Active Ingredient: Tacrolimus
Treatment of moderate to severe atopic dermatitis in children who failed to respond adequately to conventional therapies such as topical corticosteroids.
For this indication, competent medicine agencies globally authorize below treatments:
Cutaneous
2 - 2 {spreads}
From 1 To 1 {spreads} 2 time(s) per day every day
Tacrolimus can be used for short-term and intermittent long-term treatment. Treatment should not be continuous on a long-term basis.
Tacrolimus treatment should begin at the first appearance of signs and symptoms. Each affected region of the skin should be treated with tacrolimus until lesions are cleared, almost cleared or mildly affected.
Thereafter, patients are considered suitable for maintenance treatment (see below). At the first signs of recurrence (flares) of the disease symptoms, treatment should be re-initiated.
Children (2 years of age and above) should use the lower strength tacrolimus 0.03% ointment. Treatment should be started twice a day for up to three weeks. Afterwards the frequency of application should be reduced to once a day until clearance of the lesion.
Tacrolimus ointment should not be used in children aged below 2 years until further data are available.
Patients who are responding to up to 6 weeks treatment using tacrolimus ointment twice daily (lesions cleared, almost cleared or mildly affected) are suitable for maintenance treatment.
Children (2 years of age and above) should use the lower strength tacrolimus 0.03% ointment. Tacrolimus ointment should be applied once a day twice weekly (e.g. Monday and Thursday) to areas commonly affected by atopic dermatitis to prevent progression to flares. Between applications there should be 2-3 days without tacrolimus treatment.
The review of the child’s condition after 12 months treatment should include suspension of treatment to assess the need to continue this regimen and to evaluate the course of the disease.
Tacrolimus ointment should not be used in children aged below 2 years until further data are available.
Tacrolimus ointment should be applied as a thin layer to affected or commonly affected areas of the skin. Tacrolimus ointment may be used on any part of the body, including face, neck and flexure areas, except on mucous membranes. Tacrolimus ointment should not be applied under occlusion because this method of administration has not been studied in patients.
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