Clotrimazole, cream 1%, 20g

Composition

100 g of cream contains:

Active ingredient:

clotrimazole 1.0 g

excipients:

benzyl alcohol,

cetasteryl alcohol,

euthanol G (2-octylododecanol),

polysorbate 60,

span 60 (sorbitan stearate),

synthetic olbrot (synthetic spermaceti),

purified water

Description: Homogeneous mass of white color.

Pharmacological action

Clotrimazole is a broad-spectrum antifungal agent for topical use. The antimycotic effect of the active ingredient (imidazole derivative) is associated with a violation of the synthesis of ergosterol, which is part of the fungal cell membrane, which changes the membrane permeability and causes subsequent cell lysis.

In small concentrations, it acts fungistatically, and in large concentrations – fungicidal, and not only on proliferating cells. In 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.

It is effective against dermatophytes, yeast-like and mold fungi, as well as the causative agent of multi-colored lichen Pityriasis versicolor (Malazessia furfur) and the causative agent of erythrasma. It has an antimicrobial effect against gram-positive (staphylococci, streptococci) and gram-negative bacteria (Bacteroides, Gardierella vaginalis), as well as against Trichomonas vaginalis.

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 suppressive 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 caididosis caused by dermatophytes, yeast (including the genus Candida), mold and other fungi and pathogens sensitive to clotrimazole;
• mycoses complicated by secondary pyoderma.

Use during pregnancy and lactation

It should not be used in the first trimester of pregnancy (adequate and strictly controlled studies have not been conducted).

With intravaginal use in women in the second and third trimesters of pregnancy, no adverse effects on the fetus were detected, but the use of a vaginal applicator is undesirable.

With caution — during breastfeeding (it is not known whether clotrimazole penetrates into breast milk).

Contraindications

Hypersensitivity to clotrimazole or excipients, first trimester of pregnancy.

With caution – lactation period.

Side effects

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

Interaction

Amphotericin B, nystatin, natamycin reduce the effectiveness of clotrimazole when used simultaneously.

When using the cream, negative interactions with other agents are not known and should not be expected, since the resorption capacity of clotrimazole is very low.

How to take, course of use and dosage

Externally. The cream is applied in a thin layer 2-3 times a day on pre-cleaned (using soap with a neutral pH value)surfaces. and dry affected areas of the skin and gently rub.

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

Treatment of dermatomycosis is carried out for at least 4 weeks, pityriasis versicolor-1-3 weeks.

For fungal diseases of the foot track, therapy is recommended to continue for at least 2 weeks after the symptoms of the disease have been eliminated.

Overdose

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

Special instructions

It is not recommended to apply the drug on the skin in the eye area. In patients with hepatic insufficiency, the functional state of the liver should be monitored periodically.

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

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

Form of production

Cream for external use

Storage conditions

At temperatures below 25° C, keep out of the reach of children.

Shelf

life is 3 years.

Active ingredient

Clotrimazole

Dosage form

cream