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Pharmacological properties Pharmacotherapeutic group: Imidazole derivative/broad spectrum antimycotic drug ATC Code: G01AF02 The mode of action of clotrimazole is primarily fungistatic while at high concentrations it is fungicidal. Clotrimazole only acts on proliferating fungal elements. Current scientific information suggests that the antimycotic effect of clotrimazole stems from inhibition of ergosterol biosynthesis. Since ergosterol is an essential component of the cell membrane of fungi, the influence of clotrimazole is such that, after a delay due to consumption of the cytoplasmic ergosterol of the fungal cell, major changes occur in composition and properties of the membrane. The attendant impairment of membrane permeability finally leads to cell lysis. In addition, fungistatic concentrations of clotrimazole interfere with mitochondrial and peroxisome enzymes. As a consequence, the hydrogen peroxide concentrations rise to toxic levels, and this probably leads to necrocytosis (“hydrogen peroxide auto-digestion”). In vitro and in vivo clotrimazole has a broad spectrum of activity, which includes dermatophytes, fungi, moulds and dimorphic fungi. Under suitable test conditions the MIC values for these types of fungi are in a range of less than 0.062 – 4 (– 8) μg/ml substrate. In addition to its antimycotic activity clotrimazole also inhibits in vitro the reproduction of corynebacteria and gram-positive cocci, except for enterococci, in concentration of 0.5 –10 μg/ml substrate and is active with 100 μg/ml of trichomonazide. In terms of resistance clotrimazole can be classified positively, primary resistant types of fungal species are very rare, secondary resistance development of sensitive fungi have only been observed in very isolated cases under therapeutic conditions. Pharmacokinetic properties Pharmacokinetic experiments after dermal and vaginal application show that only a small part of less than 2 or rather 3 – 10 % of the clotrimazole dose is absorbed. Resultant peak plasma concentrations are less than 10 ng/ml and do not result in detectable systemic effects or side-effects. Clotrimazole undergoes oxidation and degradation of the imidazole ring (deamination, o-dealkylation) in the liver to yield ineffective hydroxy derivatives and is mainly excreted via the bile with the faeces

The active substance is Clotrimazole. 1 vaginal tablet contains 100 mg clotrimazole. The other ingedients are: lactose mono - hydrate, microcrystalline cellulose, sodium dodecyl sulphate, hypromellose, cellulose powder, colloidal anhydrous silica, magnesium stearate. Clotri-Denk 100 Vaginal is available in packs of 6 or 102 vaginal tablets.

Clotri-Denk 100 Vaginal is a drug used in the treatment of vaginal fungal infections. Clotrimazole, the active ingredient of Clotri-Denk 100 Vaginal, acts by inhibiting the growth and proliferation of fungal cells, such as yeasts (usually candida species) as well as a number of other fungal elements and some bacteria. Clotri-Denk 100 Vaginal is used for vaginal inflammation and discharge caused by a fungus (usually candida).

Do not use Clotri-Denk 100 Vaginal if you are allergic (hypersensitive) to clotrimazole or any of the other ingredients. Take special care with Clotri-Denk 100 Vaginal The concomitant application of latex products (e.g. condom or diaphragma) can cause a reduced function of these products and therefore a reduction in security due to the excipients of Clotri-Denk 100 Vaginal.

Side effects Uncommon: skin reactions (e.g. burning, stinging, reddening). In single patients generalized hypersensitivity re actions of different intensity may occur. These may affect the skin (e.g. itchin and reddening), respiration (e.g. dyspnea), circulation (decrease of blood pressure which requires treatment, up to reduced state of consciousness), gastro-intestinal system (nausea and diarrhea).

Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Clotri-Denk 100 Vaginal reduces the efficacy of other pharmaceuticals which are also taken for treatment of fungal diseases (amphotericin and other polyene anti biotics such as nystatin and natamycin).

If you use more Clotri-Denk 100 Vaginal than you should External use is not expected to cause intoxication. If you forget to use Clotri-Denk 100 Vaginal Use only one vaginal tablet the next time again and continue treatment as recommended.  If you stop using Clotri-Denk 100 Vaginal The treatment must be applied regularly and for an adequate period of time in order for it to be effective. If, nevertheless, you do not use the medication as directed, the fungal infection is likely to recur, as it more than likely has not fully healed. If you have any further questions regarding the use of this product, please ask your doctor or pharmacist.

Always use Clotri-Denk 100 Vaginal exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Medical advice should be sought if this is the first time such symptoms have occurred or if the patient has had more than 4 infections in the past 12 months. Patients aged 18 years and under should only receive treatment after consultation with a doctor and treatment should only take place under medical supervision. Usual dose If not otherwise prescribed by your physician insert one vaginal tablet daily as deep as possible for six consecutive days, preferably at night. Mode of application Clotri-Denk 100 Vaginal is best given with the patient lying on the back with legs slightly bent up. Use with applicator 1. The vaginal tablet is removed from the aluminium foil and placed in the applicator. 2. The applicator containing the tablet is then inserted as deeply as possible into the vagina. The vaginal tablet is deposited in the vagina by carefully pushing the plunger until it stops. 3. The applicator is removed from the vagina after use and cleaned carefully with warm water. The plunger is removed from the applicator for cleaning. Caution when cleaning: Do not use boiling water! Use without an applicator The vaginal tablet can also be deposited by hand into the vagina. Hands should be washed thoroughly afterwards. Note: It is not advisable to administer treatment during a period (menstruation). Treatment should be finished before the onset of menstruation. The medication should only be administered during menstruation if symptoms are severe. If treatment with Clotri-Denk 100 Vaginal is necessary during pregnancy, it should only be given as directed by a doctor and an applicator should not be used. To avoid possible re-infection the partner should be examined by the doctor at the same time. Duration of treatment Generally, a course of treatment lasting 6 days is adequate. The treatment can be repeated if necessary. Please speak to your doctor or pharmacist if you feel that the effect of Clotri-Denk 100 Vaginal is too strong or too weak.

Store in a dry place below 25 °C. Do not use after the expiry date which is stated on the carton. Keep out of reach and sight of children.