Active Ingredient: Tacrolimus
Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of 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 Protopic 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.
Treatment should be started with tacrolimus 0.1% twice a day and treatment should be continued until clearance of the lesion. If symptoms recur, twice daily treatment with tacrolimus 0.1% should be restarted. An attempt should be made to reduce the frequency of application or to use the lower strength tacrolimus 0.03% ointment if the clinical condition allows.
Generally, improvement is seen within one week of starting treatment. If no signs of improvement are seen after two weeks of treatment, further treatment options should be considered.
Specific studies have not been conducted in older people. However, the clinical experience available in this patient population has not shown the necessity for any dosage adjustment.
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.
Adult patients should use tacrolimus 0.1% 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.
After 12 months treatment, a review of the patient’s condition should be conducted by the physician and a decision taken whether to continue maintenance treatment in the absence of safety data for maintenance treatment beyond 12 months.
If signs of a flare reoccur, twice daily treatment should be re-initiated (see flare treatment section above).
Specific studies have not been conducted in older people (see flare treatment section above).
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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