KETODERM

KETODERM (ketoconazole) cream 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation. WARNINGS KETODERM (ketoconazole) cream 2% should never be employed for the treatment of infections of the eye.

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

PRECAUTIONS If a reaction suggesting sensitivity or chemical irritation should occur, use of KETODERM (ketoconazole) cream 2% should be promptly discontinued. Limited short term studies in animals and in human volunteers on whom limited quantities of KETODERM cream 2% were tested have failed to demonstrate absorption of ketoconazole in detectable amounts.

Due to the teratogenic nature of the active ingredient, ketoconazole, caution should be exercised when KETODERM cream 2% is administered to pregnant or nursing women. Cross sensitivity with miconazole and other imidazoles may exist and caution is suggested 4 when KETODERM cream 2% is employed in patients with known sensitivity to imidazoles.

ADVERSE REACTIONS Short-term studies indicate that Ketoconazole Cream 2% is well tolerated by the skin. 8%) of 167 patients treated with placebo reported side effects consisting mainly of severe irritation, pruritus and stinging. One of the patients treated with Ketoconazole Cream 2% developed a painful allergic reaction (swelling of the foot).

In rare circumstances, allergic local skin phenomena such as contact dermatitis have been associated with ketoconazole cream 2% or one of its components, namely sodium sulfite or propylene glycol. SYMPTOMS AND TREATMENT OF OVERDOSAGE There has been no experience with overdosage of Ketoconazole Cream 2%.

Treatment should include general supportive measures. DOSAGE AND ADMINISTRATION 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 5 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.