This medicine is for use on the skin only. Tacrolimus may cause a condition called pure red cell aplasia (PRCA). Post-marketing cases of increased tacrolimus blood level have been reported in these conditions. Moisturizers can be used with Tacrolimus Ointment. Tacrolimus is not for long-term use. The use of Tacrolimus Ointment may cause local symptoms such as skin burning (burning sensation, stinging, soreness) or pruritus. Not for ophthalmic use. There are no adequate and well-controlled studies of topically administered tacrolimus in pregnant women. "Mayo," "Mayo Clinic," "MayoClinic.org," "Mayo Clinic Healthy Living," and the triple-shield Mayo Clinic logo are trademarks of Mayo Foundation for Medical Education and Research. A 104-week dermal carcinogenicity study was performed in mice with Tacrolimus Ointment (0.03% - 3%), equivalent to tacrolimus doses of 1.1-118 mg/kg/day or 3.3-354 mg/m 2/day. Talk to your doctor if you have concerns about this. Follow your doctor’s advice if symptoms of eczema return after treatment with Tacrolimus Ointment. Wheezing. Tacrolimus Ointment is for use after other prescription medicines have not worked for you, or if your doctor recommends that other prescription medicines should not be used. Limit sun exposure during treatment with Tacrolimus Ointment even when the medicine is not on their skin. However, a statistically significant elevation in the incidence of pleomorphic lymphoma in high dose male (25/50) and female animals (27/50) and in the incidence of undifferentiated lymphoma in high dose female animals (13/50) was noted in the mouse dermal carcinogenicity study. BACKGROUND: Vehicle-controlled studies have demonstrated the efficacy and safety of tacrolimus ointment for patients with atopic dermatitis. The presence of other medical problems may affect the use of this medicine. Do not swallow Tacrolimus Ointment. In adults with an average of 53% BSA treated, exposure (AUC) of tacrolimus from Tacrolimus Ointment is approximately 30-fold less than that seen with oral immunosuppressive doses in kidney and liver transplant patients. In studies of oral tacrolimus no impairment of fertility was seen in male and female rats. Make sure that the tube is tightly closed. Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. In a pharmacokinetic study of 14 pediatric atopic dermatitis patients, between the ages of 2-5 years, peak blood concentrations of tacrolimus ranged from undetectable to 14.8 ng/mL after single or multiple doses of 0.03% Tacrolimus Ointment, with 86% (12/14) of patients having peak blood concentrations below 2 ng/mL throughout the study. The table also depicts the unadjusted incidence of adverse events in four safety studies, regardless of relationship to study drug. Dry skin completely before applying the ointment. Please read the first section of this Medication Guide. It has been demonstrated that tacrolimus inhibits T-lymphocyte activation by first binding to an intracellular protein, FKBP-12. Do not use a sunlamp or a tanning bed or booth. Tacrolimus Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Call your doctor if your symptoms do not improve after 6 weeks of treatment, or if they get worse while using tacrol… Use Tacrolimus Ointment only on areas of skin that have eczema. 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. The effect of renal insufficiency on the pharmacokinetics of topically administered tacrolimus has not been evaluated. All rights reserved. This could wash off the ointment. Prolonged systemic use of calcineurin inhibitors for sustained immunosuppression in animal studies and transplant patients following systemic administration has been associated with an increased risk of infections, lymphomas, and skin malignancies. Mayo Clinic is a nonprofit organization and proceeds from Web advertising help support our mission. If you would like more information, talk with your doctor. Ask your doctor or pharmacist for more information. The plasma protein binding of tacrolimus is approximately 99% and is independent of concentration over a range of 5-50 ng/mL. No drug-related tumors were noted in the mouse dermal carcinogenicity study at a daily dose of 1.1 mg/kg (0.03% Tacrolimus Ointment) (10X MRHD based on AUC comparisons). Transplant patients receiving immunosuppressive regimens (e.g., systemic tacrolimus) are at increased risk for developing lymphoma; therefore, patients who receive Tacrolimus Ointment and who develop lymphadenopathy should have the etiology of their lymphadenopathy investigated. You may report side effects to the FDA at 1-800-FDA-1088. Since the safety and efficacy of Tacrolimus Ointment have not been established in pediatric patients below 2 years of age, its use in this age group is not recommended. Rare post-marketing cases of acute renal failure have been reported in patients treated with Tacrolimus Ointment. