Suppositories Klion D - instructions for use in gynecology, analogues, reviews. Klion d, vaginal tablets Klion d 100 side

23.07.2020 Insulin

Combined drug with antibacterial, antiprotozoal and antifungal action
Preparation: KLION-D 100
The active substance of the drug: metronidazole, miconazole
ATX encoding: G01AF20
KFG: A drug with antibacterial, antiprotozoal and antifungal effects for local application in gynecology
Registration number: P No. 011743/01
Date of registration: 17.03.06
Owner reg. ID: GEDEON RICHTER Ltd. (Hungary)

Release form Klion-d 100, drug packaging and composition.

Vaginal tablets are almost white, oval, biconvex, with a pointed end, engraved with "100" on one side.
1 tab.
metronidazole
100 mg
miconazole nitrate
100 mg

Excipients: sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, povidone, sodium bicarbonate, tartaric acid, sodium carboxymethyl starch type A, crospovidone, hypromellose, lactose monohydrate.

10 pieces. - aluminum strips (1) - cardboard packs.

The description of the product is based on the officially approved instructions for use.

Pharmacological action Klion-d 100

Combined drug with antibacterial, antiprotozoal and antifungal effects for intravaginal use.

Metronidazole, a derivative of nitro-5-imidazole. Its mechanism of action consists in the biochemical reduction of the 5-nitro group 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 their nucleic acids, which leads to the death of microorganisms. Metronidazole is an effective antimicrobial and antiprotozoal agent wide range actions.

It is active against Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia intestinalis, as well as 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 Eubacterium strains.

Facultative anaerobes and obligate aerobes are resistant to metronidazole.

Miconazole has antifungal effect against dermatophytes, yeast fungi, as well as antibacterial effect against certain gram-positive bacteria. Miconazole inhibits the biosynthesis of ergosterol and changes the composition of other lipid components in the membrane, which leads to necrosis of fungal cells. Miconazole relieves itching that often accompanies infections caused by yeasts and dermatophytes. Does not change the composition of microflora and vaginal pH.

Pharmacokinetics of the drug.

Suction

With intravaginal administration, metronidazole undergoes systemic absorption. Cmax in the blood is determined after 6-12 hours and after intravaginal use is approximately 50% of the Cmax that is reached after 1-3 hours after a single dose of an equivalent dose of metronidazole inside.

With intravaginal application of miconazole, nitrate is absorbed slightly. Eight hours after intravaginal administration, 90% of miconazole is still present in the vagina. Unchanged miconazole is not found in either plasma or urine.

Indications for use:

Local treatment of Trichomonas, candidal and nonspecific vaginitis.

Dosage and method of administration of the drug.

With trichomonas vaginitis, 1 vaginal tablet is prescribed 1 time / day for 10 days in combination with taking metronidazole inside.

In case of nonspecific vaginitis or candidal vaginitis, 1 vaginal tablet is prescribed 2 times / day for 10 days, if necessary, in combination with oral metronidazole.

Rules for using the drug

Having previously released the pill from the contour package, you should moisten it with boiled chilled water and insert it deep into the vagina.

Side effect of Klion-d 100:

Local reactions: burning, itching, pain and irritation of the vaginal mucosa; thick, white, mucous vaginal discharge, odorless or faint; a burning sensation or irritation of the partner's penis.

From the side digestive system: change in taste, metallic taste in the mouth, dry mouth, decreased appetite, cramping pain in abdominal cavity, nausea, vomiting, constipation, or diarrhea.

From the side of the central nervous system: headache, dizziness.

From the hematopoietic system: leukopenia, leukocytosis.

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

From the urinary system: frequent urination; rarely - staining of urine in a red-brown color due to the presence of a water-soluble pigment formed as a result of the metabolism of metronidazole.

Contraindications to the drug:

Blood diseases;

Leukopenia (including a history);

Impaired coordination of movements;

Organic lesions Central nervous system (including epilepsy);

Hepatic impairment (when the drug is prescribed in high doses);

Pregnancy;

Lactation period ( breastfeeding);

Hypersensitivity to metronidazole, miconazole or other nitroimidazole derivatives.

