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Metromicon-Neo (supp.vag.500mg+100mg No. 14)

A country

Russia
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.

Compound

1 suppository contains: metronidazole 500 mg, miconazole 100 mg.
Excipients: semi-synthetic glycerides (Suppotsir AM) - sufficient quantity to obtain a suppository weighing 2000 mg. Vaginal suppositories are white or white with a yellowish tint, torpedo-shaped. An air rod or funnel-shaped depression is allowed on the cut.

pharmachologic effect

Metronidazole belongs to the 5-nitroimidazoles and is a drug with a bactericidal type of action that exhibits tropism (the ability to interact) with 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 interacts with the deoxyribonucleic acid of microbial cells, 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 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 common aerobes. Miconazole is an azole derivative antifungal agent. When used intravaginally, it is active mainly against Candida albicans. The fungicidal and fungistatic effect of miconazole is due to inhibition of the biosynthesis of ergosterol in 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.

Mode of application

Intravaginally. Acute vaginitis, bacterial vaginosis: 1 suppository in the morning and at night for 7 days in a row. Chronic vaginitis: 1 suppository 1 time per day, immediately before bed, for 14 consecutive days. Often recurrent vaginitis or in the absence of positive clinical dynamics when treated with other methods: 1 suppository in the morning and at night for 14 days. Having previously freed the suppository from the contour packaging using scissors (cut the film along the contour of the suppository), insert it deep into the vagina.

Interaction

Due to the entry of metronidazole into the systemic circulation, the following interaction reactions may occur when used simultaneously with certain substances: Oral anticoagulants: the effect of indirect anticoagulants is enhanced. Disulfiram: central nervous system disorders (mental reactions) may occur; No, metronidazole should be prescribed to patients who have taken disulfiram within the past 2 weeks. Phenytoin: the concentration of phenytoin in the blood increases, and the concentration of metronidazole in the blood decreases. Lithium preparations: increased toxicity may occur. 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: The interaction of metronidazole with ethanol causes disulfiram-like reactions.

Side effect

Local reactions: burning, itching, irritation of the vaginal mucosa and increased swelling. Due to inflammation of the vaginal mucosa during vaginitis, irritation may increase after the introduction of the first suppository or by the third day of treatment. These complications disappear quickly after stopping treatment. From the gastrointestinal tract: abdominal pain or cramps, “metallic” taste, dry mouth, constipation, diarrhea, loss of appetite, nausea, vomiting. From the nervous system: headache, motor disorders (ataxia), dizziness, psycho-emotional disorders, convulsions. From the hematopoietic system: leukopenia. Allergic reactions: skin rashes, including urticaria.

Contraindications

- hypersensitivity to the components of the drug or other nitroimidazole derivatives;
— I trimester of pregnancy, lactation period, — children under 18 years of age; - among virgins. With caution: with liver and kidney failure, porphyria, hematopoietic disorders and diseases of the peripheral and central nervous system, diabetes mellitus, microcirculation disorders, during pregnancy (II and III trimesters). Use during pregnancy and breastfeeding 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 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 24-48 hours after the end of treatment.

Overdose

If the recommended doses are observed, due to the low absorption of the drug, cases of overdose have not 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 (due to metronidazole overdose) . No symptoms of miconazole overdose have been identified. Treatment: symptomatic and supportive therapy, in case of accidental ingestion - gastric lavage.

special instructions

When using the drug, you should abstain 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 metlbnidazole for oral administration. During treatment and for at least 24-48 hours after the end of treatment, ethanol should be avoided (ethanol intolerance is possible). The simultaneous use of the drug with contraceptive diaphragms and rubber or latex condoms is not recommended (possible interaction with suppositories). 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 swallowed or used in any other way. If the drug is used together with metronidazole for oral administration, especially with a repeated course, monitoring of the peripheral blood picture is necessary (danger of leukopenia). Impact on the ability to drive vehicles and control potentially dangerous mechanisms: caution is recommended, since a possible negative impact on the ability to drive a vehicle and control complex mechanisms cannot be excluded. If side effects from the central nervous system occur, you should refrain from driving vehicles and working with potentially dangerous mechanisms.

