Table 4 Indications and contraindications for topical tacrolimus (ttac) 0.03% and 0.1% ointment

Indications

• Moderate to severe dermatitis in sensitive body sites (first choice)

• Moderate to severe atopic dermatitis in which (one of the following applies):

a) there is no response to first-line therapy with TCSs;

b) there are contraindications to treatment with TCSs;

c) undesirable effects induced by the use of TCSs may occur, such as skin atrophy or telangiectasia;

d) Long-term maintenance therapy is required.

Tacrolimus is approved for maintenance therapy to prevent relapses of AD and prolong intervals without flare-ups in patients experiencing a high frequency of relapses. In all these patients, sunscreen should be encouraged to reduce a hypothetical risk of photocarcinogenesis.

Contraindications

Absolute

Hypersensitivity to tTAC or other components of the ointment

Relative

a) children aged <2 years (0.03% concentration is indicated for age 2- <16 years; 0.1% concentration is indicated for ≥ 16 years). The use in this age group is off-label, but with various studies supporting the safety of use at age <2 years.

b) active skin infections (viral and/or bacterial) in place at the application site

c) eroded or ulcerated surfaces at the application site (if they were present in multiple forms, the application of this ointment should be started after the improvement of the lesions obtained with TCSs).

d) immunocompromised patients primitively, secondarily, or taking immunosuppressive drugs and/or with neoplasms

e) any lymphadenopathies present at the time of starting therapy should be evaluated and kept under observation

f) should not be used under occlusive dressing

g) the combination with phototherapy is not recommended