Klion-D 100 tab. vaginal. No. 10

Pharmacological properties

Pharmacodynamics. metronidazole — antimecotic means for topical and system administration. Miconazolum nitrate is effective anti-mycotic means which influences first of all dermatophytes and mushrooms of a sort Candida, besides, possesses the expressed bacteriostatic action against separate gram-positive cocci and bacteria at local therapy.

Combined medicine is shown to

for intravaginalny application at the infections caused by trichomonads and for prevention of mycoses of a vagina which often develop after use of metronidazole.

can use Drug at primary mycosis of a vagina.

Pharmacokinetics. At intravaginalny application metronidazole and Miconazolum nitrate are soaked up in insignificant quantity. According to researches, metronidazole level in blood plasma is 0.2 mkg/ml, nitrate Miconazolum level — 0.3 mkg/ml.

Metronidazole at oral administration is usually well soaked up by

and reaches the C _max in blood plasma through 2–3 h. At single oral administration in a dose of 250 mg the C _max in blood plasma of 5 mkg/ml is reached that is defined by method of gas chromatography. The bioavailability at oral administration is 100%. Has the large volume of distribution and to 20% contacts proteins of blood plasma. Metronidazole gets into bile and reaches the same concentration, as well as in blood plasma.

T _½ from an organism of healthy volunteers is averaged by 8 h. Metronidazole and its metabolites are emitted for 60–80% with kidneys, through intestines is removed by from 6 to 15% of a dose.

Indication

Topical treatment at women at the vaginal infections caused by trichomonads and/or mushrooms.

Use

In trichomoniasis within 10 days of 1 times a day (in the evening before going to bed) to enter deeply into a vagina 1 vaginal tablet moistened with water Klionum-d 100. at the same time within 10 days to appoint metronidazole tablets on 1 tablet (250 mg) 2 times a day (in the morning and in the evening) inside in time or right after food. to swallow of tablets entirely, without chewing.

treatment of the sexual partner by metronidazole tablets for intake is reasonable to carry out

at the same time.

If necessary a course of treatment can be repeated.

1 vaginal tablet Klion-D 100 moistened with water to enter

In a candidosis vulvovaginitis deeply into a vagina within 10 days of 1 times a day (in the evening before going to bed).

Contraindication

Hypersensitivity to acting or to any excipients of medicine. і pregnancy trimester, feeding period breast. hypersensitivity to imidazole derivatives. it is not recommended to apply in combination with Disulfiramum or alcohol (see interactions).

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Side effects

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It was reported about irritation of a mucous membrane of a vagina and sensation of discomfort in the place of application and hypersensitivity reaction.

Side reactions connected with metronidazole

At simultaneous application with metronidazole inside can arise the following side reactions:

an infection and invasion: fungal superinfection (for example candidiasis).

from blood and lymphatic system: agranulocytosis, neutropenia, thrombocytopenia, pancytopenia, leukopenia.

from the immune system: angioedema, acute anaphylaxis.

from food and a metabolism: loss of appetite.

Mental violations: hallucinations, confusion of consciousness, suppressed mood.

from central nervous system: a headache, spasms, drowsiness, dizziness, encephalopathy (for example confusion of consciousness, fervescence, hypersensitivity to light, a wryneck, hallucinations, paralysis, disorders of vision and movements) and a subacute cerebellar syndrome (for example an ataxy (lack of coordination), a dysarthtia, violation of gait, a nystagmus, a tremor which can pass after the termination of administration of drug; aseptic meningitis, violations of taste (metal smack in a mouth).

during intensive and/or long care by metronidazole peripheral touch neuropathy (hypesthesia) can arise.

from an organ of sight: temporary disorders of vision, such as diplopia and shortsightedness, vague image, decrease in visual acuity, changes in perception of flowers, optical neuropathy / neuritis.

from digestive system: pain in epigastric area, nausea, vomiting, intestinal colic, diarrhea, inflammation of a mucous membrane of an oral cavity, a glossitis with dryness in a mouth, stomatitis, anorexia, a coated tongue; pancreatitis which have reversible character at medicament withdrawal.

from a gepatobiliarny system: increase in activity of liver enzymes (AsAT, AlAT, SF), the cholestatic or mixed hepatitis, hepatocellular injuries of a liver, jaundice. The cases of a liver failure demanding transplantation of a liver from patients who were treated by metronidazole in combination with antibiotics.

from skin and hypodermic cellulose: inflows with hyperaemia, a skin itch, rash, a small tortoiseshell, isolated cases of pustulous rash and a polymorphic erythema.

Laboratory indicators: urine darkening (causes a metronidazole metabolite, has no clinical value).

from the musculoskeletal system and connective tissue: myalgia, arthralgia.

System violations and violations in the injection site: irritation in the injection site, a pyrexia.

Side reactions connected with Miconazolum: reactions of hypersensitivity, including a Quincke's disease; acute anaphylaxis.

Special instructions

Metronidazole should be applied on an extent of no more than 10 days and 2 or 3 times a year are not more often.

during treatment and within not less than 1 day after completion of treatment is forbidden to take alcoholic beverages and it is recommended to refrain from sexual contacts.

is recommended to carry out by

in the absence of satisfactory effect system antitrikhomonidazny or antifungal therapy.

possibility of a persistirovaniye of a gonococcal infection after elimination of a mecotic infection Exists.

metronidazole and its metabolites are removed by

At patients to whom carry out a hemodialysis during 8 h carrying out a hemodialysis therefore metronidazole needs to be accepted at once after carrying out a hemodialysis.

should not change

a dose at patients with a renal failure by which carry out peritoneal dialysis.

needs to use Drug with care at patients with hepatic encephalopathy. At persons with hepatic encephalopathy the daily dose needs to be lowered on ¹ / ₃ and it is possible to apply 1 time a day.

in case of local hypersensitivity of a mucous membrane of a vagina treatment should be stopped.

