Clotrimazolum
Producer: CJSC Verteks Russia
Code of automatic telephone exchange: D01AC01
Release form: Soft dosage forms. Ointment.
General characteristics. Structure:
Active ingredient: 1 g of Clotrimazolum.
Excipients: propylene glycol, poly(ethylene oxide) 400, poly(ethylene oxide) 1500, methylparahydroxybenzoate (нипагин).
Antifungal broad-spectrum agent for local action.
Pharmacological properties:
Pharmacodynamics. Clotrimazolum is antifungal broad-spectrum agent for topical administration. The anti-mycotic effect of the active operating Clotrimazolum substance (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, 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, streptococci) 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. Concentration in deep layers of epidermis is higher, than the minimum overwhelming concentration for dermatophytes.
At external use concentration of Clotrimazolum in epidermis is higher, than in a derma and hypodermic cellulose.
Indications to use:
- fungus diseases of skin, mycoses of skin folds, feet;
- the chromophytosis, an 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. Ointment is applied a thin layer by 2-3 times a day on previously cleared (using soap with neutral value рН) and dry affected areas of skin 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 treatment of onychomycoses it is necessary to watch that the processed nail plates were shortly cut or had a rough surface for the best penetration of active agent. In these cases the preference should be given to solution because of the best, getting properties.
At patients with a liver failure it is necessary to control a functional condition of a liver periodically.
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 drug during pregnancy or during feeding by a breast exerts negative impact on health of the woman or a fruit (child). However, the issue of expediency of purpose of drug has to be resolved individually after consultation of the doctor. Putting drug directly on the lactating chest gland is contraindicated.
Side effects:
Itch, burning, prickings in ointment sites of application, emergence of an erythema, blisters, hypostasis, irritation and a peeling of skin. Allergic reactions (itch, urticaria).
Interaction with other medicines:
Amphotericinum In, nystatin, натамицин reduce efficiency of Clotrimazolum at simultaneous use.
At ointment use negative interactions with other means are unknown and they should not be expected since rezorbtsionny ability of Clotrimazolum very low.
Contraindications:
Hypersensitivity to Clotrimazolum or excipients, the I trimester of pregnancy.
With care — the lactation period.
Overdose:
Use of ointment in the raised doses does not cause any reactions and states, life-threatening.
Storage conditions:
Period of validity 2 years. Not to apply after the expiry date specified on packaging. In dry, protected from light and the place, unavailable to children, at a temperature not above 20 °C.
Issue conditions:
Without recipe
Packaging:
Ointment for external use of 1%. On 20 or on 40 g of drug in a tuba or bank of dark glass. 1 tuba or bank together with the application instruction in a cardboard pack.