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Metromicon-neo - instructions for use. Instructions for use of Metromicon neo suppositories - composition and indications Use for liver dysfunction

Metromicon-Neo

Compound

1 vaginal suppository Metromicon-Neo contains:
Metronidazole – 500 mg;
Miconazole nitrate – 100 mg;
Additional ingredients.

Pharmacological action

Metromicon-Neo is a combined antiprotozoal, antibacterial and antifungal drug. Metromicon-Neo contains metronidazole and miconazole.

Metronidazole is a substance from the nitro-5-imidazole group, which has a wide spectrum of antifungal and antibacterial activity. Metronidazole is active against Clostridium spp., Peptostreptococcus spp., Fusobacterium spp., Bacteroides spp., Prevotella spp. and Veilonella. In addition, metronidazole interferes with the growth and development of protozoa, including Giardia intestinalis, Entamoeba histolytica and Trichomonas vaginalis.
Some strains of Eubacterium spp may be resistant to the action of metronidazole. and Bifidobacterium spp.

Strains of Propionibacterium, Mobiluncus and Actinomyces are not sensitive to the action of metronidazole.
Miconazole nitrate is a substance of the imidazole group with a wide spectrum of fungicidal and bactericidal activity. Miconazole inhibits the synthesis of substances that are the basis of the cell membrane of microorganisms, which leads to disruption of the growth and development of sensitive bacteria and fungi. Dermatophytes are sensitive to the action of miconazole, including strains of Trichophyton mentagrophytes, Trichophyton rubrum, Microsporum canis and Epidermophyton floccosum, yeast-like fungi of the genus Candida, as well as other pathogenic fungi, including Aspergilus niger, Malassezia furtur and Penicillium crustaceum.
Most strains of gram-positive bacteria are sensitive to the action of miconazole.

The pharmacokinetics of the drug Metromicon-Neo is not presented.

Indications for use

Metromicon-Neo is used as a local therapy in patients suffering from vaginal candidiasis, bacterial or trichomonas vaginitis.

Directions for use

Metromicon-Neo is intended for intravaginal use. Before using the drug, wash your hands thoroughly. The suppository should be administered while lying on your back. Suppositories are recommended to be administered immediately before bedtime; if the suppository is used twice a day, you should be in a horizontal position for 15-30 minutes after administration of the suppository. The duration of therapy and dose of Metromicon-Neo is determined by the doctor.
As a rule, 1 suppository of Metromicon-Neo is prescribed 1 or 2 times a day.
The recommended duration of therapy is 7 days.

For chronic vaginitis, as well as vaginitis caused by flora resistant to other antimicrobial agents, it is recommended to increase the course of treatment to 14 days (the daily dose in this case is 1 suppository).
With prolonged therapy, the blood picture should be monitored.
During therapy, sexual intercourse should be avoided.
For vaginitis caused by Trichomonas, adequate treatment should be given to both sexual partners.
It is not recommended to use hygienic tampons during therapy with Metromicon-Neo.

Side effects

Metromicon-Neo is generally well tolerated by patients. However, given the systemic absorption of metronidazole during intravaginal use, the possibility of the development of such undesirable effects during therapy with Metromicon-Neo cannot be excluded:
From the digestive and hepatobiliary system: stool disorders, nausea, pain in the epigastric and abdominal region, vomiting, stomatitis, gingivitis, changes in taste, decreased appetite. In isolated cases, the development of pancreatitis, hepatitis with cholestasis and increased activity of liver enzymes is possible.

From the central nervous system: peripheral sensory neuropathy, convulsions, headache, dizziness, confusion, hallucinations. In isolated cases, encephalopathy, subacute cerebellar syndrome and decreased visual acuity may develop.
From the hematopoietic system: neutropenia, thrombocytopenia, agranulocytosis.
Allergic reactions: urticaria, hyperthermia, pustular rash, Quincke's edema, anaphylactic shock.
Local reactions: increased itching and irritation of the vaginal mucosa with the introduction of a suppository.
In addition, metronidazole may cause a false positive Nelson test result.

