ms of atopic dermatitis resolve.
If signs and symptoms (e.g. itch, rash, and redness) do not improve within 6 weeks, patients should be re-examined by their healthcare provider to confirm the diagnosis of atopic dermatitis.
Continuous long-term use of topical calcineurin inhibitors, including PROTOPIC Ointment should be avoided, and application should be limited to areas of involvement with atopic dermatitis.
The safety of PROTOPIC Ointment under occlusion, which may promote systemic exposure, has not been eva luated. PROTOPIC Ointment should not be used with occlusive dressings.
PEDIATRIC – FOR CHILDREN 2-15 YEARS
PROTOPIC Ointment 0.03%
Apply a thin layer of PROTOPIC (tacrolimus) Ointment, 0.03% to the affected skin twice daily. The minimum amount should be rubbed in gently and completely to control signs and symptoms of atopic dermatitis. Stop using when signs and symptoms of atopic dermatitis resolve.
If signs and symptoms (e.g. itch, rash, and redness) do not improve within 6 weeks, patients should be re-examined by their healthcare provider to confirm the diagnosis of atopic dermatitis.
Continuous long-term use of topical calcineurin inhibitors, including PROTOPIC Ointment should be avoided, and application should be limited to areas of involvement with atopic dermatitis.
The safety of PROTOPIC Ointment under occlusion, which may promote systemic exposure, has not been eva luated. PROTOPIC Ointment should not be used with occlusive dressings.
HOW SUPPLIED
PROTOPIC® (tacrolimus) Ointment 0.03%
NDC 0469-5201-30 Product Code 520130
30 gram laminate tube
NDC 0469-5201-60 Product Code 520160
60 gram laminate tube
NDC 0469-5201-11 Product Code 520111
100 gram laminate tube
PROTOPIC® (tacrolimus) Ointment 0.1%
NDC 0469-5202-30 Product Code 520230
30 gram laminate tube
NDC 0469-5202-60 Product Code 520260
60 gram laminate tube
NDC 0469-5202-11 Product Code 520211
100 gram laminate tube
Store at room temperature 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).
Marketed by:
Astellas Pharma US, Inc.
Deerfield, IL 60015-2548
Manufactured by:
Astellas Toyama Co., Ltd. Toyama Plant, 2-178 Kojin-machi, Toyama 930-0809, Japan
MEDICATION GUIDE
PROTOPIC® [pro-TOP-ik]
(tacrolimus)
Ointment 0.03%
Ointment 0.1%
Read the Medication Guide every time you or a family member gets PROTOPIC Ointment. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. If you have questions about PROTOPIC Ointment, ask your doctor or pharmacist.
What is the most important information I should know about PROTOPIC Ointment?
The safety of using PROTOPIC Ointment for a long period of time is not known. A very small number of people who have used PROTOPIC Ointment have had cancer (for example, skin or lymphoma). However, a link with PROTOPIC Ointment has not been shown. Because of this concern:
Do not use PROTOPIC Ointment continuously for a long time.
Use PROTOPIC Ointment only on areas of your skin that have eczema.
Do not use PROTOPIC Ointment on a child under 2 years old.
PROTOPIC Ointment comes in two strengths:
Only PROTOPIC Ointment 0.03% is for use on children aged 2 to 15 years.
Either PROTOPIC Ointment 0.03% or 0.1% can be used by adults and children 16 years and older.
Talk to your doctor for mo |