The drug should be prescribed with caution when diabetes mellitus, microcirculation disorders.

Application during pregnancy and lactation.

Klion-D 100 is contraindicated for use during pregnancy.

If it is necessary to use Klion-D 100 during lactation, the issue of stopping breastfeeding should be resolved.

Special instructions for the use of Klion-d 100.

It is advisable to simultaneously treat the sexual partner with metronidazole for oral administration, regardless of whether he has manifestations of the disease.

Metronidazole can immobilize treponemas, resulting in a false positive TPI test (Nelson's test).

During the period of use of the drug, alcohol should not be consumed (the risk of developing disulfiram-like reactions).

Control of laboratory parameters

If there is a history of changes in the composition of peripheral blood, as well as when using the drug in high doses and / or for a long time, it is necessary to control the picture of peripheral blood.

Influence on the ability to drive vehicles and use mechanisms

The attention of patients should be drawn to the possibility of dizziness on the background of the use of Klion-D 100, which may impair the ability to perform work requiring increased attention.

Drug overdose:

Data on overdose of the drug Klion-D 100 were not provided.

Interaction of Klion-d 100 with other drugs.

With the simultaneous use of metronidazole and disulfiram, depression of consciousness, the development of mental disorders is possible.

With the simultaneous use of metronidazole and ethanol (or ethanol-containing drugs), disulfiram-like reactions may develop.

When used simultaneously with warfarin and other indirect anticoagulants, metronidazole enhances their effect, which leads to an increase in prothrombin time.

Under the influence of barbiturates, the effect of metronidazole may decrease, because its metabolism in the liver is accelerated.

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

With the simultaneous use of Klion-D 100 with lithium preparations, the concentration of the latter in the plasma may increase.

Conditions of sale in pharmacies.

The drug is available by prescription.

Terms of storage conditions for the drug Klion-d 100.

List B. The drug should be stored in a place protected from light and moisture, out of reach of children at a temperature of 15 ° to 30 ° C. The shelf life is 5 years.

One candle contains 0.1 g of active ingredient metronidazole + miconazole nitrate 0.1 g + excipients ( silicon dioxide, povidone, tartaric acid, sodium lauryl sulfate, magnesium stearate, sodium bicarbonate, sodium carboxymethyl, hypromellose, lactose, crospovidone, starch).

Release form

Vaginal suppositories of white color in strips of 10 suppositories, in cartons of 1 strip.

pharmachologic effect

Antibacterial, antiprotozoal and antifungal agent used in gynecology.

Pharmacodynamics and pharmacokinetics

The action of the drug is due to the complex effect on vaginal microflora components included in its composition.

Overdose

Overdose symptoms are nausea, vomiting and other increased manifestations of side effects. If the drug enters the digestive system, it is worth making gastric lavage , reception enterosorbents and.

Interaction

The medicine is not compatible with ethanol, , non-depolarizingmuscle relaxants, cimetidine, lithium preparations .

While taking indirect anticoagulants , it is worth additionally controlling prothrombin index .

The effectiveness of metronidazole decreases when combined with phenobarbital and phenytoin .

Terms of sale

Prescription required.

Storage conditions

In a dark, cool place, protected from children, the temperature regime is up to 30 degrees.

Shelf life

special instructions

The use of suppositories for menstruation should be coordinated with your doctor. Usually, you should take a break during your period and continue after your period ends.

Analogs

Matching ATX level 4:

The analogs of candles are:

Latin name:Klion-D 100
ATX code: G01AF20
Active substance:Metronidazole, Miconazole
Manufacturer: Gedeon Richter, Hungary
Pharmacy dispensing condition: On prescription

Klion-D 100 is an antiviral, antifungal drug for external use. The main feature is the combinatorial chemical interaction of two active substances - metronidazole and miconazole. It is a completely synthetic agent that treats diseases associated with an infectious lesion of the genital system. It can be used during pregnancy, but not in the 1st trimester.

