Nizoral 2% shampoo

Ketoconazole 2% w/w.(each gram contains 20 mg)

For a full list of excipients, see 6.1

Pink viscous shampoo.

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.

For topical administration.

Adults, Elderly and Children:

Wash affected areas and leave for 3-5 minutes before rinsing.

Treatment:

Prophylaxis:

Known hypersensitivity to ketoconazole or any of the excipients.

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have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Nizoral 2% shampoo, to prevent any potential rebound effect.

Keep out of the eyes. If the shampoo should get into the eyes, they should be bathed with water.

No interaction studies have been performed

There are no adequate and well-controlled studies in pregnant or lactating women. Data on a limited number of exposed pregnancies indicate no adverse effects of topical ketoconazole on pregnancy or on the health of the foetus/newborn child. Animal studies have shown reproductive toxicity at doses that are not relevant to the topical administration of ketoconazole. No effects on the breastfed newborn/infant are anticipated. (See Pharmacokinetic properties, section 5.2)

Plasma concentrations of ketoconazole were not detectable after topical administration of Ketoconazole Shampoo 2% to the scalp of non-pregnant humans. Plasma levels were detected after topical administration of Ketoconazole Shampoo 2% on the whole body. There are no known risks associated with the use of Ketoconazole Shampoo 2% in pregnancy or lactation.

Not relevant

The safety of ketoconazole 2% shampoo was evaluated in 2890 subjects who participated in 22 clinical trials. Ketoconazole 2% shampoo was administered topically to the scalp and/or skin. Based on pooled safety data from these clinical trials, there were no ADRs reported with an incidence 1%.

The following table displays ADRs that have been reported with the use of Ketoconazole 2% Shampoo from either clinical trial or postmarketing experiences.

The displayed frequency categories use the following convention:

Very common (1/10)

Common (1/100 to <1/10)

Uncommon (1/1,000 to <1/100)

Rare (1/10,000 to <1/1,000)

Very rare (<1/10,000)

Not known (cannot be estimated form the available clinical trial data).

In the event of accidental ingestion, supportive and symptomatic measures should be carried out. In order to avoid aspiration, neither emesis nor gastric lavage should be instigated.

Pharmacotherapeutic group: Imidazole and triazole derivatives

ATC Code: D01AC08

Ketoconazole is an imidazole-dioxolane antimycotic, active against yeasts, including Malassezia and dermatophytes. Its broad spectrum of activity is already well known.

Plasma concentrations of ketoconazole were not detectable after topical administration of Nizoral 2% shampoo on the scalp. Plasma levels were detected after topical administration of Nizoral 2% shampoo on the whole body.

Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.

Sodium lauryl ether sulphate

Disodium monolauryl ether sulphosuccinate

Coconut fatty acid diethanolamide

Laurdimonium hydrolysed animal collagen

Macrogol 120 methyl glucose dioleate

Sodium chloride

Concentrated hydrochloric acid

Imidurea

Sodium hydroxide

Erythrosine sodium

Water purified (Ph. Eur)

Not applicable

36 months.

Store below 25°C.

High density polyethylene bottles, containing120 ml shampoo.

No special requirements

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Bucks

HP12 4EG

UK

00242/0139

Date of First Authorisation: 18 April 1988

Date of Renewal of Authorisation: 24 June 2008

12 April 2011

POM