Contraindications

Metromicon-Neo is not prescribed to patients with known intolerance to metronidazole, miconazole and nitroimidazole derivatives.
Metromicon-Neo is not used for the treatment of patients suffering from porphyria, severe liver dysfunction and epilepsy.
Metromicon-Neo is not used in pediatric practice.
Caution should be exercised when prescribing Metromicon-Neo to patients suffering from severe neurological diseases and dysfunction of the hematopoietic system.
Driving a car and operating potentially unsafe mechanisms should be avoided during therapy with Metromicon-Neo.

Pregnancy

Metromicon-Neo should not be used during pregnancy.
During lactation, the use of Metromicon-Neo suppositories is allowed only after breastfeeding is stopped.

Drug interactions

Metronidazole, when used in combination with ethyl alcohol, can lead to the development of a disulfiram-like reaction.
Metronidazole potentiates the effect of anticoagulants and increases the toxicity of lithium.
With the simultaneous use of phenobarbital and phenytoin with metronidazole, a decrease in plasma concentrations of metronidazole is observed (the plasma concentration of phenytoin may increase).
With the simultaneous use of metronidazole and disulfiram, the development of psychotic reactions was observed in patients.

Metromicon-Neo, when used in combination, increases plasma concentrations of astemizole, cyclosporine, busulfan and terfenadine.
Metronidazole may alter plasma concentrations of glucose, liver enzymes, procainamide and theophylline.
Cimetidine increases plasma concentrations of metronidazole when used concomitantly and increases the risk of developing neurological symptoms.
Suppository base may help break down latex and reduce the contraceptive effect of condoms and diaphragms.

Overdose

There is no data on an overdose of Metromicon-Neo for intravaginal use. Absorption of metronidazole during intravaginal use of high doses of Metromicon-Neo is sufficient to develop undesirable effects, including nausea, abdominal pain, stool disorders, ataxia, paresthesia, convulsions, anorexia, headache, as well as changes in the color of urine and leukopenia.

There is no specific antidote. In case of accidental oral administration of the drug Metromicon-Neo, gastric lavage should be performed and enterosorbent agents should be prescribed. If overdose symptoms develop, it is recommended to carry out therapy aimed at eliminating the manifestations of intoxication.

Attention!
Description of the drug " Metromicon-Neo"on this page is a simplified and expanded version of the official instructions for use. Before purchasing or using the drug, you should consult your doctor and read the instructions approved by the manufacturer.
Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.

Metromicon-Neo: instructions for use and reviews

Latin name: Metromicon-Neo

ATX code: G01AF20

Active ingredient: metronidazole + miconazole

Manufacturer: Avexima Sibir LLC (Russia), FARMAPRIM LLC (Republic of Moldova)

Updating the description and photo: 26.10.2018

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

Release form and composition

Dosage form - vaginal suppositories: torpedo-shaped, white with a yellowish tint or white, with an airy porous core or a funnel-shaped depression on the cut (7 pcs in a strip pack or blister, 2 packs or blisters in a cardboard box).

Composition of 1 suppository:

active ingredients: metronidazole – 500 mg; miconazole nitrate – 100 mg;
auxiliary components: semi-synthetic glycerides (Suppotsir AM).

Pharmacological properties

Pharmacodynamics

The active component of the drug Metromicon-Neo, metronidazole, is a substance that produces an antimicrobial and antiprotozoal effect. The bactericidal effect is due to the biochemical reduction of the 5-nitro group of metronidazole by intracellular transport proteins of anaerobic bacteria and protozoa and the further interaction of the reduced 5-nitro group with the deoxyribonucleic acid (DNA) of the bacterial cell, during which the synthesis of nucleic acids of microorganisms is inhibited and, as a consequence, the death of bacteria.

Metronidazole is active against Gardnerella vaginalis, Trichomonas vaginalis, Entamoeba histolytica, Giardia intestinalis, obligate anaerobic bacteria - Veillonella spp., Fusobacterium spp., Prevotella spp. (Prevotella bivia, Prevotella buccae, Prevotella disiens), Bacteroides spp. (including Bacteroides ovatus, Bacteroides distasonis, Bacteroides fragilis, Bacteroides vulgatus, Bacteroides thetaiotaomicron), gram-positive bacteria - Peptostreptococcus spp., Peptococcus spp., Mobiluncus spp., Clostridium spp., Eubacterium spp., as well as gram-negative Helicobacter pylori.

