TACROLIMUS (Topical)
Some commonly used brand names are:
In the U.S.?
Category
Description
Tacrolimus (ta-KROE-li-mus) ointment is used for moderate to severeatopic dermatitis. This is a skin condition where there is itching, rednessand inflammation, much like an allergic reaction. Tacrolimus helps to suppressthese symptoms which are a reaction caused by the body's immune system. Itcan be used for short-term or long-term intermittenttreatment. It is often used when other types of treatment are not workingor not tolerated by the patient.
Tacrolimus is available only with your doctor's prescription, in the followingdosage forms:
Before Using This Medicine
In deciding to use a medicine,the risks of using tacrolimus ointment must be weighed against the good itwill do. This is a decision you and your doctor will make. For tacrolimusointment, the following should be considered:
Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to tacrolimus. Also tell your doctor and pharmacist ifyou are allergic to any other substances, such as foods, preservatives, ordyes.
Pregnancy?Tacrolimus ointment has not been studied in pregnantwomen. However, studies in animals have shown that tacrolimus taken orallycauses birth defects. Tacrolimus taken orally has been associated with kidneyproblems and high potassium concentrations in the blood of newborn infants.Before taking this medicine, make sure your doctor knows if you are pregnantor if you may become pregnant.
Breast-feeding?Tacrolimus applied as a topical ointment maypass 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-feedingduring treatment. Be sure you have discussed the risks and benefits of themedicine with your doctor.
Children?Some side effects may occur more or less oftenin children than they do in adult patients. This medicine has not been testedand should not be used in children under 2 years of age.Only the lower concentration 0.03% tacrolimus ointment should be used in children2 to 15 years of age.
Older adults?Tacrolimus ointment has been tested and has notbeen shown to cause different side effects or problems in older people thanit does in younger adults.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicine.
Other medical problems?The presence of other medicalproblems may affect the use of tacrolimus ointment. Make sure you tell yourdoctor 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 riskmay be associated with these conditions.
- Immunocompromised patients (weakened immune system)?May causeserious problems; this medicine should not be used by these patients
- Kidney problems or
- Tendency to develop kidney problems?You should use this medicinewith caution. It may cause your kidney problems to become worse.
- Precancerous condition of the skin or
- Skin cancer?You should not use this medicine.
- Skin infections, other? Safety is unknown.
- Cancer of the lymph system?May increase risk in transplantpatients receiving oral or injected immunosuppressant therapy and topicaltacrolimus
- Netherton's syndrome?May cause too much of the tacrolimus tobe absorbed into the body
Proper Use of This Medicine
Infectionsin the affected areas should be treated before starting treatment with tacrolimusointment.
Dry skin completely before applying tacrolimus ointment.
Apply a thin layer of tacrolimus ointment and rub it in well to cover theaffected areas.
Do not swallow this medicine.
Wash hand thoroughly after applying tacrolimus ointment, if hands are notany area for treatment.
Use of this medicine may cause reactions at the site of application suchas a mild to moderate feeling of warmth and/or sensation of burning. You shouldcontact your doctor if this reaction is severe or persists for more than 1week.
While using tacrolimus, if symptoms of your skin condition go away, consultyour doctor.
Do not use any occlusive dressings (a dressing that seals the are thatis being treated such as a plastic exercise suit or plastic wraps used tostore foods).
Do not bathe, shower or swim right after applying this medicine. This couldwash off the ointment.
Dosing?The dose of tacrolimus ointment will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of tacrolimus ointment. If your doseis different, do not change it unless your doctor tells you to do so.
- For ointment dosage form
- For atopic dermatitis:
- Adults?Gently apply 0.03% or 0.1% ointment to skin that isclean and dry two times a day. Do not cover the area with a bandage that sticksto the skin. Continue to treat for 1 week after symptomsare gone. Stop using when the signs and symptomsof eczema, such as itching, rash, and redness go away, as directed by yourdoctor
- Children over 2 to 15 yearsold?Gently apply 0.03% ointment to skin that is clean and dry two timesa day. Do not cover the area with a bandage that sticks to the skin.Continue to treat for 1 week after symptoms are gone.Stop using when the signs and symptoms of eczema, such as itching, rash, andredness go away, as directed by your doctor
- Children under 2 years of age?Use anddose must be determined by your doctor.