Indications

Klion-D 100 is intended for vaginal use and treatment of pathologies caused by strains of pathogens that are susceptible to drug components. Candles (tablets) are prescribed for the following diseases:

  • Thrush
  • Trichomonas vaginitis
  • Candidiasis infection
  • Inflammations of non-specific etiology
  • For prophylactic purposes during or after gynecological surgery.

Composition

Contains 100 mg of metronidzole and miconazole as leading active ingredients. Additional components:

  • Sodium docyl sulfate is a surface anionic element, which is a translucent synthetic crystals, soluble in water. Acts as an antifoam and a powerful detergent.
  • Lactose monogridate is a preservative to ensure the stability of the tablet shape and long shelf life.
  • Pyrogenic dioxide in colloidal form is a strong enterosorbent, necessary in medicines for purulent and inflammatory processes.
  • Hydroxypropyl methylcellulose is a stabilizer with a lubricating effect.
  • Magnesium stearate salt is capable of creating a homogeneous mass, without foreign inclusions from scattered components.
  • Vinylpyrrolidinone homopolymer - povidone disintegrator, detoxifier.
  • Sodium bicarbonate protects mucous membranes from burns with an acidic environment.
  • Carboxymethyl starch salt with thickening properties, oleophobic properties and high liquidity.
  • Dihydroxy succinic acid is an emulsifier.

Healing properties

Klion-D 100 has an antibacterial and antifungal effect, which ensures its two-component nature. Mitronidazole is synthesized from the natural chemical azomycin. The mechanism of the element is to restore protein transporters, which are connected to ribosomal chains, from which the production of nucleins is inhibited and pathogenic cells are destroyed.

Miconazole is intended to stop the synthesis of the ergosterol component of protozoan cell membranes. The substance reacts with individual sections of cells, exhibits fungistatic properties, breaks biochains. As a result, defective elements are built into the structure of the pathogen, damaging the membrane membranes. By changing the lipid component of bacteria, the agent does not affect the vaginal microflora and ensures the stability of the pH of the mucous membrane.

During treatment, it is active against the following strains:

  • Candida albicans
  • Peptostreptococci
  • Trichomonas vaginal
  • Eubactras
  • Gardnerells
  • Streptococci
  • Clostridia
  • Giardia intestinal
  • Guardia
  • Bacteroids
  • Waylonella
  • Dysentery amoeba
  • Fusobacteria
  • Dermatophytes
  • Yeast protozoa.

Anaerobes of the facultative type and aerobes show resistance to mitronidazole, but with mixed types of pathogens, it is able to synergize with antibiotics effective against these strains.

When used vaginally, it is absorbed into the blood. The maximum content is observed after 8-12 hours, it is about 50% of the equivalent dose for oral administration of drugs with metronidazole. The components combine with the protein element by 20%. The metabolic process takes place in the liver through oxidation and conjugation of the substrate.

It is excreted through the kidneys by 80%, of which 20% is in an unchanged state. The intestine removes about 10% of the drug. Miconazole poorly penetrates the histacytic barrier, 8 hours after application it is still at the injection site, it is not detected in the blood and urine.

Release forms

Suppositories or tablets (intravaginal) are produced in the form of a drop, with a pointed end on one side. They have a light cream shade, marked with the number 100. They are embedded in soft foil plates with cells of 10 pieces. The cardboard box contains instructions and 1 aluminum strip. The tutu is white, with a blue stripe above and a red stripe below. The convex shape of the tablets is for ease of use. The size of the candles is about 25 mm long and 15 mm wide.

Methods of administration and doses

Price: Tablets vag. 100 mg No. 10 - 500-550 rubles.

Suppositories Klion-D 100 are prescribed for treatment in the amount of 1 piece before bedtime. You must first wash your hands and genital organs with a cosmetic or bactericidal detergent. The tablet is slightly moistened with warm water, gently injected with your fingers, deep enough. The course is 10 days.

When infected with Trichomonas, the scheme is traditional, but the infection is additionally treated with the oral form of metronidazole, twice a day. If therapy has not yielded results, they are extended for the same period. It is recommended that the tablets containing the main active ingredient metronidazole be taken simultaneously for men in equivalent doses by mouth. During pregnancy, the regimen is similar, but the drug should be injected carefully.

