Tacroz/Tacroz Forte Special Precautions

Tacroz: Skin infections should be treated before starting therapy with topical Tacrolimus. It should not be used in immunocompromised patients or those with conditions that might increase systemic absorption of Tacrolimus. It must also not be applied to pre malignant skin conditions; some malignant skin conditions may mimic eczema.
Not use in children under 2 years of age.
Not use continuously for more than 6 weeks, with an application free period of up to 2 weeks.
Use in Children: Three, long term, phase two studies showed Tacrolimus (Tacroz) ointment 0.03% may be used in pediatric patients 2 years of age and older.
Use in Elderly: The adverse event profile in elderly subjects was same as that in other adult patients. No dosage adjustments are recommended for topical Tacrolimus (Tacroz) in elderly.
Tacroz Forte: Studies have not evaluated the safety and efficacy of Tacrolimus (Tacroz Forte) Ointment in the treatment of clinically infected atopic dermatitis. Before commencing treatment with Tacrolimus (Tacroz Forte) 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 (Tacroz Forte) 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 Tacrollmus (Tacroz Forte) Ointment use should be evaluated.
Transplant patients receiving immunosuppressive regimens (e.g., systemic tacrolimus) are at increased risk for developing lymphoma; therefore, patients who receive Tacrolimus (Tacroz Forte) Ojntment and who develop lymphadenopathy should have the etiology of their lymphadenopathy investigated. In the absence of a clear etiology for the lymphadenopathy, or in the presence of acute infectious mononucleosis, discontinuation of Tacrolimus (Tacroz Forte) Ointment should be considered. Patients who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves.
Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using Tacrolimus (Tacroz Forte) Ointment.
Localized symptoms (burning sensation, stinging, soreness) or pruritus are most common during the first few days of Tacrolimus (Tacroz Forte) Ointment application and typically improve as the lesions of atopic dermatitis heal.
The use of Tacrolimus (Tacroz Forte) Ointment in patients with Netherton's Syndrome is not recommended due to the potential for increased systemic absorption of tacrolimus. The safety of Tacrolimus (Tacroz Forte) Ointment has not been established in patients with generalized erythroderma.