Aerobic microorganisms are resistant to metronidazole, but in mixed flora (anaerobes and aerobes) the drug acts in synergy with antibiotics that are effective against ordinary aerobes.

Another active component of Metromicon-Neo, miconazole nitrate, is an azole-derived antifungal drug. The fungicidal and fungistatic effect of miconazole is associated with the suppression of the synthesis of ergosterol, which is a component of the fungal cell membrane and membrane, and damage to the integrity of the cell membrane, which causes the death of pathogenic cells. Dermatomycetes and yeast are most sensitive to the drug. It is active against pathogens of dermatomycosis (including Candida albicans, Microsporum, Epidermophyton floccosum, Trichophyton), the causative agent of pityriasis versicolor Malassezia furfur and other pathogenic microorganisms.

Pharmacokinetics

When administered intravaginally, the bioavailability of metronidazole is 20%. The substance is metabolized in the liver with the formation of active hydroxyl metabolites. T1/2 (half-life) of metronidazole is from 6 to 11 hours. Approximately 20% of the administered dose is excreted in the urine in its original form.

When administered intravaginally, miconazole nitrate is absorbed in small quantities and is not detected in the blood plasma.

Indications for use

According to the instructions, Metromicon-Neo is indicated for use for the following vaginal infections:

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

Contraindications

Absolute:

virginity;
first trimester of pregnancy, lactation period;
age under 18 years;
increased individual sensitivity to metronidazole, other nitroimidazole derivatives, miconazole or any excipient of the drug.

Metromicon-Neo should be prescribed with caution in cases of renal and/or liver dysfunction, porphyria, diseases of the central and peripheral nervous system, hematopoietic and microcirculation disorders, diabetes mellitus, as well as in the second and third trimesters of pregnancy.

Instructions for use Metromicon-Neo: method and dosage

Metromicon-Neo suppositories are used intravaginally. Having freed the suppository from the contour packaging using scissors, insert it deep into the vagina.

for bacterial vaginosis, acute vaginitis: one suppository 2 times a day, in the morning and immediately before bed, for 7 days;
for chronic vaginitis: one suppository 1 time per day at night for 14 days;
for frequently recurrent vaginitis or the absence of a positive clinical effect from the use of other treatment methods: one suppository 2 times a day, in the morning and before bed, for 14 days.

Side effects

local reactions: irritation of the vaginal mucosa, increased swelling, itching, burning. With vaginitis, irritation may increase after using the first suppository or on the third day of treatment due to inflammation of the vaginal mucosa. As a rule, these symptoms disappear quickly after cessation of therapy;
from the nervous system: ataxia (motor disorders), headache, dizziness, convulsions, psycho-emotional disorders;
from the digestive system: abdominal pain/cramps, diarrhea, constipation, nausea/vomiting, dry mouth, metallic taste, loss of appetite;
from the hematopoietic system: leukopenia;
allergic reactions: skin rash (including urticaria).

Overdose

Low absorption of the active components of the drug Metromicon-Neo eliminates overdose, provided the recommended dosage regimen is followed.

The following symptoms may occur: with an overdose of metronidazole - nausea, vomiting, diarrhea, abdominal pain, ataxia, metallic taste in the mouth, paresthesia, convulsions, dark coloration of urine, leukopenia, peripheral neuropathy (with long-term use of high doses); with an overdose of miconazole nitrate - nausea, vomiting, diarrhea, anorexia.

Treatment consists of symptomatic and supportive therapy. In case of accidental ingestion of the drug, gastric lavage is recommended.

Special instructions

While using Metromicon-Neo suppositories, it is recommended to abstain from sexual intercourse. To prevent re-infection, simultaneous therapy with the sexual partner is necessary, and in the case of trichomonas vaginitis, treatment of the partner with oral metronidazole dosage forms is recommended.

During the treatment period and after completion of the course of therapy, ethyl alcohol should be avoided for 24–48 hours due to the likelihood of developing disulfiram-like reactions.

In case of severe irritation of the vaginal mucosa, the drug must be discontinued.

The simultaneous use of Metromicon-Neo with a vaginal diaphragm and latex or rubber condoms is not recommended due to their possible interaction with the suppository base and a decrease in the reliability of mechanical contraception.

