Klionum D 100

General characteristics. Structure:

Active agents: metronidazole - 100 mg and Miconazolum nitrate - 100 mg

Excipients: sodium lauryl sulfate - 0,50 mg, silicon dioxide colloid - 7,00 mg, magnesium stearate - 13,00 mg, povidone - 26,00 mg, Natrii hydrocarbonas - 90,00 mg, tartaric acid - 100,00 mg, carboxymethylstarch of sodium (type A) - 100,00 mg, кросповидон - 100,00 mg, a gipromelloza - 190,00 mg, lactoses monohydrate - 473,50 mg.

Pharmacological properties:

Pharmacodynamics. The combined drug for intravaginalny use containing metronidazole and Miconazolum. Metronidazole - antiprotozoan and antimicrobic drug, derivative 5 nitroimidazoles. The mechanism of action consists in biochemical recovery 5 nitrogroups of metronidazole intracellular transport proteins of anaerobic microorganisms and protozoa. The recovered 5 nitrogroup of metronidazole interacts with DNA of a cell of microorganisms, inhibiting synthesis of their nucleic acids that leads to death of bacteria and protozoa. Entamoeba histolytica, Gardnerella vaginalis, Giardia lamblia, and also strict anaerobes of Bacteroides spp is active concerning Trichomonas vaginalis. (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.). MPK for these strains makes 0.125-6.25¼¬ú/ml.
To metronidazole aerobic microorganisms and facultative anaerobes, but in the presence of the mixed flora are insensitive (aerobes and anaerobe bacterias) metronidazole works synergy with antibiotics, effective against aerobes.
Miconazolum is effective anti-mycotic remedy which has the effect, first of all on dermatophytes and barmy mushrooms. At intravaginalny use it is active generally concerning Candida albicans. Miconazolum suppresses biosynthesis of ergosterol in mushrooms and changes structure of other lipidic components in a membrane that leads to death of fungal cells. Miconazolum does not change, structure of normal microflora and pH of a vagina.

Pharmacokinetics. At intravaginalny use metronidazole is absorbed in a system blood stream. The maximum concentration of metronidazole in blood is defined in 6 - 12 hours and makes about 50% of that maximum concentration which is reached (in 1-3 hours) after a single dose of an equivalent dose of metronidazole inside. Metronidazole gets into breast milk and the majority of fabrics, passes through a blood-brain barrier and a placenta. Communication with proteins of plasma - less than 20%. It is metabolized in a liver by a hydroxylation, oxidation and a glyukuronirovaniye. Activity of the main metabolite (2 oxymetronidazole) makes 30% of activity of initial connection.
It is removed by kidneys - 60-80% of a dose of drug of systemic action (20% of this quantity in not changed look). The metronidazole metabolite, 2 oxymetronidazole, paints urine in red-brown color, owing to presence of the water-soluble pigment which is formed as a result of metronidazole metabolism. By intestines it is removed - 6-15% of a dose of drug of systemic action.
System absorption of Miconazolum after intravaginalny use low.
Quickly collapses in a liver. Breaks Gistogematichesky barriers badly.
In 8 hours after use of drug of 90% of Miconazolum still is present at a vagina. Not changed Miconazolum is not found neither in plasma, nor in urine.

Indications to use:

Topical treatment of vaginit of the mixed etiology, Trichomonas spp caused at the same time. and Candida spp.

Route of administration and doses:

Intravaginalno. On 1 vaginal tablet (previously having moistened with water) enter deeply into a vagina in the evening before going to bed within 10 days in combination with administration of drug metronidazole inside.

Features of use:

The use of alcoholic drinks during a course of therapy Klionom-D 100 is strictly forbidden. During treatment of Klionom-D 100 it is recommended to abstain from sexual contacts. Simultaneous treatment of sexual partners is recommended.
At use of Kliona-D 100 the insignificant leukopenia therefore it is reasonable to control a blood pattern (quantity of leukocytes) at the beginning and at the end of therapy can be observed.
Metronidazole can immobilizovyvat treponemas that leads to the false positive TPI test (Treponema Pallidum Immobilization test or the treponemny test of Nelson).

