Protopic

Tacrolimus

Flare treatment of moderate to severe atopic dermatitis in adults & adolescents ≥16 yr who are not adequately responsive to or are intolerant of conventional therapies eg, topical corticosteroids; in childn ≥2 yr who failed to respond adequately to conventional therapies eg, topical corticosteroids. Maintenance treatment of moderate to severe atopic dermatitis for prevention of flares & prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (ie, occurring ≥4x per year) who have had an initial response to a max of 6 wk treatment w/ tacrolimus oint bd (lesions cleared, almost cleared or mildly affected).

Flare treatment Adult & adolescent ≥16 yr 0.1% oint bd, continue until clearance of lesion. Reduce frequency of application or use 0.03% oint if clinical condition allows. Childn 2-16 yr 0.03% oint bd for up to 3 wk, reduce to once daily until clearance of lesion. Maintenance treatment Apply once daily, twice wkly. There should be 2-3 days w/o treatment between applications. Adult & adolescent ≥16 yr 0.1% oint. Childn ≥2 yr 0.03% oint.

Hypersensitivity to tacrolimus or macrolides in general.

Minimise skin exposure to sunlight & avoid use of UV light from a solarium or therapy w/ UVB or PUVA during Protopic treatment. Do not apply to lesions that are considered to be potentially malignant or pre-malignant. Not recommended in patients w/ a skin barrier defect eg, Netherton's syndrome, lamellar ichthyosis, generalized erythroderma or cutaneous graft versus host disease. Exercise caution if applying to patients w/ extensive skin involvement over an extended period of time, especially in childn. Reports of malignancies, including cutaneous & other types of lymphoma, & skin cancers. Do not use in patients w/ congenital or acquired immunodeficiencies or in patients on therapy that cause immunosuppression. Monitor patients who receive Protopic & develop lymphadenopathy. Consider treatment discontinuation in the absence of clear lymphadenopathy aetiology or in the presence of acute infectious mononucleosis. Clinical infections at treatment sites should be cleared before commencing treatment. May be associated w/ increased risk of folliculitis & herpes viral infections. Do not apply emollients to the same area w/in 2 hr of applying Protopic. Concomitant use of systemic steroids or immunosuppressive agents. Avoid contact w/ eyes & mucous membranes. Not recommended to use under occlusion. Wash hands after application if they are not intended for treatment. Contains butylhydroxytoluene. Patients w/ hepatic failure. Pregnancy. Not recommended to breast-feed during treatment. Do not use in childn <2 yr.

Application site burning & pruritus. Local skin infection regardless of specific aetiology including but not limited to eczema herpeticum, folliculitis, herpes simplex, herpes virus infection, Kaposi's varicelliform eruption; alcohol intolerance (facial flushing or skin irritation after alcohol consumption); paraesthesias & dysaesthesias (hyperaesthesia, burning sensation); pruritus; application site warmth, erythema, pain, irritation, paraesthesia & rash.

Possibility of interactions w/ concomitant systemic administration of known CYP3A4 inhibitors (eg, erythromycin, itraconazole, ketoconazole, diltiazem) in patients w/ widespread &/or erythrodermic disease.

Other Dermatologicals

D11AH01 - tacrolimus ; Belongs to the class of agents for atopic dermatitis, excluding corticosteroids. Used in the treatment of atopic dermatitis.

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