Summary of Product Characteristics Updated 12-Feb-2019 | Janssen-Cilag Ltd
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 and seborrhoeic dermatitis. Treatment of tinea (pityriasis) versicolor.
For topical administration.
Ketoconazole shampoo 2% is for use in adolescents and adults:
Wash affected areas and leave for 3-5 minutes before rinsing. Usually, a palmful of shampoo suffices for one wash.
Dandruff and seborrhoeic dermatitis:
Wash hair twice weekly for 2-4 weeks.
Once daily for 1-5 days.
Dandruff and seborrhoeic dermatitis:
Use once every 1-2 weeks.
The safe and effective use of Nizoral 2% shampoo in infants and children under the age of 12 years has not been established.
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have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Nizoral 2% shampoo, to prevent any potential rebound effect.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.
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).
System Organ Class
Adverse Drug Reactions
(≥1/1,000 to <1/100)
(≥1/10,000 and <1/1,000)
Immune System disorders
Nervous System Disorders
Infections and Infestations
Skin and Subcutaneous Tissue Disorders
Hair texture abnormal
Skin burning sensation
Hair colour changes
General Disorders and Administration Site Conditions
Application site erythema
Application site irritation
Application site pruritus
Application site reaction
Application site hypersensitivity
Application site pustules
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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 sulfate
Disodium monolauryl ether sulphosuccinate
Coconut fatty acid diethanolamide
Laurdimonium hydrolysed animal collagen
Macrogol 120 methyl glucose dioleate
Concentrated hydrochloric acid
Water purified (Ph. Eur)
Store below 25°C.
High density polyethylene bottles, containing120 ml shampoo.
No special requirements
50-100 Holmers Farm Way
Date of First Authorisation: 18 April 1988
Date of Renewal of Authorisation: 24 June 2008
08 February 2019
Legal category POM
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