Tacrolimus Ointment

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Tacrolimus Ointment


Generic Name: Tacrolimus Ointment 0.03% (ta-KROE-li-mus)
Brand Name: Protopic

The long-term safety of Tacrolimus Ointment has not been determined. Because rare cases of cancer (eg, lymphoma, skin cancer) have been reported, continuous long-term use should be avoided and the application of Tacrolimus Ointment should be limited to the affected areas. Tacrolimus Ointment should not be used in children younger than 2 years of age.


Tacrolimus Ointment is used for:

Treating moderate to severe atopic dermatitis.

Tacrolimus Ointment is a topical immunosuppressant. How it works is not completely understood. It is thought to decrease the cell activity that causes atopic dermatitis.

Do NOT use Tacrolimus Ointment if:

  • you are allergic to any ingredient in Tacrolimus Ointment

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tacrolimus Ointment:

Some medical conditions may interact with Tacrolimus Ointment. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you are receiving any form of light therapy on your skin
  • if you have a skin infection (eg, chickenpox, herpes, shingles), a weakened immune system, mononucleosis, swollen lymph nodes, erythroderma, Netherton syndrome, skin cancer, or kidney problems

Some MEDICINES MAY INTERACT with Tacrolimus Ointment. Because little, if any, of Tacrolimus Ointment is absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tacrolimus Ointment may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tacrolimus Ointment:

Use Tacrolimus Ointment as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Tacrolimus Ointment comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Tacrolimus Ointment refilled.
  • Tacrolimus Ointment is for external use only. Do not get Tacrolimus Ointment in your eyes, nose, or mouth.
  • Dry your skin completely after a bath or shower before applying Tacrolimus Ointment.
  • Apply a thin layer of Tacrolimus Ointment to the affected area. Gently rub the medicine in until it is evenly distributed. Wash your hands after applying Tacrolimus Ointment (if hands are not an area of treatment).
  • Do not bathe, shower, or swim right after applying Tacrolimus Ointment. This could wash off the ointment.
  • Do not cover the treated area with bandages or other dressings, unless otherwise directed by your doctor.
  • Continue using Tacrolimus Ointment for 1 week after signs and symptoms of the condition clear up.
  • If you miss a dose of Tacrolimus Ointment, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Tacrolimus Ointment.

Important safety information:

  • Tacrolimus Ointment may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Tacrolimus Ointment. Use a sunscreen or wear protective clothing if you must be outside for a prolonged period.
  • If you develop a skin infection, your symptoms get worse, or your symptoms do not improve after 6 weeks of treatment, contact your doctor.
  • Tacrolimus Ointment may be harmful if swallowed. If you may have taken Tacrolimus Ointment by mouth, contact your local poison control center or emergency room immediately.
  • Tacrolimus Ointment is not recommended for use in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Tacrolimus Ointment during pregnancy. Tacrolimus Ointment is excreted in breast milk. Do not breast-feed while taking Tacrolimus Ointment.

Possible side effects of Tacrolimus Ointment:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; burning, stinging, soreness, itching, or redness of skin; flu-like symptoms; headache; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; increased sensitivity to pain or touch; indigestion; nasal congestion; muscle pain; painful menstrual periods; sensitivity to pain; skin infection; swollen glands; swollen or infected hair follicles; weakness.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Tacrolimus Ointment may be harmful if swallowed.

Proper storage of Tacrolimus Ointment:

Store Tacrolimus Ointment at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat and light. Do not store in the bathroom. Keep Tacrolimus Ointment out of the reach of children and away from pets.

General information:

  • If you have any questions about Tacrolimus Ointment, please talk with your doctor, pharmacist, or other health care provider.
  • Tacrolimus Ointment is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Tacrolimus Ointment. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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