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

Active ingredient

Composition

100 g of ointment for external use contains:

the active ingredient:

clotrimazole 1 g,

excipients:

Propylene glycol,

Polyethylene oxide 1500,

polyethylene oxide 400,

Nipagine (methylparahydroxybenzoate) or methylparaben.

How to take, the dosage

Externally. The ointment is applied in a thin layer 2-3 times a day on previously cleaned (using soap with a neutral pH) and dry affected areas of the skin and gently rubbed.

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

The treatment of dermatomycosis is carried out at least for 4 weeks, lupus ulcers – 1 – 3 weeks. In case of fungal skin diseases of the feet the therapy should be continued for at least 2 more weeks after the elimination of symptoms.

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.

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 its better, 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.

Contraindications

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

Side effects

Itching, burning, tingling in the areas where the ointment is applied, erythema, blisters, swelling, irritation and peeling of the skin.

Allergic reactions (itching, urticaria).

Overdose

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

Similarities