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 diseases of the skin, mycoses of skin folds, feet;
pityriasis versicolor, erythrasma, superficial candidiasis caused by dermatophytes, yeast (including the genus Candida), mold and other fungi and pathogens sensitive to clotrimazole;
mycoses complicated by secondary pyoderma.

Pharmacological effect

Pharmacotherapeutic group: antifungal agent.

ATX code: [D01AC01]

Pharmacological properties

Pharmacodynamics

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

Effective against dermatophytes, yeast-like and mold fungi, as well as the pathogen Pityriasis versicolor (Malazessia furfur) and the pathogen erythrasma. It has an antimicrobial effect 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 proliferation of bacteria of the Corynebacteria family and gram-positive cocci (except for 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 virtually no systemic effect. 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.

Special instructions

It is not recommended to apply the drug to the skin in the eye area.

When treating onychomycosis, it is necessary to ensure that the treated nail plates are cut short or have a rough surface for better penetration of the active substance. In these cases, preference should be given to the solution due to its better penetrating properties. In patients with liver failure, the functional state of the liver should be periodically monitored.

If signs of hypersensitivity or irritation appear, treatment is stopped.

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

Active ingredient

Clotrimazole

Composition

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

Pregnancy

Clinical and experimental studies have not found that the use of the drug during pregnancy or breastfeeding has a negative effect on the health of the woman or fetus (child). However, the question of the advisability of prescribing the drug should be decided individually after consulting a doctor.
Application of the drug directly to the lactating mammary gland is contraindicated.

Contraindications

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

Side Effects

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

Interaction

Amphotericin B, nystatin, natamycin reduce the effectiveness of clotrimazole when used simultaneously. When using the cream, negative interactions with other products are not known and should not be expected, because The resorption capacity of clotrimazole is very low.

Overdose

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

Storage conditions

Store at a temperature not exceeding 25 °C.
Keep out of the reach of children!

Shelf life

2 years.
After opening the tube, the drug is suitable for use for 1 year.
Do not use after expiration date!

Manufacturer

Merkle GmbH, Germany