Dispensing conditions in pharmacies

On prescription

Metromicon-Neo

ATX code: G01AF20 (Combinations of imidazole derivatives) Active substances metronidazole (metronidazole) Rec.INN registered by WHO miconazole (miconazole) Rec.INN registered by WHO Dosage form METROMICON-NEO vaginal suppositories. 500 mg+100 mg: 14 pcs. reg. No.: LP-001676 dated 04/28/12 - Valid

Release form, composition and packaging Vaginal suppositories are white or white with a yellowish tint, torpedo-shaped, an air rod or a funnel-shaped depression is allowed on the cut.

1 sup. metronidazole 500 mg miconazole 100 mg

Excipients: semi-synthetic glycerides (Suppotsir AM) - sufficient quantity to obtain a suppository weighing 2000 mg.

7 pcs. — cellular contour packages (2) — cardboard packs.

Clinical-pharmacological group: Drug with antibacterial, antiprotozoal and antifungal action for topical use in gynecology Pharmaco-therapeutic group: Antimicrobial combined agent (antimicrobial and antiprotozoal agent + antifungal agent)

Indications: Vaginal infections:

- vaginal candidiasis,

- Trichomonas vaginitis and vulvovaginitis, bacterial vaginosis,

- mixed vaginal infection.

ICD-10 codes ICD-10 code Indication A59 Trichomoniasis B37.3 Candidiasis of the vulva and vagina N76 Other inflammatory diseases of the vagina and vulva

Dosage regimen Intravaginal.

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

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

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

Having previously freed the suppository from the contour packaging 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 vaginal mucosa and increased swelling. Due to inflammation of the vaginal mucosa during vaginitis, irritation may increase after the introduction of the first suppository or by the third day of treatment. These complications disappear quickly after stopping treatment.

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

From the nervous system: headache, motor disorders (ataxia), dizziness, psycho-emotional disorders, convulsions.

From the hematopoietic system: leukopenia.

Allergic reactions: skin rashes, including urticaria.

Contraindications for use: hypersensitivity to the components of the drug or other nitroimidazole derivatives,

— I trimester of pregnancy, lactation period,

- children under 18 years of age,

- among virgins.

With caution: with liver and kidney failure, porphyria, hematopoietic disorders and diseases of the peripheral and central nervous system, diabetes mellitus, microcirculation disorders, during pregnancy (II and III trimesters).

Use during pregnancy and breastfeeding 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 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 24-48 hours after the end of treatment.

Use for liver dysfunction Use with caution in liver failure. Use for impaired renal function Use with caution in case of renal failure. Use in children Contraindicated in children under 18 years of age. 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 metlbnidazole for oral administration.

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

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

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 swallowed or used in any other way.

If the drug is used together with metronidazole for oral administration, especially with a repeated course, monitoring of the peripheral blood picture is necessary (danger of leukopenia).

Impact on the ability to drive vehicles and control potentially dangerous mechanisms: caution is recommended, since a possible negative impact on the ability to drive a vehicle and control complex mechanisms cannot be excluded. If side effects from the central nervous system occur, you should refrain from driving vehicles and working with potentially dangerous mechanisms.

Overdose If the recommended doses are observed, due to the low absorption of the drug, cases of overdose have not 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 (due to metronidazole overdose) .

No symptoms of miconazole overdose have been identified.

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

Drug interactions Due to the entry of metronidazole into the systemic circulation, the following interaction reactions may occur when used simultaneously with certain substances:

Oral anticoagulants: the effect of indirect anticoagulants is enhanced.

Disulfiram: CNS disturbances (mental reactions) may occur; however, metronidazole should not be prescribed 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: increased toxicity may occur.

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

Conditions for dispensing from pharmacies By prescription. Conditions and periods of storage In a dry place, protected from light, at a temperature of 15 to 25 ° C. Keep out of the reach of children. Shelf life: 3 years.