Each ml of shampoo contains:

active ingredient: ketoconazole – 20mg;

For a full list of excipients, see Section 6.1.

For topical administration.

Adults including the elderly and adolescents:

Wet hair and scalp thoroughly with water.

Apply sufficient shampoo to produce enough lather to wash the scalp and hair, gently massage it over the entire scalp and leave for 3-5 minutes before rinsing thoroughly.

Seborrhoeic dermatitis and dandruff: Use Ketoconazole, 2% shampoo twice weekly for 2-4 weeks.

Prophylaxis: Use Ketoconazole, 2% shampoo once every 1-2 weeks

Pityriasis versicolor: Use Ketoconazole, 2% shampoo once daily for a maximum of 5 days.

Prophylaxis: As patches of pityriasis versicolor become more apparent on exposure to the sun. Ketoconazole, 2% shampoo shampoo may be used once daily for a maximum of 3 days in a single treatment course before exposure to sunshine.

Pharmacotherapeutic (ATC) Classification: D01AC08

Pharmacotherapeutic group: Dermatologicals, antifungals for dermatologicals use, antifungals for topical use, Imidazole and triazole derivatives, ketoconazole.

Ketoconazole is a synthetic imidazole-dioxalane derivative. It is a broad spectrum antifungal agent which inhibits the growth of common dermatophytes and yeasts by altering the permeability of the cell membrane:

Dermatophytes: Trichophyton rubrum, T. mentagrophytes, T.tonsurans, Microsporum canis, M. audouini, M. gypseum and Epidermophyton floccosum.

Yeasts: Candida albicans, C tropicalis, Pityrosporum ovale (Malassezia ovale) and Pityrosporum orbiculare (M. furfur).

List of excipients

Cocamide DEA

Cocamidopropyl betaine

Sodium laureth sulfate

Diazolidinyl urea

Hydrochloric acid (conc)

Triethanolamine 98 %

Sodium chloride

Flavor apple

Color red E-129

Water deionized.

For more detailed information about the drug, click: http://pharm.cals.am/pharm/data/drug_134482/1734095746965.pdf