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Nizoral 2%

Travellers familiar with Nizoral 2% from the United Kingdom, Japan, or New Zealand are unlikely to encounter this exact strength and brand presentation in many other markets — it is registered in only seven countries. The brand sits in a curious geographic spread that includes Austria, Egypt, Finland, Slovakia, and the three already mentioned, rather than a single contiguous region.

The active ingredient is ketoconazole, classified as a broad-spectrum antifungal. Ketoconazole-containing topical products are used for a range of superficial fungal conditions of the skin and scalp, including dermatitis with a fungal component, tinea infections such as jock itch and athlete's foot, and certain other skin infections. The structured indication list further down this page details the registered uses for Nizoral 2% as recognised by the regulators in the markets where it is sold. Shingles is listed among the registered indications recorded for this product in the underlying data.

Outside the seven countries listed above, the Nizoral name and the 2% strength may not appear in the same form a traveller is used to. However, ketoconazole itself is one of the more widely distributed antifungal molecules in the world and circulates under a variety of brand names and presentations across most regulated pharmaceutical markets. A pharmacist in the destination country is generally well placed to identify a comparable ketoconazole-containing product or, where appropriate, a different molecule from the broader antifungal category.

Other broad-spectrum antifungal agents are sold in many of the same markets and are used for overlapping skin conditions, although they are not freely interchangeable — molecules within the antifungal class differ in their spectrum, formulation, and clinical positioning. Anyone using Nizoral 2% regularly, or trying to identify a local equivalent while abroad, should treat substitution as a clinical question and raise it with a healthcare provider rather than improvise at the pharmacy counter.

Countries
Austria Egypt Finland Japan New Zealand Slovakia United Kingdom
Diseases
Dermatitis Infection Jock Itch Shingles Athlete's foot
Ingredients
Ketoconazole
Drug Actions
Antifungal broad spectrum

Drugs with the same active ingredients

C-86 Colposan Eumicel Euronazol Faction Fangan Fitonal Grenfung Gynerium Keduo Ketoconazol fabra Ketolef Ketonazol lafedar Ketozol Micoespec-c Micoral Micoral (ketoconazol) Orifungal Perative Quadion

Overdose

Topical Application

Excessive topical application may lead to erythema, oedema and a burning sensation, which will disappear upon discontinuation of the treatment.

Ingestion

In the event of accidental ingestion, supportive and symptomatic measures should be carried out.

Shelf life

36 months.

Contraindications

Nizoral 2% cream is contra-indicated in patients with a known hypersensitivity to any of the ingredients or to ketoconazole itself.

Incompatibilities

Not applicable.

List of excipients

Propylene Glycol

Stearyl Alcohol

Cetyl Alcohol

Sorbitan Stearate

Polysorbate 60

Isopropyl Myristate

Sodium Sulphite Anhydrous (E221)

Polysorbate 80

Water purified (Ph. Eur)

Pharmaceutical form

Cream

Undesirable effects

The safety of ketoconazole cream was evaluated in 1079 subjects who participated in 30 clinical trials. Ketoconazole cream was applied topically to the skin. Based on pooled safety data from these clinical trials, the most commonly reported (>1% incidence) adverse reactions were (with % incidence): application site pruritus (2%), skin burning sensation (1.9%), and application site erythema (1%).

Including the above-mentioned adverse reactions, the following table displays adverse reactions that have been reported with the use of ketoconazole cream 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 from the available clinical trial data).

System Organ Class

Adverse Reactions

Frequency Category

Common

(>1/100 to <1/10)

Uncommon

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

Not Known

Immune System Disorders

Hypersensitivity

Skin and Subcutaneous Tissue Disorders

Skin burning sensation

Bullous eruption

Dermatitis contact

Rash

Skin exfoliation

Sticky skin

Urticaria

General Disorders and Administration Site Conditions

Application site erythema

Application site pruritus

Application site bleeding

Application site discomfort

Application site dryness

Application site inflammation

Application site irritation

Application site paresthesia

Application site reaction

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:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Preclinical safety data

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.

Therapeutic indications

For topical application in the treatment of dermatophyte infections of the skin such as tinea corporis, tinea cruris, tinea manus and tinea pedis infections due to Trichophyton spp, Microsporon spp and Epidermophyton spp. Nizoral 2% cream is also indicated for the treatment of cutaneous candidosis (including vulvitis), tinea (pityriasis) versicolor and seborrhoeic dermatitis caused by Malassezia (previously called Pityrosporum) spp.

Pharmacotherapeutic group

Antifungals for Topical Use,Imidazole and triazole derivatives

Pharmacodynamic properties

Pharmacotherapeutic group: Antifungals for Topical Use,Imidazole and triazole derivatives

ATC Code: D01AC08

Usually ketoconazole cream acts rapidly on pruritus, which is commonly seen in dermatophyte and yeast infections, as well as skin conditions associated with the presence of Malassezia spp. This symptomatic improvement is observed before the first signs of healing are observed.

Ketoconazole, a synthetic imidazole dioxolane derivative, has a potent antimycotic activity against dermatophytes such as Trichophyton spp., Epidermophyton floccosum and Microsporum spp. and against yeasts, including Malassezia spp. and Candida spp. The effect on Malassezia spp. is particularly pronounced.