Suppositories must be administered only intravaginally; swallowing and using them in other ways is prohibited.

When using the drug Metromicon-Neo together with metronidazole for oral use, especially with a repeated course, the peripheral blood picture should be monitored due to the risk of leukopenia.

Impact on the ability to drive vehicles and complex mechanisms

Patients receiving therapy with Metromicon-Neo should be careful when driving vehicles and performing actions that require increased attention and rapid motor/mental reactions. If adverse reactions occur when using the drug on the central nervous system, you should refrain from potentially hazardous activities.

Use during pregnancy and lactation

In the first trimester of pregnancy, the use of Metromicon-Neo is contraindicated. Use in the second and third trimesters is possible only in cases where the expected benefit to the woman outweighs the potential risks to the fetus.

Since metronidazole tends to pass into breast milk, if it is necessary to use suppositories during lactation, breastfeeding should be discontinued. Breastfeeding can be resumed 24–48 hours after the end of therapy.

Use in childhood

Metromicon-Neo is contraindicated in children and adolescents under 18 years of age.

For impaired renal function

In case of renal failure, the use of Metromicon-Neo requires caution.

For liver dysfunction

Metromicon-Neo should be prescribed to patients with impaired liver function with caution.

Drug interactions

The use of metronidazole and miconazole nitrate simultaneously with certain drugs can lead to the development of the following effects:

oral anticoagulants: enhancing the effect of indirect anticoagulants;
phenytoin: increased concentration of phenytoin in the blood, decreased concentration of metronidazole in the blood;
cimetidine: increased concentration of metronidazole in the blood;
disulfiram: development of disorders of the central nervous system in the form of mental reactions. It is not recommended to prescribe metronidazole to patients taking disulfiram for the past two weeks;
lithium preparations: increased toxicity;
phenobarbital: decreased concentration of metronidazole in the blood;
terfenadine, astemizole: an increase in their concentration in the blood plasma as a result of suppression of their metabolism by metronidazole and miconazole;
ethanol: development of disulfiram-like reactions.

Analogues

Analogs of Metromicon-Neo are: Ginocaps, Neo-Penotran, Neo-Penotran Forte and others.

Terms and conditions of storage

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

Keep away from children.

Shelf life – 3 years.

Included in the preparations

ATX:

G.01.A.F Imidazole derivatives

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

Pharmacodynamics:

Metronidazole

The nitro-5-imidazole derivative has antibacterial and antiprotozoal effects. Restores the 5-nitro group due to transport proteins of anaerobic bacteria and protozoan microorganisms. The reduced 5-nitro group of metronidazole inhibits the synthesis of nucleic acids in the DNA of microbial cells, which leads to their death.

Active regarding Gardnerella vaginalis, Giardia lamblia, Entamoeba histolytica, Trichomonas vaginalis, as well as against obligate anaerobes Bacteroides spp. (including .B. distasonis, B. ovatus, B. fragilis, B. vulgatus, B. thetaiotaomicron), Fusobacterium spp., Prevotella spp. (Prevotella bivia, Prevotella buccae, Prevotella disiens), Veillonella spp., and some gram-positivemicroorganisms (Clostridium spp., Eubacterium spp., Peptococcus spp., Peptostreptococcus spp.).

In mixed flora it acts synergistically with antibiotics against aerobic bacteria.

Miconazole

Active against yeast fungi, dermatophytes. When used intravaginally, it inhibits the synthesis of ergosterol in fungi of the genus Candida albicans, changes the composition of lipid components in their membranes, resulting in the death of fungal cells. Eliminates itching accompanying vaginal infections. Does not affect the pH and does not change the composition of the vaginal microflora.

Pharmacokinetics:

Metronidazole

When administered intravaginally, up to 50% is absorbed into the systemic circulation. The maximum concentration in the blood plasma is reached after 6-12 hours. The connection with plasma proteins is 20%.

The therapeutic effect develops 1-3 hours after application. Metabolism in the liver with the formation of 2-hydroxymetronidazole, which exhibits activity of 30% of the effect of the original drug.

The half-life is 8 hours. Elimination by the kidneys. Removed by hemodialysis.

