Posology : מינונים

4.2    Posology and method of administration
Protopic treatment should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis.
Protopic is available in two strengths, Protopic 0.03% and Protopic 0.1% ointment.
Posology

Flare treatment
Protopic can be used for short-term and intermittent long-term treatment. Treatment should not be continuous on a long-term basis.
Protopic 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.
Adults and adolescents (16 years of age and above)
Treatment should be started with Protopic 0.1% twice a day and treatment should be continued until clearance of the lesion. If symptoms recur, twice daily treatment with Protopic 0.1% should be restarted. An attempt should be made to reduce the frequency of application or to use the lower strength Protopic 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.

Elderly
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.

Paediatric population
Children (2 years of age and above) should use the lower strength Protopic 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 (see section 4.4).

Protopic ointment 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 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 Protopic 0.1% ointment.
Protopic 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 Protopic 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).

Elderly
Specific studies have not been conducted in older people (see flare treatment section above).

Paediatric population
Children (2 years of age and above) should use the lower strength Protopic 0.03% ointment.
Protopic 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 Protopic 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.

Protopic ointment should not be used in children aged below 2 years until further data are available.
Method of administration
Protopic ointment should be applied as a thin layer to affected or commonly affected areas of the skin. Protopic ointment may be used on any part of the body, including face, neck and flexure areas, except on mucous membranes. Protopic ointment should not be applied under occlusion because this method of administration has not been studied in patients (see section 4.4).