Metromicon-Neo (supp.vag.500mg+100mg No. 14)
A country
Russia
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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 vaginal suppositories N 14
Active substances
metronidazole (metronidazole) Rec.INN registered by WHO
miconazole (miconazole) Rec.INN registered by WHO
Dosage form
The drug is available with a prescription Metromicon-Neo®
Vaginal suppositories
Release form, packaging and composition of the drug Metromicon-Neo®
Vaginal suppositories are torpedo-shaped, white or white with a yellowish tint; an air rod or a funnel-shaped depression is allowed on the cut.
1 sup.
metronidazole 500 mg
miconazole nitrate 100 mg
Excipients: patented form - Suppotsir AM® (semi-synthetic glycerides) for the most uniform distribution of the active substance.
7 pcs. — cellular contour packages made of PVC/PE films (2) — cardboard packs.
Clinical and pharmacological group: Drug with antibacterial, antiprotozoal and antifungal effects for topical use in gynecology
Pharmacotherapeutic group: Antimicrobial combined agent (antimicrobial and antiprotozoal agent + antifungal agent)
pharmachologic effect
Combined product for intravaginal use.
Metronidazole is an antiprotozoal and antimicrobial drug, a derivative of nitro-5-imidazole. 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 DNA of microbial cells, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria and protozoa.
Active against Trichomonas vaginalis, Entamoeba histolytica, Gardnerella vaginalis, Giardia lamblia, as well as obligate anaerobes Bacteroides spp. (including Bacteroides fragilis, Bacteroides ovatus, Bacteroides distasonis, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Veillonella spp., Prevotella spp. (Prevotella bivia, Prevotella buccae, Prevotella disiens) and some gram-positive microorganisms (Eubacterium spp., Clostridium spp., Peptococcus spp., Peptostreptococcus spp.). The MIC for these strains is 0.125-6.25 μg/ml.
Aerobic microorganisms and facultative anaerobes are resistant to metronidazole, but in the presence of mixed flora (aerobes and anaerobes), metronidazole acts synergistically with antibiotics effective against aerobes.
Miconazole has an antifungal effect against dermatophytes and yeast fungi. When used intravaginally, it is active mainly against Candida albicans. Miconazole inhibits the biosynthesis of ergosterol in fungi and changes the composition of other lipid components in the membrane, which leads to the death of fungal cells. Miconazole does not change the composition of normal microflora and vaginal pH.
Pharmacokinetics
When administered intravaginally, metronidazole is absorbed into the systemic circulation. The Cmax of metronidazole in the blood is determined after 6-12 hours and is approximately 50% of the Cmax that is achieved (after 1-3 hours) after a single dose of an equivalent dose of metronidazole orally. Metronidazole penetrates into breast milk and most tissues, penetrates the BBB and the placental barrier. Plasma protein binding is less than 20%. Metabolized in the liver by hydroxylation, oxidation and glucuronidation. The activity of the main metabolite (2-hydroxymetronidazole) is 30% of the activity of the parent compound. Excreted by the kidneys - 60-80% of the dose of the systemic drug (20% of this amount unchanged). The metabolite of metronidazole, 2-hydroxymetronidazole, colors urine red-brown due to the presence of a water-soluble pigment formed as a result of the metabolism of metronidazole. The intestines excrete 6-15% of the dose of the systemic drug.
Systemic absorption of miconazole after intravaginal use is low. Rapidly destroyed in the liver. It overcomes histohematic barriers poorly. 8 hours after using the drug, 90% of miconazole is still present in the vagina. Unchanged miconazole is not detectable in either plasma or urine.
Indications of the active substances of the drug Metromicon-Neo®
For local treatment of vaginitis of mixed etiology caused simultaneously by Trichomonas spp. and Candida spp.
Dosage regimen
The method of administration and dosage regimen of a particular drug depend on its release form and other factors. The optimal dosage regimen is determined by the doctor. The compliance of the dosage form of a particular drug with the indications for use and dosage regimen should be strictly observed.
Use intravaginally in 1 single dose daily for 10 days. Can be used in combination with metronidazole for oral administration.
Side effect
Local reactions: itching, burning, pain, irritation of the vaginal mucosa; thick, white, mucous vaginal discharge with little or no odor; burning sensation or irritation of the partner's penis.
From the digestive system: nausea, vomiting, changes in taste, metallic taste in the mouth, decreased appetite, spastic abdominal pain, diarrhea, constipation.
From the side of the central nervous system: headache, dizziness.
From the hematopoietic system: leukopenia or leukocytosis.
Allergic reactions: urticaria, itching of the skin, rash.
From the urinary system: frequent urination, urine coloration in red-brown color due to the presence of a water-soluble pigment (metronidazole metabolite - 2 oxymetronidazole), formed as a result of the metabolism of metronidazole.
Contraindications for use
Leukopenia (including history); organic lesions of the central nervous system (including epilepsy); liver failure; I trimester of pregnancy; lactation period (breastfeeding); children under 18 years of age; hypersensitivity to the components of the drug and to other azoles.
Carefully
Diabetes mellitus, microcirculation disorders.
Use during pregnancy and breastfeeding
Use in the first trimester of pregnancy is contraindicated. The use of the drug in the second and third trimesters is possible only in cases where the potential benefit to the mother outweighs the risk to the fetus.
Metronidazole is excreted in breast milk. Use is contraindicated during breastfeeding. If necessary, use during lactation should stop breastfeeding.
Use for liver dysfunction
Contraindicated in case of liver failure (when prescribing the drug in high doses).
Use in children
Use is contraindicated in children under 18 years of age.
special instructions
During the use of this combination, alcohol consumption is strictly prohibited (risk of developing disulfiram-like reactions).
During the period of use of the drug, it is recommended to abstain from sexual intercourse. Simultaneous treatment of sexual partners is recommended.
During treatment, slight leukopenia is possible, so it is advisable to monitor the blood picture (the number of leukocytes) at the beginning and at the end of therapy.
Metronidazole can immobilize treponemes, resulting in a false-positive TPI test (Nelson test).
Impact on the ability to drive vehicles and machinery
If side effects from the central nervous system occur, you should refrain from driving vehicles and working with potentially dangerous mechanisms.
Drug interactions
Since the systemic absorption of miconazole is low, interactions with other drugs are caused by metronidazole.
Metronidazole is compatible with sulfonamides and antibiotics.
When consumed simultaneously, alcohol causes reactions similar to disulfiram (cramping abdominal pain, nausea, vomiting, headache, skin flushing). Concomitant use with disulfiram is unacceptable (additive effects, may cause confusion).
The drug can enhance the effect of indirect anticoagulants. Prothrombin time may increase, so dose adjustment of indirect anticoagulants is necessary.
It is not recommended to combine the drug with non-depolarizing muscle relaxants (vecuronium bromide).
Inducers of microsomal oxidation enzymes in the liver (for example, phenytoin, phenobarbital) can accelerate the elimination of metronidazole, which leads to a decrease in its concentration in the blood plasma.
Cimetidine inhibits the metabolism of metronidazole, which may lead to an increase in its concentration in the blood serum and an increased risk of side effects.
It is possible that the concentration of lithium in the blood plasma may increase during the course of treatment with metronidazole, therefore, before starting the use of this combination, it is necessary to reduce the dose of lithium or stop taking it for the duration of treatment.
