In the U.S.—

• Immunosuppressant

Tacrolimus ( ta-KROE-li-mus) ointment is used for moderate to severe atopic dermatitis. This is a skin condition where there is itching, redness and inflammation, much like an allergic reaction. Tacrolimus helps to suppress these symptoms which are a reaction caused by the body's immune system. It can be used for short-term or long-term intermittent treatment. It is often used when other types of treatment are not working or not tolerated by the patient.

Tacrolimus is available only with your doctor's prescription, in the following dosage forms:

Topical
• Ointment (U.S)

In deciding to use a medicine, the risks of using tacrolimus ointment must be weighed against the good it will do. This is a decision you and your doctor will make. For tacrolimus ointment, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to tacrolimus. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Tacrolimus ointment has not been studied in pregnant women. However, studies in animals have shown that tacrolimus taken orally causes birth defects. Tacrolimus taken orally has been associated with kidney problems and high potassium concentrations in the blood of newborn infants. Before taking PROTOPIC, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Tacrolimus applied as a topical ointment may pass into the breast milk, and may cause unwanted effects in nursing babies. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—Some side effects may occur more or less often in children than they do in adult patients. PROTOPIC has not been tested in children under 2 years of age.

Older adults—Tacrolimus ointment has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Chickenpox, existing or recent (including recent exposure) or
• Herpes simplex virus infections (skin blisters) or
• Varicella zoster virus infection (shingles)— Increased risk may be associated with these conditions

• Immunocompromised patients (weakened immune system)—May cause serious problems; PROTOPIC should not be used by these patients

• Skin infections, other— Safety is unknown

• Cancer of the lymph system—May increase risk in transplant patients receiving oral or injected immunosuppressant therapy and topical tacrolimus

• Netherton's syndrome—May cause too much of the tacrolimus to be absorbed into the body

Infections in the affected areas should be treated before starting treatment with tacrolimus ointment.

Dry skin completely before applying tacrolimus ointment.

Apply a thin layer of tacrolimus ointment and rub it in well to cover the affected areas

Do not swallow PROTOPIC.

Wash hand thoroughly after applying tacrolimus ointment, if hands are not any area for treatment.

Use of PROTOPIC may cause reactions at the site of application such as a mild to moderate feeling of warmth and/or sensation of burning. You should contact your doctor if this reaction is severe or persists for more than 1 week.

While using tacrolimus, if symptoms of your skin condition go away, consult your doctor.

Do not use any occlusive dressings (a dressing that seals the are that is being treated such as a plastic exercise suit or plastic wraps used to store foods).

Do not bathe, shower or swim right after applying PROTOPIC. This could wash off the ointment.

Dosing—

The dose of tacrolimus ointment will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of tacrolimus ointment. If your dose is different, do not change it unless your doctor tells you to do so.

• For ointment dosage form
  • For atopic dermatitis:
    • Adults—Gently apply 0.03% or 0.1% ointment to skin that is clean and dry two times a day. Do not cover the area with a bandage that sticks to the skin. Continue to treat for 1 week after symptoms are gone.
    • Children over 2 years old—Gently apply 0.03% ointment to skin that is clean and dry two times a day. Do not cover the area with a bandage that sticks to the skin. Continue to treat for 1 week after symptoms are gone.

Missed dose—

If you miss a dose of PROTOPIC, use it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store PROTOPIC:

• Keep out of the reach of children.
• Keep the medicine from freezing. Do not refrigerate.
• Keep out of direct sunlight.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.