Analogue of Klion D 100. Klion D – side effects

• rapid achievement of maximum concentration in the body and, as a result, the onset of a rapid therapeutic effect;
• the presence of several forms of release: solution for intravenous administration, tablets;
• low price compared to analogues.

Flaws:

• low bioavailability of the drug compared to analogues.

• Klion solution for infusion 5 mg/ml, 1 pc.

  126.00 rub.

• Klion tablets 250 mg, 20 pcs.

  65.80 rub.

* The maximum permissible retail price of medicines is indicated, calculated in accordance with Decree of the Government of the Russian Federation No. 865 of October 29, 2010 (For those medicines that are on the list)

Instructions for use:

Tablets are prescribed orally during or immediately after meals, without chewing and with a sufficient amount of cool, clean water.

For trichomoniasis the drug is prescribed:

children from 2 to 5 years, 250 mg per day, children from 5 to 10 years, 250–375 mg per day, over 10 years, 500 mg per day orally, with the daily dose divided into 2 doses. The course of treatment is 10 days;

For adults, the drug is prescribed 250 mg 2 times a day for 10 days or 400 mg 2 times a day for 5 – 8 days;

Women must additionally be prescribed metronidazole in the form of vaginal suppositories or tablets.

If necessary, the course of treatment is repeated after 3–4 weeks.

The course of treatment is 10 days.

For giardiasis the drug is prescribed:

children under 1 year, 125 mg per day, children from 2 to 4 years, 250 mg per day, children from 5 to 8 years, 375 mg per day, over 8 years, 500 mg per day, the daily dose is divided into 2 doses. The course of treatment is 5 days. After completion of treatment, a control laboratory test is performed 2–3 months later.

For adults, the drug is prescribed 500 mg 2 times a day. The course of treatment is 5–7 days.

For giardiasis, the drug is prescribed at a dose of 15 mg per 1 kg of body weight per day, the dose is divided into 3 doses over 5 days.

For amoebiasis, the drug is prescribed:

children (depending on age) - 1/4 - 1/2 adult dose.

adults: 1–1.5 g per day, divided into 2–3 doses, for 5–10 days.

To eradicate Helicobacter pylori, the drug is prescribed 500 mg 3 times a day for 7 days (as part of combination therapy).

For anaerobic infection, the drug is prescribed:

children under 12 years old - 7.5 mg per 1 kg of body weight 3 times a day.

adults: 400-500 mg 3-4 times a day.

The course of treatment is 7 – 10 days.

For chronic alcoholism, the drug is prescribed at 500 mg per day. The course of treatment should not exceed 6 months.

To prevent infectious complications, the drug is prescribed at 750–1500 mg per day in 3 divided doses 3–4 days before surgery or a single dose of 1000 mg on the first day after surgery. 1–2 days after surgery, the drug is taken at a dose of 750 mg for another 7 days.

The injection solution is administered intravenously. For children under 12 years of age, the dose is calculated based on body weight - 7.5 mg of the drug per 1 kg. For adults and children over 12 years of age, the drug is administered at an initial dose of 500–1000 mg, then 500 mg every 8 hours at a rate of 5 ml per minute.

The course of treatment is individual and selected by the attending physician.

The drug is prohibited for use during the first trimester of pregnancy (up to 12 - 13 weeks) and during lactation.

Children are allowed from 2 years of age.

comparison table

Drug name	Bioavailability, %	Bioavailability, mg/l	Time to reach maximum concentration, h	Half-life, h
Klion

INSTRUCTIONS KLION-D

pharmachologic effect

Antiprotozoal, antibacterial, antifungal.

The mechanism of action of metronidazole is the biochemical reduction of the 5-nitro group by 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.

Miconazole inhibits the synthesis of ergosterol in fungi and changes the composition of other lipid components in the membrane, which leads to the death of fungal cells.

