Klion-D 100: instructions for using the medicine, structure, Contraindications

Active material: Metronidazol, Mikonazol
When ATH: G01AF20
CCF: With antibacterial drug, antiprotozoal and antifungal action for local application in gynecology
ICD-10 codes (testimony): A59, B37.3, N76
When CSF: 07.01.03
Manufacturer: GEDEON RICHTER Ltd. (Hungary)

Klion-D 100: dosage form, composition and packaging

Vaginal Tablets nearly white, Oval, lenticular, with a tip, Engraved “100” on one side.

Excipients: sodium lauryl, colloidal silicon dioxide, magnesium stearate, povidone, natriya carbonate, tartaric acid, sodium carboxymethyl starch type A, krospovydon, gipromelloza, lactose monohydrate.

10 PC. – aluminum strips (1) – packs cardboard.

Klion-D 100: pharmachologic effect

Combined with an antibacterial drug, antiprotozoal and antifungal for vaginal application.

Metronidazol, proizvodnoe nitro-5-imidazole. Its mechanism of action consists in biochemical restoration of 5-nitro intracellular transport proteins of anaerobic microorganisms and protozoa. The recovered 5-nitro group of metronidazole is reacted with the cellular DNA of microorganisms, inhibiting the synthesis of nucleic acids, that leads to the death of microorganisms. Metronidazole is an effective antimicrobial and antiprotozoal agent broad spectrum.

It is active against Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica, Intestinal inflammation, as well as against obligate anaerobes (slowly- and nesporoobrazuющih) – Bacteroides spp. (Bacteroides fragilis, Bacteroides ovatus, Bacteroides distasonis, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Clostridium spp., Peptostreptococcus spp., sensitive strains Eubacterium.

Metronidazole resistant facultative anaerobes and obligate aerobes.

Miconazole has antifungal activity against dermatophytes, yeasts, as well as antibacterial activity against certain Gram-positive bacteria. Miconazole inhibits the biosynthesis of ergosterol and alters the composition of the other components in the lipid membrane, that leads to necrosis of fungal cells. Miconazole eliminates itching, often accompanied by infection, caused by yeasts and dermatophytes. It does not change the composition of the microflora and vaginal pH.

Klion-D 100: pharmacokinetics

Absorption

When intravaginal application of metronidazole undergoes systemic absorption. C_max in the blood is determined by 6-12 h and is about after intravaginal application 50% C of it_max, which is achieved through 1-3 h after a single dose equivalent dose of metronidazole inside.

In intravaginalynom primenenii miconazole nitrate absorbiruetsya neznachitelyno. Through 8 h after intravaginal application 90% Miconazole is still present in the vagina. Unchanged miconazole is not found either in plasma, audio in urine.

Klion-D 100: testimony

• local treatment of trichomonas, Candida vaginitis and nonspecific.

Klion-D 100: dosing regimen

At trihomonadnom vaginas appoint 1 vaginal tablet 1 times / day for 10 days in combination with taking into metronidazole.

At nonspecific vaginitis, or Candida vaginitis appoint 1 vaginal tablet 2 times / day for 10 days, if necessary – in combination with taking into metronidazole.

Terms of use of the drug

Pre-relieving pill for contouring package, should moisten it boiled and cooled water to enter deep into the vagina.

Klion-D 100: side effects

Local reactions: burning, itch, pain and irritation of the vaginal mucosa; thick, white, mucous discharge from the vagina, odorless or with a faint odor; burning sensation or irritation of the penis in the partner.

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

CNS: headache, dizziness.

From the hematopoietic system: leukopenia, leukocytosis.

Allergic reactions: hives, itchy skin, rash.

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

Klion-D 100: Contraindications

• blood disease;
• leukopenia (incl. history);
• dystaxia;
• organic CNS (incl. epilepsy);
• hepatic failure (when administering the drug at high doses);
• pregnancy;
• lactation (breast-feeding);
• hypersensitivity to metronidazole, miconazole or other nitroimidazole derivatives.

FROM caution should be prescribed for patients with diabetes, microcirculation disorders.

Klion-D 100: Pregnancy and lactation

Klion-D 100 contraindicated during pregnancy and lactation.

Klion-D 100: Special instructions

During the period of the drug is recommended to abstain from sexual intercourse.

It is advisable the simultaneous treatment of sexual partners for oral metronidazole, regardless of Togo, if they have any symptoms of the disease.

Metronidazol moƶet immoʙilizovatь treponemы, which leads to false positive test TPI (Nelson test).

During the period of use of the drug should not drink alcohol (the risk of developing reactions disulfiramopodobnyh).

Monitoring of laboratory parameters

When specifying a history of changes in the peripheral blood, as well as the use of the drug in high doses and / or long-term necessary to monitor patterns of peripheral blood.

Effects on ability to drive vehicles and management mechanisms

Patients should pay attention to the possibility of dizziness during treatment with Cliona-D 100, which may impair the ability to perform work, requiring greater attention.

Klion-D 100: overdose

Data on drug overdose Klion-D 100 not provided.

Klion-D 100: drug interaction

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

With simultaneous use of metronidazole and ethanol (or ethanol-containing drugs) development disulfiramopodobnyh reactions.

While the use of warfarin and other indirect anticoagulants metronidazole reinforces their action, which leads to an increase in the prothrombin time.

Under the influence of barbiturates may reduce the effect of metronidazole, tk. It is accelerating its metabolism in the liver.

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

In an application Cliona-D 100 with lithium may increase the plasma concentration of the latter.

Klion-D 100: terms of dispensing from pharmacies

The drug is released under the prescription.

Klion-D 100: terms and conditions of storage

List B. The drug should be stored away from light and moisture, inaccessible to children at temperature from 15 ° to 30 ° C. Shelf life – 5 years.