Check with your doctor immediately if any of the following side effects occur: Some side effects may occur that usually do not need medical attention. Although systemic absorption of tacrolimus following topical applications of Tacrolimus Ointment is minimal relative to systemic administration, it is known that tacrolimus is excreted in human milk. Do not use cosmetics or other skin care products on the treated skin areas. The safety of Tacrolimus Ointment under occlusion, which may promote systemic exposure, has not been evaluated. This medicine may increase your risk of getting skin tumors, especially when exposed to sunlight. Know the medicines you take. There was no evidence based on blood concentrations that tacrolimus accumulates systemically upon intermittent topical application for periods of up to 1 year. At baseline, 58% of the patients had severe disease and the mean body surface area (BSA) affected was 46%. Portions of this document last updated: Jan. 01, 2021, Original article: https://www.mayoclinic.org/drugs-supplements/tacrolimus-topical-route/precautions/DRG-20068159. There may be new information. Moisturizers can be used with Tacrolimus Ointment. Do not give Tacrolimus Ointment to other people, even if they have the same symptoms you have. The table also depicts the unadjusted incidence of adverse events in four safety studies, regardless of relationship to study drug. Ask your doctor if you have any questions. 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. Objective: The goal of the study was to evaluate the safety and efficacy over a 6-month period of tacrolimus 0.1% ointment … The effect of renal insufficiency on the pharmacokinetics of topically administered tacrolimus has not been evaluated. If your condition has not improved after 6 weeks or if they get worse, call your doctor. 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. No reduction in male or female fertility was evident. These are not all the side effects with Tacrolimus Ointment. Limit sun exposure during treatment with Tacrolimus Ointment even when the medicine is not on their skin. The duration of follow-up for adult and pediatric patients in the safety studies is tabulated below. The presence of other medical problems may affect the use of this medicine. When you begin using this medicine: If you have a severe reaction from the sun, check with your doctor. your symptoms get worse with Tacrolimus Ointment. Not for ophthalmic use. ), allergies, pre … 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. 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 … Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use). INDIA. 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 … Stop using the medicine once your symptoms have cleared up, unless your doctor has told you otherwise. A complex of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. Tacrolimus 0.03% ointment has been reserved for children <16 years and associated with hyperpigmentation, as well as hypertricosis, in the target area. The time course of improvement in the remaining secondary efficacy variables was similar to that of erythema, with improvement in lichenification slightly slower. Wheezing. Inactive Ingredients: mineral oil, paraffin, propylene carbonate, white petrolatum and white wax. Stop Tacrolimus Ointment when the signs and symptoms of eczema, such as itching, rash, and redness go away, or as directed by your doctor. Systemic absorption is more likely to occur in patients with epidermal barrier defects especially when Tacrolimus Ointment is applied to large body surface areas. 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). FOR DERMATOLOGIC USE ONLY. Your doctor may decide not to treat you with this medication or change some of the other medicines you take. The difference in efficacy between Tacrolimus Ointment 0.1% and 0.03% was particularly evident in adult patients with severe disease at baseline, adults with extensive BSA involvement, and black adults. Mean peak tacrolimus blood concentrations following oral administration (0.3 mg/kg/day) in adult kidney transplant (n=26) and liver transplant (n=17) patients are 24.2±15.8 ng/mL and 68.5±30.0 ng/mL, respectively. 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. Do not bathe, shower, or swim right after applying Tacrolimus Ointment. Tacrolimus is bound mainly to albumin and alpha-1-acid glycoprotein, and has a high level of association with erythrocytes. When given at 3.2 mg/kg (0.43X MRHD based on BSA), tacrolimus was associated with maternal and paternal toxicity as well as reproductive toxicity including marked adverse effects on estrus cycles, parturition, pup viability, and pup malformations. Do not leave Tacrolimus Ointment in your car in cold or hot weather. The amount of medicine that you take depends on the strength of the medicine. The minimum amount should be rubbed in gently and completely to control signs and symptoms of atopic dermatitis. Do not cover the skin being treated with bandages, dressings or wraps. Tacrolimus Ointment is not indicated for children less than 2 years of age. Tacrolimus Ointment is used on the skin for short periods, and if needed, treatment may be repeated with breaks in between. Because of this concern: Talk to your doctor for more information. Last updated on Jun 1, 2019. Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. your symptoms do not improve after 6 weeks of treatment. 