COMPOSITION:

Active substance:

ketoconazole;

1 g of cream contains ketoconazole 20 mg;

Excipients: Propylene glycol, Cetostearyl alcohol, Cetomacrogol 1000, White soft paraffin, Light mineral oil, Disodium Еdetate, Sodium sulfate anhydrous (E 221), Polysorbate 80, purified water.

INDICATIONS:

Treatment of fungal skin infections such as tinea pedis, epidermophytosis inguinalis, candidiasis of skin folds (intertrigo).

DOSAGE:

To treat tinea pedis it is recommended to apply Dermazole® to the affected skin and surrounding area 2 times per day. Usually, treatment of skin lesion may last for 1 week. In case of more severe lesions, the treatment should be continued for 2-3 days after all symptoms disappear to avoid recurrence of the disease.

To treat epidermophytosis inguinalis, candidiasis of skin folds it is recommended to apply Dermazole® to the affected skin and surrounding area 2 times per day. The treatment should last enough time, at least for 2-3 days after all symptoms disappear to avoid recurrence of the disease.

When necessary, the treatment may last for 6 weeks. If the symptoms persist after 4 weeks of treatment, seek medical attention.

ADVERSE REACTIONS:

General disorders and reactions in the site of application:

erythema, itching, bleeding disorder, discomfort, dryness, inflammation, irritation, paresthesia.

Skin and subcutaneous tissue disorders:

burning sensation, bullous rash, contact dermatitis, sloughing or sticky skin, urticaria.

Immune system disorders:

hypersensitivity reactions.

Pregnancy and lactation:

There are no adequate and well-controlled studies of using the drug in pregnant women and nursing mothers. The risks related to the use of the drug during pregnancy and breast-feeding are unknown.

Children:

The experience of using Dermazole® in children is absent.

PRECAUTIONS:

Cream Dermazole® is not used in ophthalmic practice.

Overdose:

Topical application.

Topical application of excessive quantity of the cream may cause erythema, edema, burning sensation on the skin which disappear after stopping the therapy.

Accidental ingestion.

In case of accidental ingestion, supporting and symptomatic therapeutic measures are recommended.

Ability to influence reaction velocity while driving or operating any other mechanisms.

Dermazole® cream does not affect the ability to drive motor transport or work with other mechanisms.

CONTRAINDICATIONS:

Cream Dermazole® is contraindicated in patients with known hypersensitivity to ketoconazole or any other ingredient of the drug.

PHARMACOLOGICAL PROPERTIES:

Antifungal agents for external use. Derivatives of imidazole and triazoles.

Code АТС D01A C08.

Ketoconazole is a synthetic imidazole dioxolane derivative active against dermatophytes and yeasts.

Ketoconazole cream quickly eliminates itching which usually accompanies an infection caused by dermatophytes and yeasts.

After topical application of the rug, ketoconazole is not defined in blood.

PHARMACEUTICAL CHARACTERISTICS:

General physic-chemical properties: Uniform white cream.

Shelf-life:

3 years.

Storage:

Store at the temperature not more than 25°c in a place protected from the sunlight

Keep out of reach of children.

Package:

15 g or 30 g are in a tube and in a carton.

Conditions of supply:

Without prescription.