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Tacrolimus is an immunosuppressant. It works by decreasing your body's immune system.
Tacrolimus topical (for the skin) is used to treat severe atopic dermatitis (eczema).
Tacrolimus may also be used for purposes not listed in this medication guide.
You should not use tacrolimus topical if you are allergic to it.
Before using tacrolimus topical, 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.
Tacrolimus 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 tacrolimus topical. 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 tacrolimus topical 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 tacrolimus 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.
You should not use tacrolimus topical if you are allergic to it.
To make sure you can safely use tacrolimus topical, tell your doctor if you have any of these other conditions:
skin cancer or a skin infection (including herpes or chickenpox);
any genetic skin disorder (such as Netherton's syndrome);
a weak immune system (caused by disease or by using certain medicines);
kidney disease; or
swelling, redness, or irritation of large areas of your skin.
Tacrolimus 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 tacrolimus 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 tacrolimus topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
Tacrolimus topical 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 tacrolimus topical on a child younger than 2 years old.
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 tacrolimus topical 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.
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.
An overdose of tacrolimus topical 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.
Avoid using other medications on the areas you treat with tacrolimus topical 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 tacrolimus topical. Do not use sunscreen on treated skin unless your doctor has told you to.
Drinking alcohol while you are using tacrolimus topical may cause your skin or face to feel hot and become flushed or red.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using tacrolimus and call your doctor at once if you have a serious side effect such as:
severe stinging, burning, itching, or soreness where the medicine is applied;
swollen glands;
redness or crusting around your hair follicles; or
signs of a skin infection (redness, swelling, itching, oozing).
Less serious side effects may include:
mild burning, stinging, or itching;
skin redness;
acne;
cold or flu symptoms such as stuffy nose, sneezing, sore throat;
headache; or
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.
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
Usual Pediatric Dose for Atopic Dermatitis:
Less than 2 years: Safety and efficacy have not been established
2 to 15 years:
0.03% ointment: Apply a thin layer to the affected areas 2 times a day and rub in gently and completely; discontinue use when symptoms resolve
0.1% ointment: Safety and efficacy have not been established
16 years and older:
0.03 or 0.1% ointment: 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.
-Children aged 2 to 15 years should only receive the 0.03% formulation of this drug.
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
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.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Tacrolimus Monohydrate (www.drugs.com/mtm/tacrolimus-topical.html).
Commonly reported side effects of tacrolimus topical include: burning sensation of skin and pruritus. Other side effects include: herpes zoster infection, varicella zoster infection, and vesicobullous dermatitis. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to tacrolimus topical: topical ointment
Topical route (Ointment)
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.
Along with its needed effects, tacrolimus topical 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 while taking tacrolimus topical:
Incidence not known
Some side effects of tacrolimus topical 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
Less common
For Healthcare Professionals
Applies to tacrolimus topical: topical ointment
CardiovascularCommon (1% to 10%): Lymphadenopathy, peripheral edema, hypertension
Uncommon (0.1% to 1%): Tachycardia, syncope, valvular heart disease, vasodilation
DermatologicVery common (10% or more): Skin burning (26%), pruritus (22%), skin infection (12%)
Common (1% to 10%): Erythema, herpes simplex, pustular rash, folliculitis, urticaria, maculopapular rash, fungal dermatitis, acne, sunburn, skin disorder, vesiculobullous rash, skin tingling, face edema, dry skin, benign skin neoplasm, varicella zoster/herpes zoster, contact dermatitis, eczema, cellulitis, Kaposi's varicelliform eruption
Uncommon (0.1% to 1%): Cutaneous moniliasis, furunculosis, leukoderma, seborrhea, skin carcinoma, skin discoloration, skin hypertrophy, skin ulcer, sweating, rosacea
GenitourinaryCommon (1% to 10%): Urinary tract infection, dysmenorrhea
Uncommon (0.1% to 1%): Breast neoplasm benign, cystitis, vaginal moniliasis, vaginitis
Frequency not reported: Unintended pregnancy
GastrointestinalCommon (1% to 10%): Diarrhea, nausea, vomiting, abdominal pain, gastroenteritis, dyspepsia, periodontal abscess, tooth disorder, alopecia
Uncommon (0.1% to 1%): Colitis, constipation, cramps, dehydration, dry mouth/nose, gastritis, GI disorder, hernia, mouth ulceration, nail disorder, photosensitivity reaction, rectal disorder, stomatitis, tooth caries
EndocrineUncommon (0.1% to 1%): Hypothyroidism
HematologicUncommon (0.1% to 1%): Anemia, ecchymosis
HepaticUncommon (0.1% to 1%): Bilirubinemia
ImmunologicVery common (10% or more): Influenza-like illness (28%)
Common (1% to 10%): Infection
Uncommon (0.1% to 1%): Abscess, moniliasis, bullous impetigo, osteomyelitis,
HypersensitivityVery common (10% or more): Allergic reaction (11%)
LocalUncommon (0.1% to 1%): Application site edema, application site burning, application site warmth, application site erythema, application site pain, application site irritation, application site paresthesia, application site rash
MetabolicCommon (1% to 10%): Alcohol intolerance
Uncommon (0.1% to 1%): Anorexia, arthrosis, hypercholesterolemia
MusculoskeletalCommon (1% to 10%): Back pain, myalgia, arthralgia
Uncommon (0.1% to 1%): Arthritis, arthrosis, bone disorder, bursitis, chest pain, hypertonia, joint disorder, neck pain, tendon disorder
Nervous systemVery common (10% or more): Headache (11%)
Common (1% to 10%): Hyperesthesia, paresthesia
Uncommon (0.1% to 1%): Dizziness, migraine, taste perversion
OcularCommon (1% to 10%): Conjunctivitis
Uncommon (0.1% to 1%): Abnormal vision, blepharitis, conjunctival edema, dry eyes, eye pain
Frequency not reported: Ophthalmic herpes infection
OncologicPostmarketing reports: Lymphomas, basal cell carcinoma, squamous cell carcinoma, malignant melanoma
OtherCommon (1% to 10%): Otitis media, pain, asthenia, cyst, ear pain
Uncommon (0.1% to 1%): Malaise, chills, ear disorder, edema, otitis externa
PsychiatricCommon (1% to 10%): Insomnia, depression
Uncommon (0.1% to 1%): Anxiety, thinking abnormal
RespiratoryCommon (1% to 10%): Cough, asthma, pharyngitis, rhinitis, sinusitis, bronchitis, pneumonia
Uncommon (0.1% to 1%): Dyspnea, epistaxis, laryngitis, lung disorder
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Tacrolimus Monohydrate (www.drugs.com/mtm/tacrolimus-topical.html).
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