Tacrolimus Topical

Name: Tacrolimus Topical

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Why is this medication prescribed?

Tacrolimus ointment is used to treat the symptoms of eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes) in patients who cannot use other medications for their condition or whose eczema has not responded to another medication. Tacrolimus is in a class of medications called topical calcineurin inhibitors. It works by stopping the immune system from producing substances that may cause eczema.

Warning

Patients have benefited from tacrolimus when it is used correctly. Long-term safety for this drug is not known at this time. There have been rare reports of cancers (e.g., skin cancer, lymphoma) in patients using tacrolimus. It is not known whether tacrolimus caused these cancers when used on the skin. Further studies to determine the long-term safety of this product are ongoing. In the unlikely event that unusual lumps, swollen glands, or growths (especially on the skin) occur, contact your doctor immediately.

The US Food and Drug Administration recommends the following: This drug should be used only if other drugs have failed or if other medications are not considered appropriate by your doctor. Tacrolimus should be used on the skin for short treatment periods only. If needed, treatment may be repeated with breaks in between. Use the smallest amount that will treat your condition properly, and apply only on the affected skin. Also, this medication should not be used in children younger than 2 years. As with all medications, discuss the risks, benefits, and proper use of this medication with your doctor.

Precautions

Before using tacrolimus, tell your doctor or pharmacist if you are allergic to it; or to other macrolide medications (e.g., sirolimus, erythromycin, clarithromycin, azithromycin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: swollen lymph nodes (e.g., lymphadenopathy, mononucleosis), use of light therapy (e.g., UVA or UVB), skin or other cancers.Before using this medication, tell your doctor or pharmacist your medical history, especially of: skin infections (e.g., herpes, shingles), other skin conditions, kidney disease.This drug may make you more sensitive to the effects of alcohol. Your face or skin may flush red and feel hot. Limit alcoholic beverages.Tacrolimus may lessen your response to a vaccine making the vaccine less effective. Do not have immunizations/vaccinations while you are using this product without the consent of your doctor. Talk with your doctor about scheduling your vaccinations before or after treatment with this product.This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This drug may pass into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Tacrolimus Pharmacokinetics

Absorption

Bioavailability

Minimally absorbed into systemic circulation following topical application to the skin.a Apparent systemic bioavailability approximately 0.5%.a

Systemic absorption decreases as atopic dermatititis resolves.a

Following topical application (53% of total body surface area) in adults, systemic exposure is approximately 30-fold less than following oral administration of immunosuppressive dosages of tacrolimus in adult kidney and liver transplant patients.a

Blood concentrations in children receiving tacrolimus topically occasionally have been in the concentration range achieved with systemic therapy.14 a

Use of occlusive dressing/wrappings or on the face or neck, large areas of the body (i.e., >50% of the total body surface area), or areas of broken skin may increase systemic exposure to the drug.3 11

Distribution

Plasma Protein Binding

Approximately 99% (mainly albumin and α1-acid glycoprotein).a

Elimination

Metabolism

Studies using systemic tacrolimus indicate that the drug is extensively metabolized in the liver and in the GI tract, principally via oxidation by CYP isoenzymes.10 11 a

Elimination Route

Following oral or IV administration, eliminated principally in feces (92%); approximately 1–2% excreted unchanged in urine.a

Half-life

Following IV administration, elimination half-life of approximately 44–48 hours in healthy individuals;a similar elimination half-life (31–48 hours) following oral administration.a

Before Using tacrolimus

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 tacrolimus, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to tacrolimus 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, tacrolimus 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

	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.

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.

Interactions with 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 tacrolimus, 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 tacrolimus 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
Amisulpride
Bepridil
Cisapride
Dronedarone
Mesoridazine
Mifepristone
Nelfinavir
Pimozide
Piperaquine
Ritonavir
Saquinavir
Sparfloxacin
Terfenadine
Thioridazine
Ziprasidone

