Ketoconazole, zinc pyrithione.
Each 100 mL contains: Ketoconazole 2 g, Zinc Pyrithione Suspension (48%) 2.08 g (equivalent to 1% w/v of Zinc Pyrithione).
Excipients/Inactive ingredients: Cocodiethanolamide, Sodium lauryl ether sulphate, Disodium monolauryl ether Sulfosuccinates, Macrogol 120 methylglucose dioleate, Propylene glycol, Conc. Hydrochloric acid, Sodium chloride, Sodium hydroxide, Butylated hydroxytoluene, Imidurea, Colour Ponceau 4R, Aloe vera powder, Fragrance AL 012514 and Purified water.
Pharmacology: Pharmacodynamics: Ketoconazole is a synthetic derivative of imidazole-dioxolane, providing fungicidal and fungistatic activity against dermatophytes (Epidermophyton spp., Microsporum spp., Trichophyton spp.) yeast and yeast-like fungi of different strains (Candida spp., Malassezia furfur-Pitysporum ovale).
When applied externally zinc pyrithione suspension has antimicrobial and antifungal activity; effective towards streptococci, staphylococci, fungi and several other pathogens. Zinc pyrithione determines anti-seborrheic effect of the drug and acts against dandruff. Shampoo with ketoconazole reduces flaking and itching, which is often associated with dandruff, seborrheic dermatitis and tinea versicolor.
Pharmacokinetics: Ketoconazole was not detected in plasma in 39 patients who shampooed 4-10 times per week for 6 months or in patients who shampooed 2-3 times per week for 3-26 months. Twelve hours after a single shampoo, hair samples taken from six patients showed that high amounts of ketoconazole were present on the hair; only about 5% had penetrated into the hair keratin. There were no detectable plasma levels after chronic shampooing twice weekly for two months with ketoconazole.
For the prevention and treatment of infection in which Malassezia (previously called Pityrosporum) is likely involved; such as dandruff, seborrheic dermatitis, and tinea (pityriasis) vesicolor.
For topical administration: Adults, Elderly and Children: Wash affected areas and leave for 3-5 minutes before rinsing.
Treatment: Dandruff and seborrhoeic dermatitis: Wash hair twice weekly for 2-4 weeks.
Tinea versicolor: Once daily for a maximum of 5 days.
Prophylaxis: Dandruff and seborrhoeic dermatitis: Use once every 1-2 weeks.
Tinea versicolor: Once daily for a maximum of 3 days before exposure to sunshine.
Mode of Administration: For topical administration.
Adults including the elderly and children.
Wet hair and scalp thoroughly with water.
Apply sufficient shampoo to wash the scalp and hair and lather well.
Leave for 3-5 minutes before rinsing thoroughly.
As the shampoo is for external use only, and ketoconazole is almost unabsorbed into systemic blood flow, the development of overdose symptoms is unlikely. In case of accidental ingestion of shampoo only supportive and symptomatic measures are used. Do not induce vomiting and perform gastric lavage to prevent aspiration.
Hypersensitivity to ketoconazole, zinc pyrithione or any of the excipients.
Ketoconazole + Zinc Pyrithione (Dermazole Plus) Shampoo may be irritating to mucous membranes of the eyes and contact with this area should be avoided. If the shampoo does get into the eyes, they should be bathed gently with cold water. Seborrheic dermatitis and dandruff are often accompanied by increased hair loss, which can in some cases continue for some time at the beginning of application of shampoo.
Ketoconazole is not detected in plasma after chronic shampooing or topical application. Ketoconazole + Zinc Pyrithione (Dermazole Plus) Shampoo is not contraindicated for pregnancy or lactation, but caution should be exercised.
Skin and subcutaneous tissue: erythema, burning sensation of the skin, itching, acne, contact dermatitis, skin irritation, rash, pustular rash at the application site, urticaria, xerosis, skin flaking enchancement, sense of discomfort, hypersensitivity. Appendages of skin: folliculitis, hair restructuring, excessive hair dryness or oiliness, hair loss (baldness), change in hair color (generally in patients with chemically damaged or gray hair), nail discoloration. There are known cases of straightening of naturally curly hair. Nervous system and sense organs: eye irritation, eyelid edema, excessive tearing, taste perversion (dysgeusia), paresthesia, hypersensitivity. Immune system: hypersensitivity reactions, including anaphylactoid reactions.
When assigning Ketoconazole + Zinc Pyrithione (Dermazole Plus) Shampoo to patients who were treated with locally applied glucocorticoids for a long time, the treatment should be continued and cancelled gradually during 2-3 weeks (to avoid withdrawal syndrome). Taking into account absence of significant systemic absorption a drug interaction with other drugs is unlikely.
Store at temperatures not exceeding 30°C.
D11AC - Medicated shampoos ; Used in the treatment of dermatological diseases.
Shampoo (bottle) (clear, pink coloured viscous liquid with specific odour) 50 mL, 100 mL.