Klion tablets 250mg, No. 20
Russian Pharmacy name:
Клион таблетки 250мг, №20
protozoal infections: extraintestinal amebiasis (including amoebic liver abscess), intestinal amebiasis (amoebic dysentery), trichomoniasis;
infections caused by Bacteroides spp. (including Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides distasonis, Bacteroides vulgatus): infections of bones and joints, infections of the central nervous system (including meningitis, brain abscess), bacterial endocarditis, pneumonia, pulmonary empyema and , sepsis;
infections caused by Clostridium spp., Peptococcus niger, Peptostreptococcus spp .: infections of the abdominal cavity (peritonitis, liver abscess), infections of the pelvic organs (endometritis, abscess of the fallopian tubes and ovaries, infections of the vaginal vault);
pseudomembranous colitis associated with antibiotic use;
gastritis or duodenal ulcer associated with Helicobacter pylori (as part of complex therapy);
prevention of postoperative complications (especially after interventions on the colon, pararectal region, appendectomy, as well as after gynecological operations).
The drug is taken orally, before or after meals with plenty of water.
With intestinal amebiasis, the drug is used in a daily dose of 1500 mg (divided into 3 doses) for 7 days.
In acute amoebic dysentery, the daily dose is 2250 mg (divided into 3 doses). Children aged 6 to 15 years are prescribed a daily dose of 500 mg (divided into 2 doses).
With liver abscess and other extraintestinal forms of amebiasis, the maximum daily dose is 2500 mg (divided into 3 doses) for 3-5 days, in combination with tetracycline antibiotics and other methods of therapy. Children aged 6 to 15 years are prescribed a daily dose of 500 mg (divided into 2 doses).
With trichomoniasis in women (urethritis and vaginitis), the drug is prescribed once in a dose of 2 g or as a course of treatment 250 mg 2 times / day for 10 days. With trichomoniasis in men (urethritis), the drug is prescribed once in a dose of 2 g or as a course of treatment, 250 mg 2 times / day for 10 days.
Treatment of anaerobic infections is usually started with intravenous infusion followed by a switch to tablets. For adults, the dose of Klion is 500 mg 3 times / day. The duration of treatment is up to 7 days.
For the treatment of pseudomembranous colitis, the drug Klion is prescribed 500 mg 3-4 times / day. The duration of treatment is determined by the doctor.
For the eradication of Helicobacter pylori , Klion is prescribed 500 mg 3 times / day as part of a combination therapy (for example, with amoxicillin).
For the prevention of postoperative complications, the drug Klion is prescribed in a daily dose of 750-1500 mg (divided into 3 doses) 3-4 days before the operation. 1-2 days after the operation (when ingestion is already allowed), the drug Klion is prescribed at 750 mg / day for 7 days.
metronidazole - 250 mg
Excipients : corn starch, microcrystalline cellulose, glycerol, povidone K30, colloidal silicon dioxide, talc, magnesium stearate.
organic lesions of the central nervous system (including epilepsy);
leukopenia (including history);
hepatic impairment (in the case of administration of the drug in high doses);
pregnancy;
breastfeeding period;
children under 6 years of age.
hypersensitivity to metronidazole, other nitroimidazole derivatives, imidazoles and other components of the drug.
With care: hepatic encephalopathy, acute and chronic diseases of the peripheral and central nervous system (risk of worsening neurological symptoms), renal failure.
Clinical and pharmacological group: Antiprotozoal drug with antibacterial activity
Pharmaco-therapeutic group: Antimicrobial and antiprotozoal agent
pharmachologic effect
Metronidazole is a 5-nitroimidazole derivative. The mechanism of action consists in the biochemical reduction of the 5-nitro group of metronidazole by intracellular transport proteins of anaerobic microorganisms and protozoa. The reduced 5-nitro group of metronidazole interacts with the DNA of the cell of microorganisms, inhibiting the synthesis of nucleic acids, which leads to the death of microorganisms.
Active against Trichomonas vaginalis, Entamoeba hystolitica, as well as gram-negative anaerobes Bacteroides spp. (including Bacteroides fragilis, Bacteroides ovatus, Bacteroides distasonis, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp. and some gram-positive anaerobes (sensitive strains Eubacterium spp., Clostridium spp., Peptococcus niger, Peptostreptococcus spp.). The MIC for these strains is 0.125-6.25 ?g / ml. In combination with amoxicillin, it is active against Helicobacter pylori (amoxicillin inhibits 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 conventional aerobes.
