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Protopic Ointment

Generic name: tacrolimus topicalta-KROE-li-mus ]
Drug class: Miscellaneous topical agents

Medically reviewed by Sanjai Sinha, MD. Last updated on Dec 6, 2021.

What is Protopic?

Protopic is a topical macrolide immunosuppressant. It works by decreasing cell activity in the body's immune system which helps to slow down the growth of atopic dermatitis (eczema) on your skin.

Protopic ointment is used short term to treat moderate to severe eczema in adults and children at least 2 years old.

Protopic is not for use in people who have a weak immune system.

Warnings

Protopic ointment is not for long-term use. 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.

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

Before using this medicine, tell your doctor if you have skin cancer or a skin infection (including herpes or chickenpox), any genetic skin disorder (such as Netherton's syndrome), a weak immune system, kidney disease, or swelling, redness, or irritation of large areas of your skin.

Protopic can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from a virus such as chicken pox or herpes (cold sores or shingles). Tell your doctor if you have been exposed to any illness.

Avoid sunlight, sun lamps, tanning beds, and phototherapy treatments with UVA or UVB light. If you must be outdoors, wear loose clothing over the skin areas treated with Protopic ointment. Do not use sunscreen on treated skin unless your doctor has told you to.

Talk to your doctor if your skin condition does not improve after using Protopic for 6 weeks.

Do not use this medication on a child younger than 2 years old. Some people have developed skin cancer or lymphoma after using Protopic or pimecrolimus (Elidel). However, it is not known if either of these medicines causes skin cancer or lymphoma. Talk to your doctor about your individual risk.

Before taking this medicine

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

Protopic is not approved for anyone younger than 2 years old.

Protopic 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.

To make sure Protopic is safe for you, 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 Protopic ointment 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 while using this ointment.

How should I use Protopic?

Use Protopic ointment exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

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 Protopic ointment 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 Protopic ointment, 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 Protopic ointment. Water may wash off the medicine.

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

Protopic 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 Protopic 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.

Dosing information

Usual Adult Dose of Protopic for Atopic Dermatitis:

Apply a thin layer to the affected areas 2 times a day and rub in gently and completely; discontinue use when symptoms resolve

Comments:
-If 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.

Use: As second-line therapy for the short-term and noncontinuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised patients who have failed to respond adequately to other topical treatments, or when those treatments are not advisable

Usual Pediatric Dose of Protopic for Atopic Dermatitis:

Less than 2 years: Safety and efficacy have not been established

2 to 15 years:
0.03% ointment: Apply a thin layer to the affected areas 2 times a day and rub in gently and completely; discontinue use when symptoms resolve
0.1% ointment: Safety and efficacy have not been established

16 years and older:
0.03 or 0.1% ointment: Apply a thin layer to the affected areas 2 times a day and rub in gently and completely; discontinue use when symptoms resolve

Comments:
-If 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.
-Children aged 2 to 15 years should only receive the 0.03% formulation of this drug.

Use: As second-line therapy for the short-term and noncontinuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised patients who have failed to respond adequately to other topical treatments, or when those treatments are not advisable

What happens if I miss a dose?

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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medicine.

What should I avoid while using 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 Protopic ointment unless your doctor tells you to.

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

Protopic side effects

Get emergency medical help if you have signs of an allergic reaction to Protopic: 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 Protopic 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.

What other drugs will affect Protopic?

Other drugs may affect Protopic ointment, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Protopic only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.