LEO Pharma


Concise Prescribing Info
Moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies eg, topical corticosteroids.
Dosage/Direction for Use
Adult & adolescent ≥16 yr Apply 0.1% oint thinly to affected area bd until lesion clearance, reduce frequency or use 0.03% oint if clinical condition allows. Restart bd treatment w/ 0.1% oint if symptoms recur. Childn ≥2 yr Apply 0.03% oint thinly to affected area bd for up to 3 wk, reduce to once daily until lesion clearance.
Hypersensitivity to tacrolimus, macrolides.
Special Precautions
Discontinue use in presence of acute infectious mononucleosis. Not to be used in patients w/ congenital or acquired immunodeficiencies or on immunosuppression therapy. Not to be applied to potentially malignant or pre-malignant lesions. Not recommended in patients w/ skin barrier defects eg, Netherton's syndrome, lamellar icthyosis, generalized erythroderma or cutaneous Graft Versus Host Disease. Increased risk of folliculitis & herpes viral infections [herpes simplex dermatitis (eczema herpeticum), herpes simplex (cold sores), Kaposi’s varicelliform eruption]. Clinically infected atopic dermatitis. Monitor patients who develop lymphadenopathy. Limit exposure to sunlight & avoid use of UV light from solarium; therapy w/ UVB or UVA in combination w/ psoralens (PUVA). Avoid contact w/ eyes & mucous membranes. Not to be applied under occlusive dressings. Prolonged & extensive use especially in childn. Not to be applied on same area w/ emollients w/in 2 hr. Increased risk of developing lymphomas & skin malignancies in transplant patients. Hepatic failure. Not to be used during pregnancy. Not recommended during lactation. Not to be used in childn <2 yr.
Adverse Reactions
Application site burning & pruritus. Local skin infection eg, eczema herpeticum, folliculitis, herpes simplex & virus infection, Kaposi's varicelliform eruption; alcohol intolerance (facial flushing or skin irritation after consumption); paraesthesias & dysaesthesia (hyperaestheisa, burning sensation); pruritus; application site warmth, erythema, pain, irritation, paraesthesia & rash.
Drug Interactions
CYP3A4 inhibitors eg, erythromycin, itraconazole, ketoconazole, diltiazem.
MIMS Class
Other Dermatologicals
ATC Classification
D11AH01 - tacrolimus ; Belongs to the class of agents for atopic dermatitis, excluding corticosteroids. Used in the treatment of atopic dermatitis.
Protopic oint 0.03%
10 g x 1's
Protopic oint 0.1%
10 g x 1's
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