Daktarin Gold 2% Cream

Ketoconazole 2% w/w.

Excipients: Propylene glycol; Cetyl alcohol; Stearyl alcohol

For a full list of excipients, see Section 6.1.

Cream

White cream

For the treatment of the following mycotic infections of the skin: tinea pedis, tinea cruris and candidal intertrigo.

For the treatment of tinea pedis (athlete's foot) and tinea cruris (dhobie itch) and candidal intertrigo (sweat rash).

For tinea pedis, Daktarin Gold 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 for 2–3 days after all signs of infection have disappeared to prevent relapse.

For tinea cruris and candidal intertrigo, apply cream to the affected areas once or twice daily until 2-3 days after all signs of infection have disappeared to prevent relapse. Treatment for up to 6 weeks may be necessary. If no improvement in symptoms is experienced after 4 weeks treatment, a doctor should be consulted.

Method of administration: Cutaneous use.

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

Daktarin Gold 2% cream is not for ophthalmic use.

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 Daktarin Gold 2% cream in the evening, and to subsequently and gradually withdraw the steroid therapy over a period of 2-3 weeks.

None known.

There are no adequate and well-controlled studies in pregnant or lactating women. To date, no other relevant epidemiological data are available. 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.

Plasma concentrations of ketoconazole are not detectable after topical application of Daktarin Gold 2% cream to the skin of non-pregnant humans (See Pharmacokinetic properties, section 5.2). There are no known risks associated with the use of Daktarin Gold 2% cream in pregnancy or lactation.

None.

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) ADRs were (with % incidence): application site pruritus (2%), skin burning sensation (1.9%), and application site erythema (1%). Including the above-mentioned adverse drug reactions (ADRs), the following table displays ADRs 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:

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.

Pharmacotherapeutic Group: Imidazole and triazole derivatives; ATC code: D01 AC08

Ketoconazole has a potent antimycotic action against dermatophytes and yeasts. Ketoconazole cream acts rapidly on the pruritus, which is commonly seen in dermatophyte and yeast infections. This symptomatic improvement often occurs before the first signs of healing are observed.

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.

Plasma concentrations of ketoconazole were not detectable after topical administration of ketoconazole cream in adults on the skin. In one study in infants with seborrhoeic dermatitis (n = 19), where approximately 40 g of ketoconazole 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.

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.

Propylene Glycol

Stearyl Alcohol

Cetyl Alcohol

Sorbitan Stearate

Polysorbate 60

Isopropyl Myristate

Sodium Sulphite Anhydrous (E221)

Polysorbate 80

Purified Water

Not applicable.

60 months.

Do not store above 25°C.

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.

Tubes of 5, 15 and 30g.

Not all pack sizes may be marketed.

Not applicable.

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

United Kingdom

PL 15513/0184

01/04/2009

20/09/2011