Can Protopic (tacrolimus) 0.1% be used in children?

Use of Protopic 0.1% (Tacrolimus) in Children

Protopic 0.1% (tacrolimus) ointment should not be used in children under 16 years of age, as it is only approved for patients aged 16 years and above, while the lower concentration (0.03%) is approved for children aged 2 years and above.

Age-Specific Recommendations for Tacrolimus

Approved Age Groups:

• Protopic 0.03%: Approved for children aged 2 years and above
• Protopic 0.1%: Approved only for patients aged 16 years and above

This age-specific recommendation is clearly stated in the Taiwan guidelines for the management of pediatric atopic dermatitis 1. The guidelines specifically mention that tacrolimus ointment is approved for patients aged 2 years and above (Protopic 0.03%) and aged 16 years and above (Protopic 0.1%) in Taiwan.

Clinical Applications in Children

Tacrolimus ointment is primarily used for:

• Atopic dermatitis: As a second-line therapy after topical corticosteroids
• Facial and intertriginous areas: Where steroid-sparing agents are preferred due to risk of skin atrophy
• Steroid-resistant cases: When topical corticosteroids have failed

For pediatric patients with moderate atopic dermatitis, the recommended approach is:

1. First-line: Topical corticosteroids (low to medium potency)
2. Second-line: Tacrolimus 0.03% for children 2-15 years old

Safety Considerations

While tacrolimus is effective for treating atopic dermatitis in children, several important safety considerations exist:

• Systemic absorption: There is concern about systemic absorption, especially when applied to larger body surface areas 1
• Monitoring: When used for extended periods, monitoring of serum or plasma drug levels may be necessary 1
• Application site reactions: Transient mild to moderate skin burning is common but typically resolves within 3-4 days 2
• Herpes simplex risk: May make patients more susceptible to herpes simplex keratitis 1
• Theoretical cancer risk: The FDA has issued warnings about theoretical risk of lymphoma with long-term use, though evidence suggests the absolute risk is low 3

Efficacy in Children

Research has demonstrated that:

• 0.03% tacrolimus ointment is significantly more efficacious than 1% hydrocortisone acetate in children with moderate to severe atopic dermatitis 2
• Effectiveness is maintained with prolonged daily use 4
• Substantial improvements in signs and symptoms are typically observed during the first week of treatment 4

Practical Application Guidelines

For children requiring tacrolimus treatment:

• For ages 2-15 years: Use only the 0.03% concentration
• For ages 16 and above: Either 0.03% or 0.1% concentration may be used
• Application frequency: Typically twice daily until improvement, then reduced to maintenance therapy
• Duration: Short-term management of flares on limited areas is recommended 1
• Monitoring: For long-term use, periodic skin examinations and potentially blood level monitoring

Alternative Options for Young Children

For children under 2 years or when tacrolimus is contraindicated:

• Low-potency topical corticosteroids for limited periods
• Emollients and proper skin care as foundation therapy
• Pimecrolimus 1% cream (approved for children ≥3 months in some regions) 1

Remember that proper education about maintaining skin barrier integrity through emollients and avoiding triggers is fundamental to managing pediatric atopic dermatitis regardless of medication choice 1.