Name:
Clomesol supp vag. in pack No. 5×2
Description:
White or white with a yellowish tint suppositories of cylindrical conical shape. The main active ingredient Clotrimazole Release form Suppositories Pharmacodynamics Combined drug with antimicrobial, antifungal and antiprotozoal action, intended for topical use. Clotrimazole is an imidazole derivative, an antifungal agent for topical use. The mechanism of action is due to a violation of the synthesis of ergosterol, which is an integral part of the cell membrane of fungi. Has a wide spectrum of action. Active against dermatophytes, Candida albicans, Malassezia furfur; Corynebacterium minutissimum, Streptococcus spp., Staphylococcus spp., Trichomonas vaginalis. Metronidazole is a derivative of 5-nitroimidazole with antiprotozoal and antibacterial action. Active against: gram-negative anaerobes – Bacteroides spp., including the group Bacteroides fragilis, Fusobacterium spp.; gram-positive anaerobes – Clostridium spp., Eubacterium spp., anaerobic gram-positive cocci, including Peptococcus spp. and Peptostreptococcus spp. protozoa – Trichomonas vaginalis, Giardia intestinalis, Entamoeba histolytica. The nitro group of the metronidazole molecule, as an electron acceptor, is introduced into the respiratory chain of protozoa and anaerobes (it competes with electron-transporting proteins), disrupting the respiratory processes and provoking cell death. In some species of anaerobes, it inhibits DNA synthesis and leads to their degradation. Neomycin is an antibiotic of the aminoglycoside group with a wide spectrum of bactericidal action. The mechanism of action is due to a direct effect on ribosomes and inhibition of protein synthesis in a bacterial cell. A number of gram-positive and gram-negative microorganisms are sensitive to the drug, incl. Escherichia coli, Shigella spp., Proteus spp., Staphylococcus aureus, Streptococcus pneumoniae, Mycobacterium tuberculosis. It has low activity against Pseudomonas aeruginosa and Streptococcus spp. Inactive against pathogenic fungi, viruses and anaerobic microorganisms. Pharmacokinetics The bioavailability of metronidazole with intravaginal use is about 20%. Metabolized in the liver. Hydroxyl metabolites are active. Passes through the blood-brain and placental barrier, penetrates into breast milk. The half-life of metronidazole is 6-11 hours. Excreted by the kidneys (about 20% unchanged) and intestines. Clotrimazole – about 3-10% of the dose is absorbed. In the liver, it is rapidly biotransformed to inactive metabolites and excreted by the kidneys and intestines. High concentrations in the vaginal secretion and low concentrations in the blood persist for 48-72 hours. Neomycin does not penetrate through the mucous membranes. Indications for use – as an adjunct to systemic therapy for urogenital trichomoniasis. – local therapy of bacterial vaginosis, candidal colpitis, mixed vaginal infection caused by sensitive microflora. Dosage and administration Intravaginally. In acute vaginitis: 1 pessary 2 times a day (morning and evening), for 1-2 days, then 1 pessary in the evening, for 6-8 days. For chronic vaginitis: 1 pessary in the evening for 8-10 days. For the purpose of prevention in the treatment of corticosteroids, immunosuppressants, cytostatics, antibiotics: 1 pessary in the evening, every 7-10 days. Use during pregnancy and lactation 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 With caution prescribed for severe violations of liver function, impaired hematopoiesis (leukopenia, etc.) and diseases of the nervous system. When using the drug should refrain from sexual intercourse. The use of pessaries can reduce the reliability of mechanical contraception (condoms, vaginal diaphragms) due to the interaction of the pessary 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 should be avoided (possibility of developing disulfiram-like reactions). Pregnancy and lactation 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. Influence on the ability to drive vehicles and control potentially dangerous mechanisms A possible negative effect on the ability to drive vehicles and control complex mechanisms cannot be ruled out. Such effects are extremely rare due to low systemic bioavailability when administered topically. Interaction with other drugs With the simultaneous use of metronidazole enhances the effect of indirect anticoagulants. With simultaneous use with disulfiram, CNS disorders may occur. With simultaneous use with lithium preparations, an increase in the toxicity of the latter can be observed. With simultaneous use with phenobarbital, the level of metronidazole in the blood decreases. With simultaneous use with cimetidine, the level of metronidazole in the blood may increase. Interaction with alcohol can cause disulfiram-like reactions. Dexamethasone in high doses inhibits the antifungal effect of clotrimazole. Contraindications Hypersensitivity to the components of the drug, I trimester of pregnancy, lactation, in virgins. Composition 1 vaginal suppository contains: Active substances: clotrimazole 150 mg, metronidazole 500 mg, neomycin sulfate 200 mg. Excipients: polysorbate 80, adipic acid, sodium lauryl sulfate, liquid paraffin, semi-synthetic glycerides up to 2.1 g. Overdose So far, no cases of drug overdose have been reported. Possible symptoms: nausea, vomiting, abdominal pain, diarrhea, itching, metallic taste in the mouth, ataxia, headache, dizziness, paresthesia, convulsions, leukopenia, dark urine staining (due to an overdose of metronidazole); Treatment: symptomatic therapy, in case of accidental ingestion – gastric lavage. Side effects 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, peripheral neuropathy (with prolonged use of the drug), convulsions. From the hemopoietic system: leukopenia. Allergic reactions: skin rashes, incl. hives. 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 Clomesol vaginal suppositories No. 5×2 The price of Clomesol vaginal suppositories No. 5×2
INN | METRONIDAZOLE+CLOTRIMASOL+NEOMYCIN |
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The code | 24 280 |
Barcode | 4 840 456 000 294 |
Active substance | Metronidazole, clotrimazole, neomycin |
Manufacturer | Farmaprim LLC, Moldova |
Importer | IOOO Interfarmaks 223028 Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Star, 19a-5, room. 5-2 |
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