Metromicon-Neo vaginal suppositories 500mg+100mg, 14pcs

Composition

Active ingredients:

miconazole nitrate-100 mg,

metronidazole-500 mg.

Auxiliary substances:

semi-synthetic glycerides.

Pharmacological action

Metromicon-Neo is a combined drug with antiprotozoal, antifungal and antibacterial effects.

Metronidazole is active against Gardnerella vaginalis; protozoa:  Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica; anaerobic gram-negative bacteria:  Bacteroides spp. (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Fusobacterium spp., Prevotella spp. (P. bivia, P. buccae, P. disiens); anaerobic gram-positive bacteria:  Clostridium spp., Eubacterium spp. ; anaerobic gram-positive cocci:  Peptococcus spp., Peptostreptococcus spp. Aerobic microorganisms and facultative anaerobes are resistant to metronidazole. The mechanism of action is due to 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 cell DNA of microorganisms, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria.

The most sensitive to miconazole are dermatomycetes and yeast. Active against the causative agent of multicolored lichen (Malassezia furfur), pathogens of some dermatomycoses (Candida albicans, Trichophyton, Epidermophyton floccosum, Microsporum). It is active against Dimorphons fungi, Cryptococcus neoformans, Aspergillus spp., Pityrosporum, Torulopsis glabrata, Pseudallescheria boydii; some gram-positive microorganisms, including staphylococci and streptococci. The fungicidal and fungistatic effect of miconazole nitrate is due to the inhibition of ergosterol biosynthesis of the fungal membrane and plasma membranes, changes in the lipid composition and cell wall permeability, causing fungal cell death.

Indications

Vaginal infections:

• vaginal candidiasis;
• trichomonas vaginitis and vulvovaginitis, bacterial vaginosis;
• mixed vaginal infection.

Use during pregnancy and lactation

The use of the drug is contraindicated in the first trimester of pregnancy. Use in the second and third 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. Breast-feeding can be resumed 24-48 hours after the end of treatment.

Contraindications

• hypersensitivity to the components of the drug or other nitroimidazole derivatives;
• I trimester of pregnancy, lactation period,
• children under 18 years of age;
• for virgins.

With caution:  with hepatic and renal insufficiency, porphyria, hematopoiesis disorders and diseases of the peripheral and central nervous system, diabetes mellitus, microcirculation disorders, during pregnancy (II and III trimesters).

Side effects

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

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

Nervous system disorders:  headache, motor disorders (ataxia), dizziness, psychoemotional disorders, convulsions.

From the hematopoietic system:  leukopenia.

Allergic reactions:  skin rashes, including hives.

Interaction

In connection with the ingestion of metronidazole into the systemic circulation, the following reactions may occur: interactions with concomitant use with certain substances:

Oral anticoagulants:  the effect of indirect anticoagulants is enhanced.

Disulfiram:  CNS disorders (psychiatric reactions) may occur; therefore, metronidazole should be prescribed to patients who have taken disulfiram for 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 the concentration in blood plasma.

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

How to take, course of use and dosage

Intravaginally.

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

Chronic vaginitis:  take 1 suppository 1 time a day, just 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.

After releasing the suppository from the contour package with scissors (cut the film along the contour of the suppository), insert it deep into the vagina.

Overdose

If the recommended doses are observed, due to the low absorption of the drug, cases of overdose were not detected.

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).

No symptoms of miconazole overdose were detected.

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

Special instructions

When using the drug, you should refrain from sexual contact. 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 metrbnidazole for oral use is advisable.

During treatment and at least for 24-48 hours after the end of the course of treatment, avoid taking ethanol (possible ethanol intolerance).

Concomitant use of the drug with contraceptive diaphragms and rubber or latex condoms is not recommended (interaction with the use of suppositories is possible).

If there is severe irritation of the vagina, treatment with the drug should be discontinued.

Suppositories should only be used intravaginally and should not be ingested or otherwise administered.

If the drug is used together with metronidazole for oral use, especially with a second course, it is necessary to monitor the picture of peripheral blood (risk of leukopenia).

Influence on the ability to drive motor vehicles and manage potentially dangerous mechanisms:  it is recommended to use caution, as possible negative effects on the ability to drive a car and manage complex mechanisms cannot be excluded. If you experience side effects from the central nervous system, you should refrain from driving vehicles and working with potentially dangerous mechanisms.

Product form

vaginal suppositories

Storage conditions

Store in a dry place, protected from light, at a temperature of 15-25 °C

Shelf life

3 years

Active ingredient

Metronidazole, Miconazole

Conditions of release from pharmacies

By prescription

Description

For adults as prescribed by a doctor, For women

Indications

Inflammation of the female genital organs, Thrush, Vaginitis