Before Using This Medicine

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