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1.2. Pediatrics

A Black Box Warning states that the long-term safety of topical calcineurin inhibitors has not been established, and continuous long-term use is not recommended. While a causal relationship for the incidence of malignancy has not been established, topical calcineurin inhibitor use should be avoided in children younger than 2 years of age as the effect on the developing immune system is not known1-5.

Recommended pediatric dosages for topical calcineurin inhibitors are summarized in Table 2.

Drug Name/StrengthRecommended Dose/Directions
  • pimecrolimus 1% cream
  • Children greater than or equal to 2 years of age: apply thin layer of cream to affected area twice daily until symptoms resolve; use should be confined only to areas affected by atopic dermatitis; should not be used with occlusive dressings
  • tacrolimus 0.03% ointment
  • tacrolimus 0.03% or 0.1% ointment
  • Children 2-15 years of age: use only 0.03% strength; apply thin layer of ointment to affected layer twice daily, rubbing in completely, and continue until symptoms resolve; use should be confined only to areas affected by atopic dermatitis; should not be used with occlusive dressings
  • Children 15-17 years of age: apply thin layer of 0.03% or 0.1% ointment to affected area twice daily, rubbing in completely, and continue until symptoms resolve; use should be confined only to areas affected by atopic dermatitis; should not be used with occlusive dressings