for medical use
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.
Pharmaceutical form. Shampoo.
Transparent, viscous pink liquid with pleasant odor.
Name and address of manufacturer.
Kusum Healthcare Pvt. Ltd.
SP 289 (A), RIICO INDL. AREA, CHOPANKI, BHIWADI (Raj.), (India).
Pharmacotherapeutic group.Antifungal agents for external use. Code ATC D01A C08.
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.
Treatment and prevention of skin and hair lesions caused by fungal microorganisms Malassezia (former name Pityrosporum), such as dandruff, pityriasis versicolor (local), seborrheic dermatitis.
Hypersensitivity to any component of the drug.
Precautions at use.
When using the shampoo, avoid contact of the drug with eyes. In case of contact with eyes, wash them with water.
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.
Using during pregnancy or breast-feeding.
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.
Effect on reaction rate when driving motor transport or operating other mechanisms.
Has no effect.
There is no experience of using the drug in children.
Administration and dosage.
Apply the shampoo with warm water on the affected areas of the scalp and leave for 3–5 minutes before rinsing.
- dandruff and seborrheic dermatitis (seborrheic eczema): 2 times per week for 2–4 weeks;
- pityriasis versicolor: every day for 5 days.
- 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.
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.
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.
Interaction with other medical agents and other types of interaction.
Store at the temperature not more than 25С in a place protected from sunlight.
Keep it out of reach of children
Shampoo 8 ml in a sachet. There are 20 sachets in a carton box.
Shampoo 50 ml or 100 ml are in shrink wrap flacons. There is 1 flacon in a carton box.
Conditions of supply. Without prescription.
Last revision date. 08.02.14 № 109