A study in 250 patients has shown that application twice daily for 7 days of ketoconazole 2% cream vs clotrimazole 1% cream for 4 weeks on both feet demonstrated efficacy in patients with tinea pedis (athlete's foot) presenting lesions between the toes. The primary efficacy endpoint was negative microscopic KOH examination at 4 weeks. Ketoconazole 2% treatment showed equivalent efficacy to 4 weeks clotrimazole 1% treatment. There was no evidence of relapse following treatment with ketoconazole cream at 8 weeks.

Pharmacokinetic properties

Plasma concentrations of ketoconazole were not detectable after topical administration of Nizoral 2% Cream in adults on the skin. In one study in infants with seborrhoeic dermatitis (n = 19), where approximately 40 g of Nizoral 2% cream was applied daily on 40% of the body surface area, plasma levels of ketoconazole were detected in 5 infants, ranging from 32 to 133 ng/mL.

Date of revision of the text

26 March 2015

Name of the medicinal product

Nizoral 2% cream

Marketing authorisation holder

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Bucks

HP12 4EG

UK

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Tube made of 99.7% aluminum, lined on inner side with heat polymerised epoxyphenol resin with a latex coldseal ring at the end of the tube. The cap is made of 60% polypropylene, 30% calcium carbonate and 10% glyceryl monostearate.

Tube of 30g.

Marketing authorisation number(s)

PL 00242/0107

Fertility, pregnancy and lactation

There are no adequate and well-controlled studies in pregnant or lactating women.) There are no known risks associated with the use of Nizoral 2% Cream in pregnancy or lactation.

Qualitative and quantitative composition

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

Excipients;

propylene glycol, 20%w/w (each gram of cream contains 200mg).

stearyl alcohol, 7.5%w/w (each gram of cream contains 75mg).

cetyl alcohol, 2.0%w/w (each gram of cream contains 20mg).

For a full list of excipients, see 6.1.

Special warnings and precautions for use

Nizoral 2% cream is not for ophthalmic use.

If coadministered with a topical corticosteroid, to prevent a rebound effect after stopping a prolonged treatment with topical corticosteroids it is recommended to continue applying a mild topical corticosteroid in the morning and to apply Nizoral 2% cream in the evening, and to subsequently and gradually withdraw the topical corticosteroid therapy over a period of 2-3 weeks.

Effects on ability to drive and use machines

Nizoral 2% cream has no influence on the ability to drive and use machines.

Dosage (Posology) and method of administration

Ketoconazole cream is for use in adults.

Tinea pedis:

Nizoral 2% cream should be applied to the affected areas twice daily. The usual duration of treatment for mild infections is 1 week. For more severe or extensive infections (eg involving the sole or sides of the feet) treatment should be continued until a few days after all signs and symptoms have disappeared in order to prevent relapse.

For other infections:

Nizoral 2% cream should be applied to the affected areas once or twice daily, depending on the severity of the infection.

The treatment should be continued until a few days after the disappearance of all signs and symptoms. The usual duration of treatment is: tinea versicolor 2-3 weeks, tinea corporis 3-4 weeks.

The diagnosis should be reconsidered if no clinical improvement is noted after 4 weeks. General measures in regard to hygiene should be observed to control sources of infection or reinfection.

Seborrhoeic dermatitis is a chronic condition and relapse is highly likely.

Method of administration: Cutaneous administration.

Paediatrics

There are limited data on the use of ketoconazole 2% cream in paediatric patients.

Special precautions for disposal and other handling

No special requirements

Date of first authorisation/renewal of the authorisation

Date of first authorization: 02 December 1983

Renewed 3 December 2002

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

Frequently asked questions

What conditions does Nizoral 2% treat?

Nizoral 2% is prescribed for a range of superficial fungal skin conditions, including dermatitis with a fungal component, jock itch, athlete's foot, and other skin infections, with shingles also recorded among its registered indications in the underlying product data. The active ingredient belongs to the broad-spectrum antifungal category. The full indication list as registered with national regulators is shown in the structured section directly below this introduction.

Which active substance is in Nizoral 2%?

Nizoral 2% contains ketoconazole, classified as a broad-spectrum antifungal. Ketoconazole is one of the more widely distributed antifungal molecules internationally and circulates under a number of different brand names and topical presentations across regulated pharmaceutical markets. The molecule itself is the same regardless of which brand carries it, although strengths, vehicles, and packaging vary by country.

In how many countries is Nizoral 2% available?

Nizoral 2% is registered in seven countries: the United Kingdom, Japan, New Zealand, Austria, Finland, Slovakia, and Egypt. The geographic spread is unusual, mixing Western Europe, Central Europe, North Africa, East Asia, and Oceania rather than forming a single regional cluster. If your country is not on this list, a local pharmacist can usually confirm whether ketoconazole is available in another topical form or brand name locally.

Are there other medications with the same active ingredient as Nizoral 2%?

Ketoconazole is sold under several brand names and topical presentations worldwide, and other molecules within the broad-spectrum antifungal category are also available in most regulated markets. They are not freely interchangeable — antifungals differ in spectrum, formulation, and clinical positioning. To identify a regional ketoconazole-containing product, search the active ingredient on Pill2Trip or ask a pharmacist about appropriate antifungal options where you are.

Should I consult a doctor before taking Nizoral 2%?

Yes. Although topical antifungals are sometimes available without prescription, the appropriate molecule, strength, and duration depend on the specific skin condition being treated and on individual factors such as the affected site and concurrent medications. Prescription requirements also vary between countries, which matters for travellers and people relocating. A healthcare provider or pharmacist familiar with the patient is the right person to confirm the choice of product.

Nizoral 2%

Available in 7 countries