FORMULATION:

Each mL contains:

Ketoconazole ……….. 20 mg

DESCRIPTION:

Clear viscous liquid of pink colour with specific odor.

INDICATIONS:

Prevention and treatment of infections in which the yeast Malassezia (previously called Pityrosporum) is likely to be involved, such as dandruff, seborrhoeic dermatitis and tinea (pityriasis) versicolor.

RECOMMENDED DOSE:

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

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) Ketoconazole Shampoo.

In rare instances, mainly in patients with chemically damaged hair or grey hair, a discoloration of the hair has been observed.

INTERACTIONS

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.

Pregnancy and lactation: Ketoconazole is not detected in plasma after chronic shampooing or topical application.

(Dermazole) Ketoconazole Shampoo is not contraindicated for pregnancy or lactation, but caution should be exercised.

Precautionszole 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.

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.

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 CONDITION:

Store at temperatures not exceeding 30°C.

CAUTION:

Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.

AVAILABILITY:

In box of 1-HDPE Bottle (50 ml in 60 ml; 100 ml in 120 ml)

MANUFACTURED BY:

Kusum Healthcare Private Limited

SP-289(A) RIICO Indl. Area

Chopanki (Bhiwadi), Distt- Alwar,

Rajasthan, INDIA

IMPORTED & DISTRIBUTED BY:

S.M.H.P Marketing & Consultancy

G/F Manor Bldg. 2629 Taft Avenue.

Malate, Manila, PHILIPPINES