Metromikon-Neo - instructions for use, dose, side effects, contraindications

Active substanceMetronidazole + MiconazoleMetronidazole + Miconazole

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Dosage form: & nbspFROMvaginal suppositories.

Composition:

One suppository contains:

active substances: metronidazole 500 mg, miconazole nitrate 100 mg;

Excipients: semisynthetic glycerides (Suppocir AM) - sufficient amount to obtain a suppository with a mass of 2000 mg.

Description:

White or white with a yellowish tinge of a torpedo-shaped suppository. On the cut, an air rod or a funnel-shaped depression is allowed.

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

ATX: & nbsp

G.01.A.F Imidazole derivatives

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

Pharmacodynamics:

Pharmacological properties

Metromicon-Neo® is a combined preparation with antiprotozoal, antifungal and antibacterial action.

Contains metronidazole itmiconazole.

Pharmacodynamics

Metronidazole refers to 5-nitroimidazole and is a drug with a bactericidal type of action, showing tropicity (the ability of interaction) to deoxyribonucleic acid.

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 reduced 5-nitro group of metronidazole reacts with the deoxyribonucleic acid of a cell of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria.

Active in respect of protozoa: Trichomonas vaginalis, Entamoeba histolytica, as well as 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 facultative anaerobic Gardnerella vaginalis.

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

Miconazole is an antifungal agent, azole derivative. When intravaginal application is active mainly in relation to Candida albicans.

The fungicidal and fungistatic effect of miconazole is due to inhibition of the biosynthesis of the ergosterol of the membrane and plasma membranes of the fungi, changes in the lipid composition and permeability of the cell wall, causing death of the fungal cell.

Pharmacokinetics:

Compared with oral administration, the bioavailability of metronidazole for intravaginal administration is 20%. Metronidazole is metabolized in the liver. Hydroxyl metabolites are active. The half-life of metronidazole is 6-11 hours. About 20% of the dose is excreted unchanged in the urine.

With intravaginal injection miconazole absorbed slightly and in the plasma is not determined.

Indications:Vaginal infections: vaginal candidiasis; trichomonas vaginitis and vulvovaginitis, bacterial vaginosis; mixed vaginal infection.

Contraindications:

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

Carefully:With hepatic and renal insufficiency, porphyria, hemopoiesis and peripheral and central nervous system diseases, diabetes mellitus, microcirculation disorders, during pregnancy (II and III trimesters).

Pregnancy and lactation:

The administration of the drug is contraindicated in the first trimester of pregnancy. Application in the II and III trimesters of pregnancy is possible only if the potential benefit to the mother exceeds the possible risk to the fetus.

If it is necessary to prescribe the drug during lactation, breastfeeding should be discontinued, since metronidazole penetrates into breast milk. Breastfeeding can be resumed 24-48 hours after the end of treatment.

Dosing and Administration:

Intravaginal.

Acute vaginitis, bacterial vaginosis: 1 suppository in the morning and at night for 7 consecutive days.

Chronic vaginitis: 1 suppository once a day, just before bedtime, for 14 consecutive days.

Often recurrent vaginitis or in the absence of positive clinical dynamics when treated by other methods: 1 suppository in the morning and at night for 14 days.

Preliminarily releasing the suppository from the contour pack using scissors (cut the film along the contour of the suppository), insert it deep into the vagina.

Side effects:

Local Reactions: burning, itching, irritation of the mucous membrane of the vagina and increased swelling.Due to inflammation of the vaginal mucosa with vaginitis, irritation may increase after the administration of the first suppository or on the third day of treatment. These complications quickly disappear after discontinuation of treatment.

From the gastrointestinal tract: pain or cramps in the abdomen, "metallic" aftertaste, dry mouth, constipation, diarrhea, loss of appetite, nausea, vomiting.

From the nervous system: headache, motor disorders (ataxia), dizziness, psychoemotional disorders, convulsions.

On the part of the hematopoiesis system: leukopenia.

Allergic reactions: skin rashes, including hives.

Overdose:

At observance of recommended doses, in connection with a low absorption of a preparation, cases of an overdosage are not revealed.

Possible Symptoms: nausea, vomiting, abdominal pain, diarrhea, itching, metallic taste in the mouth, ataxia, dizziness, paresthesia, peripheral neuropathy (with prolonged use in high doses), convulsions, leukopenia, dark urine staining (due to metronidazole overdose).

Symptoms of an overdose of miconazole are not revealed.

Treatment: symptomatic and supportive therapy, with occasional ingestion - gastric lavage.

Interaction:

In connection with the entry of metronidazole In the systemic blood stream, the following reactions of interaction can be noted when used simultaneously with certain substances:

Oral anticoagulants: increases the effect of indirect anticoagulants.

Disulfiram: there may be abnormalities from the CNS (mental reactions); should not be appointed metronidazole patients who took disulfiram within 2 weeks.

Phenytoin: increases the concentration of phenytoin in the blood; the concentration of metronidazole in the blood decreases.

Lithium preparations: may increase their toxicity.

Phenobarbital: the concentration of metronidazole in the blood decreases.

Cimetidine: may increase the concentration of metronidazole in the blood.

Astemizole and terfenadine: metronidazole and miconazole inhibit the metabolism of these drugs and increase the concentration in the blood plasma.

Ethanol: the interaction of metronidazole with ethanol causes disulfiram-like reactions.

Special instructions:

When using the drug should refrain from sexual intercourse.

In order to avoid re-infection, simultaneous treatment of the sexual partner is necessary. In the case of trichomonas vaginitis, simultaneous treatment of the sexual partner with metronidazole is advisable for oral administration.

During treatment and at least 24-48 hours after the end of treatment, ethanol should be avoided (ethanol intolerance is possible).

It is not recommended simultaneous use of the drug with contraceptive diaphragms and condoms from rubber or latex (possibly interaction with price suppositories).

If the vagina is strongly irritated, the drug should be discontinued.

Suppositories should be used only intravaginally, they can not be swallowed or used in any other way.

In the case of using the drug in conjunction with metronidazole for oral administration, especially in the second course, control of the picture of peripheral blood (danger of leukopenia) is necessary.

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

It is recommended to be cautious, since a possible negative impact on the ability to drive a motor vehicle and manage complex machinery can not be ruled out.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:

Suppositories are vaginal, 500 mg + 100 mg.

Packaging:

By 7 suppositories in a contour mesh package made of PVC / PE film.

2 contour squares with instructions for use in a pack of cardboard.

Storage conditions:

In a dry, dark place at a temperature of 15 to 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-001676

Date of registration:28.04.2012 / 01.04.2015

Expiration Date:28.04.2017

The owner of the registration certificate:AVEKSIMA, JSC AVEKSIMA, JSC Russia

Manufacturer: & nbsp

Anzhero-Sudzhensky Chemical-Pharmaceutical Plant, LLC Russia

FARMAPRIM, LLC The Republic of Moldova

Information update date: & nbsp20.09.2016

Illustrated instructions

Instructions

Metromicon-Neo® (Metromicon-Neo®)