Pronunciation:

ta-KROE-li-mus

Brand Names:

• Protopic

Dosage Forms:

• Ointment

Warnings:

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 younger than 2 years of age. Only 0.03% tacrolimus ointment is indicated for use in children 2 to 15 years of age .

Classifications:

Therapeutic—

Antipsoriatic

Pharmacologic—

Calcineurin Inhibitor

Uses of This Medicine:

Tacrolimus topical is used on the skin to treat moderate to severe atopic dermatitis in patients who have received other medicines that have not worked well. Atopic dermatitis is a skin condition where there is itching, redness, and inflammation, much like an allergic reaction. Tacrolimus helps to suppress these symptoms which are reactions caused by the body's immune system.

This medicine 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—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of tacrolimus topical in children 2 years of age and older. However, this medicine is not recommended in children younger than 2 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tacrolimus topical in the elderly.

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—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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.

• Bepridil
• Cisapride
• Dronedarone
• Fluconazole
• Lefamulin
• Mesoridazine
• Mifepristone
• Nelfinavir
• Pimozide
• Piperaquine
• Posaconazole
• Ritonavir
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abacavir
• Abametapir
• Abrocitinib
• Aceclofenac
• Acemetacin
• Adagrasib
• Adenovirus Vaccine, Live
• Alefacept
• Alfuzosin
• Amikacin
• Amiloride
• Amiodarone
• Amisulpride
• Amitriptyline
• Amlodipine
• Amphotericin B
• Amprenavir
• Amtolmetin Guacil
• Anagrelide
• Apalutamide
• Apomorphine
• Aprepitant
• Aranidipine
• Aripiprazole
• Aripiprazole Lauroxil
• Armodafinil
• Arsenic Trioxide
• Asciminib
• Asenapine
• Aspirin
• Astemizole
• Atazanavir
• Avacopan
• Azilsartan
• Azilsartan Medoxomil
• Azithromycin
• Bacillus of Calmette and Guerin Vaccine, Live
• Bedaquiline
• Benazepril
• Berotralstat
• Boceprevir
• Bosentan
• Bromfenac
• Bufexamac
• Buprenorphine
• Buserelin
• Candesartan
• Cannabidiol
• Cannabis
• Canrenoate
• Canrenone
• Capreomycin
• Captopril
• Carbamazepine
• Caspofungin
• Celecoxib
• Cenobamate
• Ceritinib
• Chloramphenicol
• Chloroquine
• Chlorpromazine
• Cholera Vaccine, Live
• Choline Salicylate
• Cilnidipine
• Cimetidine
• Ciprofloxacin
• Cisplatin
• Citalopram
• Clarithromycin
• Clevidipine
• Clofazimine
• Clomipramine
• Clonixin
• Clothiapine
• Clotrimazole
• Clozapine
• Cobicistat
• Colchicine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Cyclosporine
• Dabrafenib
• Dalfopristin
• Danazol
• Daridorexant
• Darunavir
• Dasabuvir
• Dasatinib
• Degarelix
• Delamanid
• Delavirdine
• Dengue Tetravalent Vaccine, Live
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexamethasone
• Dexibuprofen
• Dexketoprofen
• Dexmedetomidine
• Diclofenac
• Didanosine
• Diflunisal
• Diltiazem
• Dipyrone
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Droxicam
• Duvelisib
• Ebastine
• Ebola Zaire Vaccine, Live
• Echinacea
• Efavirenz
• Elacestrant
• Elagolix
• Elbasvir
• Eliglustat
• Emtricitabine
• Enalapril
• Enalaprilat
• Enasidenib
• Encorafenib
• Entrectinib
• Enzalutamide
• Eplerenone
• Eprosartan
• Erdafitinib
• Eribulin
• Erythromycin
• Escitalopram
• Eslicarbazepine Acetate
• Esomeprazole
• Ethinyl Estradiol
• Etodolac
• Etofenamate
• Etoricoxib
• Etrasimod
• Etravirine
• Famotidine
• Fedratinib
• Felbamate
• Felbinac
• Felodipine
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Fexinidazole
• Fingolimod
• Flecainide
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Formoterol
• Fosamprenavir
• Fosaprepitant
• Foscarnet
• Fosinopril
• Fosnetupitant
• Fosphenytoin
• Fostemsavir
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gentamicin
