Ketoconazole (Cream)

Ketoconazole 2% cream is used for topical application in the treatment of dermatophyte infections of the skin such as tinea corporis, tinea cruris (dhobie itch), tinea manus and tinea pedis (athlete’s foot) infections due to Trichophyton spp, Microsporon spp and Epidermophyton spp. Ketoconazole 2% cream is also indicated for the treatment of cutaneous candidosis (including vulvitis), candidal intertrigo (sweat rash), tinea (pityriasis) versicolor and seborrhoeic dermatitis caused by Malassezia (previously called Pityrosporum) spp.

Ketoconazole interacts with 14-α-sterol demethylase, a cytochrome P-450 enzyme necessary for the conversion of lanosterol to ergosterol. This results in inhibition of ergosterol synthesis and increased fungal cellular permeability due to reduced amounts of ergosterol present in the fungal cell membrane. This metabolic inhibition also results in accumulation of 14α-methyl-3,6-diol, a toxic metabolite. The increase in membrane fluidity is also thought to produce impairment of membrane-bound enzyme systems as components become less closely packed.

Tinea pedis: Ketoconazole 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 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.

Administrations: For topical administration only.

Ketoconazole 2% w/w cream is contra-indicated in patients with known hypersensitivity to Ketoconazole.

Commonly observed adverse reactions to Ketoconazole cream in clinical trials were skin application site burning sensation, erythema and pruritus. Uncommon adverse reactions are application site bleeding, discomfort, dryness, inflammation, irritation, paraesthesia and reaction; bullous eruption, dermatitis contact, rash, skin exfoliation and sticky skin.

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 following oral administration of Ketoconazole. No effects on the breastfed newborn/infant are anticipated.

Not for ophthalmic use. If a potent topical corticosteroid has been used previously in the treatment of seborrhoeic dermatitis, a recovery period of 2 weeks should be allowed before using Ketoconazole 2% w/w cream, as an increased incidence of steroid induced skin sensitisation has been reported when no recovery period is allowed.

Exaggerated topical application may lead to erythema, oedema and a burning sensation, which will disappear upon discontinuation of the treatment. If accidental ingestion of Ketoconazole 2% w/w cream occurs, no special measures have to be taken.

Drugs for subcutaneous and mycoses.

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.