riber for more information.
How should PROTOPIC Ointment be used?
Advise patients to:
Use PROTOPIC Ointment exactly as prescribed.
Use PROTOPIC Ointment only on areas of skin that have eczema.
Use PROTOPIC Ointment for short periods, and if needed, treatment may be repeated with breaks in between.
Stop PROTOPIC Ointment when the signs and symptoms of eczema, such as itching, rash, and redness go away, or as directed.
Follow their doctor’s advice if symptoms of eczema return after treatment with PROTOPIC Ointment.
Call their doctor if:
Their symptoms get worse with PROTOPIC Ointment.
They get an infection on their skin.
Their symptoms do not improve after 6 weeks of treatment. Sometimes other skin diseases can look like eczema.
To apply PROTOPIC Ointment:
Advise patients:
Wash their hands before applying PROTOPIC.
Apply a thin layer of PROTOPIC Ointment twice daily to the areas of skin affected by eczema.
Use the smallest amount of PROTOPIC Ointment needed to control the signs and symptoms of eczema.
If they are a caregiver applying PROTOPIC Ointment to a patient, or if they are a patient who is not treating their hands, wash their hands with soap and water after applying PROTOPIC. This should remove any ointment left on the hands.
Do not bathe, shower, or swim right after applying PROTOPIC. This could wash off the ointment.
Moisturizers can be used with PROTOPIC Ointment. Make sure they check with their doctor first about the products that are right for them. Because the skin of patients with eczema can be very dry, it is important to keep up good skin care practices. If they use moisturizers, apply them after PROTOPIC Ointment.
What should patients avoid while using PROTOPIC Ointment?
Advise patients:
Do not use ultraviolet light therapy, sun lamps, or tanning beds during treatment with PROTOPIC Ointment.
Limit sun exposure during treatment with PROTOPIC Ointment even when the medicine is not on their skin. If patients need to be outdoors after applying PROTOPIC Ointment, wear loose fitting clothing that protects the treated area from the sun. Doctors should advise what other types of protection from the sun patients should use.
Do not cover the skin being treated with bandages, dressings or wraps. Patients can wear normal clothing.
Avoid getting PROTOPIC Ointment in the eyes or mouth. Do not swallow PROTOPIC Ointment. Patients should call their doctor if they swallow PROTOPIC Ointment.
Drug Interactions
Formal topical drug interaction studies with PROTOPIC Ointment have not been conducted. Based on its extent of absorption, interactions of PROTOPIC Ointment with systemically administered drugs are unlikely to occur but cannot be ruled out (see CLINICAL PHARMACOLOGY). The concomitant administration of known CYP3A4 inhibitors in patients with widespread and/or erythrodermic disease should be done with caution. Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No evidence of genotoxicity was seen in bacterial (Salmonella and E. coli) or mammalian (Chinese hamster lung-derived cells) in vitro assays of mutagenicity, the in vitro CHO/HGPRT assay of mutagenicity, or in vivo clastogenicity assays performed in mice. Tacrolimus did not cause unscheduled DNA synthesis in rodent hepatocytes.
Oral (feed) carcinogenicity studies have been carried out wi |
