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The instruction for medical use of KLOTRIM medicine the Trade name Klotrim the International unlicensed name Clotrimazolum Dosage Form of the Tablet vaginal Structure One tablet contains active agent – Clotrimazolum of 100 mg excipients: starch, magnesium stearate, lactose Description Biconvex tablets of white color, oval form. Pharmacotherapeutic group of Antiseptics and antimicrobial drugs for treatment of gynecologic diseases. Imidazole derivatives the Code of automatic telephone exchange G01AF02 the Pharmacological Klotrim Pharmacokinetics properties is badly soaked up through mucous membranes and has practically no systemic action. Intravaginalny absorption is from 3 to 10% of the entered dose. High concentrations in a vaginal secret and low concentration in blood remain within 48-72 hours. In a liver are quickly metabolized before inactive connections which are removed with urine. The pharmacodynamics Clotrimazolum is synthetic antifungal broad-spectrum agent for topical administration. It is active concerning pathogenic dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis), barmy and mold mushrooms (the sort Candida, Torulopsis glabrana, the sort Rhodotorula, Malassezia, furtur), multi-colored depriving of activators, erythrasmas, gram-positive (Staphylococcus, Streptococcus, Corinobacterium minutissimum) and gram-negative bacteria (Bacteroides, Gardnerella vaginalis), a protozo (Trichomonas vaginalis). Clotrimazolum influences the sharing and growing fungal cells. In small concentration works fungistaticly, and in big it is fungicidal, and not only on proliferating cells. In fungicide concentration interacts with mitochondrial enzymes and peroxidases therefore there is an increase in concentration of peroxide of hydrogen up to toxic level that promotes destruction of fungal cells. Clotrimazolum also inhibits biosynthesis of triglycerides, DNA and phospholipids, reduces activity of oxidases and peroxidases. In high concentrations damages a cellular membrane by means of the mechanisms depending on the synthesis of sterols which is a component of a cellular membrane of a microbic wall. The inhibition of synthesis of ergosterol leads to decrease in durability of compound of fungal P450 cytochrome and enzyme 14-α of a dismetilaza which catalyze transformation of a lanosterol into ergosterol. Indications – the genital infections caused by dermatophytes, mold and yeast-like mushrooms (candidosis vulvovaginitis, trichomoniasis) the Route of administration and doses. Vaginal tablets enter deeply into a vagina once a day or on doctor’s orders. The course of treatment approximately makes 6-7 days. Use of drug is combined with processing of external genitalias cream, ointment or solution containing Clotrimazolum. A repeated course of treatment after consultation with the attending physician. Side effects – local allergic reactions: an itching, reddening, pain and hypostasis of a mucous membrane in the field of an entrance of the vagina, discharges from a vagina – in isolated cases the general allergic reaction (is possible at hypersensitivity to active agent or its components) – gastrointestinal disturbances (vomiting, a diarrhea, pains in a stomach) – increase in level of enzymes of a liver – dysuric disturbances (the speeded-up urination) of the Contraindication – hypersensitivity to drug components – the first trimester of pregnancy – the periods period Medicinal interactions Amphotericinum B reduces efficiency of Clotrimazolum. Clotrimazolum slows down action of half-yen antibiotics (nystatin, natamitsin). Special instructions use of Clotrimazolum in the period of periods is not shown. Prevention of reinfection requires simultaneous treatment of sexual partners antifungal drugs. At emergence of signs of hypersensitivity or irritation of mucous membranes and skins stop treatment. In the absence of effect within 3 days it is necessary to confirm the diagnosis. Pregnancy and lactation. In II and III trimesters of pregnancy the issue of prescribing of this drug is resolved individually. During pregnancy the treatment by vaginal tablets should be carried out without use of the applicator. In the period of a lactation drug is appointed after consultation with the attending physician. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Clotrimazolum does not affect ability of driving of vehicles and service of the mechanical equipment in the movement. Overdose of Cases of overdose it is noted. The form of release and packing On 6 or 10 tablets place in a plastic bag in blister strip packaging from a film of polyvinylchloride and printing aluminum foil. On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages put in a box of cardboard. To Store storage conditions in the dry, dark place, at a temperature not over 25 ºС. To store in the place inaccessible for children! The period of storage not to use 3 years Drug after the storage expiration. Prescription status According to the prescription Producer Kwality Pharmaceuticals PVT, Ltd, India the Owner of the registration certificate of Denovo Impex LLP, Kazakhstan the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods): Republic of Kazakhstan, Almaty, Utegen St. of the batyr, 13 Ph.: +7 (7272) 771998 E-mail address of denovokz@rambler.ru

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