COMPOSITION:
1 ml of shampoo contains: Ketoconazole USP 20 mg
Other ingredients:
Cocodiethanolamide, Sodium lauryl ether sulfate, Disodium monolauryl ether sulfosuccinate,
Macrogol 120 methyl glucose dioleate, Propylene glycol, Conc. hydrochloric acid, Sodium
chloride, Sodium hydroxide, Butylated hydroxytoluene, Imidurea, Colour Ponceau 4R,
Fragrance CK D00923, Purified water.
DESCRIPTION:
Clear viscous liquid of pink colour with specific odour.

INDICATIONS:
Ketoconazole Shampoo is indicated for the prevention and treatment of dandruff.
RECOMMENDED DOSE:
Use shampoo every 3-4 days for 2-4 weeks. There should be a minimum of 3 days between applications.
Prophylaxis:
Use shampoo once every 1-2 weeks
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.

UNDESIRABLE EFFECTS:
As with other shampoos, a local burning sensation, itching, or contact dermatitis (due to irritation or allergy) may occur on exposed areas. Oily and dry hairs have been reported rarely with the use of Dermazole shampoo.
In rare instances, mainly in patients with chemically damaged hair or grey hair, a discolouration of the hair has been observed.
INTERACTION WITH OTHER MEDICAMENTS:
Long-term treatment with steroids. Stopping prolonged treatment with steroids requires the gradual reduction of application of the steroid over a period of 2-3 weeks while simultaneously using Ketoconazole. This is to prevent the condition flaring up.

WARNING AND PRECAUTIONS:
Dermazole 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.
On rare occasions when using Dermazole Shampoo to treat pityriasis capitis (dandruff), an increase in normal hair loss and irritation associated with this condition may occur. If the scalp is not cleared within 4 weeks of treatment a doctor or pharmacist should be consulted.
PREGNANCY AND LACTATION:
Ketoconazole is not detected in plasma after chronic shampooing or topical application. Dermazole shampoo is not contraindicated for pregnancy or lactation, but caution should be exercised.

OVERDOSE AND TREATMENT:
In the event of accidental ingestion, only supportive measures should be carried out. In order to avoid aspiration, neither emesis nor gastric lavage should be instigated.
CONTRAINDICATION:
Hypersensitivity to Ketoconazole or any of the excipients.

PHARMACODYNAMICS:
Pharmacotherapeutic (ATC) Classification: D01A C08
Ketoconazole is a synthetic imidazole-dioxolane 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. audouinii, M. gypseum and Epidermophyton floccosum.
Yeasts:
Candida albicans, C tropicalis, Pityrosporum ovale (Malassezia ovale) and Pityrosporum orbiculare (M. furfur).
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.
STORAGE CONDITIONS:
Store below 30°C in dry place. Protect from direct sunlight.
SHELF LIFE:
3 years
DOSAGE FORMS AND PACKAGING AVAILABLE:
White High-density polyethylene (HDPE) multi dose bottles with polypropylene flip top closures available in pack of 50 ml and 100 ml. Each bottle is packed in a carton. Laminated aluminium foil sachet containing 8 ml shampoo. 20 sachets are packed in a carton.
NAME AND ADDRESS OF MANUFACTURER:
Kusum Healthcare Pvt. Ltd.
SP 289(A), RIICO Indl. Area,
Chopanki, Bhiwadi (Rajasthan), India
DATE OF REVISION OF PACKAGE INSERT 14001014461705
Not Applicable
MM Reg. No.: 1709AA 4701 A-