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Ketoconazole 2% (20mg/gm) shampoo
Presentation
Nizoder 2% shampoo: Pink, transparent shampoo; each ml of shampoo contains ketoconazole BP 20 mg.
Indication
Nizoder 2% shampoo (ketoconazole 2%) is indicated for the treatment and prophylaxis of infections in which the yeast Malassezia (previously called Pityrosporum) is involved, such as pityriasis versicolor (localized), seborrhoeic dermatitis and pityriasis capitis (dandruff).
Dosage and administration
The affected areas of the skin or the scalp should be washed with Nizoder 2% shampoo (ketoconazole 2%), which should be left on the skin / scalp for 3 to 5 minutes before rinsing.

Treatment:
- Dandruff & Seborrhoeic dermatitis: Twice weekly for 2 to 4 weeks.
- Pityriasis versicolor: Once daily for 5 days.
Prophylaxis:
- Dandruff & Seborrhoeic dermatitis: Once every 1 or 2 weeks.
- Pityriasis versicolor: Once daily for 3 days during a single treatment course before the summer.
Stage 1. Clean-up(Twice weekly for 2-4 weeks)
-Apply a small quantity of shampoo to the scalp.
-Use only a small amount of water, to ensure a high concentration of shampoo in the lather.
-Massage the shampoo lather into all parts of the scalp.
-Leave the shampoo on the hair for 5 minutes before rinsing.
Stage 2. Prophylactic (maintenance)(Use once weekly)
- When the dandruff is under control, it can be stabilised by washing once weekly with Nizoder 2% shampoo.

Use normal shampoos on other occasions.
Contra-indications, warnings, etc.

Contra-indication: Contra-indicated in patients with known hypersensitivity to ketoconazole.

Warnings and precaution: 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have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using ketoconazole 2% shampoo, to prevent any potential rebound effect. Increased hair shedding is often associated with seborrhoeic dermatitis and dandruff, and has been rarely reported with the use of ketoconazole 2% shampoo. Avoid contact with the eyes. If the shampoo should get into the eyes, they should be bathed with water.

Drug interaction: Not known.

Use in pregnancy and lactation: Since ketoconazole is not absorbed through the skin after topical application, pregnancy and lactation are not a contra-indication for the use of ketoconazole 2% shampoo.

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. Oily and dry hairs have been reported rarely with the use of ketoconazole 2% shampoo.

Overdose: Not expected as ketoconazole 2% shampoo is intended for external use only. In the event of accidental ingestion, only supportive measures should be carried out. To avoid aspiration, emesis or gastric lavage should not be performed.
Pharmaceutical precautions
Store in a cool and dry place, protected from light.
Packaging quantity
Nizoder 2% shampoo: Cartons containing 60 ml & 100 ml shampoo in plastic bottle.
Manufactured by
UniMed & UniHealth Manufacturers Ltd.
Gazipur, Bangladesh
® Registered Trademark