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Safety

Protopic general safety profile

Protopic has a proven safety profile in the treatment of moderate to severe eczema. Because it is not associated with the common risks of conventional prescription steroids, Protopic can be used confidently on thin or delicate skin, such as that of the face, neck, and intertriginous areas, and children as young as 2 years.1,2

 
Additionally, studies over 3 years show that Protopic is safe and effective for intermittent long-term use. Adverse events decrease over time with extended Protopic use
.4 Many conventional treatments produce cumulative side effects with extended use, and therefore, the risk for adverse events increases over time with those agents.

 
Click on a topic from the menu to the left to see clinical data related to the safety of Protopic.
 

References
 
1. Paller A, et al. J Am Acad Dermatol. 2001;44(suppl):S47-S57.
 
2. Paller A, et al. Ann Dermatol Venereol. 2002;129:1S247. Abstract IC1245.
 
3. Soter NA, et al. J Am Acad Dermatol. 2001;44(suppl):S39-S46.
 
4. Data on file. Fujisawa Healthcare, Inc., Deerfield, Ill.
 
5. Kang S, et al. J Am Acad Dermatol. 2001;44(suppl):S58-S64.
 
6. Protopic® (tacrolimus) Ointment full prescribing information. Deerfield, Ill: Fujisawa Healthcare, Inc.; 2000.

 
Important Information
 
For short-term and intermittent long-term therapy in patients with moderate to severe atopic dermatitis who should avoid the potential risks of conventional therapies or are not adequately responsive to conventional therapies. Both 0.03% and 0.1% ointment can be used for adults. In children aged 2 to 15 years, only Protopic 0.03% is indicated.

The most common adverse events associated with the use of Protopic Ointment included the sensation of skin burning, pruritus, flu-like symptoms, and headache, and it is contraindicated in patients who are hypersensitive to tacrolimus or any of the other ingredients of Protopic.

Protopic Ointment should not be used with occlusive dressings.

Skin infections should be cleared prior to application, and there may be an increased risk of certain skin infections. Patients should minimize or avoid natural or artificial sunlight exposure.

If patients have unresolved lymphadenopathy, lymphadenopathy with unclear etiology, or acute infectious mononucleosis, discontinuation of Protopic therapy should be considered.