Protopic

What is it?

An immunomodulator available as an ointment in 2 strengths containing 0.03% and 0.1% tacrnlimus as monohydrate.

Medical Uses

Atopic dermatitis which is moderate or severe that has failed to respond to other preparations.

Dosage

Adults, start with 0.1% strength and apply thinly twice each day for up to 3 weeks; then change to 0.03% strength and apply in the same way. As condition improves, reduce frequency of use until cleared. Children aged 2 to 16 years, use 0.03% strength and apply thinly 2 times each day for up to 3 weeks. Then use once each day until condition is cleared.

Special Care

Generalised erythroderma, liver failure. Any infections should be treated first before using Protonic and patients should avoid exposure to UV radiation as far as is possible. Patients who develop lymphadenopathy (disorders of lymphatic system) should be monitored, do not allow contact with mucous membranes or eyes.

Avoid Use

Children aged under 2 years, pregnancy, breastfeeding, known allergy to macrolides, patients with inborn barrier defects affecting the epidermis.

Possible Drug and Food Interactions

Vaccines, CYP3A4 inhibitors in erythrodermic or widespread conditions. Emollients should not be used for 2 hours following application of Protopic.

Known Side Effects

Reddening of skin, burning, itching, tingling sensation, intolerance of alcohol, sensitivity. Increased risk of herpes simplex, folliculitis and acne. Any adverse side effects should be reported to the Committee on the Safety of Medicines (CSM).

Manufacturer

Fujisawa.