Using tacrolimus 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
Afatinib
Alefacept
Alfuzosin
Amiodarone
Amitriptyline
Amlodipine
Amprenavir
Amtolmetin Guacil
Anagrelide
Apomorphine
Aprepitant
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Asenapine
Aspirin
Astemizole
Atazanavir
Azithromycin
Bedaquiline
Blinatumomab
Boceprevir
Bosentan
Bromfenac
Bufexamac
Buserelin
Carbamazepine
Caspofungin
Celecoxib
Ceritinib
Chloroquine
Chlorpromazine
Choline Salicylate
Ciprofloxacin
Citalopram
Clarithromycin
Clomipramine
Clonixin
Clozapine
Cobicistat
Colchicine
Conivaptan
Crizotinib
Cyclobenzaprine
Cyclosporine
Dabrafenib
Dalfopristin
Darunavir
Dasabuvir
Dasatinib
Degarelix
Delamanid
Delavirdine
Desipramine
Deslorelin
Deutetrabenazine
Dexamethasone
Dexibuprofen
Dexketoprofen
Diclofenac
Diflunisal
Diltiazem
Dipyrone
Disopyramide
Dofetilide
Dolasetron
Domperidone
Donepezil
Doxepin
Droperidol
Droxicam
Ebastine
Echinacea
Efavirenz
Elbasvir
Eliglustat
Eluxadoline
Enzalutamide
Eribulin
Erythromycin
Escitalopram
Esomeprazole
Etodolac
Etofenamate
Etoricoxib
Etravirine
Famotidine
Felbamate
Felbinac
Fenoprofen
Fepradinol
Feprazone
Fingolimod
Flecainide
Floctafenine
Flufenamic Acid
Fluoxetine
Flurbiprofen
Formoterol
Fosamprenavir
Fosaprepitant
Foscarnet
Fosphenytoin
Galantamine
Gatifloxacin
Gemifloxacin
Golimumab
Gonadorelin
Goserelin
Granisetron
Grazoprevir
Guselkumab
Halofantrine
Haloperidol
Histrelin
Hydroquinidine
Hydroxychloroquine
Hydroxyzine
Ibuprofen
Ibuprofen Lysine
Ibutilide
Idelalisib
Iloperidone
Imatinib
Imipramine
Indinavir
Indomethacin
Infliximab
Isavuconazonium Sulfate
Itraconazole
Ivabradine
Ketoconazole
Ketoprofen
Ketorolac
Lapatinib
Leuprolide
Levofloxacin
Lornoxicam
Loxoprofen
Lumacaftor
Lumefantrine
Lumiracoxib
Meclofenamate
Mefenamic Acid
Mefloquine
Meloxicam
Methadone
Metronidazole
Mibefradil
Mitotane
Mizolastine
Modafinil
Moricizine
Morniflumate
Moxifloxacin
Nabumetone
Nafarelin
Naproxen
Nefazodone
Nepafenac
Netupitant
Nevirapine
Nicardipine
Niflumic Acid
Nilotinib
Nimesulide
Nimesulide Beta Cyclodextrin
Norfloxacin
Octreotide
Ofloxacin
Olanzapine
Ombitasvir
Omeprazole
Ondansetron
Oxaprozin
Oxcarbazepine
Oxyphenbutazone
Paliperidone
Panobinostat
Parecoxib
Paritaprevir
Paroxetine
Pasireotide
Pazopanib
Pentamidine
Perphenazine
Phenobarbital
Phenylbutazone
Phenytoin
Piketoprofen
Pimavanserin
Pipamperone
Piroxicam
Pitolisant
Pixantrone
Posaconazole
Prednisone
Primidone
Probucol
Procainamide
Prochlorperazine
Proglumetacin
Promethazine
Propafenone
Propionic Acid
Propyphenazone
Proquazone
Protriptyline
Quetiapine
Quinidine
Quinine
Quinupristin
Ranolazine
Ribociclib
Rifabutin
Rifampin
Rilpivirine
Risperidone
Rofecoxib
Salicylic Acid
Salsalate
Schisandra sphenanthera
Secukinumab
Sertindole
Sevoflurane
Sirolimus
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Sodium Salicylate
Solifenacin
Sorafenib
Sotalol
St John's Wort
Sulindac
Sulpiride
Sunitinib
Tamoxifen
Telaprevir
Telavancin
Telithromycin
Tenoxicam
Tetrabenazine
Tiaprofenic Acid
Tizanidine
Tolfenamic Acid
Tolmetin
Tolterodine
Toremifene
Trazodone
Trimipramine
Triptorelin
Valdecoxib
Vandetanib
Vardenafil
Varicella Virus Vaccine
Vemurafenib
Venlafaxine
Verapamil
Vilanterol
Vinflunine
Voriconazole
Vorinostat
Zuclopenthixol

Using tacrolimus 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.

Chloramphenicol
Clotrimazole
Danazol
Ertapenem
Lansoprazole
Metoclopramide
Nifedipine

Interactions with Food/Tobacco/Alcohol

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 tacrolimus 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 tacrolimus, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Contraindications

Hypersensitivity to tacrolimus or any component of the formulation

Administration

Do not use with occlusive dressings. Burning at the application site is most common in first few days; improves as atopic dermatitis improves. Limit application to involved areas. Continue as long as signs and symptoms persist; discontinue if resolution occurs; re-evaluate if symptoms persist >6 weeks.

How should I use tacrolimus topical?

Use 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 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.

Wash your hands before and after using tacrolimus, 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 tacrolimus topical. 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.

Tacrolimus 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 tacrolimus.

Store at room temperature. Do not freeze. Keep ointment tube tightly closed when not in use.

What other drugs will affect tacrolimus topical?

It is not likely that other drugs you take orally or inject will have an effect on topically applied tacrolimus topical. But an interaction may occur if you apply tacrolimus over large skin areas. Tell your doctor about all other medicines you use, especially:

conivaptan (Vaprisol);
imatinib (Gleevec);
isoniazid (for treating tuberculosis);
an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek);
an antidepressant such as nefazodone;
antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), miconazole (Oravig), or voriconazole (Vfend);
heart or blood pressure medication such as nicardipine (Cardene) or quinidine (Quin-G);
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 tacrolimus topical. 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.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others. This drug should be used as directed for treating your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

Talk with your doctor about other ways to manage your eczema, such as using moisturizers and taking shorter baths/showers.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised March 2017. Copyright(c) 2017 First Databank, Inc.

Usual Adult Dose for Atopic Dermatitis

Apply a thin layer to the affected areas 2 times a day and rub in gently and completely; discontinue use when symptoms resolve

Comments:
-If itch, rash, and redness do not improve within 6 weeks, patients should be re-examined by their healthcare provider to confirm the diagnosis of atopic dermatitis.

Use: As second-line therapy for the short-term and noncontinuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised patients who have failed to respond adequately to other topical treatments, or when those treatments are not advisable