For thrush, candles are injected before bedtime. The treatment can be repeated an unlimited number of times, but testing for the type of pathogen is required to determine which species of Candida caused the disease.

During menstrual flow, it is not recommended to conduct a course, since the undissolved tablet is washed out, the effectiveness of the medication is significantly reduced. If your periods began unexpectedly, you should not interrupt the therapy, but you should take into account the low effectiveness, if necessary or low the final indicators, repeat the treatment.

Application during pregnancy and gv

Until the third month inclusive, the drug Klion-D 100 is contraindicated. Active substances are able to penetrate tissues, fluids and the barrier, having a negative effect on the fetus. In subsequent semesters, the appropriateness of treatment is determined by the doctor, assessing the potential danger to the child. The tests were carried out only on animals, even with the introduction of a multiple dose, no negative effects were revealed, therefore, according to vital signs during pregnancy, the drug is prescribed.

Since an insignificant part passes into milk, breastfeeding should be avoided. Lactation can be started 48 hours after the last dose.

Contraindications

Before use, one should take into account the impossibility of using it for the following diseases and conditions:

  • Increased intolerance to the components of the drug
  • Pathologies of the hematopoietic system
  • High level of leukocyte elements
  • Defeats nervous system: epilepsy, stroke
  • Children under 12 years old
  • Impaired liver function
  • 1 trimester of pregnancy
  • Severe diabetes mellitus
  • Violation of the vestibular apparatus
  • Susceptibility to the means of the azole group.

Drug interactions

Klion-D 100 can give negative reactions with other drugs, or, on the contrary, enhance the effectiveness. Do not combine the drug with the following formulations:

  • Muscle relaxants of the non-depolarizing category.
  • Phenobarbital leads to a decrease in the concentration of metronidazole.
  • Cimetidine can cause toxicity as it impairs metabolism.
  • Absolute antagonism with ethanol.
  • The content of lithium components increases, which requires adjusting the dosage of such medicines.

The drug is compatible with antibiotics of different groups, including para-aminobenzenesulfonamides. You should refrain from intimacy during the course.

Adverse reactions

Klion-D can give various negative manifestations:

  • If administered incorrectly, slight discomfort is felt until the tablet dissolves, especially during pregnancy.
  • The discharge is translucent or with whitish flakes, with a slight characteristic odor. If reddish blotches occur, you should not interrupt the treatment, as this may be due to injury to the vessels of the mucous membrane. This phenomenon can last for 1-2 weeks, should not cause concern.
  • Burning sensation refers to local irritant reactions. If it is short-term, therapy is continued, including during pregnancy. Emergence severe itching - a reason to see a doctor.
  • Nervous system - limb numbness, dizziness.
  • Allergy: rashes, anaphylactic shock.
  • Liver: biliary congestion, increased transaminase levels.
  • Digestive system: nausea, metallic taste in the mouth, cramps in the stomach or intestines, impaired peristalsis, bloating.

Overdose

There were no cases of exceeding the required amount of the drug. In case of accidental use, standard therapy is used orally - gastric lavage, hemodialysis, supportive measures.

Conditions and shelf life

The drug must be kept in a cool, dark place, without access to moisture, out of the reach of children. Suitable for use for 5 years.

Analogs

If it is impossible to use Klion-D 100, infections are prescribed with drugs with an identical mechanism of action:

Wagisept

Manufacturer: Firn M, Roosia

Cost: Tab. Vagin. No. 5 - 200-250 rubles.

Combined topical product. Effective against infections caused by Trichomonas and fungi. There are two main active components: metronidazole destroys the membranes of pathogens, integrating into ribosomal chains and disrupting their structure. Aerobic strains are resistant. Fluconazole has high fungicidal properties, destroys mycoses.

Medication is used to treat vaginosis with different etiology, including nonspecific bacterial. Contraindicated in pregnancy and children under 16 years of age. The course of therapy is 7-10 days, but may be repeated if necessary.