Pharmacokinetics
Suction
When taken orally, metronidazole is rapidly and almost completely absorbed (approximately 80% in 1 hour). Food intake does not affect the absorption of metronidazole. Bioavailability is at least 80%. After oral administration of metronidazole at a dose of 500 mg, its concentration in blood plasma is 10 ?g / ml after 1 hour, 13.5 ?g / ml - after 3 hours.
Distribution
The binding to blood proteins is insignificant and does not exceed 10-20%. Metronidazole quickly penetrates into tissues (lungs, kidneys, liver, skin, bile, cerebrospinal fluid, saliva, seminal fluid, vaginal secretions), breast milk and passes through the placental barrier.
Metabolism
About 30-60% of metronidazole is metabolized by hydroxylation, oxidation and glucuronidation. The main metabolite (2-oxymetronidazole) also has antiprotozoal and antimicrobial effects.
Withdrawal
40-70% of metronidazole is excreted by the kidneys (unchanged - about 35% of the dose taken). T1 / 2 - 8-10 hours
Pharmacokinetics in special patient groups
In patients with impaired renal function with a course of metronidazole, its concentration in the blood serum may increase.
Indications
protozoal infections: extraintestinal amebiasis (including amoebic liver abscess), intestinal amebiasis (amoebic dysentery), trichomoniasis;
infections caused by Bacteroides spp. (including Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides distasonis, Bacteroides vulgatus): infections of bones and joints, infections of the central nervous system (including meningitis, brain abscess), bacterial endocarditis, pneumonia, pulmonary empyema and , sepsis;
infections caused by Clostridium spp., Peptococcus niger, Peptostreptococcus spp .: infections of the abdominal cavity (peritonitis, liver abscess), infections of the pelvic organs (endometritis, abscess of the fallopian tubes and ovaries, infections of the vaginal vault);
pseudomembranous colitis associated with antibiotic use;
gastritis or duodenal ulcer associated with Helicobacter pylori (as part of complex therapy);
prevention of postoperative complications (especially after interventions on the colon, pararectal region, appendectomy, as well as after gynecological operations).
Dosage regimen
The drug is taken orally, before or after meals with plenty of water.
With intestinal amebiasis, the drug is used in a daily dose of 1500 mg (divided into 3 doses) for 7 days.
In acute amoebic dysentery, the daily dose is 2250 mg (divided into 3 doses). Children aged 6 to 15 years are prescribed a daily dose of 500 mg (divided into 2 doses).
With liver abscess and other extraintestinal forms of amebiasis, the maximum daily dose is 2500 mg (divided into 3 doses) for 3-5 days, in combination with tetracycline antibiotics and other methods of therapy. Children aged 6 to 15 years are prescribed a daily dose of 500 mg (divided into 2 doses).
With trichomoniasis in women (urethritis and vaginitis), the drug is prescribed once in a dose of 2 g or as a course of treatment 250 mg 2 times / day for 10 days. With trichomoniasis in men (urethritis), the drug is prescribed once in a dose of 2 g or as a course of treatment, 250 mg 2 times / day for 10 days.
Treatment of anaerobic infections is usually started with intravenous infusion followed by a switch to tablets. For adults, the dose of Klion is 500 mg 3 times / day. The duration of treatment is up to 7 days.
For the treatment of pseudomembranous colitis, the drug Klion is prescribed 500 mg 3-4 times / day. The duration of treatment is determined by the doctor.
For the eradication of Helicobacter pylori , Klion is prescribed 500 mg 3 times / day as part of a combination therapy (for example, with amoxicillin).
For the prevention of postoperative complications, the drug Klion is prescribed in a daily dose of 750-1500 mg (divided into 3 doses) 3-4 days before the operation. 1-2 days after the operation (when ingestion is already allowed), the drug Klion is prescribed at 750 mg / day for 7 days.
Side effect
From the digestive system: epigastric pain, nausea, vomiting, diarrhea; inflammation of the oral mucosa (glossitis, stomatitis), taste disturbances ('metallic' taste in the mouth), loss of appetite, anorexia, dryness of the oral mucosa, constipation; pancreatitis (reversible cases); discoloration of the tongue / 'coated' tongue (due to excessive growth of fungal microflora).