• Gepirone
• Gilteritinib
• Glasdegib
• Glecaprevir
• Gonadorelin
• Goserelin
• Granisetron
• Grazoprevir
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibuprofen
• Ibuprofen Lysine
• Ibutilide
• Idelalisib
• Iloperidone
• Imatinib
• Imipramine
• Indinavir
• Indomethacin
• Infliximab
• Influenza Virus Vaccine, Live
• Inotuzumab Ozogamicin
• Irbesartan
• Isavuconazonium Sulfate
• Isradipine
• Itraconazole
• Ivabradine
• Ivacaftor
• Ivosidenib
• Kanamycin
• Ketoconazole
• Ketoprofen
• Ketorolac
• Lamivudine
• Lanreotide
• Lansoprazole
• Lapatinib
• Larotrectinib
• Lasmiditan
• Lenacapavir
• Lenvatinib
• Lercanidipine
• Lesinurad
• Letermovir
• Leuprolide
• Levamlodipine
• Levofloxacin
• Lisinopril
• Lofexidine
• Lomitapide
• Lonafarnib
• Lopinavir
• Lorlatinib
• Lornoxicam
• Losartan
• Loxoprofen
• Lumacaftor
• Lumefantrine
• Lumiracoxib
• Macimorelin
• Manidipine
• Mavacamten
• Measles Virus Vaccine, Live
• Meclofenamate
• Mefenamic Acid
• Mefloquine
• Meloxicam
• Methadone
• Methotrimeprazine
• Methylprednisolone
• Metoclopramide
• Metronidazole
• Mirtazapine
• Mitapivat
• Mitotane
• Mizolastine
• Mobocertinib
• Modafinil
• Moexipril
• Moricizine
• Morniflumate
• Moxifloxacin
• Mumps Virus Vaccine, Live
• Mycophenolic Acid
• Nabumetone
• Nafarelin
• Nafcillin
• Naproxen
• Nefazodone
• Neomycin
• Nepafenac
• Neratinib
• Netilmicin
• Netupitant
• Nevirapine
• Nicardipine
• Nifedipine
• Niflumic Acid
• Nilotinib
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nimodipine
• Nirmatrelvir
• Nirogacestat
• Nisoldipine
• Nitrendipine
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Olmesartan
• Omaveloxolone
• Ombitasvir
• Omeprazole
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxaprozin
• Oxcarbazepine
• Oxyphenbutazone
• Ozanimod
• Pacritinib
• Palbociclib
• Paliperidone
• Panobinostat
• Papaverine
• Parecoxib
• Paritaprevir
• Paromomycin
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perindopril
• Perphenazine
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Piketoprofen
• Pimavanserin
• Pipamperone
• Piroxicam
• Pirtobrutinib
• Pitolisant
• Pixantrone
• Plazomicin
• Poliovirus Vaccine, Live
• Ponesimod
• Potassium Phosphate
• Prednisone
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Proglumetacin
• Promethazine
• Propafenone
• Propionic Acid
• Propyphenazone
• Proquazone
• Protriptyline
• Quetiapine
• Quinapril
• Quinidine
• Quinine
• Quinupristin
• Quizartinib
• Ramipril
• Ranitidine
• Ranolazine
• Relugolix
• Remdesivir
• Repotrectinib
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Risperidone
• Ritlecitinib
• Rofecoxib
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Salicylic Acid
• Salsalate
• Schisandra sphenanthera
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Simeprevir
• Siponimod
• Sirolimus
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Sodium Salicylate
• Solifenacin
• Sorafenib
• Sotalol
• Sotorasib
• Sparsentan
• Spectinomycin
• Spirapril
• Spironolactone
• Stavudine
• St John's Wort
• Streptomycin
• Sulindac
• Sulpiride
• Sultopride
• Sunitinib
• Tamoxifen
• Taurursodiol
• Telaprevir
• Telavancin
• Telithromycin
• Telmisartan
• Telotristat Ethyl
• Tenofovir
• Tenoxicam
• Tepotinib
• Tetrabenazine
• Tiaprofenic Acid
• Tipranavir
• Tobramycin
• Tocilizumab
• Tofacitinib
• Tolfenamic Acid
• Tolmetin
• Tolterodine
• Toremifene
• Trandolapril
• Trazodone
• Triamterene
• Triclabendazole
• Trimipramine
• Triptorelin
• Trofinetide
• Troleandomycin
• Tucatinib
• Typhoid Vaccine, Live
• Valdecoxib
• Valsartan
• Vandetanib
• Vardenafil
• Varicella Virus Vaccine, Live
• Vemurafenib
• Venlafaxine
• Verapamil
• Vilanterol
• Vilazodone
• Vinflunine
• Voclosporin
• Vonoprazan
• Voriconazole
• Vorinostat
• Voxilaprevir
• Yellow Fever Vaccine
• Zidovudine
• Zoster Vaccine, Live
• Zotepine
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ertapenem
• Tigecycline