It is produced in the form of torpedo-shaped tablets of a cream or light yellow shade. The soft aluminum blister contains 5 units. Cardboard box, light, with pink stains, contains 1 plate and instructions.

Advantages:

  • Antibiotic Compatibility
  • There were practically no side effects.

Disadvantages:

  • Contraindicated in pregnancy
  • Fluconazole absorption is low.

Manufacturer: Polfa, Poland

Cost: Tab. Wag. No. 10 - 300-350 rubles.

The drug is a combined type, which also includes chlorquinaldol. The first substance interacts with the DNA of the pathogen, blocks the synthesis of nucleins, which leads to the death of the virus. Active against Trichomonas, lamblia, dysentery amoeba, bacteroids, clostridia. The second element fights against pseudomonads, streptococci, staphylococci, shigella, proteus. Vaginitis of an infectious nature is treated with a medication, it is prescribed as a prophylaxis before and after surgery in the field of gynecology. It is forbidden to use during pregnancy, blood diseases, severe liver damage.

It is marketed in the form of vaginal tablets with a pointed end for ease of administration. The aluminum hard blister contains 5 units. The box contains two plates and instructions. The pack is cardboard, white, with a blue stripe along the bottom perimeter and the company logo.

Advantages:

  • The medicine is well tolerated, allergic manifestations are rare and short-term
  • The result is noticeable on the third day after the start of therapy.

Disadvantages:

  • Recommended to drive before bedtime, not suitable for daytime use
  • Increases the prothrombin index.

A synthetic combined drug of a wide spectrum of action is Klion-D 100. Instructions for use indicate that vaginal suppositories, tablets 250 mg and D 100, injections in ampoules are used as an antifungal, antibacterial and antiprotozoal agent. Doctors - gynecologists indicate that the medicine helps in the treatment of thrush and other vaginitis.

Release form and composition

Produce the following dosage forms Klion:

  • solution for infusion: colorless or slightly greenish or greenish-yellow, transparent, does not have mechanical impurities (100 ml in glass bottles, in a cardboard box 1 bottle);
  • tablets: flat-cylindrical, white or white with a tint from yellowish-greenish to light yellow with greenish, on one side of the risk, on both sides of the chamfer (10 pcs. in blisters, in a cardboard box 2 packs).

Composition of 1 tablet: active substance: metronidazole - 250 mg.

Composition of 1 ml solution:

  • water for injection - up to 1 ml;
  • sodium hydrogen phosphate dodecahydrate - 0.6 mg;
  • additional components: sodium chloride - 8 mg;
  • active substance: metronidazole - 5 mg;
  • sodium dihydrogen phosphate dihydrate - 0.45 mg.

Indications for use

What does Klion-D 100 help with? Suppositories, tablets and injections are prescribed if the patient has:

  • pseudomembranous colitis;
  • all types of diseases caused by Bacteroides, Peptostreptococcus, Clostridium, Peptococcus spp .;
  • condition after operations as part of prevention;
  • radiation therapy for patients with tumors;
  • trichomoniasis, giardiasis, cutaneous leishmaniasis, balantidiasis, amoebic liver abscess, amoebiasis and other protozoal infections;
  • stomach ulcer or erosion caused by bacteria Helicobacter pylori.

Instructions for use

Klion D 100 vaginal suppositories and tablets

Intravaginally. 1 vaginal tablet (previously moistened with water) is injected deep into the vagina in the evening before going to bed for 10 days in combination with taking the drug Klion inside.

Tablets 250 mg

The drug is taken orally during or after meals (washed down with milk), without chewing.

Giardiasis: adults are prescribed 500 mg 2 times a day for 5-7 days.

Children over 8 years old - 500 mg per day (in 2 divided doses), aged 5 to 8 years - 375 mg per day, at the age of 3 years and older - 250 mg per day; the daily dose should be divided into 2 doses; the course of treatment is 5 days. The dose of the drug can be 15 mg / kg per day in 3 divided doses for 5 days.

Treatment of chronic alcoholism: prescribed in a dose of 500 mg per day for a period of up to 6 (no more) months.

