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Ketozoral

Препарат Кетозорал. ЗАО "Фармацевтическая фирма "Дарница" Украина


Producer: CJSC Pharmaceutical Firm Darnitsa Ukraine

Code of automatic telephone exchange: D01AC08

Release form: Soft dosage forms. Shampoo.

Indications to use: Skin candidiasis. Epidermophitia. Seborrheal dermatitis. Dandruff.


General characteristics. Structure:

Active ingredient: ketoconazole; 1 g of cream contains a ketokonazol of 20 mg.

excipients: propylene glycol, liquid paraffin, a macrogoal cetostearyl ether, cetostearyl alcohol, проксанол 268, sodium sulfite anhydrous, the imidourea, water purified.




Pharmacological properties:

Ketokonazol renders 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). Less sensitive to the drug Aspergillus spp., Sporotrix schenskii, some Dermatiaceae, Mucor spp. and other fukomitseta, except for Entomophthrales. The mechanism of action is connected with synthesis oppression to ergosterol and changes of structure of other lipidic components of membranes of mushrooms under the influence of drug. Development of resistance during treatment by drug was not observed.

At topical administration it is practically not soaked up. At long use кетоконазол in blood it is not found.


Indications to use:

The seborrheal dermatitis caused by Pityrosporum ovale yeast. Skin infections, such as epidermophitia of a body, hands, feet, inguinal epidermophitia, skin candidiasis, dandruff.


Route of administration and doses:

Appoint the adult. For treatment of candidiases of skin, an epidermophitia of a body, hands, feet, an inguinal epidermophitia and a chromophytosis Ketozoral®-Darnitsa cream is recommended to be applied on the affected skin and surrounding sites of 1 times per day.

For treatment of seborrheal dermatitis: Ketozoral®-Darnitsa cream is recommended to apply on affected areas of skin 1 or 2 times a day, depending on disease severity. Treatment has to last throughout sufficient time, at least, for 2-3 days after disappearance of all symptoms of a disease. In the absence of signs of clinical recovery for 4 weeks, the diagnosis needs to be revised.

Usual duration of treatment: a chromophytosis – 2–3 weeks, the infections caused by yeast – 2–3 weeks, an inguinal epidermophitia – 2–4 weeks, shingles – 3–4 weeks, epidermophitias of feet – 4–6 weeks. As a rule, duration of treatment of cases of seborrheal dermatitis represents 2–4 weeks. For the supported therapy at seborrheal dermatitis cream is applied 1 or 2 weekly for 2 weeks.


Features of use:

Special cautions. Drug is intended only for topical administration by the adult. It is not necessary to use drug in ophthalmology.

If Ketozoral®-Darnitsa cream is applied on the struck places at once after long treatment with ointments which contain a corticosteroid, there can be an irritation. In such cases it is recommended to continue to apply local a corticosteroid on the struck place in the morning, and Ketozoral®-Darnitsa cream in the evening, and then gradually for 2–3 weeks to stop steroid therapy.

Use during pregnancy or feeding by a breast. As the drug resorption is practically absent, use during pregnancy and feeding by a breast taking into account a ratio risk/advantage is possible.

Ability to influence the speed of reactions at control of motor transport or other mechanisms. Drug does not influence the speed of reactions at control of motor transport or other dangerous mechanisms.

Children. Efficiency and safety of use are not established.


Side effects:

In rare instances there can be a local irritation of skin and a burning sensation or local manifestation of allergic reaction in the form of contact dermatitis.


Interaction with other medicines:

Interaction with other remedies was not studied.


Contraindications:

Hypersensitivity to a ketokonazol or to any of cream components.


Overdose:

Excessive use of cream can lead to an erythema, hypostasis, a burning sensation which quickly pass after the therapy termination.


Storage conditions:

Period of validity. 2 years. To store in the place, unavailable to children, in original packaging, at a temperature from 15 °C to 25 °C. Freezing of drug is not allowed.


Issue conditions:

Without recipe


Packaging:

On 15 g, 30 g in tubas, on 1 tuba in a cardboard pack.



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