Clotrimazol-Teva, cream 1% 30 g

Pharmacotherapeutic group: antifungal agent.

The ATX code: [D01AC01].

Pharmacological properties

Pharmacodynamics

Clotrimazole-Teva is a broad spectrum antifungal agent for external use. Antimycotic effect of the active active substance clotrimazole (imidazole derivative) is associated with disruption of ergosterol synthesis, which is part of the cell membrane of fungi, which changes the membrane permeability and causes subsequent cell lysis. At low concentrations it is fungistatic and at high concentrations it is fungicidal, and not only on proliferating cells. In fungicidal concentrations, it interacts with mitochondrial and peroxidase enzymes, resulting in an increase in hydrogen peroxide concentration to toxic levels, which also contributes to the destruction of fungal cells.

It is effective against dermatophytes, yeast-like and mold fungi as well as against the causative agent of variegated lichen Pityriasis versicolor (Malazessia furfur and the causative agent of erythrazma. It has antimicrobial action against Gram-positive (staphylococci, streptococci) and Gram-negative bacteria (Bacteroides, Gardnerella vaginalis), as well as against Trichomonas vaginalis.

In vitro at a concentration of 0.5-10 µg/ml, clotrimazole inhibits the reproduction of bacteria of the family Corynebacteria and Gram-positive cocci (except enterococci) and has a trichomonacid effect at a concentration of 100 µg/ml.

Pharmacokinetics

Clotrimazole is poorly absorbed through the skin and mucous membranes and has almost no systemic action. The concentration in the deep layers of the epidermis is higher than the minimum inhibitory concentration for dermatophytes. When applied externally, the concentration of clotrimazole in the epidermis is higher than in the dermis and subcutaneous tissue.

Indications

• fungal skin diseases, mycoses of skin folds, feet;
• .pityriasis, erythrazma, surface candidiasis caused by dermatophytes, yeasts (including the genus Candida), molds and other fungi and pathogens sensitive to clotrimazole;
• mycoses complicated by secondary pyoderma.

Active ingredient

Clotrimazole

Composition

100 g of the drug contain: active ingredient: clotrimazole 1.00 g, auxiliary substances: benzyl alcohol 2.00 g, sorbitan stearate 2.00 g, polysorbate-60 1.50 g, cetyl palmitate 3.00 g, cetosteril alcohol [cetyl alcohol 60%, stearyl alcohol 40%] 10.00 g, 2-octyldodecanol 13.50 g, purified water 67.00 g.

How to take, the dosage

Externally. The cream is applied in a thin layer 2-3 times a day to previously cleansed (using soap with a neutral pH) and dry affected skin and rubbed gently.

The duration of treatment depends on the severity of the disease, localization of pathological changes and the effectiveness of therapy.

The treatment of dermatomycoses lasts at least 4 weeks, pityriasis – 1-3 weeks.

In case of fungal skin diseases of the feet the therapy is recommended to be continued for at least 2 more weeks after cessation of symptoms.

Interaction

Amphotericin B, nystatin, natamycin reduce the effectiveness of clotrimazole when used simultaneously. Negative interactions with other agents are not known and should not be expected as the resorption capacity of clotrimazole is very low.

Special Instructions

Application to the skin in the eye area is not recommended.

When treating onychomycosis, care should be taken to ensure that the nail plates to be treated are trimmed short or have a roughened surface for better penetration of the active ingredient. In these cases, preference should be given to the solution because of the best, penetrating properties. In patients with hepatic insufficiency the functional status of the liver should be periodically monitored.

In case of signs of hypersensitivity or irritation, treatment should be discontinued.

If there is no effect within 4 weeks, the diagnosis should be confirmed.

Synopsis

Homogeneous cream of white color.

Contraindications

Hypersensitivity to clotrimazole or excipients, I trimester of pregnancy. With caution – the period of lactation.

Side effects

Itching, burning, tingling where the cream is applied, erythema, blisters, swelling, irritation and peeling of the skin. Allergic reactions (itching, urticaria).

Overdose

The use of the cream in high doses does not cause any reactions or life-threatening conditions.

Pregnancy use

Clinical and experimental studies have not shown that the use of the drug during pregnancy or breastfeeding has adverse effects on the health of the woman or the fetus (child). However, appropriateness of drug administration should be decided on individual basis after medical consultation. Application directly to the lactating breast is contraindicated.

Similarities

Candide, Clotrimazol-Acrihin, Clotrimazol