For the prevention of infectious complications: 750-1500 mg per day in 3 divided doses 3-4 days before surgery, or once at a dose of 1 g on the first day after surgery. 1-2 days after the operation (when oral administration is already allowed) - 750 mg per day for 7 days.

Trichomoniasis: adults are prescribed 250 mg 2 times a day for 16 days or 400 mg 2 times a day for 5-8 days. Women need to additionally prescribe Klion in the form of vaginal suppositories or tablets. If necessary, you can repeat the course of treatment or increase the dose to 0.75-1 g per day. Between courses, you should take a break of 3-4 weeks with repeated control laboratory tests.

An alternative therapy regimen is the appointment of 2 g once to the patient and his sexual partner.

For children aged 2-5 years, the drug is prescribed at a dose of 250 mg per day, at the age of 5-10 years - 250-375 mg per day; over 10 years old - 500 mg per day. The daily dose should be divided into 2 doses. The course of treatment is 10 days.

Liver abscess: maximum daily dose is 2.5 g in 1 or 2-3 doses for 3-5 days, in combination with antibiotics (tetracyclines) and as part of complex therapy.

Children from 3 years old - 1/4 dose of an adult, at the age of 3-7 years - 1/3 dose of an adult, at the age of 7-10 years - 1/2 dose of an adult.

  • Asymptomatic amoebiasis (if cysts are detected): adults are prescribed in a daily dose of 1-1.5 g (500 mg 2-3 times a day) for 5-7 days.
  • Ulcerative stomatitis: adults are prescribed 500 mg 2 times a day for 3-5 days. In this case, the drug is not indicated for children.
  • Chronic amebiasis: 1.5 g per day in 3 divided doses for 5-10 days.
  • For the eradication of Helicobacter pylori: 500 mg 3 times a day for 7 days (as part of a combination therapy, for example, in combination with amoxicillin 2.25 g per day).
  • Sharp amoebic dysentery: 2.25 g per day in 3 divided doses until symptoms stop.
  • Treatment of anaerobic infection: the maximum daily dose is 1.5-2 g.
  • Balantidiasis: 750 mg 3 times a day for 5-6 days.
  • Pseudomebranous colitis: 500 mg 3-4 times a day.

See also: how to take analog.

pharmachologic effect

Klion-D 100 is a broad-spectrum drug. The main active ingredient is metronidazole, which is a derivative of nitro-5-imidazole. The mechanism of action of this substance is to restore the 5-nitro group in anaerobic microorganisms and protozoa. This leads to the death of microorganisms due to the interaction of the reduced 5-nitro group of metronidazole with the DNA of the cell of microorganisms.

Klion-D 100 is active against a large number of microorganisms such as Entamoeba histolytica, Giardia lamblia, Trichomonas vaginalis, Gardnerella vaginalis, and it is also active against anaerobic bacteria - Bacteroides spp. Veillonella spp., Fusobacterium spp., Prevotella spp.

Effective use this drug and for the treatment of diseases caused by certain gram-positive microorganisms such as Clostridium spp., Eubacterium spp., Peptococcus spp., Peptostreptococcus spp. Facultative anaerobes and aerobic microorganisms are insensitive to Klion-d 100, but its use is recommended for the treatment of mixed aerobic-anaerobic infections.

Klion-D 100 is very effective against fungi, including dermatophytes and yeasts. Suppositories for intravaginal use effectively fight Candida albicans. Miconazole is able to inhibit the biosynthesis of ergosterol in fungal cells, which leads to their death. At the same time, the normal microflora and pH of the vagina do not change during treatment with this drug.

Contraindications

Absolute:

  • hepatic impairment (with the appointment of Klion in high doses);
  • I trimester of pregnancy and the period of breastfeeding;
  • organic lesions of the central nervous system, including epilepsy;
  • leukopenia, including a burdened history;
  • age up to 3 years (tablets);
  • individual intolerance to the components of the drug and other nitroimidazoles.

Relative (diseases / conditions in the presence of which the appointment of Klion requires caution):

  • hepatic / renal failure;
  • II – III trimesters of pregnancy.

