Metromikon-Neo

General characteristics. Structure:

Active ingredients: 500 mg metronidazole, 100 mg of Miconazolum nitrate.

Excipients: semi-synthetic glycerides (Suppotsir AM) - enough for receiving suppository weighing 2000 mg.

Metromikon-Neo – the combined drug with antiprotozoan, antifungal and antibacterial action. Contains metronidazole and Miconazolum.

Pharmacological properties:

Pharmacodynamics. Metronidazole belongs to 5 nitroimidazoles and is drug with the bactericidal type of action showing a tropnost (ability of interaction) to deoxyribonucleic acid.

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 deoxyribonucleic acid of a cell of microorganisms, inhibiting synthesis of their nucleic acids that leads to death of bacteria.

It is active concerning protozoa: Trichomonas vaginalis, Entamoeba histolytica, and also obligate anaerobic bacteria: gram-negative - Bacteroides spp. (including Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Veillonella spp., Prevotella spp. (Prevotella bivia, Prevotella buccae, Prevotella disiens), gram-positive - Clostridium spp., Eubacterium spp., Peptococcus spp., Peptostreptococcus spp., Mobiluncus spp. and a facultative anaerobe – Gardnerella vaginalis.

To metronidazole aerobic microorganisms, but in the presence of the mixed flora are insensitive (aerobes and anaerobe bacterias) metronidazole works synergistically with antibiotics, effective against usual aerobes.

Miconazolum is the antifungal means derivative of an azol. At intravaginalny use it is active generally concerning Candida albicans. The fungicidal and fungistatic effect of Miconazolum is caused by inhibition of biosynthesis of ergosterol of a cover and plasma membranes of mushrooms, change of lipidic structure and permeability of a cell wall, causing death of a cell of a mushroom.

Pharmacokinetics. In comparison with intake bioavailability of metronidazole at intravaginalny introduction makes 20%. Metronidazole is metabolized in a liver. Hydroxylic metabolites are active. The elimination half-life of metronidazole makes 6 - 11 h.

About 20% of a dose are removed in not changed view with urine. At intravaginalny introduction Miconazolum is soaked up slightly and in plasma is not defined.

Indications to use:

Vulval infections:
• vaginal candidiasis;
• mecotic vaginitis and vulvovaginitis,
• bacterial vaginosis;
• the mixed vaginal infection.

Route of administration and doses:

Intravaginalno.
Acute vaginita, bacterial vaginosis: on 1 suppository in the morning and for the night within 7 days in a row.

Chronic vaginita: on 1 suppository of 1 times a day, just before a dream, within 14 days in a row.

Often recurrent vaginita or in the absence of positive clinical dynamics at treatment by other methods: on 1 suppository in the morning and for the night within 14 days.

Previously having exempted suppository from planimetric packaging by means of scissors (to cut a film on a suppository contour), to enter it deeply into a vagina.

Features of use:

Use at pregnancy and during breastfeeding. Purpose of drug is contraindicated in the I trimester of pregnancy. Use in II and III trimesters of pregnancy is possible only if the potential advantage for mother exceeds possible risk for a fruit.

In need of purpose of drug in the period of a lactation breastfeeding has to be stopped as metronidazole gets into breast milk. Breastfeeding can be resumed in 24-48 h after the end of treatment.

At use of drug it is necessary to abstain from sexual contacts.
For the purpose of avoidance of repeated infection simultaneous treatment of the sexual partner is necessary. In case of a mecotic vaginitis reasonablly simultaneous treatment of the sexual partner metronidazole for intake.
During treatment and, at least, during 24-48 h after the termination of a course of treatment it is necessary to avoid ethanol reception (the intolerance of ethanol is possible).

Simultaneous use of drug with contraceptive diaphragms and condoms from rubber or latex is not recommended (interaction with a basis of suppositories is possible).

At strong irritation of a vagina treatment by drug should be stopped. Suppositories should be applied only intravaginalno, they cannot be swallowed or applied in a different way.

In case of use of drug together with metronidazole for intake, especially at a repeated course, control of a picture of peripheral blood (danger of a leukopenia) is necessary.

Influence on ability to driving of motor transport and to control of potentially dangerous mechanisms: it is recommended to be careful as the possible negative impact on ability to driving of the car and control of difficult mechanisms cannot be excluded. 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: burning, itch, irritation of a mucous membrane of a vagina and strengthening of puffiness. Because of an inflammation of a mucous membrane of a vagina at a vaginitis the irritation can amplify after administration of the first suppository or by third day of treatment. These complications quickly disappear after the treatment termination.

From digestive tract: pain or spasms in a stomach, "metal" smack, dryness in a mouth, a lock, diarrhea, appetite loss, nausea, vomiting.

From a nervous system: headache, motive disturbances (ataxy), dizziness, psychoemotional disturbances, spasms.

From system of a hemopoiesis: leukopenia.

Allergic reactions: skin rashes, including urticaria.

Interaction with other medicines:

Due to the hit of metronidazole in a system blood stream can note the following reactions of interaction at simultaneous use with some substances:

Peroral anticoagulants: effect of indirect anticoagulants amplifies.

Disulfiramum: disturbances from TsNS (mental reactions) can be observed; it is not necessary to appoint metronidazole sick which accepted Disulfiramum within the last 2 weeks;

Phenytoinum: concentration of Phenytoinum in blood increases, and concentration of metronidazole in blood decreases. Lithium drugs: increase in their toxicity can be observed.

Phenobarbital: concentration of metronidazole in blood decreases.

Cimetidinum: concentration of metronidazole in blood can increase.

Astemizol and терфенадин: metronidazole and Miconazolum inhibit metabolism of these drugs and increase concentration in a blood plasma.

Ethanol: interaction of metronidazole with ethanol causes disulfiramopodobny reactions.

Contraindications:

Hypersensitivity to components of drug or other derivatives of a nitroimidazole, the I trimester of pregnancy, the lactation period, children's age up to 18 years; at virgins.

With care appoint at a liver and renal failure, a porphyria, disturbance of a hemopoiesis and diseases peripheral and the central nervous system, a diabetes mellitus, microcirculation disturbances, at pregnancy (II and III trimesters).

Overdose:

At observance of the recommended doses, in connection with low absorption of drug, cases of overdose are not revealed.

Possible symptoms: nausea, vomiting, an abdominal pain, diarrhea, an itch, metal smack in a mouth, an ataxy, dizziness, paresthesias, a peripheral neuropathy (at long use in high doses), spasms, a leukopenia, dark coloring of urine (it is caused by metronidazole overdose).

Symptoms of overdose of Miconazolum are not revealed. Treatment: a symptomatic and maintenance therapy, at accidental intake — a gastric lavage.

Storage conditions:

In the dry place protected from light at a temperature from 15 to 25 °C. To store in the place, unavailable to children. Period of validity 3 years. Not to use after expiry date!

Issue conditions:

According to the recipe

Packaging:

Suppositories the vaginal 500 mg containing metronidazole and Miconazolum nitrate of 100 mg. On 7 suppositories in a blister strip packaging from film PVH/PE. On the 2nd blister strip packagings together with the application instruction in a pack cardboard.