Presentation
Ketoconazole Shampoo: Each 1 ml shampoo contains Ketoconazole BP 20 mg.

Description
Ketoconazole, a synthetic imidazole dioxolane derivative, has a potent antifungal activity against dermatophytes, such as Trichophyton sp., Epidermophyton sp., Microsporum sp., and yeasts, such as Candida sp. and Malassezia spp.(Pityrosporum spp). Ketoconazole 2% shampoo rapidly relieves scaling and pruritus, which are usually associated with Seborrhoeic dermatitis, Pityriasis capitis (dandruff) and Pityriasis versicolor.

Indications and Uses
Treatment and prophylaxis of infections in which the yeast Malassezia (previously called Pityrosporum) is involved, such as-
Dandruff (Pityriasis capitis)
Pityriasis versicolor (localized)
Inflammatory skin condition with greasy, red and scaly areas (Seborrhoeic dermatitis)

Contraindications
Known hypersensitivity to ketoconazole or any of the excipients.

Dosage And Administration
To use the Ketoconazole 2% shampoo, follow these steps:
Use a small amount of water to wet the area where Ketoconazole 2% shampoo is to be applied
Apply the shampoo to the affected skin/scalp and a large area around it
Use fingers to rub the shampoo until it forms lather
Leave the shampoo on skin/scalp for 5 minutes
Rinse the shampoo off skin/scalp with water

Treatment
Pityriasis versicolor: once daily for 5 days.
Seborrhoeic dermatitis and Pityriasis capitis: twice weekly for 2 to 4 weeks.

Prophylaxis
Pityriasis versicolor: once daily for 3 days during a single treatment course before the summer.
Seborrhoeic dermatitis and Pityriasis capitis: once every 1 or 2 weeks.



Precautions
In patients who have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Ketoconazole 2% shampoo to prevent any potential rebound effect.

Avoid contact with the eyes. If the shampoo enters the eyes, rinse immediately with plenty of water.

Side Effects
Topical treatment with Ketoconazole 2% shampoo is generally well tolerated. As with other shampoos, a local burning sensation, itching, or contact dermatitis (due to irritation or allergy), may occur on exposed areas. In rare instances, mainly in patients with chemically damaged hair or gray hair, a discoloration of the hair has been observed with the use of Ketoconazole 2% shampoo.

Use in pregnancy & lactation
Since Ketoconazole is not absorbed through the skin after topical application, Ketoconazole 2% shampoo is not contraindicated in pregnancy and lactation.

Overdosage
Not expected as Ketoconazole 2% shampoo is intended for external use only. Accidental oral ingestion is usually followed by nausea and vomiting due to detergent, only supportive measures should be carried out.

Storage
Keep this medication in the container it came in, tightly closed, and out of reach of the children.
Store it at room temperature and do not allow it to freeze.
Protect the medication from light and keep away from excess heat and moisture.