Protopic (tacrolimus) ointment

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved December 2000

Specific Treatments:

Moderate to severe atopic dermatitis

Therapeutic Areas

General Information

Protopic (tacrolimus) is a non-steroidal topical ointment for the treatment of the signs and symptoms of atopic dermatitis, more commonly known as eczema. The 0.1% concentration of tacrolimus ointment was approved for the treatment of adults, while the lower 0.03% concentration was approved for the treatment of both children (ages two and above) and adults for short-term and intermittent long-term therapy.

Eczema is a chronic, life-altering disease characterized by painfully red, swollen, itchy, flaky skin. In some cases the itching and redness is so vast and intense that sufferers will scratch themselves until they bleed, increasing the risk of secondary infection. The majority of eczema cases are diagnosed in early childhood. While 40% of children suffering from eczema outgrow the disease, others live with it throughout their lives.

Routine treatment for eczema frequently includes the use of steroid creams applied to the skin; however, steroids have been associated with side effects including skin thinning and discoloration. Protopic offers physicians another treatment option when conventional treatment is deemed inadvisable because of potential risks, or when patients are not adequately responsive to or are intolerant of conventional therapies.

Clinical Results

Protopic's safety and effectiveness was evaluated in 28 worldwide trials with more than 4,000 adults and children - including those as young as 24 months of age. Trials were conducted in the United States, Europe and Japan, and over one-third of the subjects were children.

The trial data indicated that both concentrations of Protopic significantly improved or cleared the signs and symptoms of the condition in more than two-thirds of the subjects. Many subjects exhibited marked improvement after receiving one week of treatment. Overall, the 0.1% concentration exhibited statistically significant greater efficacy than the 0.03% concentration in adults.

Side Effects

Similar to other dermatological products currently marketed, it is advised that individuals practice safe sun techniques to avoid direct exposure to natural or artificial sunlight. Skin burning and itching have been associated with the application of Protopic; however, the incidence of these events decreased as the disease improved.

Mechanism of Action

Protopic is a topical immunomodulator (TIM) that acts at the site of the immune imbalance to help stop the redness and itching of eczema inflammation.

Additional Information

For additional information on atopic dermatitis and other forms of eczema, please visit the web site of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Please visit for further information on Protopic.