Metromicon Neo vaginal suppositories, No. 14

Vaginal infections:

• vaginal candidiasis;

• trichomonas vaginitis and vulvovaginitis,

• bacterial vaginosis;

• mixed vaginal infection.

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

Chronic vaginitis:
1 suppository 1 time per day, immediately before bedtime, for 14 consecutive days.

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

Having previously released the suppository from the contour packaging using scissors (cut the film along the contour of the suppository), insert it deep into the vagina.

One suppository contains:
active ingredients: metronidazole 500 mg, miconazole nitrate 100 mg;
excipients: semi-synthetic glycerides (suppositor AM) - a sufficient amount to obtain a suppository weighing 2000 mg.

Hypersensitivity to drug components or other nitroimidazole derivatives, I trimester of pregnancy, lactation, children under 18 years of age; from virgins.

It is prescribed with caution for hepatic and renal failure, porphyria, hematopoiesis disorder and diseases of the peripheral and central nervous system, diabetes mellitus, microcirculation disorders, during pregnancy (II and III trimesters).

Trade name of the drug:

Metromicon-Neo

INN or grouping name:

metronidazole + miconazole.

Dosage form:

vaginal suppositories

Composition:

One suppository contains:
active ingredients: metronidazole 500 mg, miconazole nitrate 100 mg;
excipients: semi-synthetic glycerides (suppositor AM) - a sufficient amount to obtain a suppository weighing 2000 mg.

Description:
Torpedo-shaped suppositories, white or white with a yellowish tinge. On the cut, the presence of an air rod or a funnel-shaped depression is allowed.

Pharmacotherapeutic group:

Combined antimicrobial agent (antimicrobial and antiprotozoal agent + antifungal agent).

ATX code: G01AF20.

Pharmacological properties

Metromicon-Neo is a combined drug with antiprotozoal, antifungal and antibacterial action. Contains metronidazole and miconazole.

Pharmacodynamics.

Metronidazole belongs to 5-nitroimidazoles and is a drug with a bactericidal type of action, exhibiting tropism (ability to interact) to deoxyribonucleic acid.

The mechanism of action consists in 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 interacts with the deoxyribonucleic acid of the cell of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria.

Active against 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 a facultative anaerobe, Gardnerella vaginalis.

Aerobic microorganisms are insensitive to metronidazole, but in the presence of mixed flora (aerobes and anaerobes), metronidazole acts synergistically with antibiotics that are effective against conventional aerobes.

Miconazole is an azole derivative antifungal agent. With intravaginal use, it is active mainly against Candida albicans. The fungicidal and fungistatic effect of miconazole is due to inhibition of the biosynthesis of ergosterol of the membrane and plasma membranes of fungi, changes in the lipid composition and permeability of the cell wall, causing the death of the fungal cell.

Pharmacokinetics.

Compared with oral administration, the bioavailability of metronidazole with 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 administration, miconazole is absorbed slightly and is not detected in plasma.

Indications for use

Vaginal infections:

• vaginal candidiasis;

• trichomonas vaginitis and vulvovaginitis,

• bacterial vaginosis;

• mixed vaginal infection.

Contraindications

Hypersensitivity to drug components or other nitroimidazole derivatives, I trimester of pregnancy, lactation, children under 18 years of age; from virgins.

It is prescribed with caution for hepatic and renal failure, porphyria, hematopoiesis disorder and diseases of the peripheral and central nervous system, diabetes mellitus, microcirculation disorders, during pregnancy (II and III trimesters).

Application during pregnancy and during breastfeeding

Prescribing 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 outweighs the possible risk to the fetus.

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

Method of administration and dosage

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

Chronic vaginitis:
1 suppository 1 time per day, immediately before bedtime, for 14 consecutive days.

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

Having previously released the suppository from the contour packaging using scissors (cut the film along the contour of the suppository), insert it deep into the vagina.

Side effect

Local reactions:
burning, itching, irritation of the vaginal mucosa and increased swelling. Due to inflammation of the vaginal mucosa with vaginitis, irritation may increase after the introduction of the first suppository or by the third day of treatment. These complications quickly disappear after stopping treatment.

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

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

From the hematopoietic system:
leukopenia.

Allergic reactions:
skin rashes, including urticaria.

Overdose

Subject to the recommended doses, due to the low absorption of the drug, no cases of overdose have been identified.

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 an overdose of metronidazole).
Symptoms of miconazole overdose have not been identified.

Treatment: symptomatic and supportive therapy, in case of accidental ingestion - gastric lavage.

Interaction with other medicinal products

In connection with the ingress of metronidazole into the systemic circulation, the following interaction reactions may be noted when used simultaneously with certain substances:

Oral anticoagulants: the effect of indirect anticoagulants is enhanced.

Disulfiram: disorders of the central nervous system (mental reactions) may occur; you should not prescribe metronidazole to patients who have taken disulfiram within the last 2 weeks;

Phenytoin: The concentration of phenytoin in the blood increases, and the concentration of metronidazole in the blood decreases. Lithium preparations: there may be an increase in their toxicity.

Phenobarbital: the concentration of metronidazole in the blood decreases.

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

Astemizole and terfenadine: metronidazole and miconazole inhibit the metabolism of these drugs and increase plasma concentrations.

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

special instructions

When using the drug, you 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, it is advisable to simultaneously treat the sexual partner with oral metronidazole.

During treatment and at least for 24-48 hours after the end of the course of treatment, ethanol should be avoided (possible intolerance to ethanol).
The simultaneous use of the drug with contraceptive diaphragms and condoms made of rubber or latex is not recommended (interaction with the suppository base is possible).

In case of severe irritation of the vagina, treatment with the drug should be discontinued. Suppositories should only be used intravaginally and should not be swallowed or otherwise used.

In the case of using the drug in conjunction with metronidazole for oral administration, especially with a repeated course, it is necessary to control the picture of peripheral blood (risk of leukopenia).

Impact on the ability to drive vehicles and operate potentially dangerous mechanisms:
it is recommended to be careful, since a possible negative impact on the ability to drive a car and control complex mechanisms cannot be ruled out. If side effects from the central nervous system appear, you should refrain from driving and working with potentially dangerous mechanisms.

Release form

Vaginal suppositories containing metronidazole 500 mg and miconazole nitrate 100 mg.
7 suppositories in a blister strip packaging made of PVC / PE film.
2 blister packs with instructions for use in a cardboard box.

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!