Protopic

Brand Name

Protopic

Common Name

tacrolimus topical ointment

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are any nutrients depleted by this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

How does this medication work? What will it do for me?

Tacrolimus belongs to the class of medications called immunosuppressants. This medication is used on a short-term or long-term intermittent basis to treat atopic dermatitis (eczema). It is also used to prevent eczema flare-ups.

This medication works on certain areas of the immune system that may be involved in developing this skin condition. It is used when standard treatments have not worked or if there is a reason they cannot be used. Tacrolimus topical ointment should not be used by people with a suppressed immune system.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

How should I use this medication?

Eczema treatment: Apply a thin layer of this medication to the affected areas of skin twice daily.

Prevention of eczema flare-ups: Apply a thin layer of this medication to the affected areas of skin once daily, twice a week. There should be 2 to 3 days between applications (e.g., Monday and Thursday).

Do not apply to wet skin. Wash your hands after applying the medication if your hands are not an area for treatment. For people aged 16 years and over, the 0.03% or 0.1% strengths may be used. For those aged 2 years to 15 years, only the 0.03% strength should be used.

Do not use this medication under dressings that do not breathe. Do not take this medication by mouth. If this happens, get medical attention right away.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, apply it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not apply a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

Each gram of white to slightly yellowish ointment contains either 0.03% or 0.1% tacrolimus. Nonmedicinal ingredients: mineral oil, paraffin, propylene carbonate, white petrolatum, and white wax.

Who should NOT take this medication?

Tacrolimus topical ointment should not be used by anyone who is allergic to tacrolimus or to any of the ingredients of the medication.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• acne
• cysts (closed pouches of tissue filled with materials such as air, fluid, or pus)
• diarrhea
• fever
• flu-like symptoms (e.g., congestion, coughing, or sneezing)
• flushing or redness of the skin or face after drinking alcohol
• headache
• herpes zoster infection (chickenpox or shingles)
• increased sensitivity of the skin to hot or cold temperatures
• muscle pain
• skin infection in the area where the medication was applied
• skin tingling
• stinging, burning, or itching of the skin area being treated
• swollen or infected hair follicles
• symptoms of impetigo (e.g., skin infection with red, fluid-filled blisters that break)
• upset stomach

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Stop taking the medication and seek immediate medical attention if any of the following occur:

• cysts (small sac under skin filled with fluid or pus)
• signs of kidney problems (e.g., nausea, vomiting, fever, swelling of hands and feet, fatigue, thirst, dry skin, dark urine, rash, weight gain, loss of appetite, drowsiness, confusion, coma)
• signs of a serious allergic reaction (e.g., hives, difficulty breathing, swelling of the face or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are any nutrients depleted by this medication?

Some medications can affect vitamin and nutrient levels in the body. Below is a list of nutrient depletions associated with this medication. Talk to your doctor or pharmacist about whether taking a supplement is recommended or if you have any questions or concerns.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Infections: Before you start treatment with tacrolimus topical ointment, you should be free of infections.

Long-term use of this medication may increase the risk of developing infections. There may be an increased risk of skin infections such as chicken pox, shingles, or cold sores.

If your skin becomes infected or if you notice lymph node swelling in the neck, armpits, or groin, contact your doctor as soon as possible.

Kidney function: If you are applying tacrolimus topical ointment over a large part of your body, it may be absorbed through the skin, which can affect kidney function. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Skin cancer and other cancers: Although rare, people using tacrolimus topical ointment have reported skin cancer and lymphoma. The relationship between long-term use of this medication and certain types of skin cancers or lymphomas has not been established. Discuss any concerns you have with your doctor.

Skin reaction: During the first few days of treatment with this medication, you may experience skin reactions (e.g., burning sensation, stinging, soreness). This is normal and usually goes away after a short period of time.

Sun exposure: If you use tacrolimus topical ointment, protect yourself from too much sun exposure. Use a sunscreen with a sun protection factor (SPF) of at least 30, wear hats and long-sleeved clothing, and avoid the sun during its strongest times (between 10 am and 4 pm). Avoid tanning beds and other ultraviolet (UV) A or B treatments while using this medication.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while using this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are breast-feeding and are using tacrolimus topical ointment, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using tacrolimus topical ointment have not been established for children under 2 years of age. Children aged 2 to 15 years should use the 0.03% strength of tacrolimus ointment only.

What other drugs could interact with this medication?

There may be an interaction between tacrolimus topical ointment and any of the following:

• alcohol
• aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
• calcium channel blockers (e.g., diltiazem, verapamil)
• cobicistat
• conivaptan
• dronedarone
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• letermovir
• macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)
• medications that weaken the immune system
• abatacept
• azathioprine
• certain biologics (e.g., adalimumab, anakinra, infliximab, rituximab)
• corticosteroids (e.g., budesonide, dexamethasone, hydrocortisone, fluticasone, prednisone)
• cyclosporine
• fingolimod
• hydroxyurea
• leflunomide
• medications to treat cancer (e.g., carboplatin, cyclophosphamide, doxorubicin, ifosfamide, vincristine)
• mycophenolate
• pomalidomide
• protein kinase inhibitors (e.g., bosutinib, dasatinib, idelalasib, imatinib, nilotinib, tofacitinib)
• sirolimus
• other forms of tacrolimus
• mifepristone
• other medications applied to the skin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2025. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Protopic