Side effects

The drug is well tolerated by patients, but in some cases the following side reactions develop:

  • Discoloration of urine;
  • Increased vaginal discharge;
  • The change clinical picture blood;
  • On the part of the digestive tract - in rare cases, a violation of the stool, a change in taste, dry mouth, nausea, abdominal pain, increased gas production;
  • Allergic reactions - skin rash, urticaria, in rare cases, the development of angioedema;
  • From the side of the central nervous system - dizziness and headaches;
  • Local manifestations - discomfort, itching, burning, swelling, redness of the mucous membranes, sensation foreign body in the vagina.

During pregnancy and breastfeeding

The drug is contraindicated for use in the 1st trimester of pregnancy and during breastfeeding.

special instructions

During the period of using the drug, you should not drink alcohol (risk of developing disulfiram-like reactions). During the period of using the drug, it is recommended to refrain from sexual intercourse. Simultaneous treatment of sexual partners is recommended.

Metronidazole can immobilize treponemas, resulting in a false positive TPI test (Nelson's test). When using Klion-D 100, slight leukopenia may occur, therefore it is advisable to monitor the blood picture (leukocyte count) at the beginning and at the end of therapy.

If side effects from the central nervous system appear, one should refrain from driving and working with potentially dangerous mechanisms.

Drug interactions

Phenytoin, phenobarbital and other inducers of liver microsomal oxidation enzymes reduce the effectiveness of the drug.

Cimetidine and sulfonamides, increase the concentration of metronidazole in blood plasma. Not compatible with ethanol. Enhances the effect of anticoagulants and lithium preparations.

Analogs of the drug Klion

Analogs are determined by structure:

  1. Rosex.
  2. Rosamet.
  3. Tricho-PIN.
  4. Metron.
  5. Metroseptol.
  6. Flagil.
  7. Metronidal.
  8. Deflamon.
  9. Metronidazole.
  10. Trichobrol.
  11. Orvagil.
  12. Batsimex.
  13. Cyptrogil.
  14. Metrolacer.
  15. Efloran.
  16. Metrowagin.
  17. Metroxan.
  18. Trichocept.

Vacation conditions and price

The average cost of Klion D 100 (vaginal tablets No. 10) in Moscow is 425 rubles. Dispensed by prescription.

Store in a dark place at a temperature of 15-30 ° C. Keep out of the reach of children. Shelf life:

  • tablets - 5 years;
  • infusion solution - 3 years.

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Dosage Form: & nbspvaginal pills Composition:

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 tablets of an oval shape with a pointed end, almost white, engraved with "100" on one side.

Pharmacotherapeutic group:Combined antimicrobial agent (antimicrobial and antiprotozoal agent + antifungal agent) ATX: & nbsp

G.01.A.F Imidazole derivatives

G.01.A.F.20 Combinations of imidazole derivatives

Pharmacodynamics:

Combined preparation for intravaginal use, containing and.

Metronidazole is an antiprotozoal and antimicrobial drug derived from 5-nitroimidazole. 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 their nucleic acids, which leads to the death of bacteria and protozoa.

Active in relation Trichomonas vaginalis, Entamoeba histolytica, Gardnerella vaginalis, Giardia lambliaas well as obligate anaerobes Bacteroides spp. (incl.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) it acts synergistically with antibiotics effective against aerobes.

Miconazole is an effective antimycotic agent that acts primarily on dermatophytes and yeasts.

With intravaginal use active mainly regarding 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 normal microflora and vaginal pH.

Pharmacokinetics:

With intravaginal use, it 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 reached (after 1-3 hours) after a single dose of an equivalent dose of metronidazole inside. penetrates into breast milk and most tissues, passes through the blood-brain barrier and the placenta. The connection with plasma proteins is less than 20%. It is metabolized in the liver by hydroxylation, oxidation and glucuronidation. The activity of the main metabolite (2-oxymetronidazole) is 30% of the activity of the parent compound. It is excreted by the kidneys - 60-80% of the dose of the drug of systemic action (20% of this amount unchanged). The metabolite of metronidazole, 2-oxymetronidazole, stains urine reddish-brown due to the presence of a water-soluble pigment resulting from the metabolism of metronidazole. The intestine removes 6-15% of the dose of the systemic drug.