Pharmacokinetics

Metronidazole. When administered intravaginally, it is absorbed into the systemic circulation. Cmax in the blood is determined after 6–12 hours and is approximately 50% of the Cmax that is achieved (after 1–3 hours) after a single dose of metronidazole orally.

Miconazole. Systemic absorption of miconazole nitrate after intravaginal use is limited. 8 hours after application of the drug, 90% of miconazole is still present in the vagina. Unchanged miconazole is not detectable in either plasma or urine.

Pharmacodynamics

Metronidazole is a broad-spectrum antimicrobial and antiprotozoal agent. Active against Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia intestinalis and also against obligate anaerobes (spore- and non-spore-forming), Bacteroides spp. (Bacteroides fragilis, Bacteroides ovatus, Bacteroides distasonis, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Clostridium spp., Peptostreptococcus spp., sensitive strains of Eubacterium. Aerobic microorganisms and facultative anaerobes are not sensitive to metronidazole.

Miconazole has antifungal activity against common dermatophytes, yeasts and various other fungi and antibacterial activity against certain gram-positive bacteria.

Quickly relieves itching that often accompanies infections caused by yeast and dermatophytes. Does not change the composition of the microflora and pH of the vagina.

Indications for use

Treatment of infectious and inflammatory diseases caused by anaerobic bacteria (bacteroides, fusobacteria, clostridia, anaerobic cocci), such as sepsis, peritonitis, osteomyelitis, brain and lung abscesses, abscesses in the pelvic area, gas gangrene, endometritis, meningitis. Prevention of postoperative infectious complications caused by anaerobic flora, primarily bacteroides and anaerobic streptococci, especially after surgical interventions on the pelvic and abdominal organs.

Local treatment of vaginal infection with Trichomonas and/or fungi using Kliona-D.

Mode of application

Pills:

For trichomonas in the morning and evening, 1 tablet (250 mg) orally for 10 days. Application of a single large dose: 8 tablets (2 g) Kliona In the evening.

For giardiasis in adults: 2 times, 2 tablets per day for 5-7 days.

For amebiasis in adults: 3 times a day, 2 tablets for 7-10 days.

Infusion solution:

Adults and children over 12 years old Klion 100 ml is administered every 8 hours at a rate of 5 ml/min dropwise. The course of treatment lasts on average 7 days. If necessary, intravenous administration of the drug is continued for a longer time. The daily dose should be no more than 4 g. According to indications, switch to maintenance oral therapy with metronidazole at a dose of 400 mg 3 times a day.

Children under 12 years of age Klion administered at the rate of 1.5 ml of solution (7.5 mg of active substance) per 1 kg of body weight.

For preventive purposes for adults and children over 12 years of age Klion prescribed as an intravenous infusion in a dose of 100 ml immediately before, during or after surgery. Every 8 hours the drug is administered in the same dose until switching to maintenance therapy with oral forms of metronidazole (200-400 mg orally).

For children under 12 years of age, a single dose Kliona when administered intravenously for the purpose of prophylaxis, it is 1.5 ml (7.5 mg of active substance) per 1 kg of body weight.

Vaginal tablets

For trichomanosis, for 10 days, 1 tablet moistened with water is inserted deep into the vagina once a day (in the evening before bedtime). Klion-D. Tablets are used at the same time Klion for oral use in a dose of 1 tablet 2 times a day.

Side effects

Local: itching, burning, pain and irritation in the vagina; thick, white, mucous vaginal discharge without odor or with a faint odor, frequent urination; a burning sensation or irritation of the penis in a sexual partner.

From the gastrointestinal tract: nausea, changes in taste, “metallic” taste and dry mouth, loss of appetite, cramping pain in the abdominal cavity; vomiting, constipation or diarrhea.

Allergic reactions: urticaria, itching of the skin, rash.

From the nervous system: headache, dizziness.

Other: leukopenia or leukocytosis. In rare cases, urine is colored red-brown (due to the presence of a water-soluble pigment formed as a result of the metabolism of metronidazole).

