Clotrimazole-ACOS, 1% 20 g ointment

Clotrimazole is a broad-spectrum antifungal agent for local use. Antimycotic effect of the active substance (imidazole derivative) is associated with disruption of ergosterol synthesis, which is a part of the cell membrane of fungi, which changes membrane permeability and causes subsequent cell lysis.

In low concentrations it is fungistatic and in high concentrations it is fungicidal, and not only on proliferating cells. In fungicidal concentrations it interacts with mitochondrial and peroxidase enzymes, resulting in increase of hydrogen peroxide concentration to toxic level, which also promotes destruction of fungal cells.

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

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

Clotrimazole is a broad-spectrum antifungal agent for topical use. The antimycotic effect of the active substance (imidazole derivative) is associated with disruption of 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 small concentrations it has a fungistatic effect, and in large 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.

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 trimmed 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 ointment for external use contains:

active ingredient:

clotrimazole 1 g,

excipients:

propylene glycol,

polyethylene oxide 1500,

polyethylene oxide 400,

nipagin (methyl parahydroxybenzoate) or methylparaben.

Contraindications

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

Side Effects

Itching, burning, tingling in areas where the ointment 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 ointment, negative interactions with other agents are not known and should not be expected, because The resorption capacity of clotrimazole is very low.

Overdose

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

Storage conditions

In a place protected from light, at a temperature of 2 °C to 25 °C. Keep out of reach of children.

Shelf life

2 years.

Manufacturer

Sintez, Russia