Clotrimazolum
Producer: JSC Chemical and Pharmaceutical Plant AKRIKHIN Russia
Code of automatic telephone exchange: D01AC01
Release form: Liquid dosage forms. Solution for external use.
General characteristics. Structure:
The operating substance: 1 g of Clotrimazolum in 100 ml of solution.
Excipients: isopropyl myristate, ethanol of 99,9%.
Pharmacological properties:
Pharmacodynamics. Clotrimazolum is antifungal broad-spectrum agent for topical administration. The anti-mycotic effect of active active ingredient of Clotrimazolum (derivative an imidazole) is connected with disturbance of synthesis of the ergosterol which is a part of a cellular membrane of mushrooms that changes permeability of a membrane and causes the subsequent lysis of a cell. In small concentration affects fungistaticly, and in big – fungitsidno, and not only proliferating cells. In fungicidal concentration interacts with mitochondrial and peroksidazny enzymes therefore there is an increase in concentration of peroxide of hydrogen up to toxic level that also promotes destruction of fungal cells.
It is effective concerning dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis), drozhzhepodobny and mold mushrooms, and also the activator multi-colored depriving of Pityriasis versicolor (Malazessia furfur) and the activator of an erythrasma. Has antimicrobic effect concerning gram-positive (Staphylococcus, Streptococcus) and gram-negative bacteria (Bacteroides, Gardnerella vaginalis), and also concerning Trichomonas vaginalis.
Pharmacokinetics. Clotrimazolum is badly soaked up through skin and mucous membranes and has practically no systemic action. Has penetration, collects in a corneous layer of epidermis, gets into a keratin of nails. At external use concentration of Clotrimazolum in epidermis is higher, than in a derma and hypodermic cellulose.
Indications to use:
- Fungus diseases of skin, skin folds, feet;
- the chromophytosis, erythrasma, superficial candidiases caused by dermatophytes, barmy (including the sort Candida), the mold and other mushrooms and activators sensitive to Clotrimazolum;
- the mycoses complicated by a secondary pyoderma.
Route of administration and doses:
Outwardly. Solution is applied with a thin layer on previously cleared (using soap with neutral PH value) also by dry affected areas of skin 2 times a day (in the morning and in the evening) and carefully rub.
Duration of treatment depends on disease severity, localization of pathological changes and efficiency of therapy.
Treatment of dermatomycoses is carried out by not less than 4 weeks, a chromophytosis — 1-3 weeks.
At fungus diseases of skin of legs therapy is recommended to be continued within not less than 2 weeks after elimination of symptoms of a disease.
Features of use:
Putting drug on skin in eyes is not recommended.
At emergence of signs of hypersensitivity or irritation treatment is stopped.
In the absence of effect within 4 weeks it is necessary to confirm the diagnosis.
Use during pregnancy and during feeding by a breast. At clinical and pilot studies it was not established that use of Clotrimazolum during pregnancy or during feeding by a breast exerts negative impact on health of the woman or a fruit (child). However, the question of expediency of purpose of drug in II and III trimesters of pregnancy has to be solved individually after consultation of the doctor. Putting drug directly on a mammary gland when breastfeeding is not recommended.
Side effects:
Allergic reactions (urticaria, hypostasis, rash, erythema) and local reactions are in rare instances observed (burning, an itch, a peeling of skin, paresthesia, irritation in drug sites of application).
With care: lactation period.
Interaction with other medicines:
Amphotericinum In, nystatin, натамицин reduce efficiency of Clotrimazolum at simultaneous use.
At solution use negative interactions with other means are not known and they should not be expected as rezorbtsionny ability of Clotrimazolum very low.
Contraindications:
- Hypersensitivity to Clotrimazolum or excipients of drug;
- I trimester of pregnancy.
Overdose:
There are no data on cases of overdose of Clotrimazolum at external use.
Storage conditions:
To store at a temperature from 15 °C to 25 °C, in the dry and protected from light place. To store in places unavailable to children. Not to apply after the expiration of term of the validity. A period of validity - 3 years.
Issue conditions:
Without recipe
Packaging:
Solution for external use of 1%. On 15 ml of drug in bottles of dark glass with the screwing-up cover from polyethylene. 1 bottle together with a polyethylene dropper and the application instruction is placed in a cardboard pack.