* 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 |
الوزن | 100 kg |
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TACROLIMUS 0.03% (0.3 MG/GM)