Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: LEO Pharma A/S, Industriparken 55 2750, Ballerup, Denmark
Protopic 0.1% ointment is indicated in adults and adolescents (16 years of age and above).
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.
Treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).
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.
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.
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.
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.
Only Protopic 0.03 % ointment should be used in children from the age of 2 to 16 years. Protopic 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.
Adult patients (16 years of age and above) 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).
Specific studies have not been conducted in older people (see flare treatment section above).
Only Protopic 0.03% ointment should be used in children from the age of 2 to 16 years. Protopic ointment should not be used in children aged below 2 years until further data are available.
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).
Overdosage following topical administration is unlikely.
If ingested, general supportive measures may be appropriate. These may include monitoring of vital signs and observation of clinical status. Due to the nature of the ointment vehicle, induction of vomiting or gastric lavage is not recommended.
3 years.
Do not store above 25°C.
Laminate tube with an inner lining of low-density-polyethylene fitted with a white polypropylene screw cap.
Package sizes: 10 g, 30 g and 60 g. Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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