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Dry skin completely before applying the ointment. The peak concentrations for this subject were 14.8 ng/mL on day 1 and 4.1 ng/mL on day 14. Your doctor may decide not to treat you with this medication or change some of the other medicines you take. Tacrolimus Ointment is not indicated for children less than 2 years of age. Tendency to develop kidney problems—Use with caution. Based on the information above and the mechanism of action, there is a concern about potential risk with the use of topical calcineurin inhibitors, including Tacrolimus Ointment. The safety of using Tacrolimus Ointment for a long period of time is not known. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Only 0.03% Tacrolimus Ointment is indicated for use in children 2-15 years of age. The safety of using Tacrolimus Ointment for a long period of time is not known. For non-prescription products, read the label or package ingredients carefully. Tacrolimus ointment is a nonsteroidal topical immunomodulator that was formulated specifically for the treatment of atopic dermatitis. The effect of hepatic insufficiency on the pharmacokinetics of topically administered tacrolimus has not been evaluated but dose-adjustment is not expected to be needed. Patients who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Apply a thin layer of Tacrolimus Ointment to the affected skin twice daily. Four studies were conducted involving a total of about 4,400 patients 2-15 years of age: one 12-week randomized vehicle-controlled study and three open-label safety studies of one to three years duration. Village - Matoda, Bavla Road, Ta. Stop using when signs and symptoms of atopic dermatitis resolve. ), allergies, pre … What should I avoid while using Tacrolimus Ointment? Stay out of the sun even when the medicine is not on your skin. Use Tacrolimus Ointment for short periods, and if needed, treatment may be repeated with breaks in between. You can use moisturizers with Tacrolimus Ointment. If you use moisturizers, apply them after Tacrolimus Ointment. Because the two adult studies were identically designed, the results from these studies were pooled in this table. Of these 112 cases, the majority had either a clear etiology or were known to resolve. Tacrolimus Ointment should be used during pregnancy only if the potential benefit to the mother justifies a potential risk to the fetus. 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. Over 80% of patients had atopic dermatitis affecting the face and/or neck region. Systemic absorption is more likely to occur in patients with epidermal barrier defects especially when Tacrolimus Ointment is applied to large body surface areas. Apply a sunblock product that has a skin protection factor (SPF) of at least 15. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Their symptoms get worse with Tacrolimus Ointment. 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 you need to be outdoors after applying Tacrolimus Ointment, wear loose fitting clothing that protects the treated area from the sun. In general as treatment continued, systemic exposure declined as the skin returned to normal. Although not all of these side effects may occur, if they do occur they may need medical attention. Use Tacrolimus Ointment exactly as prescribed. Tacrolimus Ointment is not indicated for use in children less than 2 years of age. Each gram of Tacrolimus Ointment contains (w/w) either 0.03% or 0.1% of tacrolimus in a base of mineral oil, paraffin, propylene carbonate, white petrolatum and white wax. Systemic levels of tacrolimus have also been measured in pediatric patients (see Special Populations: Pediatrics). If you do, call your doctor. Effects on female reproductive function (parturition) and embryolethal effects were indicated by a higher rate of pre-implantation loss and increased numbers of undelivered and nonviable pups. Uses This form of tacrolimus is used on the skin to treat a skin condition called eczema (atopic dermatitis) in patients who have not responded well to (or should not use) other eczema … If you are a caregiver applying Tacrolimus Ointment to a patient, or if you are a patient who is not treating your hands, wash your hands with soap and water after applying Tacrolimus Ointment. burning or stinging sensation of the face, change in size, shape, or color of an existing mole, muscle spasm or jerking of all extremities, red rash with watery, yellow-colored, or pus filled blisters, small, red skin lesion, growth, or bump usually on the face, ears, neck, hands, or arms, swelling of the face, ankles, lower legs, hands, or fingers, skin flushing in areas of ointment application when drinking alcohol, pain or tenderness around the eyes and cheekbones, swelling of the eye, eyelid, or inner lining of the eyelid. