warnings

What is the most important information I should know about Tacrolimus Topical (Protopic)?

You should not use tacrolimus if you are allergic to it.

Not approved for anyone younger than 2 years old.

Tacrolimus ointment in 0.03% or 0.1% strengths may be used by adults and children 16 years and older. Only the 0.01% strength should be used on a child 2 to 15 years old.

Tell your doctor if you have ever had:

skin cancer;
a bacterial or viral skin infection (including herpes or chickenpox);
Netherton's syndrome (a genetic skin disorder); or
a weak immune system (caused by disease or by using certain medicine).

A small number of people using tacrolimus or pimecrolimus skin medications have developed skin cancer or lymphoma. However, it is not known if either of these medicines causes cancer. Ask your doctor about your risk.

It is not known if tacrolimus topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed.

Side Effects

What are the side effects of Tacrolimus Topical (Protopic)?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

severe pain, burning, itching, or stinging;
new or worsened skin symptoms (warts, unusual rash or skin lesions, blistering or oozing);
a mole that has changed in size or color; or
symptoms of a viral skin infection--cold sores around your mouth, skin sores or blisters, scabs, itching, tingling.

Common side effects may include:

burning, stinging, itching, or tingling of treated skin (especially during the first few days of treatment);
viral skin infection;
your skin being more sensitive to hot or cold temperatures;
acne, redness or crusting around your hair follicles;
upset stomach;
headache, muscle pain;
runny or stuffy nose; or
fever, chills, body aches, sore throat, cough, swollen glands.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Interactions

What drugs and food should I avoid while taking Tacrolimus Topical (Protopic)?

Avoid getting this medicine in your eyes, nose, mouth, rectum, or vagina. If this does happen, wipe off the cream and rinse the area with cold water.

Avoid sunlight, tanning beds, and phototherapy treatments with ultraviolet light. Wear loose clothing over treated skin. Ask your doctor before using sunscreen on treated skin.

Do not share this medicine with another person, even if they have the same symptoms you have.

Avoid using other medications on the areas you treat with tacrolimus topical unless your doctor tells you to.

Drinking alcohol while using this medicine can cause warmth, flushing, or redness in your skin or face.

Dosage Guidelines & Tips

How to take Tacrolimus Topical (Protopic)?

Use Tacrolimus Topical (Protopic) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not take by mouth. Topical medicine is for use only on the skin.

Wash your hands before and after applying this medicine, unless you are treating eczema on your hands. If you are applying the medicine to another person, wash your hands with soap and water afterward.

Apply a thin layer of tacrolimus topical to clean, dry skin and rub in gently. Use the smallest amount needed to control the symptoms of eczema.

Use this medicine only on skin that is affected by eczema. Avoid applying to an area that may be affected with skin cancer.

Right after applying tacrolimus, you may need to use a moisturizing cream or lotion to keep your skin from getting too dry. Ask your doctor about which cream or lotion to use.

Do not cover treated skin with a bandage unless your doctor tells you to.

Do not bathe, shower, or swim right after applying tacrolimus topical. Water may wash off the medicine.

Call your doctor if your symptoms do not improve after 6 weeks.

Tacrolimus topical is not for long-term use. Stop using this medicine when symptoms of eczema clear up, unless your doctor has told you otherwise. You may need to take a short break from using tacrolimus topical if you need to repeat this treatment.

You may get viral infections more easily, such as chickenpox or herpes (cold sores or shingles).

Store tightly closed at room temperature. Do not store this medicine in your car in hot or cold temperatures.

What should I do if I missed a dose of Tacrolimus Topical (Protopic)?

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.