Protopic Ointment is the only topical calcineurin inhibitor indicated for moderate to severe eczema (atopic dermatitis, or AD).

Since approval by the Food and Drug Administration (FDA) in December 2000, an estimated 2.1 million patients in the United States and 5.4 million patients worldwide have been treated with Protopic.¹

Important Safety Information

Protopic Ointment, both 0.03% and 0.1% for adults and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis or when those treatments are not advisable. Protopic is not indicated for children younger than 2 years of age.

WARNING: Long-term safety of topical calcineurin inhibitors has not been established (beyond 1 year of non-continuous use). Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including Protopic. Therefore, continuous long-term use of topical calcineurin inhibitors, including Protopic, in any age group should be avoided and application limited to areas of involvement with atopic dermatitis. The diagnosis of atopic dermatitis should be confirmed if signs and symptoms do not improve within 6 weeks.

Protopic is contraindicated in patients with a history of hypersensitivity to tacrolimus or any other component of the ointment.

The most common adverse events associated with the use of Protopic included the sensation of skin burning, pruritus, flu-like symptoms, and headache. The use of Protopic should be avoided on known or suspected malignant lesions. The use of Protopic on patients with Netherton's syndrome or similar skin diseases is not recommended. Patients should minimize or avoid natural or artificial sunlight exposure. Skin infections should be cleared prior to application, and there may be an increased risk of certain skin infections. Protopic should not be used with occlusive dressings.