Exposure of the skin to sunlight should be minimized and the use of ultraviolet (UV) light from a solarium, therapy with UVB or UVA in combination with psoralens (PUVA) should be avoided during use of tacrolimus ointment. Physicians should advise patients on appropriate sun protection methods eg, minimization.
Of the time in the sun, use of sunscreen product and covering of the skin with appropriate clothing. Emollients should not be applied to the same area within 2 hrs of applying tacrolimus ointment. Concomitant use of other topical preparations have not been assessed. There is no experience of concomitant use of systemic steroids or immunosuppressive agents.
Tacrolimus ointment has not been evaluated for its efficacy and safety in the treatment of clinically infected atopic dermatitis. Before commencing treatment with tacrolimus ointment, clinical infections at treatment sites should be cleared. Patients with atopic dermatitis are predisposed to superficial skin infections. Treatment with tacrolimus will be associated with an increased risk of herpes viral infections. In the presence of these infections, the balance of risk and benefits associated with tacrolimus use should be evaluated. Beyond 4 years of treatment, the potential for local immunosuppression (possibly resulting in infections or cutaneous malignancies) is unknown. Care should be taken to avoid contact with eyes and mucous membranes. If accidentally applied to these areas, the ointment should be thoroughly wiped off and/or rinsed off with water. The use of tacrolimus ointment under occlusion has not been studied in patients. Occlusive dressings are not recommended.
As with any topical medicinal product, patients should wash hands after application if the hands are not indicated for treatment.
Tacrolimus is extensively metabolized in the liver and although blood concentration are low following topical therapy, the ointment should be used with caution in patients with generalized erythroderma.
Use in pregnancy & lactation: There no adequate and well-controlled studies of topically administered tacrolimus in pregnant women. The experience with tacrolimus ointment when used by pregnant women is limited.
Tacrolimus is transferred across the placenta. It is secreted also in milk.
Although clinical data have shown that systemic exposure from application of tacrolimus ointment is minimal relative to systemic administration, tacrolimus ointment should be used during pregnancy and in nursing mothers only if the potential benefit to the mother justifies a potential risk to the fetus.
Use in children: The use of tacrolimus ointment has not been evaluated in children <2 years.
Use in the elderly: Twenty five (25) patients >65 years received tacrolimus ointment in phase III studies. The adverse event profile for these was consistent with that of adult patients.