Clotrimazole cream 1%, 20g

For external treatment of fungal skin diseases caused by dermatophytes, yeast-like fungi, mold fungi, as well as pathogens sensitive to clotrimazole:

• mycoses of feet, hands, trunk, skin folds;

• candidal vulvitis, candidal balanitis;

• versicolor versicolor, erythrasma;

• fungal infections of the outer ear.

For external use. The cream should be applied to the affected skin 2-3 times a day.

To prevent relapse, treatment should be continued for at least two weeks after all symptoms of infection have disappeared.

The cream should be applied to clean, dry areas of the affected skin (washed with neutral pH soap), the cream should be applied to the feet between the toes.

The duration of treatment depends on the severity of the disease, its location, and the effectiveness of treatment.

Duration of treatment:

• dermatomycosis - within 3-4 weeks;

• erythrasma - 2-4 weeks;

• versicolor versicolor - 1-3 weeks;

• vulvitis candidiasis and balanitis - 1-2 weeks.

The duration of treatment may vary according to individual characteristics, but a duration of treatment less than 3 weeks is not recommended.

To prevent recurrence of infection, you should continue using the drug for 1-2 weeks after the disappearance of all symptoms of the disease.

If symptoms do not improve after 7 days of treatment, you should consult your doctor.

Active ingredient: Clotrimazole - 1.00

Excipients: Cetostearyl alcohol - 11.50, octyldodecanol - 10.00, polysorbate-60 - 1.50, sorbitan stearate - 2.00, synthetic spermaceti - 3.00, benzyl alcohol - 1.00, purified water * - 70 , 00

The total mass of the batching unit is 100.00

* Water is introduced with an excess of 1.5%, which is removed during the technological process.

• Hypersensitivity to clotrimazole or other components of the drug.

Trade name of the drug:

Clotrimazole / Clotrimazole.

International non-proprietary name:

clotrimazole / clotrimazole.

Dosage form:

cream for external use.

Composition for 100 g of cream:

Active ingredient: Clotrimazole - 1.00

Excipients: Cetostearyl alcohol - 11.50, octyldodecanol - 10.00, polysorbate-60 - 1.50, sorbitan stearate - 2.00, synthetic spermaceti - 3.00, benzyl alcohol - 1.00, purified water * - 70 , 00

The total mass of the batching unit is 100.00

* Water is introduced with an excess of 1.5%, which is removed during the technological process.

Description

Homogeneous mass of white, homogeneous consistency.

Pharmacotherapeutic group

Antifungal agent.

ATX code:

D01AC01.

Pharmacological properties

Pharmacodynamics

Mechanism of action

Clotrimazole is a broad-spectrum antifungal agent for external use. The antifungal effect of clotrimazole (an imidazole derivative) is associated with a violation of the synthesis of ergosterol, which is part of the cell membrane of fungi, which changes the membrane permeability and causes subsequent cell lysis. In low concentrations it acts fungistatically, 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 the concentration of hydrogen peroxide to a toxic level, which also contributes to the destruction of fungal cells.

Effective against dermatophytes (Epidermophyton, Microsporum, Trichophyton), yeast-like (mainly Candida albicans), molds and protozoa, as well as the causative agent of pityriasis versicolor (Malazessia furfur) and the causative agent of erythrasma.

Has antimicrobial effect against gram-positive microorganisms and anaerobes. Clotrimazole has no effect on lactobacilli.

Pharmacokinetics

Clotrimazole is poorly absorbed through the skin and has practically no systemic effect. When applied externally, the concentration of clotrimazole in the epidermis is higher than in the dermis and subcutaneous tissue.

Indications for use

For external treatment of fungal skin diseases caused by dermatophytes, yeast-like fungi, mold fungi, as well as pathogens sensitive to clotrimazole:

• mycoses of feet, hands, trunk, skin folds;

• candidal vulvitis, candidal balanitis;

• versicolor versicolor, erythrasma;

• fungal infections of the outer ear.

