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 forte No. 7 vaginal suppositories
Metromicon forte No. 7 vag.supp
Composition of the drug 1 vaginal suppository contains: Active substances: metronidazole 750 mg, miconazole nitrate 200 mg. Excipients: semi-synthetic glycerides.
Description of the drug Vaginal suppositories of a cylindroconical shape, white in color with a yellowish tint. The cut is allowed to have an airy porous rod and a funnel-shaped depression. Pharmacotherapeutic group and ATC code Antiseptics and antimicrobials for the treatment of gynecological diseases. Combinations of imidazole derivatives. ATX code: G01A F20
Pharmacological properties Pharmacodynamics Metromicon Forte is a combination 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 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 ergosterol biosynthesis, changes in lipid composition and cell wall permeability, which causes fungal cell death. Pharmacokinetics The bioavailability of metronidazole when used intravaginally in the form of pessaries is 20% of the administered dose. Passes through the blood-brain and placental barrier, penetrates into breast milk. Metabolized in the liver to form active hydroxyl metabolites. The half-life of metronidazole is 6-11 hours. It is excreted by the kidneys (about 20% unchanged) and with feces. Systemic absorption of miconazole after intravaginal administration is low (approximately 1.4% of the dose). 8 hours after application of the drug, 90% of miconazole is still present in the vagina. Unchanged miconazole is not detectable in either plasma or urine.
Indications Local treatment of vaginal infections: - bacterial vagina3 - trichomonas vulvovaginitis; - vaginal candidiasis; - vaginitis caused by mixed infections.
Method of administration and dosage : Intravaginally, one pessary 1 time per day, immediately before bedtime, for 7 days. For recurrent vaginitis or vaginitis resistant to other types of treatment, one pessary is prescribed once a day, before bed, for 14 days.
Side effects MedDRA convention on frequency Very common (≥1/10); frequent (≥1/100, with vaginal use of the drug, side effects occur rarely (>1/10000 and Gastrointestinal disorders: abdominal pain or cramps, metallic taste, dry mouth, constipation, diarrhea, loss of appetite, nausea , vomiting. Disorders of the nervous system: headache, motor disorders (ataxia), dizziness, psycho-emotional disorders, peripheral neuropathy (with long-term use of the drug), convulsions. Disorders of the hematopoietic system: leukopenia. Disorders of the genitourinary system: staining of urine in a red-brown color, due to the presence of a water-soluble pigment formed as a result of the metabolism of metronidazole. Allergic reactions: urticaria, itching of the skin, rash. Local reactions: itching, burning, pain and irritation of the vaginal mucosa, especially at the beginning of treatment, which does not require cessation of treatment and is determined by the effect of the drug on the inflamed vaginal mucosa.In case of severe irritation, treatment should be discontinued.
Contraindications - Hypersensitivity to the components of the drug or to other nitroimidazole derivatives; - epilepsy; - porphyria; - severe liver dysfunction; — I trimester of pregnancy, lactation period; - children under 18 years of age.
Overdose To date, no cases of drug overdose have been reported. Precautions and particulars of use Pessaries should only be used intravaginally and should not be swallowed or used in any other way. Do not cut into pieces, since such a change in the storage conditions of the drug can lead to disruption of the distribution of the active substance. Pregnancy and lactation 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. Breastfeeding can be resumed 24 to 48 hours after the end of treatment. Impact on the ability to drive a car and use dangerous mechanisms If side effects from the central nervous system occur, you should refrain from driving vehicles and working with potentially dangerous mechanisms. Interaction with other drugs, other interactions When used simultaneously, metronidazole enhances the effect of indirect anticoagulants. Prothrombin time may increase, so dose adjustment of indirect anticoagulants is necessary. With the simultaneous use of metronidazole with disulfiram, the development of various neurological symptoms is possible; with phenytoin, the level of phenytoin in the blood increases, and the level of metronidazole in the blood decreases; with lithium preparations, an increase in the toxicity of the latter may be observed; with phenobarbital, the level of metronidazole in the blood decreases; with cimetidine, the level of metronidazole in the blood may increase. Metronidazole and miconazole nitrate inhibit the metabolism of astemizole and terfenadine, resulting in increased plasma concentrations of astemizole and terfenadine. It is possible to change the concentration of theophylline and procainamide in the blood plasma when used simultaneously with the drug Metromicon Forte.
Release form, packaging 7 pessaries in a blister pack. 1 blister pack along with instructions for use in a cardboard box. Storage conditions Store in a dry place, protected from light, at a temperature of 15-25˚C. Keep out of the reach of children.
Shelf life: 3 years. Do not use the drug after the expiration date indicated on the package.
Dispensing conditions Dispensed with a doctor's prescription
