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* Indications: Tacrolimus Ointment, for adults, and for children aged 2 to 15 years, is indicated for short-term and
& intermittent long-term therapy in the treatment of patients with moderate to severe atopic dermatitis in
& whom the use of alternative, conventional therapies are deemed inadvisable because of potential risks,
& or in the treatment of patients who are not adequately responsive to or are intolerant of alternative,
& conventional therapies.
* Dosage and Method of Administration:
# Adult:
& Apply a thin layer of Tacrolimus Ointment to the affected skin areas twice daily and rub in gently and
& completely. Treatment should be continued for one week after clearing of signs and symptoms of atopic
& dermatitis.
& The safety of Tacrolimus Ointment under occlusion which may promote systemic exposure, has not been
& evaluated. Tacrolimus Ointment should not be used with occlusive dressings.
# Pediatric:
& Apply a thin layer of Tacrolimus Ointment 0.03% to the affected skin areas twice daily and rub in gently
& and completely. Treatment should be continued for one week after clearing of signs and symptoms of
& atopic dermatitis. he safety of Tacrolimus Ointment under occlusion, which may promote systemic
& exposure, has not been evaluated. Tacrolimus Ointment 0.03% should not be used with occlusive
& dressings.
* Contraindications:
& Tacrolimus Ointment is contraindicated in patients with a history of hypersensitivity to tacrolimus or any
& other component of the preparation.
* Warnings and precautions:
# General:
& Studies has not evaluated the safety and efficacy of tacrolimus ointment in the treatment of clinically
& infected atopic dermatitis. Before commencing treatment with tacrolimus ointment, clinical infections at
& treatment sites should be cleared.
& While patients with atopic dermatitis are predisposed to superficial skin infections including eczema
& herpeticum (Kaposi’s varicelliform eruption), treatment with Tacrolimus Ointment may be associated with
& an increased risk of varicella zoster virus infection (chicken pox or shingles), herpes simplex virus
& infection, or eczema herpeticum. In the presence of these infections, the balance of risks and benefits
& associated with Tacrolimus Ointment use should be evaluated.
& In clinical studies, 33 cases of lymphadenopathy (0.8%) were reported and were usually related to
& infections (particularly of the skin) and noted to resolve upon appropriate antibiotic therapy. Of the 33
& cases, the majority had either a clear etiology or were known to resolve. Transplant patients receiving
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