Tacroz

Tacroz

tacrolimus

Manufacturer:

Glenmark Pharma

Distributor:

Uni Drug House
Concise Prescribing Info
Contents
Tacrolimus
Indications/Uses
Flare treatment of moderate to severe atopic dermatitis in adults & adolescents ≥16 yr w/ inadequate response to or intolerant of conventional therapies eg, topical corticosteroids. Maintenance treatment of moderate to severe atopic dermatitis for prevention of flares & prolongation of flare-free intervals in patients w/ initial response to max 6 wk of tacrolimus oint bd treatment experiencing high frequency of disease exacerbations ie, occurring ≥4 yrly.
Dosage/Direction for Use
Adult & adolescent ≥16 yr Flare treatment Apply thinly to affected area bd until lesion clearance, reduce frequency or use if clinical condition allows. Maintenance treatment Apply thinly to affected area once daily twice wkly w/ 2-3 days interval.
Contraindications
Hypersensitivity to tacrolimus or macrolides.
Special Precautions
Discontinue use in absence of clear lymphadenopathy aetiology or 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 ichthyosis, generalized erythroderma or cutaneous graft versus host disease. Increased risk of folliculitis & herpes viral infections eg, herpes simplex dermatitis, herpes simplex, Kaposi's varicelliform eruption; lymphomas & skin malignancies in transplant patients; opportunistic infections in immunosuppressed patients; severe burns. 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. Avoid contact w/ eyes & mucous membranes. Not recommended to be applied under occlusive dressings. Emollients should not be applied to the same area w/in 2 hr. Prolonged & extensive use especially in childn. 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; paraesthesias, dysaesthesia eg, hyperaesthesia, 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.
Presentation/Packing
Form
Tacroz oint 0.1% w/w
Packing/Price
30 g x 1's
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