishmaniasis, trichomonas vaginitis, trichomonas urethritis.

Infections caused by Bacteroides spp. (including B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus): infections of bones and joints, infections of the central nervous system, incl. meningitis, brain abscess, bacterial endocarditis, pneumonia, empyema and lung abscess.

Infections caused by Bacteroides species, including the B. fragilis group, Clostridium, Peptococcus and Peptostreptococcus species: abdominal infections (peritonitis, liver abscess), pelvic infections (endometritis, endomyometritis, fallopian tube and ovarian abscess, vaginal vault infections after surgery ), skin and soft tissue infections.

Infections caused by Bacteroides species, including the B. fragilis group and Clostridium species: sepsis.

Pseudomembranous colitis (associated with antibiotic use).

Gastritis or duodenal ulcer associated with Helicobacter pylori.

Prevention of postoperative complications (especially after interventions on the colon, in the peri-rectal area, appendectomy, gynecological operations).

Release form of the drug Klion

solution for infusion 5 mg/ml; bottle (bottle) 100 ml, cardboard pack 1;

Solution for infusion 5 mg/ml; bottle (bottle) 100 ml, cardboard box (box) 42;

Compound
Solution for infusion 1 fl.
metronidazole 500 mg
excipients: sodium hydrogen phosphate; sodium dihydrogen phosphate; sodium chloride; water for injections
in bottles of 100 ml; 1 bottle in a box.

Pharmacodynamics of the drug Klion

The mechanism of action is the biochemical reduction of the 5-nitro group of intracellular transport proteins of anaerobic microorganisms and protozoa. The reduced 5-nitro group interacts with the DNA of the microbial cell, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria. Active against Trichomonas vaginalis, Entamoeba histolytica, Gardnerella vaginalis, Giardia intestinalis, Lamblia spp., as well as obligate anaerobes Bacteroides spp. (including Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Veillonella spp., Prevotella (P.bivia, P.buccae, P.disiens), and some gram-positive microorganisms ( Eubacterium spp., Clostridium spp., Peptococcus spp., Peptostreptococcus spp.). The minimum inhibitory concentration for these strains is 0.125–6.25 μg/ml. In combination with amoxicillin, it is active against Helicobacter pylori (amoxicillin suppresses the development of resistance to metronidazole). Aerobic microorganisms and facultative anaerobes are insensitive to metronidazole, but in the presence of mixed flora (aerobes and anaerobes), metronidazole acts synergistically with antibiotics effective against common aerobes. Increases the sensitivity of tumors to radiation, causes sensitization to alcohol (disulfiram-like effect), stimulates reparative processes.

Pharmacokinetics of the drug Klion

Absorption - high (bioavailability of at least 80%). It has high penetrating ability, reaching bactericidal concentrations in most tissues and body fluids, including lungs, kidneys, liver, skin, cerebrospinal fluid, brain, bile, saliva, amniotic fluid, abscess cavities, vaginal secretions, seminal fluid, breast milk; penetrates the BBB and placental barrier. Volume of distribution: adults - approximately 0.55 l/kg, newborns - 0.54–0.81 l/kg. Cmax - from 6 to 40 mcg/ml depending on the dose. Time to reach maximum concentration is 1–3 hours. Plasma protein binding is 10–20%. With intravenous administration of 500 mg over 20 minutes, Cmax in the blood serum after 1 hour is 35.2 μg/ml, after 4 hours - 33.9 μg/ml, after 8 hours - 25.7 μg/ml; Cmin - 18 µg/ml. The time for the onset of maximum concentration is 30–60 minutes, the therapeutic concentration remains for 6–8 hours. With normal bile formation, the concentration of metronidazole in bile after intravenous administration can significantly exceed the concentration in plasma. About 30–60% of metronidazole is metabolized in the body through hydroxylation, oxidation and glucuronidation. The main metabolite (2-oxymetronidazole) also has antiprotozoal and antimicrobial effects.

T1/2 with normal liver function - 8 hours (from 6 to 12 hours), with alcoholic liver damage - 18 hours (from 10 to 29 hours), in newborns: those born at a gestational age of 28–30 weeks - approximately 75 hours, 32 –35 weeks - 35 hours, 36–40 weeks - 25 hours, respectively. 60–80% is excreted by the kidneys (20% unchanged), and 6–15% through the intestines. Renal clearance - 10.2 ml/min. In patients with impaired renal function, accumulation of metronidazole in the blood serum may occur after repeated administration (therefore, the frequency of dosing should be reduced in patients with severe renal impairment). Metronidazole and its main metabolites are quickly removed from the blood during hemodialysis (T1/2 is reduced to 2.6 hours). During peritoneal dialysis, it is excreted in small quantities.

Use of the drug Klion during pregnancy

Metronidazole passes through the placenta; therefore, the use of the drug in the first trimester is not recommended.

Metronidazole is excreted into breast milk, creating concentrations similar to blood plasma. It can impart a bitter taste to mother's milk. To avoid the effect of the drug on the child, it is necessary to stop breastfeeding during and after stopping the course of treatment for another 1–2 days.

