Metromicon-Neo vaginal suppositories 500mg/100mg №7×2

NameMetromicon-Neo supp.vag.500mg/100mg in a cell.pack No. 7×2 On the cut, the presence of an air and porous rod, and a funnel-shaped recess is allowed. The main active substance Metronidazole Release form Suppositories Dosage 500 mg / 100 mg Pharmacological action Antiseptics and antimicrobials for the treatment of gynecological diseases. Combinations of imidazole derivatives. ATX code: G01A F20 PharmacodynamicsMetromicon-Neo is a combined preparation with antiprotozoal, antifungal and antibacterial action. 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 microorganism cells, inhibiting the synthesis of their nucleic acids, which leads to the death of bacteria. The most sensitive to miconazole are dermatomycetes and yeasts. It is active against the causative agent of multi-colored lichen (Malassezia furfur), pathogens 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 of the shell and plasma membranes of fungi, changes in the lipid composition and permeability of the cell wall, causing the death of the fungal cell. Pharmacokinetics The bioavailability of metronidazole when administered intravaginally in the form of vaginal suppositories is 20%. Passes through the blood-brain and placental barrier, penetrates into breast milk. Metabolized in the liver. Hydroxyl metabolites are active. The half-life of metronidazole is 6-11 hours. Excreted by the kidneys (about 20% unchanged) and intestines. With intravaginal administration of miconazole, nitrate is absorbed slightly and is not detected in plasma. Indications for use Metromicon-Neo is used for topical treatment of: bacterial vaginosis; trichomoniasis; candidal vaginitis; mixed vaginal infection. If you need more information about your condition, ask your doctor for advice. Method of administration and doses The use of this medicinal product is possible only after consulting a doctor! Do not stop taking Metromicon-Neo without first consulting with your doctor! If you have any doubts or questions, please contact your doctor. Metromicon-Neo is used intravaginally and injected deep into the vagina. With trichomoniasis, 1 vaginal suppository is prescribed 1 time per day, in the evening before bedtime for 7 days, in combination with taking metronidazole orally. In case of bacterial vaginosis, 1 vaginal suppository is prescribed 1-2 times a day, for 7 days, if necessary, in combination with metronidazole intake. With vulvovaginal candidiasis, 1 vaginal suppository is injected deep into the vagina 1 time per day for 7 days. For recurrent vaginitis or vaginitis resistant to other treatment: 1 vaginal suppository at night and 1 vaginal suppository in the morning for 14 days. Children: not recommended for children. Patients with renal / hepatic insufficiency Renal insufficiency: the half-life does not change. Dose reduction is not required. However, in severe cases requiring hemodialysis, dose adjustment is necessary. In cases of severe hepatic insufficiency, the clearance of metronidazole may be impaired. At high levels of metronidazole in blood plasma, an increase in the symptoms of encephalopathy can be observed, so metronidazole should be used with caution in patients with hepatic encephalopathy. The daily dose in patients with hepatic encephalopathy should be reduced to 1/3. With vulvovaginal candidiasis, 1 suppository Metromicon is injected deep into the vagina for 10 days, 1 time per day (in the evening before bedtime). Use during pregnancy and lactation If you are pregnant or breastfeeding, if you suspect that you are pregnant or do not rule out the possibility of pregnancy, tell your doctor about it. The drug is contraindicated in the first trimester of pregnancy. Application in the II and III trimesters of pregnancy is possible only if the potential benefit to the mother outweighs the possible risk to the fetus. If necessary, the appointment of the drug during lactation, breastfeeding should be discontinued. Breastfeeding can be resumed 24-48 hours after the end of treatment. Precautions and Precautions With caution prescribed for severe violations of liver function (including porphyria), impaired hematopoiesis, diseases of the peripheral and central nervous system. When using the drug should refrain from sexual intercourse. The use of suppositories can reduce the reliability of mechanical contraception (condoms, vaginal diaphragms) due to the interaction of the suppository base with latex or rubber. In order to prevent re-infection, simultaneous treatment of the sexual partner is necessary, and in the case of trichomonas vaginitis, oral preparations. During treatment and for 24-48 hours after the end of the course of treatment, alcohol intake should be avoided (possibility of