Prolonged use of medicine demands control of a blood count. If at the patient the leukopenia develops, it is important to compare carefully expected advantage of continuation of treatment with possible risk. It is necessary to remember risk of deterioration in the neurologic status of patients with a serious, chronic or acute neurologic illness at treatment by metronidazole.

to Patients with the permanent or progressing neuropathy should appoint metronidazole by

very carefully.

needs to stop treatment at emergence of an ataxy, dizziness, hallucinations and at deterioration in the neurologic status of the patient.

Metronidazole is capable to record treponemas that results in false positive test result of Nelson.

to Apply

with care at patients with diabetes with microcirculation violation.

Use during pregnancy and feeding by a breast. In the I trimester of pregnancy it is contraindicated to use drug.

Metronidazole gets through a placental barrier and quickly gets to a fruit blood-groove.

Researches with participation of pregnant women were not conducted by

.

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On the basis of the carried-out metaanalysis of researches at introduction of metronidazole to the I trimester of pregnancy drew a conclusion that increase in negative influence on a fruit was not noted. But despite this, it is possible to appoint metronidazole in the II-III trimester of pregnancy only after careful assessment of the expected advantages and negative consequences of use of medicine.

Feeding by a breast. At oral administration, metronidazole gets into breast milk in the concentration equal to its concentration in blood plasma. It can give to breast milk bitter smack. To avoid negative impact of medicine on the child, it is necessary to stop feeding by a breast for treatment and after the therapy termination — on 1–2 days

Children. This dosage form is intended for application for adults.

Ability to influence speed of response at control of vehicles or work with other mechanisms. Vaginal tablets Klion-D 100 do not influence control of vehicles or work with mechanisms, but at a concomitant use with metronidazole inside patients have to know about potentiality of developing of dizziness, hallucinations, spasms which can influence control of vehicles or work with mechanisms.

Interaction

do not have data on interaction at vaginal use of metronidazole and Miconazolum of nitrate with other medicines.

At simultaneous application of the vaginal tablet containing metronidazole and Miconazolum nitrate with oral metronidazole can arise:

• strengthening of effect of oral anticoagulating medicines. The risk of hemorrhagic complications because of delay of their metabolism in a liver increases. It is necessary to carry out observation of levels of the international normalized relation (INR). Dose adjustment of oral anticoagulant is recommended during intake of metronidazole and within 8 days after its cancellation;
• change of MNO at the patients receiving antibacterial therapy; registered numerous cases of strengthening of activity of oral anticoagulants. At the same time presence of an infection or the expressed inflammation, age of the patient and the general state of his health act as the risk factors causing tendency to such complication. In these circumstances it is difficult to define in what measure violation of balance of MNO is influenced by an infection or its treatment. However some classes of antibiotics play at the same time an important role, in particular ftorkhinolona, macroleads, tsiklina, trimoksazol and some cephalosporins:
• inductors of enzymes (for example Phenytoinum, phenobarbital) can accelerate metronidazole removal that will lead to decrease in its level in blood plasma with simultaneous increase in clearance of Phenytoinum;
• inhibitors of enzymes (for example Cimetidinum) can increase T _½ , reduce clearance of metronidazole;
• simultaneous consumption of alcoholic beverages causes the side reactions similar to Disulfiramum (spasmodic abdominal pain, nausea, vomiting, a headache, erubescence);
• lities: it is necessary to control concentration in blood plasma of lithium, creatinine and electrolytes at the patients accepting lithium and metronidazole at the same time;
• contraindicated simultaneous application with Disulfiramum (it was reported about cases of sharp tranzitorny frustration with nonsense and also about additive action which can cause additive effect, psychotic states, confusion of consciousness);
simultaneous introduction of cyclosporine with metronidazole can lead
• to increase in level of cyclosporine in blood plasma that demands laboratory control (determination of level of cyclosporine in blood plasma);
• metronidazole reduces clearance of a fluorouratsil in this connection its toxicity increases;
• busulfan: metronidazole can increase levels of a busulfan in blood plasma that can lead to considerable toxic action of a busulfan;
• metronidazole can affect results of researches of biochemical indicators of blood plasma, such as AsAT, AlAT, LDG, glyukozo-hexokinase and TG levels.

At system application Miconazolum inhibits CYP P450 cytochrome 3A4/2C9 and metabolism of medicines which are metabolized by means of these enzymes oppresses. Due to the limited system availability clinically significant interactions are rare. However medicament should be used with care along with oral anticoagulants (for example warfarin) and to control anticoagulating effect.

At the combined use of Miconazolum with hypoglycemic means — derivatives of urea or Phenytoinum — strengthening of action of the last is possible.

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does not recommend simultaneous use of medicine with other topical forms of medicines.

Overdose Drug is intended to

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only for vaginal application. at accidental reception in a high dose the gastric lavage is inside shown.

to carry out by

At emergence of symptoms of overdose (leukopenia, neuropathy, nausea, vomiting, an ataxy and an easy disorientation) only symptomatic therapy (gastric lavage, intake of activated carbon, carrying out a hemodialysis) as metronidazole has no specific antidote. Metronidazole and its metabolites eliminirutsya well by means of a hemodialysis.

Storage conditions

At a temperature not above 30 °C in original packing for protection against influence of light and moisture.