international and chemical names: ketoconazole; 1-atsetil-4-[4-[[(2RS,4SR)-2-(2,4 dichlorophenyl)-2-(1H-imidazole-1-илметил) - 1,3-dioxolane-4il] metoks] phenyl] piperazin;
Main physical and chemical characteristics: cream of white or almost white color;
Structure. 1 g of drug includes a ketokonazol of 0,02 g;
other components: propylene glycol, imidourea, isopropyl myristate, cetostearyl alcohol, a macrogoal the 12th cetostearyl ether, octyllauryl alcohol, potassium dihydrophosphate, dinatrium phosphate dodecahydrate, the water purified.
Form of release of medicine. Outside use cream.
Farmakoterapevtichesky group. Antifungal drugs for local use. Derivatives of an imidazole and triazole. Code of automatic telephone exchange D01A C08.
Effect of the medicine.
Pharmacodynamics. Ketokonazol-fitofarm - antifungal drug. The antifungal effect is caused by suppression of synthesis of ergosterol and change of structure of other lipidic components of membranes of mushrooms. Ketokonazol shows fungicidal and a fungistasis concerning dermatophytes (Trichophyton spp., Epidermophyton floccosum, Microsporum spp.), barmy mushrooms (Candida spp., Pityrosporum, Torulopsis, Cryptococcus, Malassezia furfur), dimorphous highest mushrooms (eumitset). Are less sensitive to a ketokonazol of Aspergillus spp., Sporotrix schenskii, some Dermatiaceae, Mucor spp. and other fukomitseta except for Entomophthrales. Development of resistance during treatment by drugs of a ketokonazol is not revealed. Drug quickly liquidates an itch.
Pharmacokinetics. At topical administration of cream ketokonazol it is practically not soaked up; at prolonged use in blood it is not found.
Indications for use. For topical treatment and prevention of diseases of skin which are caused by activators, sensitive to a ketokonazol, such as: dermatomycosis of smooth skin; inguinal epidermophitia; epidermophitia of brushes and feet, and also candidiasis of skin and chromophytosis. Treatments seborrheal to dermatitis that the caused Pityrosporum ovale.
Way of use and dose. Cream is applied locally. Before putting drug it is necessary to clear and dry affected areas carefully. At treatment of a dermatomycosis of smooth skin, an inguinal epidermophitia, epidermophitia of brushes and feet, skin candidiases, and also a chromophytosis it is recommended to apply cream of 1 times a day on an affected area and a site of skin which directly adjoins to it. At treatment of seborrheal dermatitis cream is applied by 1 or 2 times a day depending on extent of defeat.
Treatment should be continued during final time, at least within several more days after disappearance of all symptoms of a disease and before receiving negative results of mycologic research. If no clinical improvement after 4 weeks of treatment is found, drug should be cancelled, and the diagnosis – to reconsider.
It is necessary to adhere to the general actions of hygiene for prevention of infection and a reinfitsirovaniye.
The usual term of treatment makes: a chromophytosis – 2 - 3 weeks; barmy infections – 2 - 3 weeks; an inguinal epidermophitia – 2 - 4 weeks; a dermatomycosis of smooth skin – 3 - 4 weeks; an epidermophitia of feet – 4 - 6 weeks; seborrheal dermatitis – 2 - 4 weeks, but for a maintenance therapy at this disease continue to apply cream 1 - 2 time a week.
Side effect. In places of application of drug there can seldom be local irritations of skin and a burning sensation or local manifestation of allergic reaction in the form of contact dermatitis.
Contraindications. Hypersensitivity to a ketokonazol or other components of drug.
Overdose. Because system absorption of a ketokonazol at topical administration is practically absent, overdose is improbable.
Use of cream in excessive can lead quantities to emergence of an erythema, a cutaneous dropsy and burning. These symptoms ordinary disappear after a therapy suspension.
Features of use. Cream is intended only for outside use on skin. It is necessary to avoid its hit in eyes. At hit of cream in eyes they need to be washed out water.
If in 4 weeks after an initiation of treatment clinical improvement is noted, it is necessary to confirm the diagnosis with a microbiological method and to exclude other cause of illness.
To avoid a withdrawal after a suspension of prolonged topical treatment corticosteroids recommend to continue external use of corticosteroids in the morning, and cream "Ketokonazol-Fitofarm" in the evening with a further gradual dose decline and cancellation of corticosteroids within 2 - 3 weeks.
Pregnancy and lactation. As the resorption of a ketokonazol at topical administration of creams is practically absent, use of drug during pregnancy and a lactation is possible.
Interaction with other medicines. Interaction with other medicines is not revealed.
Conditions and periods of storage. To store in the place, nedostupnry for children, at a temperature from 15 °C to 25 °C. Not to freeze. A period of validity – 2 years.