developing disulfiram-like reactions). When using the drug, there may be a change in the level of liver enzymes in the blood and glucose (when determined by the hexokinase method). With severe irritation of the vagina, treatment with the drug should be discontinued. During therapy, other vaginal agents (tampons, syringe, spermicidal agents) should not be used. Do not swallow or otherwise apply! Interaction with other drugs If you are currently or have recently taken other drugs, tell your doctor. As a result of the absorption of metronidazole and miconazole nitrate, interactions with the drugs listed below may be noted: Oral anticoagulants: the effect of indirect anticoagulants is enhanced, which increases the risk of bleeding. Disulfiram: CNS disorders (mental reactions) may occur. Phenytoin: the concentration of phenytoin in the blood increases, and the concentration of metronidazole in the blood decreases. Lithium preparations: there may be an increase in their toxicity. Phenobarbital: The level of metronidazole in the blood decreases. Fentanyl: Increased long-term opioid effects (CNS depression, respiratory depression). Cimetidine: The level of metronidazole in the blood may increase. Astemizole, cisapride and terfenadine: Metronidazole and miconazole inhibit the metabolism of these drugs and increase plasma concentrations. Theophylline and procainamide: it is possible to change the concentration of theophylline and procainamide in the blood plasma with simultaneous use. Alcohol: The interaction of metronidazole with alcohol causes disulfiram-like reactions. Trimetrexate: Increased toxicity of trimetrexate (bone marrow suppression, renal and hepatic dysfunction, gastrointestinal manifestations). Tolterodine: Increased bioavailability of tolterodine in patients with insufficient cytochrome P450 2D6 activity. Pimozide: increased risk of cardiotoxicity (prolongation of the QT interval, bidirectional spindle-shaped ventricular tachycardia, cardiac arrest). Oxycodone: increased plasma concentrations of oxycodone. Decreased ground clearance. Oxybutynin: increased plasma concentration (exposure) of oxybutynin (dry mouth, constipation, headache). Cyclosporine: increased risk of cyclosporine toxicity (renal dysfunction, cholestasis, parasthesia). Carbamazepine: Decreased metabolism of carbamazepine. Glimepiride: increased hypoglycemic effect. Contraindications hypersensitivity to the components of the drug and its derivatives; 1 trimester of pregnancy; lactation (breastfeeding); children’s age up to 18 years; virginity; epilepsy; porphyria; severe liver dysfunction. Use in patients who drink alcohol during treatment or plan to use it within 3 days after the end of treatment: the interaction of metronidazole with alcohol causes the development of disulfiram-like reactions. Use in patients taking disulfiram during treatment or planning to use it within 2 weeks after the end of treatment: there may be changes in the central nervous system (mental reactions). Composition 1 suppository contains: active substances: metronidazole – 500 mg, miconazole nitrate – 100 mg; excipients: semi-synthetic glycerides. Overdose There are no data on overdose in humans with intravaginal use of metronidazole. After intravaginal administration, metronidazole may be absorbed in sufficient amounts to cause systemic effects. In case of accidental ingestion of large doses of the substance, if necessary, gastric lavage can be performed. Treatment can be prescribed to persons who have taken 12 g of metronidazole orally. There is no specific antidote. Symptomatic and supportive therapy is recommended. Symptoms of an overdose of metronidazole: nausea, vomiting, abdominal pain, diarrhea, itching, metallic taste in the mouth, movement disorders (ataxia), dizziness, paresthesia, convulsions, leukopenia, dark urine color. Symptoms of an overdose of miconazole nitrate: nausea, vomiting, inflammation of the throat and mouth, loss of appetite, headache, diarrhea. Side effects If side effects occur, tell your doctor about it. This applies to all possible side effects, including those not described in this package insert. 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, psychoemotional disorders, peripheral neuropathy (with prolonged use of the drug), convulsions. From the hemopoietic system: leukopenia. Allergic reactions: skin rashes, including urticaria. Local reactions: burning, itching, especially at the beginning of treatment, which, however, do not require discontinuation of treatment and are determined by the effect of the drug on the irritated vaginal mucosa. Storage conditionsStore in a dry and dark place, at a temperature of 15–25 °C. Keep out of the reach of children!Buy Metromicon-Neo vaginal suppositories 500mg/100mg №7×2