Pronunciation:

ta-KROE-li-mus

Brand Names:

• Protopic

Dosage Forms:

• Ointment

Warnings:

Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe tacrolimus. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient .

Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe, and they should have complete information requisite for the follow-up of the patient .

Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe tacrolimus. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient .

Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe, and they should have complete information requisite for the follow-up of the patient .

Long-term safety of topical calcineurin inhibitors has not been established. Although a causal relationship has not been established, rare cases of malignancy (eg, skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including tacrolimus ointment. Therefore: Continuous long-term use of topical calcineurin inhibitors, including tacrolimus ointment, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis. Tacrolimus ointment is not indicated for use in children less than 2 years of age. Only 0.03% tacrolimus ointment is indicated for use in children 2-15 years of age .

Long-term safety of topical calcineurin inhibitors has not been established and rare cases of malignancy (eg, skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including tacrolimus ointment. Avoid continuous long-term use in any age group, and apply to limited areas of involvement with atopic dermatitis. Not indicated for use in children less than 2 years of age. Only 0.03% tacrolimus ointment is indicated for use in children 2-15 years of age .

Classifications:

Therapeutic—

Antipsoriatic

Uses of This Medicine:

Tacrolimus ointment is used for moderate to severe atopic dermatitis. This is a skin condition where there is itching, redness and inflammation, much like an allergic reaction. Tacrolimus helps to suppress these symptoms which are a reaction caused by the body's immune system. It can be used for short-term or long-term intermittent treatment. It is often used when other types of treatment are not working or not tolerated by the patient.

Tacrolimus is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Some side effects may occur more or less often in children than they do in adult patients. This medicine has not been tested and should not be used in children under 2 years of age. Only the lower concentration of 0.03% tacrolimus ointment should be used in children 2 to 15 years of age.

Older adults—

Tacrolimus ointment has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ziprasidone

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor 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 risk may be associated with these conditions.

• Immunocompromised patients (weakened immune system)—May cause serious problems; this medicine should not be used by these patients

• Kidney problems or
• Tendency to develop kidney problems—You should use this medicine with 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 transplant patients receiving oral or injected immunosuppressant therapy and topical tacrolimus

• Netherton's syndrome—May cause too much of the tacrolimus to be absorbed into the body

Proper Use of This Medicine:

Infections in the affected areas should be treated before starting treatment with tacrolimus ointment.

Dry skin completely before applying tacrolimus ointment.

Apply a thin layer of tacrolimus ointment and rub it in well to cover the affected areas

Do not swallow this medicine.

Wash hand thoroughly after applying tacrolimus ointment, if hands are not any area for treatment.

Use of this medicine may cause reactions at the site of application such as a mild to moderate feeling of warmth and/or sensation of burning. You should contact your doctor if this reaction is severe or persists for more than 1 week.

While using tacrolimus, if symptoms of your skin condition go away, consult your doctor.

Do not use any occlusive dressings (a dressing that seals the are that is being treated such as a plastic exercise suit or plastic wraps used to store foods).

Do not bathe, shower or swim right after applying this medicine. This could wash off the ointment.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ointment dosage form
  • For atopic dermatitis:
    • Adults—Gently apply 0.03% or 0.1% ointment to skin that is clean and dry two times a day. Do not cover the area with a bandage that sticks to the skin. Stop using when the signs and symptoms of eczema, such as itching, rash, and redness go away, as directed by your doctor.
    • Children 2 to 15 years old—Gently apply 0.03% ointment to skin that is clean and dry two times a day. Do not cover the area with a bandage that sticks to the skin. Stop using when the signs and symptoms of eczema, such as itching, rash, and redness go away, as directed by your doctor.
    • Children under 2 years of age—Use and dose must be determined by your doctor.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. Your doctor will want to make sure the tacrolimus ointment is working properly and to check for unwanted effects. If your condition has not improved after 6 weeks, your doctor will want to reexamine you.

Report any adverse reactions or side effects to your doctor.

Use this medicine only for the condition for which it was prescribed by your doctor.

You should not use this medicine beyond a year.

Tacrolimus ointment may increase the risk of skin tumors, when patients are also exposed to sunlight. The association between topical tacrolimus and the incidence of skin tumors has not been proven. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.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 about this, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protect your 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 may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Incidence not known

Agitation

black, tarry stools

bloody urine

burning or stinging sensation of face

change in 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 blood pressure

increased thirst

irritability

lethargy

looks very ill

loss of appetite

loss of bladder control

lower back/side pain

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 vessels on 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

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Cough

fever

general aches and pains

headache

itching skin–in children

loss of appetite

skin burning

skin flushing in areas of ointment application when drinking alcohol

sneezing

weakness

Less common

Acid or sour stomach

acne

back pain

belching

burning, itching, or pain in hairy areas

chills

cyst

flushing

heartburn

increased sensitivity to sunlight

increased skin sensitivity

indigestion

itching eyes

joint pain

muscle aches or pain

pain in eye

pain or tenderness around eyes and cheekbones

pus at root of hair

rash

redness in eye

runny nose

severe skin rash or hives

skin blisters—in children

skin tingling

stomach discomfort, upset, or pain

stuffy nose

swelling of eye, eyelid, or inner lining of eyelid

swollen glands

tightness of chest

troubled breathing or wheezing

watery eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.