Protopic

Protopic treatment should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis. 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. eDoc-000593873 - Version 19. 0 3 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. 1% twice a day and treatment should be continued until clearance of the lesion. 1% should be restarted. 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. 03% ointment. Treatment should be started twice a day for up to three weeks. 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. 1% ointment. 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). 03% ointment. g. Monday and Thursday) to areas commonly affected by atopic dermatitis to prevent progression to flares.

In clinical studies approximately 50% of patients experienced some type of skin irritation adverse reaction at the site of application. Burning sensation and pruritus were very common, usually mild to moderate in severity and tended to resolve within one week of starting treatment.

Erythema was a common skin irritation adverse reaction. Sensation of warmth, pain, paraesthesia and rash at the site of application were also commonly observed. Alcohol intolerance (facial flushing or skin irritation after consumption of an alcoholic beverage) was common.

Patients may be at an increased risk of folliculitis, acne and herpes viral infections. Adverse reactions with suspected relationship to treatment are listed below by system organ class. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. System Organ Class Very Common ≥1/10 Common ≥1/100, <1/10 Uncommon ≥1/1000, <1/100 Not known (cannot be estimated from the available data) Infections and infestations Local skin infection regardless of specific aetiology including but not limited to: Eczema herpeticum, Folliculitis, Herpes simplex, Herpes virus infection, Kaposi’s varicelliform eruption* Ophthalmic Herpes Infection* Metabolism and nutrition disorders Alcohol intolerance (facial flushing or skin irritation after consumption of an alcoholic beverage) Nervous system disorders Paraesthesias and dysaesthesias (hyperaesthesia, burning sensation) Skin and subcutaneous tissue disorders Pruritus Acne* Rosacea* Lentigo* General disorders and administration site conditions Application site burning, Application site pruritus Application site warmth, Application site erythema, Application site pain, Application site irritation, Application site paraesthesia, Application site rash Application site oedema*eDoc-000593873 - Version 19.

3). Physicians should advise patients on appropriate sun protection methods, such as minimisation of the time in the sun, use of a sunscreen product and covering of the skin with appropriate clothing. Protopic ointment should not be applied to lesions that are considered to be potentially malignant or pre-malignant.

The development of any new change different from previous eczema within a treated area should be reviewed by the physician. The use of tacrolimus ointment is not recommended in patients with a skin barrier defect, such as Netherton’s syndrome, lamellar ichthyosis, generalized erythroderma, pyoderma gangrenosum or cutaneous Graft Versus Host Disease.

These skin conditions may increase systemic absorption of tacrolimus. Post-marketing cases of increased tacrolimus blood level have been reported in these conditions. Protopic should not be used in patients with congenital or acquired immunodeficiencies or in patients on therapy that cause immunosuppression.

2). Patients, particularly paediatric patients should be continuously evaluated during treatment with Protopic with respect to the response to treatment and the continuing need for treatment. 2). 1). Protopic contains the active substance tacrolimus, a calcineurin inhibitor.

In transplant patients, prolonged systemic exposure to intense immunosuppression following systemic administration of calcineurin inhibitors has been associated with an increased risk of developing lymphomas and skin malignancies. Patients with atopic dermatitis treated with Protopic have not been found to have significant systemic tacrolimus levels and the role of local immunosuppression is unknown.

Based on the results of long-term studies and experience, a link between Protopic ointment treatment and development of malignancies has not been confirmed, but definitive conclusions cannot be drawn. 2). 8%) reported in clinical trials.

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