COMPOSITION:

Active substance:

ketoconazole;

1 ml of shampoo contains 20 mg of ketoconazole;

Excipients: Cocodietanolamide, sodium lauryl ether sulfate, disodium monolauril ether sulfosuccinate, macrogol 120 methyl glucose dioleate, propylene glycol, concentrated hydrochloric acid, sodium chloride, sodium hydroxide, butylated hydroxytoluene (E 321), imidurea, Ponceau 4R (E 124), fragrance CK D00923, purified water.

INDICATIONS:

Treatment and prevention of skin and hair lesions caused by fungal microorganisms Malassezia (former name Pityrosporum), such as dandruff, pityriasis versicolor (local), seborrheic dermatitis.

DOSAGE:

Apply the shampoo with warm water on the affected areas of the scalp and leave for 3–5 minutes before rinsing.

Treatment:

– dandruff and seborrheic dermatitis (seborrheic eczema): 2 times per week for 2–4 weeks;

– pityriasis versicolor: every day for 5 days.

Prevention:

– dandruff and seborrheic dermatitis (seborrheic eczema): every week or once per two weeks;

– pityriasis versicolor: every day for 3 days (one-time treatment course) before the summer season

ADVERSE REACTIONS:

Immune system disorders:

Hypersensitivity reactions including angioneurotic edema.

Nervous system disorders:

Dysgeusia (distortion of the sense of taste).

Infection and invasions:

Folliculitis.

Vision disorders:

Increased lacrimation, eye irritation.

Disorders of cutaneous and subcutaneous tissues:

Alopecia, dry skin, changing the normal hair structure, rash, urticaria, burning skin sensation, acne, contact dermatitis, dry skin, skin diseases, desquamation, increased greasiness or dryness of hair, changes in the hair color (in patients with chemically damaged or gray hair).

General disorders and reactions at the site of application:

Erythema, irritation, itching, feeling of discomfort, hypersensitivity, pustular rash at the site of application.

Drug interactions:

To prevent withdrawal syndrome at long-term topical treatment with corticosteroids, it is recommended to continue the topical use of corticosteroids in combination with Dermazole® shampoo followed by a gradual corticosteroids withdrawal during 2–3 weeks.

Pregnancy and lactation:

There were no adequate and properly controlled clinical trial of ketoconazole in pregnant women and breast-feeding mothers. Upon topical use of ketoconazole shampoo in non-pregnant women, serum ketoconazole concentration was not determined. Serum concentrations upon topical use of ketoconazole shampoo were determined after its applying on entire body skin. Owing to absence of known risk factors, drug usage during pregnancy or breast-feeding is not contraindicated.

Children:

There is no experience of using the drug in children.

PRECAUTIONS:

When using the shampoo, avoid contact of the drug with eyes. In case of contact with eyes, wash them with water.

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

Has no effect.

Overdose:

Since the shampoo is for external use only, and ketoconazole is almost unabsorbed into systemic circulation, overdose symptoms are unlikely to develop.

In case of accidental ingestion, the necessary treatment consists of supporting and symptomatic measures. In order to avoid aspiration, it is prohibited to cause vomiting or perform gastric lavage.

CONTRAINDICATIONS:

Hypersensitivity to any component of the drug.

PHARMACOLOGICAL PROPERTIES:

Pharmacodynamics:

Dermazole® shampoo is antifungal agent for external use, imidazoledioxolan derivative. It has pronounced antifungal effect and specifically blocks synthesis of fungous ergosterols. It is effective against dermatophytes: Trichophytum spp., Microsporum spp., Epidermophyton floccosum and yeasts such as Candida spp., Malassezia furfur (Pityrosporum ovale).

Pharmacological properties are determined by its damaging action on the fungal cell membranes via inhibition of cytochrome P450-dependent 14α-demethylase which catalyzes lanosterol transformation into ergosterol – the main structure component of fungal membrane.

Ketoconazole is almost unresorpted at external use. Prolonged administration in form of 2% shampoo causes moderate ketoconazole accumulation in hair keratin.

PHARMACEUTICAL CHARACTERISTICS:

General physic-chemical properties:

Transparent, viscous pink liquid with pleasant odor.

Shelf-life:

3 years.

Storage:

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

Keep it out of reach of children

Package:

Shampoo 8 ml in a sachet. There are 20 sachets in a carton box.

Shampoo 50 ml or 100 ml – in vials. There is 1 vial in a carton box.

Conditions of supply:

By prescription.