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Tacrolimus ointment

Pronunciation

Generic Name: tacrolimus (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 16 years old.


Tacrolimus ointment is used for:

Short-term treatment of moderate to severe atopic dermatitis in certain patients.

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
  • you are receiving any form of light therapy (eg, ultraviolet light therapy) on your skin
  • you have a skin infection (eg, chickenpox, herpes, shingles) at the application site, certain skin problems (eg, a precancerous skin condition, skin cancer, Netherton syndrome), or a weakened immune system

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

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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 have mononucleosis, swollen lymph nodes, or kidney problems
  • if you have a history of a certain type of cancer (lymphoma) or a personal or family history of skin cancer

Some MEDICINES MAY INTERACT with tacrolimus ointment. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Certain calcium channel blockers (eg, diltiazem), cimetidine, erythromycin, fluconazole, itraconazole, or ketoconazole because they may increase the risk of tacrolimus ointment's side effects in certain patients

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 extra patient information sheet called a Medication Guide. Read it carefully. Read it again 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.
  • Wash your hands before using tacrolimus ointment.
  • Apply a thin layer of tacrolimus ointment to the affected area only. Use the smallest amount needed to control your condition. 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).
  • If you are a caregiver applying tacrolimus ointment to someone else's skin, wash your hands with soap and water after applying tacrolimus ointment.
  • 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 or wraps, unless otherwise directed by your doctor.
  • Stop using tacrolimus ointment when the signs and symptoms of the condition (eg, itching, rash, redness) go away, unless your doctor directs you otherwise.
  • 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:

  • Avoid or limit exposure to the sun while you are using tacrolimus ointment, even when it is not on your skin. Avoid using sunlamps or tanning booths during treatment with tacrolimus ointment. Wear protective clothing if you must be outside for more than a short time. Discuss with your doctor what other types of protection from the sun you should use.
  • Tacrolimus ointment should be used for short periods of time. If recommended by your doctor, treatment may be repeated with breaks in between. Do not use tacrolimus ointment continuously for a long time unless directed by your doctor.
  • You can use a skin moisturizer while you use tacrolimus ointment as directed by your doctor. Talk with your doctor before you use any other medicines or cleansers on your skin. If you use a moisturizer, apply it after you apply tacrolimus ointment.
  • Drinking alcohol while you are using tacrolimus ointment may cause your skin or face to become flushed or red and feel hot. Discuss any questions or concerns with your doctor.
  • 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 cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
  • Tell your doctor or dentist that you take tacrolimus ointment before you receive any medical or dental care, emergency care, or surgery.
  • Tacrolimus ointment should not be used in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using tacrolimus ointment while you are pregnant. Tacrolimus ointment is found 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 at the application site; common cold; headache; stuffy nose; upset stomach.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; change in the size, shape, or appearance of a mole; cold sores; decreased urination; fever, chills, cough, or persistent sore throat; increased sensitivity to pain or touch; increased skin sensitivity to heat or cold; muscle pain; skin infection (eg, warm, red, swollen, or painful skin); swollen glands; swollen or infected hair follicles; tingling of the skin; unusual skin lumps or growths; weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, 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. Do not leave tacrolimus ointment in your car in cold or hot weather. 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take tacrolimus ointment or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about tacrolimus ointment. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to tacrolimus ointment. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using tacrolimus ointment.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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