Miconazole

When administered intravaginally, it has no systemic effect.

Indications:

Used for local treatment of vaginitis and colpitis.

I.A50-A64.A59.0 Urogenital trichomoniasis

I.B35-B49.B37.3 Candidiasis of the vulva and vagina (N77.1*)

Contraindications:

Organic lesions of the central nervous system (epilepsy), liver failure, individual intolerance.

With caution:

Microcirculation disorders, diabetes mellitus.

Pregnancy and lactation: Directions for use and dosage:

Intravaginally, pre-moistened with water, 1 tablet deep into the vagina before bed for 10 days in combination with taking metronidazole tablets orally.

Highest daily dose: 1 vaginal tablet.

Highest single dose: 1 vaginal tablet.

Side effects:

Central nervous system: headache, dizziness.

Hematopoietic system: leukocytosis or leukopenia.

Digestive system: nausea, metallic taste in the mouth, decreased appetite, constipation or diarrhea.

Urinary system: staining of urine in a red-brown color due to the metabolite 2-oxymetronidazole.

Local reactions: itching, burning, irritation of the vaginal mucosa.

Allergic reactions.

Overdose:

With simultaneous use of metronidazole intravaginally and orally, an overdose is manifested by vomiting, diarrhea, ataxia, paresthesia, and convulsive syndrome.

Treatment is symptomatic. Hemodialysis is effective.

Interaction:

Metronidazole

With the simultaneous consumption of alcohol, disulfiram-like reactions develop: skin flushing, vomiting, cramping pain in the lower abdomen.

Enhances the effect of indirect coagulants.

Not compatible with non-depolarizing muscle relaxants ().

When used simultaneously, drugs that stimulate microsomal oxidation enzymes in the liver (phenithion,) accelerate elimination and reduce the concentration of metronidazole in the blood plasma.

Strengthens the toxic effects of lithium preparations.

When used simultaneously with cimetidine, the concentration of metronidazole in the blood serum increases, which leads to increased side effects.

Miconazole

Does not have a systemic effect.

Special instructions:

When treating trichomonas and candidiasis colpitis in women, it is necessary to treat sexual partners and abstain from sexual activity for the period of taking the drug.

Instructions

All active ingredients

Latin name[edit]

Metronidazole/Miconazole

Pharmacological group[edit]

Antifungal agents in combinations

Characteristics of the substance[edit]

Pharmacology[edit]

Pharmacological action - antifungal, antiprotozoal, antimicrobial.

Metronidazole/miconazole is a combination drug with antibacterial, antiprotozoal and antifungal effects for intravaginal use.

Metronidazole, a derivative of nitro-5-imidazole. The mechanism of its action is the biochemical reduction of the 5-nitro group 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 microorganisms.

Active against Trichomonas vaginalis, Entamoeba histolytica, Gardnerella vaginalis, Giardia lamblia, as well as against obligate anaerobes Bacteroides spp. (including B. fragilis, B. ovatus, B. distasonis, B. thetaiotaomicron, B. 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 maximum concentration of metronidazole in the blood is determined after 6-12 hours and is approximately 50% of the maximum concentration that is achieved (after 1-3 hours) after a single oral dose of metronidazole.

Systemic absorption of miconazole after intravaginal use is low.

Metronidazole passes into breast milk and most tissues, crosses the blood-brain barrier and the placenta.

Plasma protein binding is less than 20%.

Metabolized in the liver by hydroxylation, oxidation and glucuronidation. The activity of the main metabolite (2-oxymetronidazole) 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. Rapidly destroyed in the liver.

Miconazole does not overcome histogematic barriers well. 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.

Application[edit]

Local treatment of vaginitis of mixed etiology caused simultaneously by Trichomonas spp. and Candida spp.

Metronidazole/miconazole: Contraindications[edit]

leukopenia (including history);
organic lesions of the central nervous system (including epilepsy);
liver failure;
pregnancy (first trimester); lactation period (breastfeeding);
children under 12 years of age;
hypersensitivity to the components of the drug;
hypersensitivity to other azoles.

