for medical use
the Trade name
the International unlicensed
name Clotrimazolum Dosage Form
of the Tablet vaginal 100 mg
One tablet contains
active agent – Clotrimazolum of 100.0 mg,
excipients: lactoses monohydrate, starch corn, cellulose microcrystalline, silicon dioxide colloidal anhydrous, adipic acid, calcium stearate.
of the Tablet of white or almost white color, an oval form, with a biconvex surface.
of Antiseptics and antimicrobial and antiseptic drugs for treatment of gynecologic diseases. Imidazole derivatives. Clotrimazolum.
The ATX G01A F02 code
Pharmacokinetics At properties intravaginalny introduction absorption is 3-10% of the entered dose. High concentrations in a vaginal secret and low concentration in blood remain during 48-72 h. The absorbed Clotrimazolum is metabolized in a liver to inactive metabolites and removed with urine and a stake.
Clotrimazolum – synthetic anti-mycotic and antiprotozoan (trikhomonatsidny) means of group of derivatives of an imidazole. The mechanism of action consists in slowing down of synthesis of the ergosterol necessary for creation of a cellular membrane of mushrooms that leads to disturbance of its permeability and the subsequent lysis of a cell. In the minimum bactericidal concentration Clotrimazolum promotes an exit from cells of potassium, compounds of phosphorus and to destruction of cellular nucleic acids. Inhibits synthesis of triglycerides and phospholipids. Besides, oppressing activity of peroxidases, Clotrimazolum increases concentration of peroxide of hydrogen in a mushroom cell to toxic level that leads to the subsequent destruction of a cell.
The spectrum of action of Clotrimazolum includes dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis and also Coccidioides immitis, Histoplasma capsulatum, Aspergillus spp.), barmy mushrooms (Candida spp., including Candida albicans), staphylococcus (Staphylococcus spp.), activators of an erythrasma (Corynebacterium minutissimum), trichomonad (Trichomonas vaginalis).
– the genital infections caused by barmy mushrooms of the sort Candida and/or Trichomonas vaginalis (candidosis vulvitis, a vulvovaginitis, trichomoniasis).
The route of administration and doses
Usually use drug on 1 tablet 2 times a day within 3 days or on 1 tablet a day within 6 – 7 days. The tablet should be entered deeply into a vagina. Treatment has to be complete prior to the beginning of periods.
– an itching, reddening, pain and hypostasis of a mucous membrane in the field of an entrance to
a vagina (at emergence of these symptoms the treatment should be stopped)
– hypersensitivity to Clotrimazolum or other components
– pregnancy and the period of a lactation
– the menstrual period
– children’s age up to 18 years
– at simultaneous use of Clotrimazolum with nystatin the activity
of Clotrimazolum can decrease
– the dexamethasone applied in high doses reduces antifungal
effect of Clotrimazolum
– antimicrobic effect of Clotrimazolum is strengthened by high local
concentrations of propyl ether of p-hydroxybenzoic acid
– at simultaneous use Clotrimazolum reduces activity
of Amphotericinum B and other half-yen antibiotics.
simultaneous processing of external genitals of 1% ointment or in 1% Clotrimazolum solution is On doctor’s orders possible, if necessary additional system medicines can be appointed by the doctor (for example, metronidazole inside). At patients with an abnormal liver function it is necessary to check its functional state periodically. In the absence of effect, it is necessary to conduct a microbiological research for confirmation of the diagnosis and an exception of other cause of illness. Simultaneous treatment of both sexual partners is recommended.
Emergence of irritation or other manifestations of hypersensitivity demands obligatory consultation of the doctor.
Drug can reduce efficiency of the contraceptives made of latex (condoms, diaphragms). This effect temporary is also observed only during treatment.
It is necessary to use drug throughout all term of treatment even if symptoms of a disease disappeared earlier. Observance of these recommendations will help to prevent development of reinfection.
It is forbidden to apply tablets inside!
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
at control of motor transport or work with other mechanisms was not reported About cases of influence of drug on speed of response.
Information is absent.
Form of release and packing
of the Tablet vaginal 100 mg. On 10 tablets in blister strip packaging from a film of the polyvinylchloride and printing aluminum foil varnished. On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in original packing at a temperature not higher than 25 wasps.
To store out of children’s reach!
not to use a period of storage after an expiration date.
the Public joint stock company Producer Borshchagovsky Chemical and Pharmaceutical Plant research and production center.
Ukraine, 03134, Kiev, Mira St., 17.
The name and the country of the owner of the registration certificate
Borshchagovsky Chemical and Pharmaceutical Plant research and production center Public joint stock company, Ukraine
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
Representative office of PJSC NPC Borshchagovskiy HFZ in the territory of the Republic of Kazakhstan
050063, Almaty, Auezovsky district, mdt. Zhetysu-3, house 25, office 27
fax: +7 (272) 313-23-34,