As systemic exposure is low with tacrolimus ointment, the high binding of tacrolimus (>98.8%) to plasma proteins is considered not to be clinically relevant.Following topical application of tacrolimus ointment, tacrolimus is selectively delivered to the skin with minimal diffusion into the systemic circulation.Metabolism of tacrolimus by human skin was not detectable. In both adults and children with an average of 50% body surface area treated, systemic exposure (i.e. The primary endpoint was the area-under-the-curve (AUC) of the mEASI as a percentage of baseline averaged over the treatment period.
In patients using tacrolimus ointment, cases of malignancies, including cutaneous and other types of lymphoma, and skin cancers have been reported (see section 4.8) Protopic should not be used in patients with congenital or acquired immunodeficiencies or in patients on therapy that cause immunosuppression.
In a 24-month dermal carcinogenicity study performed in mice with 0.1% ointment, no skin tumours were observed. 3. The most common side effects of tacrolimus ointment are
However, both the extent and the rate of topical absorption of tacrolimus decrease as the skin heals. In case of persistent lymphadenopathy, the aetiology of the lymphadenopathy should be investigated. The primary endpoint was the response rate at month 3 defined as the proportion of patients with at least 60% improvement in the mEASI (modified Eczema Area and Severity Index) between baseline and month 3.
Concomitant use of other topical preparations has not been assessed.
(59 F - 86 F). If symptoms recur, twice daily treatment with Protopic 0.1% should be restarted.
Tacrolimus is extensively distributed in the body. The steady-state volume of distribution based on plasma concentrations is approximately 1300 l (healthy subjects). The effect of treatment with Protopic ointment on the developing immune system of children aged below 2 years has not been established (see section 4.1).Protopic contains the active substance tacrolimus, a calcineurin inhibitor. Alcohol intolerance (facial flushing or skin irritation after consumption of an alcoholic beverage) was common.Patients may be at an increased risk of folliculitis, acne and herpes viral infections.Adverse reactions with suspected relationship to treatment are listed below by system organ class. Take the Atopic Eczema (Atopic Dermatitis) Quiz to learn...This condition is the most common of all pediatric dermatoses. Systemic exposure from topical application of tacrolimus ointment is low (< 1.0 ng/ml) and is unlikely to be affected by concomitant use of substances known to be inhibitors of CYP3A4.
It is recommended to use tacrolimus ointment at the lowest strength and the lowest frequency for the shortest duration necessary as determined by the physician's evaluation of the clinical condition (see section 4.2).Lymphadenopathy was uncommonly (0.8%) reported in clinical trials. In the absence of a clear aetiology for the lymphadenopathy or in the presence of acute infectious mononucleosis, discontinuation of Protopic should be considered.
§ Topical corticosteroid regimen = 0.1% hydrocortisone butyrate on trunk and extremities, 1% hydrocortisone acetate on face and neckThe incidence and nature of most adverse events were similar in the two treatment groups. Hypersensitivity to the active substance, macrolides in general, or to any of the excipients listed in section 6.1.Exposure of the skin to sunlight should be minimised and the use of ultraviolet (UV) light from a solarium, therapy with UVB or UVA in combination with psoralens (PUVA) should be avoided during use of Protopic ointment (see section 5.3).
However, the possibility of interactions cannot be ruled out and the concomitant systemic administration of known CYP3A4 inhibitors (e.g.
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Treatment duration was for up to three weeks.Median mEASI Percentage Decrease (Primary Endpoint)§The primary endpoint was defined as the percentage decrease in mEASI from the baseline to end of treatment.
In one arm patients received Protopic 0.03% ointment (n=121) twice a day for 3 weeks and thereafter once a day until clearance.
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