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In the U.S.—

Protopic

• 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 this medicine, 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. This medicine 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.

Other medical problems—The presence of other medical problems may affect the use of tacrolimus ointment. Make sure you tell your doctor if you have any other medical problems, especially:

• 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

• 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.

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

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 this medicine, 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 this medicine:

• 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.

It is very important that your doctor check your progress at regular visits. Your doctor will want to make sure the tacrolimus ointment is working properly and to check for unwanted effects.

Report any adverse reactions or side effects to your doctor.

Use this medicine only for the condition for which it was prescribed by your doctor.

Tacrolimus ointment may increase the risk of skin tumors, when patients are also exposed to sunlight. The association between topical tacrolimus and the incidence of skin tumors has not been proven. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

Side Effects of This Medicine

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More common
  • Skin flushing in areas of ointment application when drinking alcohol;  cough;  loss of appetite;  general aches and pains;  sneezing;  weakness;  skin burning;  itching skin–in children;  headache;  fever 
  
  

• Less common
  • Watery eyes;  troubled breathing or wheezing ;  severe skin rash or hives;  flushing;  chills;  runny nose;  increased sensitivity to sunlight;  joint pain;  swollen glands;  acne;  back pain;  redness in eye;  pain in eye;  swelling of eye, eyelid, or inner lining of eyelid;  itching eyes;  cyst ;  acid or sour stomach;  belching;  heartburn;  indigestion;  stomach discomfort, upset, or pain;  skin blisters—in children;  burning, itching, or pain in hairy areas ;  pus at root of hair;  increased skin sensitivity;  muscle aches or pain ;  rash;  stuffy nose;  skin tingling;  pain or tenderness around eyes and cheekbones;  tightness of chest 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 05/24/2001

Revised: 07/16/2001