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Tacrolimus Ointment 0.03% w/w / Tacrolimus Ointment 0.1% w/w treatment should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis.
Posology: Atopic Dermatitis flare treatment: Tacrolimus Ointment 0.03% w/w / Tacrolimus Ointment 0.1% w/w can be used for short-term and intermittent long-term treatment. Treatment should not be continuous on a long-term basis.
Tacrolimus Ointment 0.03% w/w / Tacrolimus Ointment 0.1% w/w treatment should begin at the first appearance of signs and symptoms. Each affected region of the skin should be treated with Tacrolimus Ointment 0.03% w/w / Tacrolimus Ointment 0.1% w/w until lesions are cleared, almost cleared or mildly affected. Thereafter, patients are considered suitable for maintenance treatment (see Maintenance treatment as follows). At the first signs of recurrence (atopic dermatitis flares) of the disease symptoms, treatment should be reinitiated.
Adults and adolescents (16 years of age and above): Treatment should be started with Tacrolimus Ointment 0.1% w/w twice a day and treatment should be continued until clearance of the lesion. If symptoms recur, twice daily treatment with Tacrolimus Ointment 0.1% w/w should be restarted. An attempt should be made to reduce the frequency of application or to use the lower strength Tacrolimus Ointment 0.03% w/w 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.
Elderly patients: Specific studies have not been conducted in elderly patients. However, the clinical experience available in this patient population has not shown the necessity for any dosage adjustment.
Paediatric population: Children (2 years of age and above) should use the lower strength Tacrolimus Ointment 0.03% w/w.
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 0.03% w/w / Tacrolimus Ointment 0.1% w/w should not be used in children aged below 2 years until further data are available.
Maintenance treatment: Patients who are responding to up to 6 weeks treatment using Tacrolimus Ointment 0.03% w/w / Tacrolimus Ointment 0.1% w/w twice daily (lesions cleared, almost cleared or mildly affected) are suitable for maintenance treatment.
Adults and adolescents (16 years of age and above): Adult patients should use Tacrolimus Ointment 0.1% w/w.
Tacrolimus Ointment 0.03% w/w / Tacrolimus Ointment 0.1% w/w should be applied once a day twice weekly (e.g. Monday and Thursday) to areas commonly affected by atopic dermatitis to prevent progression to atopic dermatitis flares. Between applications, there should be 2-3 days without Tacrolimus Ointment 0.03% w/w / Tacrolimus Ointment 0.1% w/w 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 an atopic dermatitis flare reoccur, twice daily treatment should be reinitiated (see Atopic Dermatitis flare treatment as previously mentioned).
Elderly patients: Specific studies have not been conducted in elderly patients (see Atopic Dermatitis flare treatment as previously mentioned).
Paediatric population: Children (2 years of age and above) should use the lower strength Tacrolimus Ointment 0.03% w/w.
Tacrolimus Ointment 0.03% w/w should be applied once a day twice weekly (e.g. Monday and Thursday) to areas commonly affected by atopic dermatitis to prevent progression to atopic dermatitis flares. Between applications, there should be 2-3 days without Tacrolimus Ointment 0.03% w/w 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 0.03% w/w / Tacrolimus Ointment 0.1% w/w should not be used in children aged below 2 years until further data are available.
Method of administration: Tacrolimus Ointment 0.03% w/w / Tacrolimus Ointment 0.1% w/w should be applied as a thin layer to affected or commonly affected areas of the skin. Tacrolimus Ointment 0.03% w/w / Tacrolimus Ointment 0.1% w/w may be used on any part of the body, including face, neck and flexure areas, except on mucous membranes. Tacrolimus Ointment 0.03% w/w / Tacrolimus Ointment 0.1% w/w should not be applied under occlusion because this method of administration has not been studied in patients.
