Product Information

NIZODER SHAMPOO

Nizoder® 2% Shampoo(Ketoconazole 2%)

Presentation

Nizoder 2% shampoo: Pink, transparent shampoo; each ml of shampoo contains ketoconazole BP 20 mg.

Indication

Nizoder 2% (ketoconazole 2%) shampoo 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). The affected areas of the skin or the scalp should be washed with Nizoder 2% (ketoconazole 2%) shamp

Dosage and administration

which should be left on the skin / scalp for 3 to 5 minutes before rinsing.

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.

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steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using ketoconazole shampoo 2%, to prevent any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 shampoo 2%. 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 shampoo 2%.

Side-effects: Topical treatment with ketoconazole shampoo 2% 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 hair have been

reported rarely with the use of ketoconazole shampoo 2%.

Overdose: Not expected as k-etoconazole shampoo 2% 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 or 100 ml shampoo in plastic bottle.