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Tacrolimus topical

Generic name: tacrolimus topical (ta KROE li mus)
Brand name: Protopic
Dosage forms: topical ointment (0.03%; 0.1%)
Drug class: Miscellaneous topical agents

Medically reviewed by Drugs.com on Nov 9, 2021. Written by Cerner Multum.

What is tacrolimus topical?

Tacrolimus topical (for the skin) is used short term to treat moderate to severe eczema in adults and children at least 2 years old.

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

Tacrolimus may also be used for purposes not listed in this medication guide.

Warnings

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

Before taking this medicine

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.

How should I use tacrolimus topical?

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 tacrolimus topical, 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 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 tacrolimus topical?

Avoid getting tacrolimus topical 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.

Tacrolimus topical side effects

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.

Tacrolimus topical dosing information

Usual Adult Dose 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 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

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What other drugs will affect tacrolimus topical?

Other drugs may affect tacrolimus topical, 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 this medication only for the indication prescribed.

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