Drug Notebook

FDA Alerts

  • Long-term safety of topical tacrolimus not established.
  • Malignancies (e.g., skin cancers, lymphoma) reported rarely in patients treated with topical calcineurin inhibitors, including tacrolimus; causal relationship not established.
  • Avoid continuous long-term use of topical tacrolimus; limit application to areas affected by atopic dermatitis. (See Carcinogenicity under Cautions.)
  • Topical tacrolimus is not indicated for use in children <2 years of age; only the 0.03% ointment is indicated for use in children 2–15 years of age.

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tacrolimus topical
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(ta KRA lih muss TOP ik al)

What should I discuss with my healthcare provider before using tacrolimus topical?

Before using tacrolimus topical, tell your doctor if you have:

  • skin cancer or a skin infection (including herpes or chicken pox);

  • Netherton's syndrome (a genetic skin disorder);

  • a weak immune system (from cancer treatments, HIV/AIDS or certain medicines such as steroids);

  • kidney disease; or

  • swelling, redness, or irritation of large areas of your skin.

If you have any of these conditions, you may not be able to use tacrolimus or you may need a dosage adjustment or special tests during treatment.

Tacrolimus can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from a virus such as chicken pox or herpes (cold sores or shingles). Tell your doctor if you have been exposed to any illness.

FDA pregnancy category C: This medication may be harmful to an unborn baby. Do not use tacrolimus without telling your doctor if you are pregnant. Tell your doctor if you become pregnant during treatment. Tacrolimus passes into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

A small number of people have developed skin cancer after using tacrolimus or pimecrolimus (Elidel) skin medications. However, it is not known if either of these medicines causes skin cancer. Talk to your doctor about your individual risk.

How should I use tacrolimus topical?

Use this medication only on the skin, exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor. Tacrolimus is not for long-term use.

Do not use tacrolimus topical on a child 2 years of age or younger.

If you are using this medicine on a child younger than 16 years old, use only the 0.03% ointment. The 0.1% ointment is for adults and children who are at least 16 years old, but is too strong to use on younger children.

Stop using the medicine once your symptoms have cleared up, unless your doctor has told you otherwise.

Wash your hands before and after using tacrolimus, unless you are using the medication to treat a hand condition.

Apply the medicine only to clean, dry skin. Use the smallest amount needed to apply a thin layer to the skin areas diagnosed with atopic dermatitis. Rub in gently. Do not cover the treated skin with a bandage.

Do not bathe, shower, or swim right after applying tacrolimus topical. Water may wash off the medicine.

Right after applying tacrolimus, you may need to rub in a moisturizing cream or lotion to keep your skin from getting too dry. Ask your doctor about which cream or lotion to use.

Talk to your doctor if your skin condition does not improve after using tacrolimus topical for 6 weeks.

Store tacrolimus topical at room temperature. Do not freeze. Keep the cap on the ointment tube when not in use.

What happens if I miss a dose?

If you miss a dose, use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Tacrolimus is not expected to cause overdose symptoms.
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