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. If it does get on these areas, rinse it off right away. Make sure you check with your doctor first about the products that are right for you. Patients can wear normal clothing. When you begin using this medicine: If you have a severe reaction from the sun, check with your doctor. In man, less than 1% of the dose administered is excreted unchanged in urine. This effect has been shown to prevent the dephosphorylation and translocation of nuclear factor of activated T-cells (NF-AT), a nuclear component thought to initiate gene transcription for the formation of lymphokines (such as interleukin-2, gamma interferon). Using this medicine with any of the following medicines is not recommended. It is very important that your doctor check your or your child's progress at regular visits. The mean clearance of IV administered tacrolimus in patients with renal dysfunction was similar to that of normal volunteers. Portions of this document last updated: Jan. 01, 2021, Original article: https://www.mayoclinic.org/drugs-supplements/tacrolimus-topical-route/precautions/DRG-20068159. The use of Tacrolimus Ointment should be avoided on pre-malignant and malignant skin conditions. The use of Tacrolimus Ointment is not recommended in patients having skin conditions with a skin barrier defect where there is the potential for increased systemic absorption of tacrolimus, including but not limited to, Netherton's syndrome, lamellar ichthyosis, generalized erythroderma or cutaneous Graft Versus Host Disease. Apply a sun block lipstick that has an SPF of at least 15 to protect your lips. are pregnant, breastfeeding, or planning to become pregnant. Inactive Ingredients: mineral oil, paraffin, propylene carbonate, white petrolatum and white wax. While patients with atopic dermatitis are predisposed to superficial skin infections including eczema herpeticum (Kaposi’s varicelliform eruption), treatment with Tacrolimus Ointment may be independently associated with an increased risk of varicella zoster virus infection (chicken pox or shingles), herpes simplex virus infection, or eczema herpeticum. Make sure your doctor knows if you are receiving any type of UV light treatment or "phototherapy". Follow their doctor’s advice if symptoms of eczema return after treatment with Tacrolimus Ointment. Tacrolimus is extensively metabolized by the mixed-function oxidase system, primarily the cytochrome P-450 system (CYP3A). Other side effects include acne, swollen or infected hair follicles, headache, increased sensitivity of the skin to hot or cold temperatures, or flu-like symptoms such as the common cold and stuffy nose, skin tingling, upset stomach, muscle pain, swollen glands (enlarged lymph nodes), or skin infections including cold sores, chicken pox or shingles. Atopic dermatitis (AD) requires long‐term management, mainly with topical anti‐inflammatory agents. In clinical studies, 112/13494 (0.8%) cases of lymphadenopathy were reported and were usually related to infections (particularly of the skin) and noted to resolve upon appropriate antibiotic therapy. Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible. Call a doctor or poison control center right away if you accidentally swallow this medicine. Avoid getting Tacrolimus Ointment in the eyes or mouth. Precautions. The mean clearance of radiolabel was 0.029 ± 0.015 L/hr/kg and clearance of tacrolimus was 0.029 ± 0.009 L/hr/kg. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Ask your doctor if you have any questions. Protopic (tacrolimus ointment) is an immunosuppressant topical drug (applied to the skin) used to treat atopic dermatitis (eczema). If your doctor recommends a moisturizer, apply it after applying this medicine. Four hundred and four (404) patients ≥ 65 years old received Tacrolimus Ointment in phase 3 studies. Tacrolimus helps to suppress these symptoms which are reactions caused by the body's immune system. NDC 16729- 422-12 Rx only, ATTENTION: DISPENSE WITH ENCLOSED MEDICATION GUIDE TO EACH PATIENT 60g, Tacrolimus Ointment Caution should also be exercised in patients predisposed to renal impairment. Other adverse events which occurred at an incidence between 0.2% and less than 1% in clinical studies in the above table include: abnormal vision, abscess, anaphylactoid reaction, anemia, anorexia, anxiety, arthritis, arthrosis, bilirubinemia, blepharitis, bone disorder, breast neoplasm benign, bursitis, cataract NOS, chest pain, chills, colitis, conjunctival edema, constipation, cramps, cutaneous moniliasis, cystitis, dehydration, dizziness, dry eyes, dry mouth/nose, dyspnea, ear disorder, ecchymosis, edema, epistaxis, eye pain, furunculosis, gastritis, gastrointestinal disorder, hernia, hypercholesterolemia, hypertonia, hypothyroidism, joint disorder, laryngitis, leukoderma, lung disorder, malaise, migraine, moniliasis, mouth ulceration, nail disorder, neck pain, neoplasm benign, oral moniliasis, otitis externa, photosensitivity reaction, rectal disorder, seborrhea, skin carcinoma, skin discoloration, skin hypertrophy, skin ulcer, stomatitis, tendon disorder, thinking abnormal, tooth caries, sweating, syncope, tachycardia, taste perversion, unintended pregnancy, vaginal moniliasis, vaginitis, valvular heart disease, vasodilatation, and vertigo. 