Safety

Proven safety profile in 3 years of pediatric clinical trials²

• Gentle enough for children, even when treating the head, neck, intertriginous areas, and large body surface areas^1,2
• Studied in more than 6000 pediatric patients⁴
• No immunosuppression or effect on immune parameters^1,2,4
• No skin atrophy or growth retardation⁵
• In children aged 2 to 15 years, only Protopic 0.03% is indicated²

 
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.