Tacrolimus (On the skin)

Introduction

Tacrolimus (ta-KROE-li-mus)

Treats atopic dermatitis (a skin rash and type of eczema).

Brand Name(s)

Protopic

When This Medicine Should Not Be Used

How to Use This Medicine

Ointment

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine is for use on the skin only. Do not get it in your eyes, nose, or mouth. Do not use it on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away.
• Wash your hands before you apply this medicine. If you are not treating a skin rash on your hands, then you should also wash your hands with soap and water after you apply the medicine. However, do not wash your hands after if you are treating a rash on your hands. Do not bathe or swim immediately after applying this medicine. This could wash the medicine off.
• Apply a thin layer to the affected area. Rub it in gently. Apply the medicine 2 times daily, at least 12 hours apart, unless your doctor tells you otherwise. Apply just enough to cover the area. Only apply this medicine to areas where eczema appears.
• You may apply a moisturizer to your skin after you apply the medicine, if your doctor approves it.
• Do not cover the treated area with a bandage unless your doctor has told you to.
• This medicine is not for long-term use. Use the medicine only until your skin symptoms are gone. If the eczema comes back, you may start using the medicine again if your doctor approves. You must take breaks in between treatments.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• If you miss a dose or forget to use your medicine, apply it as soon as you can. If it is almost time for your next dose, wait until then to apply the medicine and skip the missed dose. Do not apply extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not leave the ointment in the car in cold or hot weather. Make sure that the tube is tightly closed.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of the used medicine container and any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding. Tell your doctor if you have kidney problems, mononucleosis (mono), weakened immune system, or a history of an organ transplant. Tell your doctor if you have a skin infection, skin cancer, lymphoma, or skin absorption problems (such as lamellar ichthyosis, graft versus host disease, erythroderma, or Netherton syndrome).
• This medicine should not be used continuously for a long time. When the rash is gone, stop using the medicine. If your doctors says it is okay, you may start using the medicine again if the rash comes back, but you should allow time in between treatments.
• If your symptoms do not improve or if they get worse, call your doctor. Call your doctor if your symptoms do not improve within 6 weeks.
• Rarely, patients who have used the oral or topical forms of this medicine have developed skin cancer or lymphoma. It is not known if this was related to the medcine.
• Do not use this medicine for a skin problem that has not been checked by your doctor.
• This medicine may increase your chances of catching chicken pox, shingles, or herpes virus (including cold sores). Avoid people who have these infections. Call your doctor if you think you have been exposed to one of these illnesses.
• This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds. Limit your time in the sun as much as possible. Cover the treated areas of your skin with loose clothing if you must be outside.
• This medicine may make you sick if it is not used correctly. Call a doctor or poison control center right away if you accidentally swallow this medicine.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using cimetidine (Tagamet®), tacrolimus capsules (Prograf®), an antibiotic such as erythromycin (Ery-tab®), or an antifungal medicine such as fluconazole, ketoconazole, itraconazole, Diflucan®, Nizoral®, or Sporanox®. Tell your doctor if you are also using blood pressure medicines such as diltiazem, nifedipine, verapamil, Adalat®, Calan®, Cardizem®, Lotrel®, Plendil®, or Procardia®.
• Make sure your doctor knows if you are receiving any type of UV (ultraviolet) light treatment or phototherapy.
• Alcohol may cause flushing or redness in your face.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Cold or flu symptoms such as fever, chills, cough, runny or stuffy nose, sore throat, and body aches
• New skin problems, including chicken pox, shingles, or cold sores
• Swollen, painful, or tender glands in your neck, armpit, or groin

If you notice these less serious side effects, talk with your doctor:

• Acne
• Mild burning, stinging, tingling, redness, or itching when the medicine is applied
• Extra sensitive skin
• Headache
• Mild fever
• Swollen or infected hair follicles

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088