Moderate-to-severe atopic dermatitis in immunocompetent patients not responsive to conventional therapy or when conventional therapy is not appropriate.(UTD)

Suppresses cellular immunity (inhibits T-lymphocyte activation), by binding to an intracellular protein, FKBP-12 and complexes with calcineurin dependent proteins to inhibit calcineurin phosphatase activity.(UTD)

Absorption: Minimally absorbed
Bioavailability: ~0.5%

Hypersensitivity to tacrolimus or any component of the formulation.(UTD)

C(UTD)

Tacrolimus is excreted into breast milk following systemic administration. Refer to the Tacrolimus (Systemic) monograph for additional information.(UTD)

Central nervous system: Headache (adults 19% to 20%)
Dermatologic: Burning sensation of skin (43% to 58%), pruritus (41% to 46%), erythema (25% to 28%), skin infection (adults 12%)
Hypersensitivity: Hypersensitivity reaction (adults 6% to 12%)
Otic: Otitis media (children 12%)
Respiratory: Flu-like symptoms (23% to 31%), increased cough (children 18%)
Miscellaneous: Fever (children 21%)
(UTD)

Atopic dermatitis (moderate-to-severe):
1. Treatment: Apply thin layer of 0.03% or 0.1% ointment to affected area twice daily; rub in gently and completely. Discontinue use when symptoms have cleared. If no improvement within 6 weeks, patients should be re-examined to confirm diagnosis.
2. Maintenance therapy: Apply one application (thin layer of 0.03% or 0.1% ointment) to areas usually affected twice a week, allowing 2 to 3 days between applications. Re-evaluate after 12 months. Safety of maintenance therapy >12 months has not been established.

1. Children 2 to 15 years: Apply thin layer of 0.03% ointment to affected area twice daily; rub in gently and completely. Discontinue use when symptoms have cleared. If no improvement within 6 weeks, patients should be re-examined to confirm diagnosis.
2. Children >15 years: Refer to adult dosing.