Clotrimazole-Vertex, 1% 20 g ointment

Clotrimazole is a broad-spectrum antifungal agent for local use. The antimycotic effect of the active ingredient (imidazole derivative) is associated with disruption of ergosterol synthesis, which is a part of the cell membrane of fungi, which changes the permeability of the membrane 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 an increase in hydrogen peroxide concentration to toxic levels, which also helps destroy fungal cells. Effective against dermatophytes, yeast-like and mold fungi as well as Pityriasis versicolor (Malazessia furfur) and erythrazma pathogen. It has antimicrobial action against Gram-positive (staphylococci, streptococci) and Gram-negative bacteria (Bacteroides, Gardiierella vaginalis) and against Trichomonas vaginalis.

Pharmacokinetics
Clotrimazole is poorly absorbed through the skin and mucous membranes and has almost no systemic action. 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 the ointment contain:
active ingredient: clotrimazole 1.0 g
excipients: castor oil, water-soluble methylcellulose, distilled monoglycerides, propylene glycol, emulsifier, nipagin, amber acid, sodium benzoate, purified water.

How to take, the dosage

The ointment 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 dermatomycosis is carried out at least for 4 weeks, pityriasis -1-3 weeks.

In case of fungal diseases of foot ruts, it is recommended to continue therapy for at least 2 more weeks after the elimination of symptoms of the disease.

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, as the resorption capacity of clotrimazole is very low.

Special Instructions

Application of the drug to the skin in the eye area is not recommended. In patients with hepatic impairment, periodic monitoring of liver function should be performed.

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, in the first trimester of pregnancy.

With caution – 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 ointment in high doses does not cause any life-threatening reactions or conditions.

Pregnancy use

It should not be used in the first trimester of pregnancy (adequate and strictly controlled studies have not been conducted). When intravaginal use in women in the second and third trimesters of pregnancy no adverse effects on the fetus have been found, but the use of a vaginal applicator is undesirable.

With caution – during breast-feeding (it is unknown whether clotrimazole penetrates into breast milk).

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