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.

tacrolimus topical is not for long-term use. A small number of people using tacrolimus, or another similar medication have developed skin cancer or lymphoma. However, it is not known if tacrolimus 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.

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

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

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 using it to treat a hand condition.

Use only a small amount of medicine. Apply a thin layer and rub in gently.

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.

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.

Call your doctor if:

• your symptoms get worse or do not improve after 6 weeks;

• you get viral infections more easily, such as chickenpox or herpes (cold sores or shingles); or

• your symptoms return after treatment with tacrolimus ointment.

Store tightly closed at room temperature, away from moisture and heat.

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

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

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

Tell your doctor if you have ever had:

• skin cancer (melanoma);

• 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 medicines).

A small number of people using tacrolimus, or another similar medication have developed skin cancer or lymphoma. However, it is not known if tacrolimus causes cancer. Ask your doctor about your risk.

Tell your doctor if you are pregnant, plan to get pregnant, or breastfeeding before starting this medicine.

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.

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

Avoid getting tacrolimus topical in your eyes or mouth. Rinse with water if this medicine gets in your eyes or mouth.

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 flushing (sudden warmth, redness, or tingly feeling) on your skin or face.

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

Tacrolimus topical may cause serious side effects. 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 of tacrolimus topical 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.