Tacrolimus topical

Generic Name: tacrolimus topical (ta KRA lih muss TOP ik al)Brand Names: Protopic

What is tacrolimus topical?

Tacrolimus is an immunosuppressant. It works by decreasing your body's immune system to help slow down the growth of atopic dermatitis (eczema) on your skin.

Tacrolimus topical is used to treat severe atopic dermatitis when other medications have not worked well.

Tacrolimus may also be used for purposes other than those listed here.

What is the most important information I should know about tacrolimus topical?

Do not use tacrolimus topical on a child 2 years of age or younger.

A small number of people have developed skin cancer after using tacrolimus or pimecrolimus (Elidel) skin medications. However, it is not known if either of these medicines causes skin cancer. Talk to your doctor about your individual risk.

Use this medication only on the skin, exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor. Tacrolimus is not for long-term use.

If you are using this medicine on a child younger than 16 years old, use only the 0.03% ointment. The 0.1% ointment is for adults and children who are at least 16 years old, but is too strong to use on younger children.

Before using this medication, tell your doctor if you are pregnant or breast-feeding.

Avoid sunlight, sun lamps, tanning beds, and phototherapy treatments with UVA or UVB light. If you must be outdoors, wear loose clothing over the skin areas treated with tacrolimus topical. Do not use sunscreen on treated skin unless your doctor has told you to.

Talk to your doctor if your skin condition does not improve after using tacrolimus topical for 6 weeks.

If you miss a dose, use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

There may be other drugs or skin products that can affect tacrolimus. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Stop using this medication and get emergency medical help if you think you have used too much medicine or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, and you may have none at all. Talk to your doctor about any side effect that seems unusual or is especially bothersome.

What should I discuss with my healthcare provider before using tacrolimus topical?

Before using tacrolimus topical, tell your doctor if you have:

  • skin cancer or a skin infection (including herpes or chicken pox);

  • Netherton's syndrome (a genetic skin disorder);

  • a weak immune system (from cancer treatments, HIV/AIDS or certain medicines such as steroids);

  • kidney disease; or

  • swelling, redness, or irritation of large areas of your skin.

If you have any of these conditions, you may not be able to use tacrolimus or you may need a dosage adjustment or special tests during treatment.

Tacrolimus can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from a virus such as chicken pox or herpes (cold sores or shingles). Tell your doctor if you have been exposed to any illness.

FDA pregnancy category C: This medication may be harmful to an unborn baby. Do not use tacrolimus without telling your doctor if you are pregnant. Tell your doctor if you become pregnant during treatment. Tacrolimus passes into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

A small number of people have developed skin cancer after using tacrolimus or pimecrolimus (Elidel) skin medications. However, it is not known if either of these medicines causes skin cancer. Talk to your doctor about your individual risk.

How should I use tacrolimus topical?

Use this medication only on the skin, exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor. Tacrolimus is not for long-term use.

Do not use tacrolimus topical on a child 2 years of age or younger.

If you are using this medicine on a child younger than 16 years old, use only the 0.03% ointment. The 0.1% ointment is for adults and children who are at least 16 years old, but is too strong to use on younger children.

Stop using the medicine once your symptoms have cleared up, unless your doctor has told you otherwise.

Wash your hands before and after using tacrolimus, unless you are using the medication to treat a hand condition.

Apply the medicine only to clean, dry skin. Use the smallest amount needed to apply a thin layer to the skin areas diagnosed with atopic dermatitis. Rub in gently. Do not cover the treated skin with a bandage.

Do not bathe, shower, or swim right after applying tacrolimus topical. Water may wash off the medicine.

Right after applying tacrolimus, you may need to rub in a moisturizing cream or lotion to keep your skin from getting too dry. Ask your doctor about which cream or lotion to use.

Talk to your doctor if your skin condition does not improve after using tacrolimus topical for 6 weeks.

Store tacrolimus topical at room temperature. Do not freeze. Keep the cap on the ointment tube when not in use.

What happens if I miss a dose?

If you miss a dose, use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Tacrolimus is not expected to cause overdose symptoms.

What should I avoid while using tacrolimus topical?

Avoid using any other skin product that has not been recommended by your doctor.

Avoid sunlight, sun lamps, tanning beds, and phototherapy treatments with UVA or UVB light. If you must be outdoors, wear loose clothing over the skin areas treated with tacrolimus topical. Do not use sunscreen on treated skin unless your doctor has told you to. Avoid drinking alcohol. Drinking alcohol while you are using tacrolimus topical may cause your skin or face to feel hot and become flushed or red.

Tacrolimus topical side effects

Stop using tacrolimus and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using tacrolimus and call your doctor if you have:

  • worsened skin symptoms;

  • signs of a skin infection (redness, swelling, itching, oozing);

  • swollen glands; or

  • fever, chills, body aches, flu symptoms.

Less serious side effects are more likely to occur. Continue using tacrolimus and talk with your doctor if you have any of these side effects:

  • burning, stinging, tingling, or soreness of treated skin (especially during the first few days of treatment);

  • swollen hair follicles;

  • acne;

  • upset stomach;

  • muscle pain;

  • headache; or

  • feeling more sensitive to hot or cold temperatures.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Tacrolimus topical Dosing Information

Usual Adult Dose for Atopic Dermatitis:

Initial dose: Apply a thin layer to the affected areas twice daily and rub in gently and completely.Maintenance dose: Continue for 1 week after resolution of symptoms.

Usual Pediatric Dose for Atopic Dermatitis:

15 years: 0.03 or 0.1% ointment: Apply a thin layer to the affected areas twice daily and rub in gently and completely. Continue for 1 week after resolution of symptoms.

What other drugs will affect tacrolimus topical?

Before using tacrolimus topical, tell your doctor if you are using any of the following drugs:

  • cimetidine (Tagamet).

  • erythromycin (Ery-Tab, E-Mycin, E.E.S. and others);

  • an antifungal medicine such as ketoconazole (Nizoral), itraconazole (Sporanox), or fluconazole (Diflucan); or

  • a heart medicine such as verapamil (Calan, Verelan), diltiazem (Cardizem, Dilacor XR, Tiazac), nifedipine (Adalat, Procardia), or nicardipine (Cardene).

There may be other drugs or skin products that can affect tacrolimus. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist has additional information about tacrolimus topical written for health professionals that you may read.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 4.02. Revision Date: 4/12/2009 4:44:32 PM.
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