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Manufacturers: Gedeon Richter (Hungary)
Active ingredients
- Miconazole
- Metronidazole
Disease class
- Trichomoniasis
- Candidiasis
- Other inflammatory diseases of the vagina and vulva
Clinical and pharmacological group
- Not indicated. See instructions
Pharmacological action
- Antifungal
- Antiprotozoal
- Antibacterial
Pharmacological group
- Antifungal agents in combinations
- Other synthetic antibacterial agents in combinations
Pharmacological properties of the drug Klion-d 100
Combined drug for intravaginal use for infections caused by Trichomonas vaginalis and/or pathogenic fungi. The active ingredients of the drug are metronidazole (1-(β-hydroxyethyl)-2-methyl-5-nitroimidazole) and miconazole (1-[2,4-dichloro-β-((2,4-dichlorobenzyl)oxy)-phenethyl]- imidazole). Metronidazole has antiprotozoal and antibacterial effects. Active against Trichomonas vaginalis , Entamoeba histolytica , obligate anaerobes, including anaerobic gram-negative bacilli ( Bacteroides spp. Bacteroides fragilis group , Fusobacterium spp. ), anaerobic gram-positive bacilli ( Clostridium spp. and sensitive strains of Eubacterium ), anaerobic gram-positive cocci cove ( including Peptococcus spp. and Peptostreptococcus spp. ). Metronidazole penetrates into microorganisms, where its nitro group is converted into hydroxylamine, which enhances the effect of the drug on the DNA of microorganisms, leading to their death. Miconazole nitrate has an antifungal (fungicidal) effect. Active (when used intravaginally) mainly against Candida albicans . When administered intravaginally, metronidazole is absorbed and enters the systemic circulation, the maximum concentration in the blood plasma is observed after 6-8 hours. It is about 50% of the maximum concentration achieved 1-3 hours after a single oral dose of the same dose. When administered intravaginally, miconazole is absorbed and enters the systemic circulation in small quantities.
Klion-D tablets 100 mg No. 10
Indications
Local treatment of vaginitis of mixed etiology caused simultaneously by Trichomonas spp. and Candida spp.
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.
special instructions
During the period of use of the drug, you should not drink alcohol (risk of developing disulfiram-like reactions).
During the period of use of the drug, it is recommended to abstain from sexual intercourse. Simultaneous treatment of sexual partners is recommended.
Metronidazole can immobilize treponemes, resulting in a false-positive TPI test (Nelson test).
Control of laboratory parameters
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.
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.
Compound
| 1 tab. | |
| metronidazole/td> | 100 mg |
| miconazole nitrate | 100 mg |
Excipients: sodium lauryl sulfate - 0.5 mg, colloidal silicon dioxide - 7 mg, magnesium stearate - 13 mg, povidone - 26 mg, sodium bicarbonate - 90 mg, tartaric acid - 100 mg, sodium carboxymethyl starch (type A) - 100 mg, crospovidone - 100 mg, hypromellose - 190 mg, lactose monohydrate - 473.5 mg.
Contraindications
- leukopenia (including history);
- organic lesions of the central nervous system (including epilepsy);
- liver failure;
- pregnancy (first trimester);
- lactation period (breastfeeding);
- children under 12 years of age;
- hypersensitivity to the components of the drug;
- hypersensitivity to other azoles.
- The drug should be prescribed with caution for diabetes mellitus and microcirculation disorders.
Use during pregnancy and breastfeeding
The drug is contraindicated for use in the first trimester of pregnancy and during breastfeeding.
Side effects
Local reactions: burning, itching, pain and irritation of the vaginal mucosa;
thick, white, mucous vaginal discharge with little or no odor; burning sensation or irritation of the partner's penis. From the digestive system: nausea, vomiting, changes in taste, metallic taste in the mouth, decreased appetite, spastic abdominal pain, constipation or diarrhea.
From the side of the central nervous system: headache, dizziness.
From the hematopoietic system: leukopenia or leukocytosis.
Allergic reactions: urticaria, itching of the skin, rash.
From the urinary system: urine is colored red-brown due to the presence of a water-soluble pigment (metronidazole metabolite - 2 oxymetronidazole), formed as a result of the metabolism of metronidazole.
Overdose
data regarding overdose with intravaginal use of metronidazole vaginal tablets .
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, dark urine.