From the immune system: angioedema, anaphylactic shock.
From the nervous system: peripheral sensory neuropathy; headache, convulsions, dizziness. It has been reported about the development of encephalopathy (for example, confusion) and subacute cerebellar syndrome (impaired coordination and synergism of movements, ataxia, dysarthria, gait disturbances, nystagmus and tremor), which undergo a regression after discontinuation of metronidazole; aseptic meningitis.
Mental disorders : psychotic disorders, including confusion, hallucinations; depression, insomnia, irritability, hyperexcitability.
From the side of the organ of vision: transient visual impairments such as diplopia, myopia, blurred vision, decreased visual acuity, impaired color perception; neuropathy / optic neuritis.
From the side of the organ of hearing and labyrinth disorders: hearing impairment / hearing loss (including sensorineural deafness); noise in ears.
From the hematopoietic system: agranulocytosis, leukopenia, neutropenia and thrombocytopenia.
From the liver and biliary tract: increased activity of 'hepatic' enzymes (ACT and ALT, ALP), the development of cholestatic or mixed hepatitis, hepatocellular liver damage, sometimes accompanied by jaundice. In patients who received treatment with metronidazole in combination with other antibiotics, there were cases of liver failure, which required liver transplantation.
On the part of the skin and subcutaneous tissues: rash, itching, flushing of the skin, flushing of the skin, urticaria; pustular skin rash; acute generalized exanthematous pustulosis; fixed drug rash; Stevens-Johnson syndrome, toxic epidermal necrolysis.
From the urinary system: it is possible to stain urine in a brownish-reddish color, due to the presence in the urine of a water-soluble metabolite of metronidazole; dysuria, polyuria, cystitis, urinary incontinence, candidiasis.
General disorders and disorders at the injection site: fever, nasal congestion, arthralgia, weakness.
Influence on the results of laboratory and instrumental studies: flattening of the T wave on the ECG.
Contraindications for use
organic lesions of the central nervous system (including epilepsy);
leukopenia (including history);
hepatic impairment (in the case of administration of the drug in high doses);
pregnancy;
breastfeeding period;
children under 6 years of age.
hypersensitivity to metronidazole, other nitroimidazole derivatives, imidazoles and other components of the drug.
With care: hepatic encephalopathy, acute and chronic diseases of the peripheral and central nervous system (risk of worsening neurological symptoms), renal failure.
Application during pregnancy and lactation
Since metronidazole crosses the placental barrier and its effect on the organogenesis of the human fetus is unknown, the use of Klion during pregnancy is contraindicated.
Metronidazole passes into breast milk, therefore, the use of the drug Klion during breastfeeding is contraindicated.
Application for violations of liver function
The use of the drug in high doses is contraindicated in liver failure.
The drug should be prescribed with caution for hepatic encephalopathy.
Application for impaired renal function
The drug should be prescribed with caution in case of renal failure.
Application in children
Use is contraindicated in children under 6 years of age.
special instructions
Since the simultaneous administration of metronidazole with alcohol (ethanol) can have an effect similar to the action of disulfiram (hyperemia of the skin, flushing of the skin, vomiting, tachycardia), patients should be warned that during treatment and for at least one day after after taking the drug Klion, you should not consume alcoholic beverages or medications containing ethanol.
The indications for long-term administration of the drug Klion should be carefully weighed and, in the absence of strict indications, its prolonged use should be avoided. If, in the presence of strict indications, the drug is used for a longer time than is usually recommended, treatment should be carried out under the control of hematological parameters (especially leukocytes) and adverse reactions, such as peripheral or central neuropathy (paresthesia, ataxia, dizziness, convulsions), upon the appearance of which treatment should be terminated.
When treating Trichomonas vaginitis in women and Trichomonas urethritis in men, it is necessary to refrain from sexual intercourse. Simultaneous treatment of sexual partners is mandatory. Treatment should not be discontinued during menstruation. After trichomoniasis therapy, control tests should be carried out for 3 successive cycles before and after menstruation.
Metronidazole should be used with caution in patients with hepatic encephalopathy, as well as in patients with acute or chronic diseases of the central or peripheral nervous system due to the possible risk of neurological deterioration.
