Source: Health Products and Food Branch (CA) Revision Year: 2003
KETODERM (ketoconazole) cream 2% may be indicated for the topical treatment of tinea pedis, tinea corporis and tinea cruris caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; and in the treatment of tinea versicolor (pityriasis) caused by Malassezia furfur (Pityrosporum orbiculare); and in the treatment of seborrhoeic dermatitis caused by Pityrosporum ovale; and in the treatment of cutaneous candidiasis caused by Candida albicans.
When clinically warranted, therapy with KETODERM (ketoconazole) cream 2% may be initiated while results of culture and susceptibility tests are pending. Treatment should be adjusted according to the findings.
KETODERM cream 2% should be applied to the affected and immediate surrounding area in patients with the following conditions:
| Conditions | Frequency | Duration |
|---|---|---|
| Tinea pedis | once daily | 4-6 weeks |
| Tinea corporis | once daily | 3-4 weeks |
| Tinea cruris | once daily | 2-4 weeks |
| Tinea versicolor | once daily | 2-3 weeks |
| Cutaneous candidiasis | once daily | 2-3 weeks |
More resistant cases may be treated twice daily depending on patient response.
| Seborrheic dermatitis | twice daily | 4 weeks |
The full course of therapy should be followed to reduce the possibility of recurrence. If however, there is no response within the recommended treatment period, the diagnosis should be re-evaluated.
The safety of Ketoconazole cream 2% has not been established with treatment periods exceeding those recommended, therefore, treatment must not exceed the recommended duration of therapy indicated above.
There has been no experience with overdosage of Ketoconazole Cream 2%. Treatment should include general supportive measures.
Store at room temperature, between 15° and 25°C. Keep from freezing.
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