Contraindications to the use of the drug Klion

Hypersensitivity, leukopenia (including history), organic lesions of the central nervous system (including epilepsy), liver failure (in case of high doses), pregnancy (first trimester), breastfeeding period, children under 12 years of age .

With caution: pregnancy (II–III trimesters), renal failure, liver failure.

Side effects of the drug Klion

From the digestive system: diarrhea, loss of appetite, nausea, vomiting, intestinal colic, constipation, metallic taste in the mouth, dry mouth, glossitis, stomatitis, pancreatitis.

From the nervous system: dizziness, impaired coordination of movements, ataxia, confusion, irritability, depression, increased excitability, weakness, insomnia, headache, convulsions, hallucinations, peripheral neuropathy.

Allergic reactions: urticaria, skin rash, skin hyperemia, nasal congestion, fever, arthralgia.

From the urinary system: dysuria, cystitis, polyuria, urinary incontinence, candidiasis, red-brown coloration of urine.

Local reactions: thrombophlebitis (pain, redness or swelling at the injection site).

Other: neutropenia, leukopenia, flattening of the T wave on the ECG.

Method of administration and dosage of the drug Klion

Parenterally, adults and children over 12 years of age at an initial dose of 0.5–1 g intravenously (infusion duration is 30–40 minutes), and then every 8 hours, 500 mg at a rate of 5 ml/min. If well tolerated, after the first 2-3 infusions, switch to jet administration.

The course of treatment is 7 days. If necessary, intravenous administration is continued for a longer time. The maximum daily dose is 4 g. According to indications, switch to maintenance oral administration at a dose of 400 mg 3 times a day.

For purulent-septic diseases, 1 course of treatment is usually carried out.

For preventive purposes, adults and children over 12 years of age - 0.5-1 g intravenously on the eve of surgery, on the day of surgery and the next day - 1.5 g / day (500 mg every 8 hours). After 1–2 days, they switch to maintenance therapy orally. For patients with chronic renal failure and creatinine Cl less than 30 ml/min and/or liver failure, the maximum daily dose is no more than 1 g, the frequency of administration is 2 times a day.

Overdose of the drug Klion

Symptoms: nausea, vomiting, ataxia.

Treatment: symptomatic therapy, hemodialysis, because Metronidazole does not have a specific antidote.

Interactions of the drug Klion with other drugs

Strengthens the effect of indirect anticoagulants, which leads to an increase in the time of prothrombin formation.

Similar to disulfiram, it causes ethanol intolerance.

Concomitant use with disulfiram can lead to the development of various neurological symptoms (the interval between prescriptions is at least 2 weeks).

Cimetidine inhibits the metabolism of metronidazole, which may lead to an increase in its concentration in the blood serum and an increased risk of side effects.

The simultaneous administration of drugs that stimulate microsomal oxidation enzymes in the liver (phenobarbital, phenytoin) can accelerate the elimination of metronidazole, resulting in a decrease in its plasma concentration.

When taken simultaneously with lithium preparations, the concentration of the latter in the plasma may increase and the development of symptoms of intoxication.

Sulfonamides enhance the antimicrobial effect of metronidazole.

Special instructions when taking the drug Klion

During the treatment period, ethanol intake is contraindicated (a disulfiram-like reaction may develop: cramping abdominal pain, nausea, vomiting, headache, sudden flushing of the face).

With long-term therapy, it is necessary to monitor the blood picture.

With leukopenia, the possibility of continuing treatment depends on the risk of developing an infectious process.

The appearance of ataxia, dizziness and any other deterioration in the neurological status of patients requires cessation of treatment.

May immobilize treponemes and lead to a false-positive Nelson test.

Colors urine dark.

When treating trichomonas vaginitis in women and trichomonas urethritis in men, it is necessary to abstain from sexual activity. Simultaneous treatment of sexual partners is mandatory. After treatment for trichomoniasis, control tests should be carried out during three consecutive cycles before and after menstruation.

After treatment for giardiasis, if symptoms persist, 3 stool tests should be performed after 3-4 weeks at intervals of several days (in some successfully treated patients, lactose intolerance caused by infestation may persist for several weeks or months, resembling the symptoms of giardiasis).

Metronidazole does not affect the ability to drive a car, as well as perform other types of work that require speed of psychomotor reactions.

Storage conditions for the drug Klion

List B.: In a dark place, at a temperature of 15–30 °C.

Shelf life of the drug Klion

The drug Klion belongs to the ATX classification:

J Antimicrobials for systemic use

J01 Antimicrobials for systemic use

J01X Other antibacterial drugs

J01XD Imidazole derivatives

Latin name: KlionComposition and release form:

Tablets 250 mg.

Composition (1 table):

• active substance: metronidazole 250 mg.

20 tablets each.

Solution for infusion 5 mg/ml.

Composition (100 ml):

• active substance: metronidazole 500 mg.

100 ml of solution in a colorless glass bottle for infusion.