Systemic absorption of miconazole after intravaginal administration is low. It is rapidly destroyed in the liver. Poorly overcomes histohematogenous barriers. 8 hours after application of the drug, 90% of miconazole is still present in the vagina. Unchanged is not found in either plasma or urine.

Indications:

Local treatment of vaginitis of mixed etiology caused at the same time Trichomonas spp. and Candida spp.

Contraindications:

Hypersensitivity to the drug components and other azoles;

- pregnancy (I trimester);

Lactation period;

Leukopenia (including a history);

Organic lesions of the central nervous system (including epilepsy);

Liver failure;

Childhood (up to 12 years old).

Carefully:

Diabetes mellitus, microcirculation disorders.

Pregnancy and lactation:

Pregnancy

Klion-D 100 is contraindicated for use in the first trimester of pregnancy. The use of the drug in the II and III 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 necessary, use the drug, you should stop breastfeeding. During the period of breastfeeding, the use of Klion-D 100 is contraindicated.

Method of administration and dosage:

Intravaginally. 1 vaginal tablet (previously moistened with water) is injected deep into the vagina in the evening before going to bed for 10 days in combination with taking the drug inside.

Side effects:

Local reactions: itching, burning, pain, irritation of the vaginal mucosa; thick, white, mucous vaginal discharge, odorless or faintly odorless, frequent urination; a burning sensation or irritation of the penis in a sexual partner;

From the digestive system: nausea, vomiting, change in taste, metallic taste in the mouth, decreased appetite, abdominal pain of a spastic nature, diarrhea, constipation;

Allergic reactions: hives, itching of the skin, rash;

From the side of the central nervous system: headache, dizziness;

From the hematopoietic system: leukopenia or leukocytosis;

From the genitourinary system: coloration of urine in a red-brown color causes the 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 on overdose with intravaginal use of metronidazole. However, with simultaneous use with metronidazole orally, systemic effects may develop.

Symptoms of a 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.

Symptoms of a miconazole overdose not identified.

Treatment: in case of accidental ingestion of a large number of vaginal tablets Klion-D 100, if necessary, gastric lavage, the introduction of activated carbon, and hemodialysis can be performed. has no specific antidote. and its metabolites are well eliminated by hemodialysis.

If any symptoms of an overdose appear, symptomatic and supportive therapy is recommended.

Interaction:

Since the systemic absorption of miconazole is low, interactions with other medicines due to metronidazole.

Metronidazole is compatible with sulfonamides and antibiotics.

With the simultaneous use of alcohol, it causes reactions similar to disulfiram (cramping abdominal pain, nausea, vomiting, headache, skin flushing). Unacceptable joint application with disulfiram (additive effect, may cause confusion).

The drug can enhance the effect of indirect anticoagulants. Prothrombin time may increase, therefore, dose adjustment of indirect anticoagulants is necessary.

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

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

The concentration of lithium in the blood may increase during the course of treatment with metronidazole, therefore, before starting the use of Klion-D 100, it is necessary to reduce the dose of lithium or to stop taking it during treatment.

Special instructions:

The use of alcoholic beverages during the course of therapy with Klion-D 100 is strictly prohibited.

When using Klion-D 100, slight leukopenia may occur, therefore it is advisable to control the blood picture (leukocyte count) at the beginning and at the end of therapy.

Metronidazole can immobilize treponemas, resulting in a false positive TPI test (Treponema Pallidum Immobilization test or Nelson's treponemal test).

Impact on the ability to drive vehicles. Wed and fur .:

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

Release form / dosage:

Vaginal tablets, 100 mg + 100 mg.

Packaging:

10 tablets in a strip of soft aluminum foil, coated on one side and varnished on the other.

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.

Shelf life:

Do not use after the expiration date.

Terms of dispensing from pharmacies:On prescription Registration number:P N011743 / 01 Registration date:09.03.2011 Expiration date:Indefinite