Tacroz/Tacroz Forte

Tacrolimus

Treatment of moderate to severe atopic dermatitis in adults & adolescents ≥16 yr who are inadequately responsive to or are intolerant of conventional therapies eg, topical corticosteroids. Maintenance treatment for the prevention of atopic dermatitis flares & prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (ie, occurring ≥4 times per yr) who have had an initial response to a max of 6 wk treatment of bd tacrolimus oint (lesions cleared, almost cleared or mildly affected). Tacroz Treatment of moderate to severe atopic dermatitis in childn ≥2 yr who failed to adequately respond to conventional therapies eg, topical corticosteroids.

Apply a thin layer to affected or commonly affected areas. Atopic dermatitis flare treatment Adult & adolescent ≥16 yr Initiate treatment w/ Tacroz Forte bd & continue until clearance of lesion. Restart Tacroz Forte bd if symptoms recur. Attempt to reduce frequency of application or use Tacroz if clinical condition allows. Childn ≥2 yr Tacroz bd for up to 3 wk. Afterwards, reduce frequency of application to once daily until clearance of lesion. Maintenance treatment Suitable for patients responding to up to 6 wk treatment w/ Tacroz/Tacroz Forte bd (lesions cleared, almost cleared or mildly affected). Adult & adolescent ≥16 yr Apply Tacroz Forte (for adult) or Tacroz (for adolescent ≥16 yr) once daily twice wkly to areas commonly affected by atopic dermatitis. There should be 2-3 days w/o treatment between applications. Reinitiate bd treatment if signs of flare reoccur. Childn ≥2 yr Apply Tacroz once daily twice wkly to areas commonly affected by atopic dermatitis. There should be 2-3 days w/o treatment between applications.

Hypersensitivity to tacrolimus or macrolides.

Treatment should not be continuous on a long-term basis. Do not apply under occlusion. Do not apply emollients to the same area w/in 2 hr of applying Tacroz/Tacroz Forte. Avoid contact w/ eyes & mucous membranes. Wash hands after application if they are not intended for treatment. Minimise skin exposure to sunlight & avoid use of UV light from solarium, therapy w/ UVB or PUVA during treatment. Do not apply to lesions considered to be potentially malignant or pre-malignant. Not recommended in patients w/ skin barrier defect eg, Netherton's syndrome, lamellar ichthyosis, generalized erythroderma or cutaneous graft-versus-host disease. Caution if applying to patients w/ extensive skin involvement over an extended period of time, especially in childn. Continuously evaluate patients during treatment w/ respect to treatment response & continuing need for treatment. Suspend treatment in paed patients after 12 mth. Prolonged systemic exposure to intense immunosuppression following systemic administration of calcineurin inhibitors has been associated w/ an increased risk of developing lymphomas & skin malignancies in transplant patients. Do not use in patients w/ congenital or acquired immunodeficiencies or in patients on immunosuppressive therapy. Risk of lymphadenopathy. Consider treatment discontinuation in the absence of a clear aetiology for lymphadenopathy or in the presence of acute infectious mononucleosis. Efficacy & safety in the treatment of clinically infected atopic dermatitis has not been evaluated. May be associated w/ an increased risk of folliculitis & herpes viral infections. No experience w/ concomitant use of systemic steroids or immunosuppressive agents. Patients w/ hepatic failure. Pregnancy. Breast-feeding during treatment is not recommended. Do not use in childn <2 yr.

Application site burning, pruritus. Local skin infection eg, 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.

Possible interactions w/ systemic administration of known CYP3A4 inhibitors (eg, erythromycin, itraconazole, ketoconazole, diltiazem).

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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