No symptoms of miconazole overdose have been identified.
Storage conditions
The drug should be stored in a place protected from light and moisture at a temperature of 15° to 30°C.
Best before date
5 years.
pharmachologic effect
Klion-D 100 is a combined drug with antibacterial, antiprotozoal and antifungal effects for intravaginal use.
Metronidazole, a derivative of nitro-5-imidazole. The mechanism of its action is 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 with a broad spectrum of action.
Active against: Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica, Lamblia intestinalis, Obligate anaerobes (spore-forming and non-spore-forming): Bacteroides spp, Bacteroides fragilis, Bacteroides ovatus, Bacteroides distasonis, Bacteroides thetaiotaomicron, Bacteroides vulgatus, Fusobacterium sp p, Clostridium spp, Peptostreptococcus spp.
Facultative anaerobes and obligate aerobes are resistant to metronidazole.
Miconazole has an antifungal effect against dermatophytes, yeasts, and also an 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 the itching that often accompanies infections caused by yeasts and dermatophytes. Does not change the composition of the microflora and pH of the vagina.
Drug interactions
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 can enhance the effect of indirect anticoagulants. Prothrombin time may increase, so dose adjustment of indirect anticoagulants is necessary.
It is not recommended to combine the drug 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 leads to a decrease in its concentration in the blood plasma.
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.
It is possible to increase the concentration of lithium in the blood plasma 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.
Use of the drug Klion-d 100
Locally, for vaginitis caused by Trichomonas vaginalis , 1 tablet of the drug, moistened with water, is injected deep into the vagina once a day, in the evening before bed. The course of treatment is 10 days. At the same time, metronidazole is prescribed for oral administration (1 tablet during or immediately after meals, 2 times a day in the morning and evening). It is advisable to simultaneously treat the sexual partner with metronidazole (orally). If the effectiveness is insufficient, local treatment is continued for another 10 days. For candidal vaginitis, 1 tablet of the drug, moistened with water, is injected deep into the vagina once a day, in the evening before bed. The course of treatment is 10 days.
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** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before starting to use the drug Klion-D 100, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.
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** Attention! The information presented in this medication guide is intended for medical professionals and should not be used as a basis for self-medication. The description of the drug Klion-D 100 is provided for informational purposes and is not intended for prescribing treatment without the participation of a doctor. Patients need to consult a specialist!
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Analogs
Level 4 ATX code matches:
Gainomax
Sertaconazole
Ornisis
Metrogil Plus
Livarol
Flagyl
Ginofort
Zalain
Ketoconazole
Candide B6
Candide
Gyno-Travogen Ovulum
Kanizon
Metromicon-Neo
Lomexin
Neo-Penotran
Gyno-Pevaril
Ginesol
Antifungol
Analogs of suppositories are: Metromicon-Neo, Ginalgin, Clomezol, Neo-Penotran Forte, Clevazol, Pulsitex, Candibene, Ketodin, Candide, Ketonazole, Livarol, Metronidazole, Clotrimazole, Trichopolum, Econazole.
What is the difference between Klion and Klion-D 100?
Klion tablets contain metronidazole and have a wider range of applications. Usually, to combat trichomoniasis, oral intake of tablets alone is not enough, for which Klion-D 100 suppositories are prescribed.
Interaction
The medicine is not combined with ethanol, disulfiram , non-depolarizing muscle relaxants, cimetidine, and lithium preparations .
When taking indirect anticoagulants , it is worth additionally monitoring the prothrombin index .
The effectiveness of metronidazole is reduced when combined with phenobarbital and phenytoin .
Pharmacodynamics and pharmacokinetics
The effect of the drug is due to the complex effect on the vaginal microflora of its constituent components.
Miconazole is an antifungal agent that destroys dermatophytes and yeasts , but does not disturb the pH or destroy healthy microflora in the vagina. The substance directly affects the synthesis of lipid components in the fungal membrane, thereby destroying it. It does not penetrate into the blood and is not found in the kidneys and products of the excretory organs; 90% remains in the vagina. The maximum concentration is after 8 hours.
Metronidazole is an antibiotic . It inhibits the process of RNA and DNA of destructive bacteria by restoring the 5-nitro group by transport proteins inside the cell. After entering the vagina, it penetrates into the blood. Its maximum concentration in the blood (half of the administered dose) can be detected after 9 hours.
