Tacrolimus Ointment (marketed as Protopic)
What is Protopic Ointment?
* Protopic Ointment is used to treat moderate to severe atopic dermatitis, a form of eczema. It should be used only for a short time. It is not for continuous long-term use.
* Protopic Ointment should not be the first prescription treatment that you try to treat your atopic dermatitis. Use Protopic Ointment only after other prescription treatments did not work or if other prescription treatments are not right for you.
* Protopic Ointment is approved for adults and children 2 years and older with normal immune systems.
* Protopic Ointment is available in two strengths, 0.03% and 0.1%.
o Adults can use both strengths of Protopic Ointment.
o In children 2 to 15 years old, only the 0.03% strength of Protopic Ointment is approved for use.
Who Should Not Use Protopic Ointment?
Do not use if:
* Your child with atopic dermatitis is younger than 2 years
* You have been told you have an immune system problem
* You have any infection on your skin including chicken pox or herpes
* You have NethertonâEUR(TM)s Syndrome. This is a rare inherited condition where the skin is red, itchy, and covered with large coarse scales.
* You are pregnant or breastfeeding, unless directed by your doctor.
* You are allergic to Protopic Ointment or any of its ingredients
What are The Risks?
The following are the major potential risks and side effects of Protopic Ointment therapy. However, this list is not complete.
* Possible risk of cancer: As noted in the Protopic Ointment label and patient Medication Guide, although a link has not been made, rare cases of cancer (for example, skin and lymphoma) have been reported in patients who use Protopic Ointment. The manufacturer is conducting studies to examine the risk of cancer. These studies may take many years to complete.
* Viral infections: Protopic Ointment may increase the chance of getting chicken pox, shingles, skin warts, or other viral infections.
* Skin irritation: Protopic OintmentâEUR(TM)s most common side effects are stinging, soreness, a burning feeling, or itching of the skin where you apply the ointment. See your doctor if these side effects continue or become a problem.
* Other side effects may include headache, skin redness, and flu-like symptoms.
What Should I Tell My Healthcare Professional?
Before you start using Protopic Ointment, tell your healthcare professional if:
* You are getting light therapy for your skin (phototherapy, UVA or UVB) or a lot of sun exposure
* You are taking any prescription or nonprescription (over-the-counter) medicine or supplements
* You are using any other skin product
After you start using Protopic Ointment, tell your healthcare professional if:
* Your atopic dermatitis does not get better after 6 weeks of use
* Your atopic dermatitis gets worse
* You get an infection on your skin
How Do I Use Protopic Ointment?
* Wash your hands before using Protopic Ointment.
* Make sure your skin is dry before applying Protopic Ointment.
* Put a thin layer of Protopic Ointment on the affected skin twice a day, unless otherwise directed by your doctor. Rub in completely. Use the minimum amount of Protopic Ointment necessary and apply only to the affected skin areas.
* Wash your hands after applying Protopic Ointment unless you are treating your hands.
* Do not use Protopic Ointment under a bandage or wrap that keeps out air.
* Stop using Protopic Ointment once your symptoms go away.
* Minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using Protopic Ointment, even while Protopic Ointment is not on your skin.