Use during pregnancy and breastfeeding[edit]

Metronidazole/miconazole is contraindicated for use in the first trimester of pregnancy. The use of metronidazole/miconazole in the second and third trimesters is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

During breastfeeding, the use of metronidazole/miconazole is contraindicated. If it is necessary to use the drug during lactation, breastfeeding should be stopped.

Metronidazole/miconazole: Side effects[edit]

Local reactions: burning, itching, pain and 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, constipation or diarrhea.

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: coloration of urine in a 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.

Interaction[edit]

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 metronidazole/miconazole can enhance the effect of indirect anticoagulants. Prothrombin time may increase, so dose adjustment of indirect anticoagulants is necessary.

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 to increase the concentration of lithium in the blood plasma during the course of treatment with metronidazole, therefore, before starting use, it is necessary to reduce the dose of lithium or stop taking it for the duration of treatment.

Metronidazole/miconazole: Method of administration and dosage[edit]

Intravaginally. 1 vaginal tablet (pre-moistened with water) is inserted deep into the vagina in the evening before bed for 10 days in combination with taking metronidazole orally.

Precautions[edit]

While using the drug metronidazole/miconazole, you should not drink alcohol (risk of developing disulfiram-like reactions).

During the period of use of the drug metronidazole/miconazole, it is recommended to abstain from sexual intercourse. Simultaneous treatment of sexual partners is recommended.

Metronidazole can immobilize treponemes, leading to a false-positive TPI test (Nelson test).

When used, slight leukopenia may be observed, so it is advisable to monitor the blood picture (the number of leukocytes) at the beginning and at the end of therapy.

If side effects from the central nervous system occur, you should refrain from driving vehicles and working with potentially dangerous mechanisms.

Storage conditions[edit]

Suppositories can be stored in the refrigerator (2–8 °C).

Trade names[edit]

Klion-D 100: vaginal tablets 100 mg + 100 mg; Gedeon Richter (Hungary)

Metromicon-Neo: vaginal suppositories 500 mg + 100 mg; Pharmaprim (Republic of Moldova)

Neo-Penotran: vaginal suppositories; Jenapharm (Germany)

Neo-Penotran Forte: vaginal suppositories 750 mg + 200 mg; Jenapharm (Germany)

wikimed.pro

Vaginal suppositories Metromicon- a combined drug with antifungal, antiprotozoal and antibacterial effects, an antiseptic and an antimicrobial drug for the treatment of gynecological diseases.
Contains metronidazole and miconazole nitrate.
Metronidazole is active against Trichomonas vaginalis, Gardnerella vaginalis, Giardia intestinalis, Entamoeba histolytica; anaerobic gram-negative bacteria: Bacteroides spp. (Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides vulgatus), Fusobacterium spp., Prevotella spp. (Prevotella bivia, Prevotella buccae, Prevotella 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 DNA of microbial cells, 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 pityriasis versicolor Malassezia furfur, causative agents of some dermatomycosis (Candida albicans, Trichophyton, Epidermophyton floccosum, Microsporum).

shows activity 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 inhibition of the biosynthesis of ergosterol in the fungal cell membrane, 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 when administered intravaginally 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 in the urine (unchanged and in the form of metabolites), and unchanged in feces. When miconazole is administered intravaginally, nitrate is only slightly absorbed.

Indications for use:
Candles Metromicon intended for the treatment of vaginal infections: trichomonas vaginitis and urethritis, anaerobic infections caused by microorganisms sensitive to metronidazole; vaginal and vulvovaginal candidiasis; superinfection caused by gram-positive microorganisms;

Directions for use:
Suppositories Metromicon used intravaginally. Adults: one vaginal suppository 1 time per day, immediately before bedtime for 10 days. Treatment is continued for several days after all symptoms of the disease disappear. The duration of treatment courses and their frequency are determined individually.

Side effects:
When using suppositories Metromicon Local reactions may occur: itching, burning, irritation of the vaginal mucosa, especially at the beginning of treatment.

Contraindications:
Contraindications to the use of suppositories Metromicon are: hypersensitivity to the components of the drug or to other nitroimidazole derivatives, first trimester of pregnancy.

Pregnancy:
Application Metromicon in the second and third trimesters of pregnancy is possible only under strict indications in the case where the expected benefit to the mother outweighs the potential risk to the fetus.