Contraindications

Hypersensitivity to the components of the drug (including other nitroimidazole derivatives), blood diseases, leukopenia (including a history); impaired coordination of movements, organic lesions of the central nervous system (including epilepsy); liver failure (if large doses are prescribed), pregnancy (1st trimester), breastfeeding period.

With caution - diabetes mellitus, microcirculation disorders.

Drug interactions

Like disulfiram, it causes ethanol intolerance. Concomitant use with disulfiram can lead to the development of various mental disorders and depression of consciousness.

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

Co-administration with barbiturates may accelerate the elimination of metronidazole, resulting in a decrease in its effect.

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.

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

List B. In a dry place, protected from light, at a temperature of 15–30 °C.

Synonyms

Klion-D 100, Neo-Penotran.

Compound

Vaginal tablets are almost white in color, special almond-shaped with a slightly uneven surface. The color of the fracture surface of the tablets should practically match the color of the tablets.

One vaginal tablet contains: metronidazole - 100 mg, miconazole nitrate - 100 mg, excipients: sodium lauryl sulfate; colloidal anhydrous silicon oxide; magnesium stearate; povidone; sodium bicarbonate; tartaric acid; sodium carboxymethyl starch A; crospovidone; hydroxypropyl methylcellulose 2910; lactose monohydrate.

Main settings

Name:	KLION-D
ATX code:	G01AF20 -

Combined antimicrobial agents.

Composition of Klion-D

1 vaginal suppository contains metronidazole 0.5 g and miconazole nitrate 0.1 g.

Manufacturers

Gedeon Richter A.O., packaged by Gedeon Richter-Rus (Hungary)

pharmachologic effect

Antibacterial, antifungal, antiprotozoal.

Metronidazole is active against Gardnerella vaginalis and Trichomonas vaginalis, anaerobic bacteria, including anaerobic Streptococcus.

Miconazole has a broad spectrum of antifungal action (especially active against Candida albicans) and is effective against gram-positive bacteria.

Side effects of Klion-D

The following undesirable effects are possible:

• From the nervous system and sensory organs: headache,
• movement disorders (ataxia,
• dizziness,
• psycho-emotional disorders,
• peripheral neuropathy (with overdose and long-term use,
• convulsions.

From the gastrointestinal tract:

• abdominal pain,
• metal graft,
• dry mouth,
• zapo,
• rarely - diarrhea,
• loss of appetite,
• nausea, nausea
• vomit.

From the genitourinary system:

• vaginal irritation (burning,
• itching).

Allergic reactions:

• hives.

From the cardiovascular system and blood (hematopoiesis, hemostasis):

• leukopenia.

From the skin:

• rash.

Indications for use

Vaginal infections caused by fungal (including Candida albicans), some bacterial and other pathogenic microorganisms (including Trichomonas vaginalis).

Contraindications Klion-D

Hypersensitivity, breastfeeding, pregnancy (first trimester).

Overdose

Possible symptoms:

• dizziness, nausea, vomiting, abdominal pain, diarrhea, itching, metallic taste in the mouth, movement disorders (ataxia), convulsions, paresthesia, leukopenia, dark urine (caused by an overdose of metronidazole); nausea, vomiting, inflammation of the throat and oral cavity, loss of appetite, diarrhea, headache (caused by an overdose of miconazole nitrate).

Treatment:

• symptomatic,
• in case of accidental ingestion, gastric lavage.

Interaction

Enhances the effect of oral anticoagulants, may increase the toxicity of lithium preparations, the level of phenytoin, astemizole and terfenadine in the blood.

Phenytoin and phenobarbital reduce the level of metronidazole in the blood, cimetidine increases it.

special instructions

Caution should be used in persons with severe liver diseases, incl. porphyria, diseases of the nervous system, hematopoietic disorders.

In order to avoid re-infection, simultaneous treatment of the sexual partner is necessary.

Breastfeeding can be resumed 24-48 hours after the end of treatment.

During treatment and at least 24-48 hours after the end of the course, you should avoid drinking alcohol (a disulfiram-like reaction is possible).