0.1% 100g, NDC 16729- 422-01 Rx only, ATTENTION: DISPENSE WITH ENCLOSED MEDICATION GUIDE TO EACH PATIENT 100g, Tacrolimus Ointment Read and follow these instructions carefully. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Tacrolimus ointment should not be used with occlusive dressings. Oral ingestion of Tacrolimus Ointment may lead to adverse effects associated with systemic administration of tacrolimus. 90% of the pruritus events had a duration between 3 minutes and 10 hours (median 20 minutes) (see ADVERSE REACTIONS). The pooled results from three pharmacokinetic studies in 88 adult atopic dermatitis patients indicate that tacrolimus is minimally absorbed after the topical application of Tacrolimus Ointment. Village - Matoda, Bavla Road, A total of 255 children, 2 to 15 years of age, with moderate to severe atopic dermatitis applied 0.1% tacrolimus ointment twice daily for up to 12 months to assess long-term safety … have a skin disease called Netherton’s syndrome (a rare inherited condition). We comply with the HONcode standard for trustworthy health information -, manufacture(16729-421, 16729-422), analysis(16729-421, 16729-422). The mean clearance following IV administration of tacrolimus is 0.040, 0.083 and 0.053 L/hr/kg in healthy volunteers, adult kidney transplant patients and adult liver transplant patients, respectively. Lymphoma, skin cancer, and other types of cancer have rarely happened in people treated with tacrolimus 0.1% ointment. : 457, 458, With Tacrolimus Ointment 0.1%, 90% of the skin burning events had a duration between 2 minutes and 3 hours (median 15 minutes). The safety of using tacrolimus ointment for a long period of time is not known. This should remove any ointment left on the hands. In clinical studies with periodic blood sampling, a similar distribution of tacrolimus blood levels was also observed in adult patients, with 90% (1253/1391) of patients having a blood concentration less than 2 ng/mL. This Medication Guide summarizes the most important information about Tacrolimus Ointment. Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. In a US study, the ratio of whole blood concentration to plasma concentration averaged 35 (range 12 to 67). Do not use Tacrolimus Ointment for a condition for which it was not prescribed. Tacrolimus ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic … Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. 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. Make sure they check with their doctor first about the products that are right for them. Stop using the medicine once your symptoms have cleared up, unless your doctor has told you otherwise. These side effects may go away during treatment as your body adjusts to the medicine. Do not use Tacrolimus Ointment continuously for a long time. Peak tacrolimus blood concentrations ranged from undetectable to 20 ng/mL after single or multiple doses of 0.03% and 0.1% Tacrolimus Ointment, with 85% (75/88) of the patients having peak blood concentrations less than 2 ng/mL. When administered PO, the mean recovery of the radiolabel was 94.9 ± 30.7%. A complex of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. Stop Tacrolimus Ointment when the signs and symptoms of eczema, such as itching, rash, and redness go away, or as directed. In three 12 week randomized vehicle-controlled studies and four safety studies, 655 and 9,163 patients respectively, were treated with Tacrolimus Ointment. Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use). If patients need to be outdoors after applying Tacrolimus Ointment, wear loose fitting clothing that protects the treated area from the sun. You may report side effects to FDA at 1-800-FDA-1088. If they are a caregiver applying Tacrolimus Ointment to a patient, or if they are a patient who is not treating their hands, wash their hands with soap and water after applying Tacrolimus Ointment. In addition to skin burning and pruritus, the less common events (< 5%) of varicella zoster (mostly chicken pox), and vesiculobullous rash were more frequent in patients treated with Tacrolimus Ointment 0.03% compared to vehicle. Tacrolimus, given orally at 1.0 and 3.2 mg/kg (0.04X-0.12X MRHD based on BSA) to pregnant rats after organogenesis and during lactation, was associated with reduced pup weights. Stop using when signs and symptoms of atopic dermatitis resolve. Do not leave Tacrolimus Ointment in your car in cold or hot weather. However, this medicine is not recommended in children younger than 2 years of age.