Interaction with other drugs:
When used simultaneously, the drug Metromicon enhances the effect of indirect anticoagulants, antidiabetic drugs (sulfonamides, urea derivatives), phenytoin.

Overdose:
Cases of drug overdose Metromicon if the recommended doses are observed, they have not been identified.

Storage conditions:
Store in a dry place, protected from light, at a temperature not exceeding 15 - 25o C. Keep out of the reach of children.

Release form:
Metromicon - vaginal suppositories.
5 vaginal suppositories in a blister pack. 2 blister packs No. 5 together with instructions for use are placed in a cardboard box.

Compound:
1 vaginal suppository Metromicon contains:
Active ingredients: metronidazole 100 mg, miconazole nitrate 100 mg.
Excipients: semi-synthetic glycerides up to 2.0 g.

Additionally:
When using the drug Metromicon Alcohol consumption is contraindicated. You should abstain from sexual intercourse.
When treating trichomoniasis, simultaneous treatment of the sexual partner should be carried out.
Use with caution in severe liver dysfunction, hematopoietic disorders and diseases of the peripheral and central nervous system.

www.medcentre.com.ua

Release form and composition

Composition of 1 suppository:

active ingredients: metronidazole – 500 mg; miconazole nitrate – 100 mg;
auxiliary components: semi-synthetic glycerides (Suppotsir AM).

Pharmacological properties

Pharmacodynamics

Aerobic microorganisms are resistant to metronidazole, but in mixed flora (anaerobes and aerobes) the drug acts in synergy with antibiotics that are effective against ordinary aerobes.

Pharmacokinetics

When administered intravaginally, miconazole nitrate is absorbed in small quantities and is not detected in the blood plasma.

Indications for use

According to the instructions, Metromicon-Neo is indicated for use for the following vaginal infections:

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

Contraindications

Absolute:

virginity;
first trimester of pregnancy, lactation period;
age under 18 years;
increased individual sensitivity to metronidazole, other nitroimidazole derivatives, miconazole or any excipient of the drug.

Instructions for use Metromicon-Neo: method and dosage

Metromicon-Neo suppositories are used intravaginally. Having freed the suppository from the contour packaging using scissors, insert it deep into the vagina.

for bacterial vaginosis, acute vaginitis: one suppository 2 times a day, in the morning and immediately before bed, for 7 days;
for chronic vaginitis: one suppository 1 time per day at night for 14 days;
for frequently recurrent vaginitis or the absence of a positive clinical effect from the use of other treatment methods: one suppository 2 times a day, in the morning and before bed, for 14 days.

Side effects

local reactions: irritation of the vaginal mucosa, increased swelling, itching, burning. With vaginitis, irritation may increase after using the first suppository or on the third day of treatment due to inflammation of the vaginal mucosa. As a rule, these symptoms disappear quickly after cessation of therapy;
from the nervous system: ataxia (motor disorders), headache, dizziness, convulsions, psycho-emotional disorders;
from the digestive system: abdominal pain/cramps, diarrhea, constipation, nausea/vomiting, dry mouth, metallic taste, loss of appetite;
from the hematopoietic system: leukopenia;
allergic reactions: skin rash (including urticaria).

Overdose

Low absorption of the active components of the drug Metromicon-Neo eliminates overdose, provided the recommended dosage regimen is followed.

Treatment consists of symptomatic and supportive therapy. In case of accidental ingestion of the drug, gastric lavage is recommended.

Special instructions

During the treatment period and after completion of the course of therapy, ethyl alcohol should be avoided for 24–48 hours due to the likelihood of developing disulfiram-like reactions.

In case of severe irritation of the vaginal mucosa, the drug must be discontinued.

Suppositories must be administered only intravaginally; swallowing and using them in other ways is prohibited.

When using the drug Metromicon-Neo together with metronidazole for oral use, especially with a repeated course, the peripheral blood picture should be monitored due to the risk of leukopenia.

Impact on the ability to drive vehicles and complex mechanisms

Use during pregnancy and lactation

Use in childhood

Metromicon-Neo is contraindicated in children and adolescents under 18 years of age.

For impaired renal function

In case of renal failure, the use of Metromicon-Neo requires caution.