If vaginal irritation becomes severe, treatment should be discontinued.

During treatment, results may change when determining liver enzymes, glucose (hexokinase method), theophylline and procainamide.

P N011743/01

Tradename:

Klion-D 100

INN or group name:

Metronidazole + miconazole&

Dosage form:

vaginal tablets

Compound

for 1 tablet:
Active substances: metronidazole - 100 mg and miconazole nitrate - 100 mg;
Excipients: sodium lauryl sulfate - 0.50 mg, colloidal silicon dioxide - 7.00 mg, magnesium stearate - 13.00 mg, povidone - 26.00 mg, sodium bicarbonate - 90.00 mg, tartaric acid - 100.00 mg, sodium carboxymethyl starch (type A) - 100.00 mg, crospovidone - 100.00 mg, hypromellose - 190.00 mg, lactose monohydrate - 473.50 mg.

Description

Biconvex oval tablets with a pointed end, almost white in color, with “100” engraved on one side.

Pharmacotherapeutic group:

combined antimicrobial agent (antimicrobial and antiprotozoal agent + antifungal agent).

ATX code:

G01AF20.

Pharmacological properties

Pharmacodynamics
A combined drug for intravaginal use containing metronidazole and miconazole. Metronidazole is an antiprotozoal and antimicrobial drug, a derivative of 5-nitroimidazole. The mechanism of action is 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 microbial cells, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria and protozoa. Active against Trichomonas vaginalis, Entamoeba histolytica, Gardnerella vaginalis, Giardia lamblia, as well as obligate anaerobes Bacteroides spp. (including Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, 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.
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 aerobes.
Miconazole is an effective antimycotic agent that acts primarily against dermatophytes and yeast fungi. When used intravaginally, it is active mainly against Candida albicans.
Miconazole inhibits the biosynthesis of ergosterol in fungi and changes the composition of other lipid components in the membrane, which leads to the death of fungal cells. Miconazole does not change the composition of normal microflora and vaginal pH.

Pharmacokinetics
When administered intravaginally, metronidazole is absorbed into the systemic circulation. The maximum concentration of metronidazole in the blood is determined after 6-12 hours and is approximately 50% of the maximum concentration that is achieved (after 1-3 hours) after a single oral dose of metronidazole. Metronidazole passes into breast milk and most tissues, crosses the blood-brain barrier and the placenta. Communication with plasma proteins is less than 20%. Metabolized in the liver by hydroxylation, oxidation and glucuronidation. The activity of the main metabolite (2-hydroxymetronidazole) is 30% of the activity of the parent compound.
Excreted by the kidneys - 60-80% of the dose of the systemic drug (20% of this amount unchanged). The metabolite of metronidazole, 2-hydroxymetronidazole, colors urine red-brown due to the presence of a water-soluble pigment formed as a result of the metabolism of metronidazole. The intestines excrete 6-15% of the dose of the systemic drug.
Systemic absorption of miconazole after intravaginal use is low.
Rapidly destroyed in the liver. It overcomes histohematic barriers poorly.
8 hours after using the drug, 90% of miconazole is still present in the vagina. Unchanged miconazole is not detectable in either plasma or urine.

Indications for use

Local treatment of vaginitis of mixed etiology caused simultaneously by Trichomonas spp. and Candida spp.

Contraindications

• increased individual sensitivity to the components of the drug and other azoles;
• pregnancy (first trimester);
• lactation period;
• leukopenia (including history);
• organic lesions of the central nervous system (including epilepsy);
• liver failure;
• children's age (up to 12 years).

Carefully

Diabetes mellitus, microcirculation disorders.

Use during pregnancy and lactation

Pregnancy
Klion-D 100 is contraindicated for use in the first trimester of pregnancy. The use of the drug in the second and third trimesters is possible only in cases where the potential benefit to the mother outweighs the risk to the fetus.
Lactation period
Klion-D 100 passes into breast milk. If you need to use the drug, you should stop breastfeeding. During breastfeeding, the use of Klion-D 100 is contraindicated.