Missed dose? If you miss a dose of this medicine, use itas soon as possible. However, if it is almost time for your next dose, skipthe missed dose and go back to your regular dosing schedule. Do not doubledoses.
Storage?To store this medicine:
- Keep out of the reach of children.
- Keep the medicine from freezing. Do not refrigerate.
- Keep out of direct sunlight.
- Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
It is very important that your doctor check your progress atregular visits. Your doctor will want to make sure the tacrolimus ointmentis working properly and to check for unwanted effects. If yourcondition has not improved after 6 weeks, your doctor will want to reexamineyou.
Report any adverse reactions or side effects to your doctor.
Use this medicine only for the condition for which it was prescribed byyour doctor.
You should not use this medicine beyond a year.
Tacrolimus ointment may increase the risk of skin tumors, when patientsare also exposed to sunlight. The association between topical tacrolimus andthe incidence of skin tumors has not been proven. When you begin taking thismedicine:
- Stay out of direct sunlight, especially between the hours of 10:00a.m. and 3:00 p.m., if possible.
- Wear protective clothing, including a hat. Also, wear sunglasses.
- Apply a sun block product that has a skin protection factor (SPF)of at least 15. Some patients may require a product with a higher SPF number,especially if they have a fair complexion. If you have any questions aboutthis, check with your health care professional.
- Apply a sun block lipstick that has an SPF of at least 15 to protectyour lips.
- Do not use a sunlamp or tanning bed or booth.
If you have a severe reaction from the sun,check with your doctor.
Side Effects of This Medicine
Along with its needed effects, a medicine may cause some unwanted effects.Although not all of these side effects may occur, if they do occur, they mayneed medical attention.
Check with your doctor as soon as possible ifany of the following side effects occur:
Incidence not known
Agitation; black, tarry stools; bloody urine; burningor stinging sensation of face; changein size, shape, or color of existing mole; coma; confusion; convulsions; decreased frequency/amount of urine; depression; fever; general feeling of illness; growth or bump on skin; hostility; increase in bone pain; increased bloodpressure; increased thirst; irritability; lethargy; looks very ill; loss of appetite; loss of bladder control; lower back/sidepain; mole that leaks fluid or bleeds; muscle spasm or jerking of all extremities; muscle twitching; nausea; new mole; rapid weight gain; red rash with watery, yellow-colored, or pus filled blisters; redness of face; seizures; small, red skin lesion, growth,or bump usually on face, ears, neck, hands, or arms; sore that will not heal; spider-like blood vesselson the face; stupor; sudden loss of consciousness; swelling of face, ankles,lower legs, hands, or fingers; swollen glands; thick yellow to honey-colored crusts; unusual tiredness or weakness; vomiting; weight gain; weight loss; yellow skin and eyes
Other side effects may occur that usually do not need medical attention.These side effects may go away during treatment as your body adjusts to themedicine. However, check with your doctor if any of the following side effectscontinue or are bothersome.
Less common
Watery eyes; troubled breathing or wheezing; severe skin rash or hives; flushing; chills; runnynose; increased sensitivity to sunlight; joint pain; swollen glands; acne; back pain; redness in eye; pain in eye; swelling of eye, eyelid, or inner lining of eyelid; itching eyes; cyst ; acidor sour stomach; belching; heartburn; indigestion; stomach discomfort, upset, or pain; skin blisters?inchildren; burning, itching, or pain in hairy areas; pus at root of hair; increased skin sensitivity; muscle aches or pain; rash; stuffy nose; skin tingling; pain or tenderness aroundeyes and cheekbones; tightness of chest
Other side effectsnot listed above may also occur in some patients. If you notice any othereffects, check with your doctor.
Developed: 05/24/2001
Revised: 03/27/2006