Contraindications

• Hypersensitivity to clotrimazole or other components of the drug.

Use during pregnancy and breastfeeding, effects on fertility

Fertility

Studies of the effect of clotrimazole on fertility in humans have not been conducted; in animal studies, the effect of the drug on fertility has not been found.

Pregnancy

Data on the use of the drug in pregnant women are limited. In clinical and experimental studies, it was not found that the use of the drug during pregnancy has a negative effect on the health of a woman or fetus. Clotrimazole in a dosage form cream for external use is contraindicated for use in the first trimester of pregnancy. The question of the advisability of using the drug in the second and third trimesters of pregnancy should be decided individually after consulting a doctor.

Breastfeeding period

Clotrimazole is excreted in breast milk. If it is necessary to use the drug, breastfeeding should be discontinued.

Method of administration and dosage

For external use. The cream should be applied to the affected skin 2-3 times a day.

To prevent relapse, treatment should be continued for at least two weeks after all symptoms of infection have disappeared.

The cream should be applied to clean, dry areas of the affected skin (washed with neutral pH soap), the cream should be applied to the feet between the toes.

The duration of treatment depends on the severity of the disease, its location, and the effectiveness of treatment.

Duration of treatment:

• dermatomycosis - within 3-4 weeks;

• erythrasma - 2-4 weeks;

• versicolor versicolor - 1-3 weeks;

• vulvitis candidiasis and balanitis - 1-2 weeks.

The duration of treatment may vary according to individual characteristics, but a duration of treatment less than 3 weeks is not recommended.

To prevent recurrence of infection, you should continue using the drug for 1-2 weeks after the disappearance of all symptoms of the disease.

If symptoms do not improve after 7 days of treatment, you should consult your doctor.

Special patient groups

There are no data on dose adjustment for children, elderly patients, patients with impaired renal and hepatic function.

Side effect

Immune system disorders

Unknown: allergic reaction (manifested by urticaria, fainting, arterial hypotension, shortness of breath).

Skin and subcutaneous tissue disorders

Not known: rash, itching, blistering, scaling, pain or discomfort, swelling, burning, irritation, erythema, tingling.

If any of the side effects indicated in the instructions are aggravated or you notice any other side effects not listed in the instructions, inform your doctor.

Overdose

Symptoms

In case of accidental ingestion of the drug, the following symptoms may appear: dizziness, nausea, vomiting.

Treatment

In case of accidental ingestion of the cream, symptomatic treatment should be carried out.

With external use of the drug, an overdose is unlikely.

Interaction with other medicinal products

Has not been studied.

special instructions

Avoid getting the cream on the mucous membrane of the eyes. Do not swallow.

All infected areas should be treated at the same time.

Clotrimazole contains cetostearyl alcohol, which can cause local skin reactions (for example, contact dermatitis).

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

Laboratory data indicate that the use of contraceptives containing latex can cause damage when used together with clotrimazole. Consequently, the effectiveness of such contraceptives may decrease. Patients should be advised to use alternative methods of contraception for at least five days after using clotrimazole.

Influence on the ability to drive vehicles, mechanisms

There is no data on the negative effect of the drug on the ability to perform potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions (driving, working with moving mechanisms).

Release form

Cream for external use, 1%.

20 g each in an aluminum tube, lacquered from the inside, sealed with a membrane, sealed with a plastic or polypropylene screw cap. 1 tube with instructions for use in a cardboard box with first opening control.

Shelf life

3 years.

Do not use after the expiration date printed on the package.

Storage conditions

Store at a temperature not exceeding 25 ? C.

Do not freeze.

Keep out of the reach of children.

Vacation conditions

Without recipe.

Manufacturer (issuing quality control):

GlaxoSmithKline Pharmaceuticals S.A. / GlaxoSmithKline Pharmaceuticals SA
Poznan, 60-322, st. Grunwaldzka 189, Poland / ul. Grunwaldzka, 189, 60-322, Poznan, Poland