Home » Drug Information » FDA Approved Drugs » 2000
Medical Areas: Dermatology | Family Medicine
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Protopic (tacrolimus) ointment
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Fujisawa Healthcare
Approval Status: Approved December 2000
Treatment Area: Moderate to severe atopic dermatitis
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
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
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.
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.
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
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.