Directions for use and doses

Intravaginally. 1 vaginal tablet (pre-moistened with water) is inserted deep into the vagina in the evening before bed for 10 days in combination with taking the drug metronidazole orally.

Side effect

Local reactions: itching, burning, pain, irritation of the vaginal mucosa; thick, white, mucous vaginal discharge without odor or with a faint odor, frequent urination; burning sensation or irritation of the penis in a sexual partner;
From the digestive system: nausea, vomiting, changes in taste, metallic taste in the mouth, loss of appetite, spastic abdominal pain, diarrhea, constipation;
Allergic reactions: urticaria, itching of the skin, rash;
From the central nervous system: headache, dizziness;
From the hematopoietic system: leukopenia or leukocytosis;
From the genitourinary system: The red-brown coloration of urine is caused by a metabolite of metronidazole, 2-oxymetronidazole, due to the presence of a water-soluble pigment formed as a result of the metabolism of metronidazole.

Overdose

There are no data regarding overdose with intravaginal use of metronidazole. However, when used concomitantly with metronidazole orally, systemic effects may develop.
Symptoms of metronidazole overdose: nausea, vomiting, abdominal pain, diarrhea, generalized itching, metallic taste in the mouth, movement disorders (ataxia), dizziness, paresthesia, convulsions, peripheral neuropathy, leukopenia, darkening of urine.
No symptoms of miconazole overdose have been identified.
Treatment: in case of accidental ingestion of a large number of vaginal tablets Klion-D 100, if necessary, gastric lavage, administration of activated charcoal, and hemodialysis can be performed. Metronidazole does not have a specific antidote. Metronidazole and its metabolites are readily eliminated by hemodialysis.
If any symptoms of overdose occur, symptomatic and supportive therapy is recommended.

Interaction with other drugs

Since the systemic absorption of miconazole is low, interactions with other drugs are caused by metronidazole.
Metronidazole is compatible with sulfonamides and antibiotics. When consumed simultaneously, alcohol causes reactions similar to disulfiram (cramping abdominal pain, nausea, vomiting, headache, skin flushing).
Concomitant use with disulfiram is unacceptable (additive effects, may cause confusion).
The drug may enhance the effect of indirect anticoagulants. Prothrombin time may increase, so dose adjustment of indirect anticoagulants is necessary. It is not recommended to combine with non-depolarizing muscle relaxants (vecuronium bromide). Inducers of microsomal oxidation enzymes in the liver (for example, phenytoin, phenobarbital) can accelerate the elimination of metronidazole, which will lead to a decrease in its concentration in the blood plasma.
Cimetidine inhibits the metabolism of metronidazole, which can lead to an increase in its concentration in the blood serum and an increased risk of developing side effects.
The concentration of lithium in the blood may increase during the course of treatment with metronidazole, therefore, before starting to use Klion-D 100, it is necessary to reduce the dose of lithium or stop taking it for the duration of treatment.

special instructions

The consumption of alcoholic beverages during the course of therapy with Klion-D 100 is strictly prohibited. During treatment with Klion-D 100, it is recommended to abstain from sexual intercourse. Simultaneous treatment of sexual partners is recommended.
When using Klion-D 100, slight leukopenia may be observed, so it is advisable to monitor the blood picture (the number of leukocytes) at the beginning and at the end of therapy.
Metronidazole can immobilize treponemes, resulting in a false-positive TPI test (Treponema Pallidum Immobilization test or Nelson's treponemal test).

Impact on the ability to drive a car and other mechanical means.
If side effects from the central nervous system occur, you should refrain from driving vehicles and working with potentially dangerous mechanisms.

Release form

Vaginal tablets, 100 mg+100 mg.
10 tablets in a soft aluminum foil strip, coated on one side and varnished on the other side. 1 strip with instructions for use in a cardboard box.

