Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Protopic

Descriptions


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.

This product is available in the following dosage forms:

  • Ointment

Before Using

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.

Pediatric

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.

Geriatric

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

Pregnancy

Information about this tacrolimus-topical-route
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.

Breastfeeding

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.

Drug Interactions

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.

  • Amifampridine
  • Dronedarone
  • Mifepristone
  • Nelfinavir
  • Pimozide
  • Piperaquine
  • Posaconazole
  • 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.

  • Aceclofenac
  • Acemetacin
  • Adalimumab
  • Afatinib
  • Alefacept
  • Amikacin
  • Amiloride
  • Amiodarone
  • Amtolmetin Guacil
  • Artemether
  • Aspirin
  • Atazanavir
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Basiliximab
  • Bedaquiline
  • Bromfenac
  • Bufexamac
  • Buserelin
  • Carbamazepine
  • Caspofungin
  • Celecoxib
  • Ceritinib
  • Choline Salicylate
  • Cisplatin
  • Citalopram
  • Clarithromycin
  • Clonixin
  • Clozapine
  • Colchicine
  • Crizotinib
  • Cyclosporine
  • Dabrafenib
  • Darunavir
  • Delamanid
  • Deslorelin
  • Dexibuprofen
  • Dexketoprofen
  • Dibekacin
  • Diclofenac
  • Diflunisal
  • Dipyrone
  • Efavirenz
  • Enzalutamide
  • Erythromycin
  • Escitalopram
  • Eslicarbazepine Acetate
  • Esomeprazole
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Etravirine
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Floctafenine
  • Flufenamic Acid
  • Fluoxetine
  • Flurbiprofen
  • Fosphenytoin
  • Gentamicin
  • Gonadorelin
  • Goserelin
  • Haloperidol
  • Histrelin
  • Ibuprofen
  • Ibuprofen Lysine
  • Idelalisib
  • Iloperidone
  • Indomethacin
  • Infliximab
  • Itraconazole
  • Ivabradine
  • Kanamycin
  • Ketoconazole
  • Ketoprofen
  • Ketorolac
  • Lapatinib
  • Leuprolide
  • Lornoxicam
  • Loxoprofen
  • Lumefantrine
  • Lumiracoxib
  • Measles Virus Vaccine, Live
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Mitotane
  • Morniflumate
  • Mumps Virus Vaccine, Live
  • Nabumetone
  • Nafarelin
  • Naproxen
  • Nefazodone
  • Neomycin
  • Nepafenac
  • Netilmicin
  • Niflumic Acid
  • Nilotinib
  • Nimesulide
  • Omeprazole
  • Ondansetron
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Pazopanib
  • Phenobarbital
  • Phenylbutazone
  • Phenytoin
  • Piketoprofen
  • Piroxicam
  • Pixantrone
  • Poliovirus Vaccine, Live
  • Pranoprofen
  • Primidone
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Quetiapine
  • Ranolazine
  • Rifabutin
  • Rifampin
  • Rofecoxib
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Salicylic Acid
  • Salsalate
  • Sertraline
  • Sevoflurane
  • Siltuximab
  • Simeprevir
  • Sirolimus
  • Smallpox Vaccine
  • Sodium Salicylate
  • Spironolactone
  • St John's Wort
  • Streptomycin
  • Sulindac
  • Sunitinib
  • Telaprevir
  • Telithromycin
  • Tenofovir
  • Tenoxicam
  • Tiaprofenic Acid
  • Tizanidine
  • Tobramycin
  • Tocophersolan
  • Tolfenamic Acid
  • Tolmetin
  • Triamterene
  • Triptorelin
  • Typhoid Vaccine
  • Ulipristal
  • Valdecoxib
  • Vandetanib
  • Varicella Virus Vaccine
  • Vemurafenib
  • Vilanterol
  • Vinflunine
  • Voriconazole
  • Yellow Fever Vaccine

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.

  • Amprenavir
  • Boceprevir
  • Chloramphenicol
  • Clotrimazole
  • Dalfopristin
  • Danazol
  • Diltiazem
  • Ertapenem
  • Metoclopramide
  • Metronidazole
  • Mibefradil
  • Nevirapine
  • Nifedipine
  • Quinupristin
  • Rifapentine
  • Ritonavir
  • Saquinavir
  • Schisandra sphenanthera
  • Theophylline
  • 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

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

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

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

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

  1. Agitation
  2. black, tarry stools
  3. bloody urine
  4. burning or stinging sensation of the face
  5. change in size, shape, or color of an existing mole
  6. coma
  7. confusion
  8. convulsions
  9. decreased frequency or amount of urine
  10. depression
  11. fever
  12. general feeling of illness
  13. growth or bump on skin
  14. hostility
  15. increase in bone pain
  16. increased blood pressure
  17. increased thirst
  18. irritability
  19. lethargy
  20. looks very ill
  21. loss of appetite
  22. loss of bladder control
  23. lower back or side pain
  24. mole that leaks fluid or bleeds
  25. muscle spasm or jerking of all extremities
  26. muscle twitching
  27. nausea
  28. new mole
  29. rapid weight gain
  30. red rash with watery, yellow-colored, or pus filled blisters
  31. redness of the face
  32. seizures
  33. small, red skin lesion, growth, or bump usually on the face, ears, neck, hands, or arms
  34. sore that will not heal
  35. spider-like blood vessels on the face
  36. stupor
  37. sudden loss of consciousness
  38. swelling of the face, ankles, lower legs, hands, or fingers
  39. swollen glands
  40. thick, yellow to honey-colored crusts
  41. unusual tiredness or weakness
  42. vomiting
  43. weight gain
  44. weight loss
  45. 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

  1. Cough
  2. fever
  3. general aches and pains
  4. headache
  5. itching skin—in children
  6. loss of appetite
  7. skin burning
  8. skin flushing in areas of ointment application when drinking alcohol
  9. sneezing
  10. weakness

Less common

  1. Acid or sour stomach
  2. acne
  3. back pain
  4. belching
  5. burning, itching, or pain in hairy areas
  6. chills
  7. cyst
  8. flushing
  9. heartburn
  10. increased sensitivity to sunlight
  11. increased skin sensitivity
  12. indigestion
  13. itching eyes
  14. joint pain
  15. muscle aches or pain
  16. pain in the eye
  17. pain or tenderness around the eyes and cheekbones
  18. pus at root of the hair
  19. rash
  20. redness in the eye
  21. runny nose
  22. severe skin rash or hives
  23. skin blisters—in children
  24. skin tingling
  25. stomach discomfort, upset, or pain
  26. stuffy nose
  27. swelling of the eye, eyelid, or inner lining of the eyelid
  28. swollen glands
  29. tightness of the chest
  30. troubled breathing or wheezing
  31. 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.