KETODERM Cream Ref.[27880] Active ingredients: Ketoconazole

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 when KETODERM cream 2% is employed in patients with known sensitivity to imidazoles.

Short-term studies indicate that Ketoconazole Cream 2% is well tolerated by the skin. During clinical trials, 43 (5.0%) of 867 patients treated with the cream and 3 (1.8%) 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.