For liver dysfunction

Metromicon-Neo should be prescribed to patients with impaired liver function with caution.

Drug interactions

The use of metronidazole and miconazole nitrate simultaneously with certain drugs can lead to the development of the following effects:

oral anticoagulants: enhancing the effect of indirect anticoagulants;
phenytoin: increased concentration of phenytoin in the blood, decreased concentration of metronidazole in the blood;
cimetidine: increased concentration of metronidazole in the blood;
disulfiram: development of disorders of the central nervous system in the form of mental reactions. It is not recommended to prescribe metronidazole to patients taking disulfiram for the past two weeks;
lithium preparations: increased toxicity;
phenobarbital: decreased concentration of metronidazole in the blood;
terfenadine, astemizole: an increase in their concentration in the blood plasma as a result of suppression of their metabolism by metronidazole and miconazole;
ethanol: development of disulfiram-like reactions.

Analogues

Analogs of Metromicon-Neo are: Ginocaps, Neo-Penotran, Neo-Penotran Forte and others.

Terms and conditions of storage

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

Keep away from children.

Shelf life – 3 years.

Conditions for dispensing from pharmacies

Dispensed by prescription.

Reviews about Metromicon-Neo

Judging by the reviews, Metromicon-Neo is not suitable for all patients. Quite often, suppositories cause irritation in the vagina, as well as nausea and abdominal pain. In addition, after a course of treatment with the drug, many women require restoration of the vaginal microflora.

Price for Metromicon-Neo in pharmacies

The average price for Metromicon-Neo is 370 rubles per pack of 14 pcs.

www.neboleeem.net

Analogs, articles Comments

Registration number:

Trade name of the drug:

Metromicon-Neo

INN or group name:

metronidazole + miconazole.

Dosage form:

vaginal suppositories

Compound:

One suppository contains:
active substances: metronidazole 500 mg, miconazole nitrate 100 mg;
excipients: semisynthetic glycerides (Suppotsir AM) - a sufficient amount to obtain a suppository weighing 2000 mg.

Description:
White or white with a yellowish tint, torpedo-shaped suppositories. An air rod or funnel-shaped depression is allowed on the cut.

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 effects. Contains metronidazole and miconazole.

Pharmacodynamics.

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.

Pharmacokinetics.

Compared with oral administration, the bioavailability of metronidazole when administered intravaginally 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. When administered intravaginally, 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 the components of the drug or other nitroimidazole derivatives, first trimester of pregnancy, lactation period, children under 18 years of age; in virgins.

With caution prescribed for 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 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 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.

Directions for use and doses

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 bedtime, for 14 days in a row.

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 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, movement disorders (ataxia), dizziness, psycho-emotional disorders, convulsions.

From the hematopoietic system:
leukopenia.

Allergic reactions:
skin rashes, including urticaria.

Overdose

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 coloration of 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.

Interaction with other drugs
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 be observed; 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.

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 metronidazole 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 the suppository base).

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

Release form

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

Storage conditions

In a dry place, protected from light, at a temperature of 15 to 25° C.
Keep out of the reach of children.

Best before date

3 years.
Do not use after the expiration date!

Conditions for dispensing from pharmacies

Dispensed with a doctor's prescription.

Manufacturing company
FARMAPRIM LLC, address: Republic of Moldova,
MD-2028, Chisinau, st. G. Tudor, 3.

Catad_pgroup Local antibacterials used in gynecology

Metromicon-Neo - instructions for use

Registration number:

LP-001676

Trade name of the drug:

Metromicon-Neo

INN or group name:

metronidazole + miconazole.

Dosage form:

vaginal suppositories

Compound:

One suppository contains:
active substances: metronidazole 500 mg, miconazole nitrate 100 mg;
excipients: semisynthetic glycerides (Suppotsir AM) - sufficient quantity to obtain a suppository weighing 2000 mg.

Description:
White or white with a yellowish tint, torpedo-shaped suppositories. An air rod or funnel-shaped depression is allowed on the cut.

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 effects. Contains metronidazole and miconazole.

Pharmacodynamics.

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.

Pharmacokinetics.

Compared with oral administration, the bioavailability of metronidazole when administered intravaginally 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. When administered intravaginally, 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.