It has been reported on the development of severe hepatotoxicity / acute hepatic failure (including fatal cases that developed very quickly after the start of treatment) in patients with Cockayne's syndrome when treated with metronidazole for systemic use. For this category of patients, metronidazole should be prescribed only after a careful assessment of the benefit / risk ratio and only in the absence of alternative treatment.
Liver function tests should be carried out before starting treatment, during therapy and after its completion until the liver function indicators reach normal values, or until the baseline values ??of these indicators are reached. If the indicators of liver function are significantly exceeded during treatment, then the drug should be discontinued.
Patients with Cockayne syndrome should be advised to immediately inform the doctor about the development of any symptoms of potential liver damage and to stop using metronidazole.
Cases of severe bullous skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or acute generalized exanthematous pustulosis, have been reported after taking metronidazole. With the development of symptoms or signs of these diseases, treatment with Klion should be stopped immediately.
It must be taken into account that metronidazole can immobilize treponemas, which leads to a false positive Nelson's test.
Long-term use of metronidazole must be carefully justified due to possible mutagenicity and carcinogenicity.
Influence on the ability to drive vehicles and mechanisms
Given the risk of developing such adverse reactions as confusion, dizziness, hallucinations, visual impairments, it is recommended during treatment to refrain from driving, from engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.
Overdose
It has been reported that single doses of metronidazole were taken orally up to 12 g in suicidal attempts and accidental overdoses.
Symptoms: vomiting, ataxia, slight disorientation.
Treatment: there is no specific antidote. In case of suspicion of a significant excess of the dose, symptomatic and supportive therapy should be carried out.
Drug interactions
—ообщалось о развитии психотических реакций у пациентов, получавших одновременно метронидазол и дисульфирам (интервал между применением этих лекарственных препаратов должен быть не менее 2 недель).
ѕри одновременном применении с этанолом возможно возникновение дисульфирамоподобных реакций (гипереми¤ кожных покровов, приливы крови к кожным покровам, рвота, тахикарди¤).
ѕри одновременном применении с непр¤мыми антикоагул¤нтами (варфарин) - усиление антикоагул¤нтного эффекта и повышение риска развити¤ кровотечени¤, св¤занного со снижением печеночного метаболизма непр¤мых антикоагул¤нтов, что может приводить к удлинению протромбинового времени. ¬ случае одновременного применени¤ метронидазола и непр¤мых антикоагул¤нтов требуетс¤ более частый контроль протромбинового времени и при необходимости коррекци¤ доз антикоагул¤нтов.
ѕри одновременном применении метронидазола с препаратами лити¤ может повышатьс¤ концентраци¤ последнего в плазме крови. ѕри одновременном применении следует контролировать концентрации лити¤, креатинина и электролитов в плазме крови.
ѕри одновременном применении метронидазола с циклоспорином может повышатьс¤ концентраци¤ циклоспорина в плазме крови. ¬ случае необходимости одновременного применени¤ метронидазола и циклоспорина следует контролировать концентрации циклоспорина и креатинина в плазме крови.
?иметидин ингибирует метаболизм метронидазола, что может привести к повышению его концентрации в плазме крови и увеличению риска развити¤ побочных ¤влений.
ќдновременное применение метронидазола с лекарственными препаратами, индуцирующими изоферменты микросомального окислени¤ в печени (фенобарбитал, фенитоин), может ускор¤ть выведение метронидазола, в результате чего снижаетс¤ его концентраци¤ в плазме крови.
ћетронидазол уменьшает клиренс фторурацила, привод¤ к увеличению его токсичности.
ћетронидазол повышает концентрацию бусульфана в плазме крови, что может приводить к развитию т¤желого токсического действи¤ бусульфана.
Ќе рекомендуетс¤ примен¤ть препарат с недепол¤ризующими миорелаксантами (векурони¤ бромид).
—ульфаниламиды усиливают противомикробное действие метронидазола.
—ледует избегать одновременного применени¤ мебендазола и метронидазола.
”слови¤ хранени¤
ѕрепарат следует хранить в оригинальной упаковке в недоступном дл¤ детей месте при температуре не выше 25?—.
—рок годности
The shelf life is 5 years. Do not use after the expiration date printed on the package.
Terms of sale
The drug is available with a prescription.
Contacts for inquiries
GEDEON RICHTER JSC (Hungary)