Protopic (tacrolimus)is a topical macrolide immunosuppressant. It works by decreasing cell activity in the body"s immune system which helps to slow down the growth of atopic dermatitis (eczema) on your skin.
Protopic is used to treat severe atopic dermatitis (eczema).
Protopic may also be used for purposes not listed in this medication guide.
Important information
You should not use Protopic if you are allergic to tacrolimus.
Before using Protopic, tell your doctor if you have skin cancer or a skin infection (including herpes or chickenpox), any genetic skin disorder (such as Netherton"s syndrome), a weak immune system, kidney disease, or swelling, redness, or irritation of large areas of your skin.
Protopic 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.
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 Protopic. 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 Protopic for 6 weeks.
Do not use this medication on a child younger than 2 years old. Some people have developed skin cancer or lymphoma after using Protopic or pimecrolimus (Elidel). However, it is not known if either of these medicines causes skin cancer or lymphoma. Talk to your doctor about your individual risk.
Before using Protopic
You should not use Protopic if you are allergic to tacrolimus.
To make sure you can safely use Protopic, tell your doctor if you have any of these other conditions:
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skin cancer or a skin infection (including herpes or chickenpox);
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any genetic skin disorder (such as Netherton"s syndrome);
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a weak immune system (caused by disease or by using certain medicines);
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kidney disease; or
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swelling, redness, or irritation of large areas of your skin.
Protopic 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.
Some people have developed skin cancer or lymphoma after using Protopic or pimecrolimus (Elidel). However, it is not known if either of these medicines causes skin cancer or lymphoma. Talk to your doctor about your individual risk.
FDA pregnancy category C. It is not known whether Protopic will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Tacrolimus can pass 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. Do not use Protopic on a child younger than 2 years old.
See also: Pregnancy and breastfeeding warnings (in more detail)
How should I use Protopic?
Use Protopic exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
If you are using Protopic 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.
Wash your hands before and after using Protopic, unless you are using the medication to treat a hand condition.
Apply the medicine in a thin layer, only to skin areas affected by eczema. Do not cover the treated skin with a bandage.
Do not bathe, shower, or swim right after applying Protopic. Water may wash off the medicine.
You may need to use a moisturizing cream or lotion to keep your skin from getting too dry. Ask your doctor about which moisturizer to use.
Protopic is not for long-term use. Stop using the medicine once your symptoms have cleared up, unless your doctor has told you otherwise.
Call your doctor if your symptoms do not improve after 6 weeks of treatment, or if they get worse while using Protopic.
Store Protopic at room temperature. Do not freeze. Keep ointment tube tightly closed when not in use.
What happens if I miss a dose?
Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
What happens if I overdose?
An overdose of Protopic is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.
What should I avoid?
Avoid using other medications on the areas you treat with Protopic unless your doctor tells you to.
Avoid exposure to sunlight or tanning beds, and phototherapy treatments with UVA or UVB light. If you must be outdoors, wear loose clothing over the skin areas treated with Protopic. Do not use sunscreen on treated skin unless your doctor has told you to. Drinking alcohol while you are using Protopic may cause your skin or face to feel hot and become flushed or red.
Protopic side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Protopic: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using Protopic and call your doctor at once if you have a serious side effect such as:
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severe stinging, burning, itching, or soreness where the medicine is applied;
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swollen glands;
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redness or crusting around your hair follicles; or
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signs of a skin infection (redness, swelling, itching, oozing).
Less serious Protopic side effects may include:
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mild burning, stinging, or itching;
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skin redness;
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acne;
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cold or flu symptoms such as stuffy nose, sneezing, sore throat;
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headache; or
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feeling more sensitive to hot or cold temperatures.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect Protopic?
It is not likely that other drugs you take orally or inject will have an effect on topically applied Protopic. But an interaction may occur if you apply Protopic over large skin areas. Tell your doctor about all other medicines you use, especially:
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conivaptan (Vaprisol);
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imatinib (Gleevec);
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isoniazid (for treating tuberculosis);
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an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek);
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an antidepressant such as nefazodone;
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antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), miconazole (Oravig), or voriconazole (Vfend);
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heart or blood pressure medication such as nicardipine (Cardene) or quinidine (Quin-G);
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HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir, Kaletra);
This list is not complete and other drugs may interact with Protopic. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
