Protopic Special Precautions

Patients with atopic dermatitis are predisposed to skin infections. In the presence of clinical skin infection, the use of tacrolimus ointment should be evaluated for relative risk and benefit.
Although causal relationship has not been established, rare cases of malignancies including skin malignancies and lymphomas have been reported in patients treated with tacrolimus ointment.
During the course of tacrolimus ointment use, exposure of skin to natural or artificial sunlight should be minimized.
Tacrolimus ointment is intended for dermal application without occlusive dressing. The use of tacrolimus ointment is not recommended in patients having skin conditions with a skin barrier defect in which there is the potential for increased systemic absorption of tacrolimus, for example Netherton's syndrome, lamellar ichthyosis, generalized erythroderma or cutaneous Graft Versus Host Disease. Oral application is also not recommended. Post-marketing cases of increased tacrolimus blood level have been reported in these conditions.
If signs or symptoms of atopic dermatitis do not improve, further treatment options should be considered.
The safety and efficacy of topical tacrolimus ointment has not been established in patients younger than two years of age.
Effects on Ability to Drive and Use Machines: Not applicable.