Influence on ability to drive the car and other mechanical means.
At emergence of side effects from the central nervous system it is necessary to refrain from control of motor transport and work with potentially dangerous mechanisms.

Side effects:

Local reactions: itch, burning, pain, irritation of a mucous membrane of a vagina; dense, white, mucous allocations from an inodorous vagina or with a slight smell, the speeded-up urination; a burning sensation or irritation of a penis at the sexual partner;
- From the alimentary system: nausea, vomiting, change of flavoring feelings, metal smack in a mouth, a loss of appetite, abdominal pain of spastic character, diarrhea, a lock;
Allergic reactions: urticaria, itch of integuments, rash;
- From the central nervous system: headache, dizziness;
- From the hemopoietic system: leukopenia or leukocytosis;
- From urinogenital system: coloring of urine in red-brown color causes a metronidazole metabolite - 2 oxymetronidazole, owing to presence of the water-soluble pigment which is formed as a result of metronidazole metabolism.

Interaction with other medicines:

As system absorption of Miconazolum low, interaction with other medicines is caused by metronidazole.
Metronidazole is compatible to streptocides and antibiotics. At simultaneous alcohol intake causes reactions, similar to Disulfiramum (colicy pains in a stomach, nausea, vomiting, a headache, a dermahemia).
Unacceptably combined use with Disulfiramum (the additive action, can cause confusion of consciousness).

Drug can strengthen effect of indirect anticoagulants. The prothrombin time can increase therefore dose adjustment of indirect anticoagulants is necessary. It is not recommended to combine with not depolarizing muscle relaxants (a vekuroniya bromide). Inductors of enzymes of a microsomal oxidation in a liver (for example, Phenytoinum, phenobarbital) can accelerate metronidazole elimination that will lead to decrease in its concentration in a blood plasma.
Cimetidinum suppresses metronidazole metabolism that can lead to increase in its concentration in blood serum and to increase in risk of development, by-effects.
Concentration of lithium in blood can increase during a course of treatment metronidazole therefore before use of Kliona-D 100 it is necessary to lower a dose of lithium or to stop its reception for the period of treatment.

Contraindications:

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

With CARE Diabetes mellitus, microcirculation disturbances. USE AT PREGNANCY And in the period of the Beremennost Klion-D LACTATION 100 it is contraindicated to use in the I trimester of pregnancy. Use of drug in II and III trimesters is possible only when the potential advantage for mother exceeds risk for a fruit. The period of a lactation of Klion-D 100 gets into breast milk. In need of drug use, it is necessary to stop breastfeeding. During breastfeeding use of Kliona-D 100 is contraindicated.

Overdose:

The overdoses given relatively at intravaginalny use of metronidazole are absent. However at simultaneous use with metronidazole system effects inside can develop.
Metronidazole overdose symptoms: nausea, vomiting, an abdominal pain, diarrhea, a generalized itch, metal smack in a mouth, motive disturbances (ataxy), dizziness, paresthesias, spasms, a peripheral neuropathy, leukopenia, urine darkening.
Symptoms of overdose of Miconazolum are not revealed.
Treatment: at accidental intake of a large number of tablets of vaginal Kliona-D 100 if necessary the gastric lavage, administration of absorbent carbon, carrying out a hemodialysis can be made. Metronidazole has no specific antidote. Metronidazole and its metabolites eliminirutsya well at a hemodialysis.
At emergence of any symptoms of overdose the symptomatic and maintenance therapy is recommended.

Storage conditions:

To store at a temperature of 15-30 °C in the place protected from light and moisture.
To store in the place, unavailable to children!

Issue conditions:

According to the recipe

Packaging:

Tablets are vaginal, 100 mg +100 mg.
10 tablets in a strip from soft aluminum foil with a covering on one party and with the varnished covering on other party. 1 strip with the application instruction in a cardboard pack.