Protopy

Protopy should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis. Treatment should be intermittent and not continuous. Protopy ointment should be applied as a thin layer to affected areas of the skin.

Protopy ointment may be used on any part of the body, including face, neck and flexure areas, except on mucous membranes. 4). Each affected region of the skin should be treated with Protopy until clearance occurs and then treatment should be discontinued.

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. Protopy can be used for short term and intermittent long term treatment.

At the first signs of recurrence (flares) of the disease symptoms, treatment should be re-initiated. Protopy is not recommended for use in children below age of 2 years until further data are available. Use in children (2 years of age and above) Treatment should be started twice a day for up to three weeks.

4). 1% ointment. 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. Medicinal product no longer authorised3 Use in elderly (65 years of age and above) 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. As clinical efficacy studies were performed with abrupt cessation of treatment, no information is available on whether tapering of the dosage would reduce recurrence rate.

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, < 1/10) and uncommon (> 1/1,000, < 1/100).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 4).

Protopy should not be used in patients with congenital or acquired immunodeficiencies or in patients on therapy that cause immunosuppression. 1). 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.

Protopy ointment should not be applied to lesions that are considered to be potentially malignant or pre-malignant. Emollients should not be applied to the same area within 2 hours of applying Protopy ointment. Concomitant use of other topical preparations has not been assessed.

There is no experience with concomitant use of systemic steroids or immunosuppressive agents. Protopy ointment has not been evaluated for its efficacy and safety in the treatment of clinically infected atopic dermatitis. Before commencing treatment with Protopy ointment, clinical infections at treatment sites should be cleared.

Patients with atopic dermatitis are predisposed to superficial skin infections. Treatment with Protopy may be associated with an increased risk of herpes viral infections (herpes simplex dermatitis [eczema herpeticum], herpes simplex [cold sores], Kaposi’s varicelliform eruption).

In the presence of these infections, the balance of risks and benefits associated with Protopy use should be evaluated. e. 1). Protopy 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.

8). Patients with atopic dermatitis treated with Protopy have not been found to have significant systemic tacrolimus levels. 8%) reported in clinical trials. The majority of these cases related to infections (skin, respiratory tract, tooth) and resolved with appropriate antibiotic therapy.

Hypersensitivity to macrolides in general, to tacrolimus or to any of the excipients.