NIZORAL

NIZORAL® (ketoconazole) 2% shampoo is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation. WARNINGS Irritation may occur when NIZORAL® (ketoconazole) 2% shampoo is used immediately after prolonged treatment with topical corticosteroids.

To prevent a rebound effect after stopping a prolonged treatment with topical corticosteroids, it is recommended to continue applying a mild topical corticosteroid at the onset of treatment with NIZORAL® shampoo, 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 NIZORAL® (ketoconazole) 2% shampoo should be discontinued. There are no adequate and well-controlled studies in pregnant or lactating women.

NIZORAL® shampoo does not produce detectable blood levels after topical application to the scalp. Plasma levels were detected after topical administration of NIZORAL® shampoo on the whole body. There are no known risks associated with the use of NIZORAL® shampoo 2% in pregnancy or lactation.

There were reports of spontaneous abortion and anencephaly after exposure to NIZORAL® shampoo during pregnancy, although there is insufficient information to confirm any association between NIZORAL® shampoo and these abnormal pregnancy outcomes.

However, due to the teratogenic nature of the active ingredient, ketoconazole, the use of NIZORAL® shampoo is not recommended in pregnant or nursing women except under the advice of a physician. 4 Clinical data on the use of NIZORAL® shampoo in children under 12 are not available; therefore, such use is not recommended except under the advice of a physician.

ADVERSE REACTIONS Clinical Trial Data The safety of NIZORAL® Shampoo 2% was evaluated in 2890 subjects in 22 clinical trials where NIZORAL® Shampoo 2% was administered topically to the scalp and/or skin. No adverse drug reactions (ADRs) were reported in 1% of NIZORAL® Shampoo 2% -treated subjects.

Adverse drug reactions that occurred in <1% of NIZORAL® Shampoo 2%-treated subjects in the clinical datasets are listed in Table 1. 5 Table 1. Adverse Drug Reactions Reported in <1% of 2890 NIZORAL® Shampoo 2%-treated Subjects in 22 Clinical Trials System Organ Class Preferred Term Eye Disorders Eye irritation Increased lacrimation General Disorders and Administration Site Conditions Application site erythema Application site irritation Application site hypersensitivity Application site pruritus Application site pustules Application site reaction Immune System Disorders Hypersensitivity Infections and Infestations Folliculitis Nervous System Disorders Dysgeusia Skin and Subcutaneous Tissue Disorders Acne Alopecia Dermatitis contact Dry skin Hair texture abnormal Rash Skin burning sensation Skin disorder Skin exfoliation Post-marketing Experience Adverse drug reactions first identified during post-marketing experience with NIZORAL® Shampoo 2% are included in Table 2.