Ketoconazole cream

KETOKANT (Ketoconazole Cream 2% w/w)

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KETOKANT (Ketoconazole Cream 2% w/w)

Pharmacodynamicy properties

Usually ketoconazole cream acts rapidly on pruritus, which is commonly seen in dermatophyte 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 cream

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 concentration of ketoconazole were not detectable after topical administration of ketoconazole 2% cream in adults on the skin. In one study in infants with seborrhoeic dermatitis(n=19), where approximately 40g of ketoconazole 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 133ng/ml

Indications

It is used for topical treatment of Tinea Crusis and Tinea Corporis caused by dermatomycosis and infection caused by candida species. Candidura and systemic candidosis

Contra-indications

Hypersensitivity to imidazoles and triazoles

Posology and method of administration

Tinea pedis

Ketoconazole 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 (e.g. 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

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

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The treatment should be continued until a few days after the disappearance of all signs and symptoms. The usual duration of treatment: 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 re-infection.

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. Or as directed by physician

Special warning and precautions for use

Ketoconazole 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 ketoconazole 2%  cream in the evening, and to subsequently and gradually withdrawal the topical corticosteroid therapy over a period of 2-3 weeks

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed

Fertility, pregnancy and lactation

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.

Plasma concentration of ketoconazole are not detectable after topical application of ketoconazole 2% cream to the skin of non-pregnant humans. There are no known risks associated with the use of ketoconazole 2% cream in pregnancy or lactation.

Effects on ability to drive or use machines

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

Side effects

Pruritus, burning, irritation and allergic contact dermatitis, rash

Overdose

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

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