Presentation

Dancel Shampoo: Each gram 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

Treatment and prophylaxis of infections in which the yeast Malassezia is involved, such asDandruff (Pityriasis capitis)

Inflammatory skin condition with greasy, red and scaly areas (Seborrheic dermatitis) Pityriasis versicolor (localized)

Dosage & Administration

To use the Ketoconazole 2% shampoo, follow these steps:

* Shake the bottle well before use

* 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

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.

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that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using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.

Use in Pregnancy & Lactation

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

Drug Interaction

Not known

Over Dose

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.

Withdrawal Period

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.

Commercial Pack

Dancel Shampoo: Each plastic bottle contains 100 ml of shampoo.