Storage conditions

Store at a temperature of 15-30 °C, protected from light and moisture.
Keep out of the reach of children!

Women face problems with infectious gynecological diseases. Painful sensations and itching appear, creating the possibility of infecting a partner or child at the time of birth. The main danger is relapses and complications. Suppositories with metronidazole will help you cope, but it is important to read the instructions for the product.

Klion-D - indications

The drug in its release form (vaginal tablets) is used for the local treatment of gynecological infections caused by bacteria and fungi. Efficiency is determined by 2 effective elements in the composition. The following are active:

• metronidazole is an antibacterial, antiprotozoal substance that destroys bacteria;
• Miconazole is an antifungal component.

Klion-D are suppositories made as almond-shaped tablets, which are moistened with water before use and inserted into the vagina. Doctors recommend doing such procedures at night. What does Klion-D treat? First of all, gynecological infections. Indications for use of Klion-D are candidiasis or thrush, gardnerellosis. Features of the use of medicine for vaginitis:

• if the disease is caused by Trichomonas, in addition to suppositories, metronidazole is taken orally;
• for candidiasis infection, microflora imbalance, Klion suppositories are given twice a day.

Klion-D candles - instructions for use

The main active ingredients of the drug are metronidazole and miconazole. Manufacturers add additional substances to the composition of candles:

• hydroxypropyl methylcellulose 2910;
• sodium bicarbonate;
• sodium lauryl sulfate;
• povidone;
• magnesium stearate;
• colloidal anhydrous silicon;
• lactose monohydrate;
• sodium carboxymethyl starch type A;
• crospovidone;
• tartaric acid.

In order to avoid complications and side effects, it is necessary to study the instructions for the Klion D suppositories. The instructions stipulate:

• contraindications for use;
• inadmissibility of consumption together with alcohol;
• avoiding use during breastfeeding due to the drug getting into milk;
• compatibility of the drug with antibiotics;
• enhancing the effect of anticoagulants;
• when used with ethanol, the appearance of mental disorders;
• careful use when driving vehicles.

According to the instructions, it is recommended to use vaginal suppositories once, at night. They are pre-moistened with water to facilitate deep insertion into the vagina. The package contains 10 suppositories, which are enough for a course of treatment. The drug Klion-D acts quickly, eliminating unpleasant symptoms in a short time. It is important to note that when using candles you need:

• carry out simultaneous treatment of a partner;
• refrain from working with complex units;
• exclude sexual contacts for this time;
• monitor leukocyte levels due to decreased values ​​during treatment.

Klion-D during pregnancy

The period of waiting for a baby is often accompanied by a drop in immunity and the occurrence of candidiasis, which can also cause harm to the child. During pregnancy, Klion-D should not be used in the early stages, when the fetus is developing organs and systems. Self-administration of medications during this period is excluded. With great caution, in case of serious problems, gynecologists prescribe Klion-D vaginal tablets in the last weeks of pregnancy. Before childbirth, suppositories are used to cleanse the birth canal so as not to infect the newborn.

Klion-D - side effects

When prescribing a drug, doctors must take into account that there is an individual intolerance to individual components. The instructions specify contraindications for use:

• epilepsy;
• breastfeeding period;
• blood diseases;
• leukopenia;
• impaired coordination of movements;
• 1st trimester of pregnancy;
• liver failure;
• children under 12 years of age;
• organic disorders of the central nervous system.

The patient should be warned by the doctor about the side effects of Klion-D. There is a high likelihood of the following symptoms:

• irritation of the mucous membrane;
• burning, itching in the woman’s genitals;
• headache;
• white discharge with mucus;
• skin rash;
• diarrhea;
• nausea;
• dizziness;
• constipation;
• abdominal cramps;
• vomit;
• irritation, burning of the partner’s penis;
• dark colored urine.

Klion-D candles - cheaper analogues

The drug is considered a very effective remedy with an affordable price. On the pharmaceutical market you can find similar ones that differ in cost in both directions, but are no less effective. Analogues of Klion-D.