Clofan cream 1% tube 20 g
Composition
active ingredient: clotrimazole;
1 g of cream contains clotrimazole 10 mg;
excipients: cetyl palmitate, cetostearyl alcohol, sorbitan monostearate, polysorbate 60, octyldodecanol, benzyl alcohol, purified water.
Pharmacotherapeutic group
Dermatological preparations. Antifungal preparations for use in dermatology. Antifungal preparations for topical use. Imidazole and triazole derivatives. Clotrimazole. ATX code D01A C01.
Pharmacological properties
Pharmacodynamics
The mechanism of antimycotic action of clotrimazole is associated with inhibition of ergosterol synthesis, which leads to structural and functional damage to the cytoplasmic membrane of fungi.
Clotrimazole has a broad spectrum of antifungal activity in vitro and in vivo and is active against dermatophytes, yeasts, molds and other types of fungi.
Under appropriate testing conditions, the minimum inhibitory concentration for these types of fungi is approximately 0.062–8.0 μg/mL substrate.
The mechanism of action of clotrimazole is associated with primary fungistatic or fungicidal activity, depending on the concentration of clotrimazole at the site of infection.
In vitro activity is limited to proliferating fungal elements; fungal spores have only minor sensitivity.
In addition to antifungal activity, clotrimazole also acts on gram-positive microorganisms ( Streptococci/Staphylococci/Gardnerella vaginalis ) and gram-negative microorganisms ( Bacteroids ).
In vitro, clotrimazole inhibits the growth of Corynebacteria and Gram-positive cocci (except Enterococci ) at concentrations of 0.5–10 μg/ml of substrate.
Primary resistant strains of susceptible fungal species are very rare; the development of secondary resistance of susceptible fungi during treatment has so far been observed only in very isolated cases.
Pharmacokinetics
When applied to intact or inflamed skin, clotrimazole enters the human bloodstream in minimal amounts. Peak serum concentrations of clotrimazole were below the detection limit of 0.001 μg/mL, indicating that systemic effects or adverse reactions are unlikely with topical application of clotrimazole.
Indication
Dermatomycoses caused by molds and other fungi (e.g. Trichophyton ).
Dermatomycoses caused by yeast fungi ( Candida ).
A skin disease resulting from secondary infection with these fungi.
Candidal vulvitis and candidal balanitis.
Contraindication
Hypersensitivity to the active substance or to any of the excipients of the medicinal product.
Do not use the cream to treat nail or scalp infections.
Interaction with other medicinal products and other types of interactions
When used simultaneously with latex contraceptives, the cream may cause damage to them and reduce their effectiveness. Patients are advised to use alternative methods of contraception for at least five days after using this medication.
Application features
The drug contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
Use during pregnancy or breastfeeding
Fertility.
Clinical studies on the effect of clotrimazole on fertility in women have not been conducted, but animal studies have not shown any effect on fertility.
Pregnancy.
There are limited data on the use of clotrimazole in pregnant women. Animal studies have shown reproductive toxicity of clotrimazole when administered orally at high doses. Given the low systemic exposure to clotrimazole after topical treatment, no harmful effects on reproductive function are expected. Clotrimazole can be used during pregnancy, but only under medical supervision.
Breastfeeding period.
Available pharmacodynamic/toxicological data in animals indicate that clotrimazole or its metabolites are excreted in human milk after intravenous administration. A risk to the breast-fed child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from clotrimazole therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Ability to influence reaction speed when driving vehicles or other mechanisms
Clotrimazole cream has no or negligible influence on the ability to drive and use machines.
Method of administration and doses
The drug is intended for topical use.
Apply a thin layer of the cream to the affected area of the skin 2-3 times a day and rub in gently. A strip of cream (½ cm long) is sufficient to treat an area the size of a hand. Treatment should be continued for at least one month in the case of dermatophyte infections and for at least two weeks in the case of candidal infections.
In case of foot infection, wash and dry your feet, especially between the toes, before applying the cream.
Children.
There is no experience with the use of the drug in children.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging. Do not freeze.
Keep out of reach of children.
Vacation category
Without a prescription.