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol
• Grapefruit Juice

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:

• Cutaneous T-cell lymphoma (type of skin cancer) or
• Mononucleosis ("mono") or
• Skin problems (e.g., lamellar ichthyosis, erythroderma, or Netherton's syndrome) or
• Skin tumors or
• Weakened immune system—Should not be used in patients with these conditions.

• Infection of the skin at the affected areas—Should be treated first before using this medicine.

• Kidney failure or
• Lymphadenopathy (disease of the lymph nodes) or
• Tendency to develop kidney problems—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should not be the first medicine you use to treat your condition. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects.

This medicine may be associated with an increased risk for developing chicken pox, eczema herpeticum, herpes simplex virus infections (skin blisters), or varicella zoster virus infection (shingles). Ask your doctor if you have questions about this and report any signs or symptoms of these conditions to your doctor.

This medicine should not be used continuously for a long time. If needed, treatment may be repeated with breaks in between.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine is for use on the skin only. Do not get it in your eyes, nose, or mouth. Do not use on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away.

To use:

• Wash your hands with soap and water before and after using this medicine. If you are treating a rash on your hands, do not wash your hands after using the medicine.
• Dry skin completely before applying the ointment.
• Apply a thin layer of ointment (use a small amount just enough to cover area) and rub it in well to cover the affected areas.
• Do not cover the treated skin with occlusive dressings, bandages, or wraps.
• Do not bathe, shower, or swim right after applying this medicine. This could wash off the ointment.
• If your doctor recommends a moisturizer, apply it after applying this medicine.

Do not use cosmetics or other skin care products on the treated skin areas.

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 topical dosage form (ointment):
  • For atopic dermatitis:
    • Adults and teenagers 16 years of age and older—Apply 0.03% or 0.1% ointment to a clean, dry, and intact skin two times a day.
    • Children 2 to 15 years old—Apply 0.03% ointment to a clean, dry, and intact skin two times a day.
    • Children younger than 2 years of age—Use is not recommended.

Storage—

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.

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

Do not leave the ointment in the car in cold or hot weather. Make sure that the tube is tightly closed.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits. This is to make sure the medicine is working properly and to check for unwanted effects. If your condition has not improved after 6 weeks or if they get worse, call your doctor.

This medicine may increase your risk of getting skin cancer or cancer of the lymph system (lymphoma). Talk to your doctor if you have concerns about this.

Stop using this medicine if signs and symptoms of eczema, such as itching, burning, stinging, rash, and redness go away, or as directed by your doctor.

This medicine may increase your risk of getting skin tumors, especially when exposed to sunlight. When you begin using this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible. Stay out of the sun even when the medicine is not on your skin.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sunblock 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 doctor.
• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
• Make sure your doctor knows if you are receiving any type of UV light treatment or "phototherapy".
• Do not use a sunlamp or a tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

This medicine may cause you to be very sick if it is not used correctly. Call a doctor or poison control center right away if you accidentally swallow this medicine.

Do not use this medicine for a skin problem that has not been checked by your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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 immediately if any of the following side effects occur:

Incidence not known

Agitation

black, tarry stools

bloody urine

burning or stinging sensation of the face

change in size, shape, or color of an existing mole

coma

confusion

convulsions

decreased frequency or 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 or 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 the face

seizures

small, red skin lesion, growth, or bump usually on the 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 the 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 the eye

pain or tenderness around the eyes and cheekbones

pus at root of the hair

rash

redness in the eye

runny nose

severe skin rash or hives

skin blisters—in children

skin tingling

stomach discomfort, upset, or pain

stuffy nose

swelling of the eye, eyelid, or inner lining of the eyelid

swollen glands

tightness of the 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.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.