Klion-D 100 - instructions for use, dose, side effects, contraindications

Excipients: sodium lauryl sulfate 0.50 mg, silicon colloidal dioxide 7.00 mg, magnesium stearate 13.00 mg, povidone 26.00 mg, sodium hydrogen carbonate 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 are oval-shaped with a pointed end, almost white in color, with an engraving "100" on one side.

Pharmacotherapeutic group:Antimicrobial agent combined (antimicrobial and antiprotozoal agent + antifungal agent)

ATX: & nbsp

G.01.A.F Imidazole derivatives

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

Pharmacodynamics:

Combination drug for intravaginal use, containing metronidazole and miconazole.

Metronidazole is an antiprotozoal and antimicrobial drug, a derivative of 5-nitroimidazole. The mechanism of action is the biochemical reduction of the 5-nitro group of metronidazole by intracellular transport proteins of anaerobic microorganisms and protozoa. The restored 5-nitro group of metronidazole interacts with the DNA of a cell of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria and protozoa.

Active in a relationship Trichomonas vaginalis, Entamoeba histolytica, Gardnerella vaginalis, Giardia lamblia, as well as obligate anaerobes Bacteroides spp. (incl. Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Veillonella spp., 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.

Metronidazole is insensitive to aerobic microorganisms and facultative anaerobes, but in the presence of mixed flora (aerobes and anaerobes) metronidazole acts synergistically with antibiotics effective against aerobes.

Miconazole is an effective antimycotic agent that exerts its effect primarily on dermatophytes and yeast fungi.

With intravaginal application active mainly in relation to 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 not changes the composition of normal microflora and pH of the vagina.

Pharmacokinetics:

With intravaginal application metronidazole 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 (in 1-3 hours) after a single dose of equivalent dose of metronidazole inside. Metronidazole 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%. Metabolized in the liver by hydroxylation, oxidation and glucuronation. The activity of the main metabolite (2-hydroxymethonidazole) is 30% of the activity of the parent compound. It is excreted by the kidneys - 60-80% of the dose of the systemic action drug (20% of this quantity in unchanged form). Metronidazole Metabolite, 2-oximetronidazole, stains urine in a reddish-brown color, due to the presence of a water-soluble pigment formed as a result of metronidazole metabolism. The intestine displays 6-15% of the dose of the systemic drug.

Systemic absorption of miconazole after intravaginal application is low. Rapidly destroyed in the liver. Histohematetic barriers overcome badly. In 8 hours after application of the preparation, 90% of miconazole is still present in the vagina. Unchanged miconazole is not found either in plasma or in urine.

Indications:

Local treatment of mixed etiologies of vaginitis caused simultaneously Trichomonas spp. and Candida spp.

Contraindications:

- Increased individual sensitivity to the components of the drug and other azoles;

- pregnancy (I trimester);

- lactation period;

- leukopenia (including in the anamnesis);

- organic lesions of the central nervous system (including epilepsy);

- liver failure;

- children's age (up to 12 years).

Carefully:

Diabetes mellitus, disorders of microcirculation.

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 exceeds the risk to the fetus.

Lactation period

Klion-D 100 penetrates into breast milk. If you need to use the drug, you should stop breastfeeding. During the period of breast-feeding, the use of Clion-D 100 is contraindicated.

Dosing and Administration:

Intravaginal. One vaginal tablet (previously moistened with water) is injected deep into the vagina in the evening before going to bed for 10 days in conjunction with taking the drug metronidazole inside.

Side effects:

Local Reactions: itching, burning, pain, irritation of the vaginal mucosa; thick, white, mucous discharge from the vagina without smell or with a faint odor, frequent urination; sensation of burning or irritation of the penis in the sexual partner;

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

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

From the central nervous system: headache, dizziness;

From the hematopoietic system: leukopenia or leukocytosis;

From the genitourinary system: the staining of urine in red-brown color causes metronidazole metabolite - 2-oximetronidazole, due to the presence of a water-soluble pigment formed as a result of metronidazole metabolism.

Overdose:

Data on overdose with intravaginal application of metronidazole are not available. However, with simultaneous use with metronidazole inside, systemic effects can develop.

Symptoms of an overdose of metronidazole: nausea, vomiting, abdominal pain, diarrhea, generalized itching, metallic taste in the mouth, motor disorders (ataxia), dizziness, paresthesia, convulsions, peripheral neuropathy, leukopenia, darkening of urine.

Symptoms of an overdose of miconazole not identified.

Treatment: with the occasional ingestion of a large number of vaginal Clion-D 100 tablets, if necessary, gastric lavage, the introduction of activated carbon, and hemodialysis may be performed. Metronidazole does not have a specific antidote. Metronidazole and its metabolites are well eliminated in hemodialysis.

When any symptoms of an overdose occur, symptomatic and supportive therapy is recommended.

Interaction:

Since systemic absorption of miconazole is low, interaction with other drugs is caused by metronidazole.

Metronidazole is compatible with sulfonamides and antibiotics.

With the simultaneous use of alcohol causes reactions like disulfiram (cramping pain in the abdomen, nausea, vomiting, headache, skin hyperemia). It is inadmissible to use together with disulfiram (additive effect, can cause confusion).

The drug may increase the effect of indirect anticoagulants. Prothrombin time can increase, so correction of the dose of indirect anticoagulants is necessary.

It is not recommended to combine with nondepolarizing muscle relaxants (vecuronium bromide).

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

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

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

Special instructions:

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

During the treatment with Clion-D 100 it is recommended to abstain from sexual intercourse. Simultaneous treatment of sexual partners is recommended.

When applying Clion-D 100, minor leukopenia can be observed, so it is advisable to monitor the blood picture (the number of white blood cells) at the beginning and at the end of therapy.

Metronidazole can immobilize treponema, which leads to a false positive TPI test (Treponema Pallidum Immobilization test or Nelson's treponemal test).

Effect on the ability to drive transp. cf. and fur:

When there are side effects from the central nervous system, one should refrain from managing motor vehicles and working with potentially dangerous mechanisms.

Form release / dosage:

Tablets are vaginal, 100 mg + 100 mg.

Packaging:

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

1 strip with instructions for use in a cardboard box.

Storage conditions:

Store at a temperature of 15-30 ° C, in a place protected from light and moisture.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N011743 / 01

Date of registration:09.03.2011

Expiration Date:Unlimited

The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary

Manufacturer: & nbsp

GEDEON RICHTER, Ltd. Hungary

Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary

Information update date: & nbsp29.01.2018

Illustrated instructions

Instructions

Klion-D 100 (Klion-D 100)