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. Tacrolimus, given orally at 1.0 mg/kg (0.12X MRHD based on body surface area [BSA]) to male and female rats, prior to and during mating, as well as to dams during gestation and lactation, was associated with embryolethality and with adverse effects on female reproduction. Suite 210-B, Only the lower concentration, 0.03%, of Tacrolimus Ointment is recommended for use as a second-line therapy for short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised children 2 to 15 years of age who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. One (Pediatric) study included 351 patients 2-15 years of age, and the other two (Adult) studies included a total of 632 patients 15-79 years of age. This medicine may increase your risk of getting skin cancer or cancer of the lymph system (lymphoma). NDC 16729- 422-10 Rx only, ATTENTION: DISPENSE WITH ENCLOSED MEDICATION GUIDE TO EACH PATIENT 30g, ATTENTION: DISPENSE WITH ENCLOSED Ask your doctor if you have questions about this and report any signs or symptoms of these conditions to your doctor. Children 2 to 15 years old—Apply 0.03% ointment to a clean, dry, and intact skin two times a day. Studies have not evaluated the safety and efficacy of Tacrolimus Ointment in the treatment of clinically infected atopic dermatitis. 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. Only Tacrolimus Ointment 0.03% is for use on children aged 2 to 15 years. Along with its needed effects, a medicine may cause some unwanted effects. 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. In adult patients who had achieved ≥ 90% improvement at the end of treatment, 35% of those treated with Tacrolimus Ointment 0.03% and 41% of those treated with Tacrolimus Ointment 0.1%, regressed from this state of improvement at 2 weeks after end-of-treatment. Not for ophthalmic use. Bullous impetigo, osteomyelitis, septicemia, Lymphomas, basal cell carcinoma, squamous cell carcinoma, malignant melanoma, Acute renal failure in patients with or without Netherton’s syndrome, renal impairment, To report SUSPECTED ADVERSE REACTIONS, contact Accord Healthcare Inc. at 1-866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Wash their hands before applying Tacrolimus Ointment. Mayo Clinic is a nonprofit organization and proceeds from Web advertising help support our mission. This could wash off the ointment. 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. It has the following structural formula: Tacrolimus has an empirical formula of C 44H 69NO 12•H 2O and a formula weight of 822.03. 90% of the pruritus events had a duration between 3 minutes and 10 hours (median 20 minutes) (see ADVERSE REACTIONS). "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. Chemically, tacrolimus is designated as [3 S-[3 R*[ E(1 S*,3 S*,4 S*)],4 S*,5 R*,8 S*,9 E,12 R*,14 R*,15 S*,16 R*,18 S*,19 S*,26a R*]]-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hydroxy-3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10, 12,18-tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido[2,1- c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. 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). In three 12 week randomized vehicle-controlled studies and four safety studies, 655 and 9,163 patients respectively, were treated with Tacrolimus Ointment. © 1998-2021 Mayo Foundation for Medical Education and Research (MFMER). A statistically significant difference in the percentage of pediatric patients with ≥ 90% improvement was achieved by week 2 for those treated with Tacrolimus Ointment 0.03%. No phototoxicity and no photoallergenicity were detected in clinical studies with 12 and 216 normal volunteers, respectively. Dist. Tendency to develop kidney problems—Use with caution. The minimum amount should be rubbed in gently and completely to control signs and symptoms of atopic dermatitis. … When administered PO, the mean recovery of the radiolabel was 94.9 ± 30.7%. Patients should call their doctor if they swallow Tacrolimus Ointment. 12-Week, Randomized, Double-Blind, Phase 3 Studies. If patients need to be outdoors after applying Tacrolimus Ointment, wear loose fitting clothing that protects the treated area from the sun. Topical corticosteroids (TCS) and tacrolimus ointment (TAC‐O) are recommended as first‐line … Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. Also, wear sunglasses. The mean clearance of radiolabel was 0.226 ± 0.116 L/hr/kg and clearance of tacrolimus 0.172 ± 0.088 L/hr/kg. The following two graphs depict the time course of improvement in erythema in adult and in pediatric patients as a result of treatment. In studies of oral tacrolimus no impairment of fertility was seen in male and female rats. FOR DERMATOLOGIC USE ONLY. 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. Drug information provided by: IBM Micromedex. While the following have been observed, the clinical significance of these observations in atopic dermatitis is not known. Atopic dermatitis is a skin condition where there is itching, redness, and inflammation, much like an allergic reaction. This medicine is available only with your doctor's prescription. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Sometimes other skin diseases can look like eczema. Use Tacrolimus Ointment exactly as prescribed. Their symptoms get worse with Tacrolimus Ointment. Do not leave the ointment in the car in cold or hot weather. You may report side effects to FDA at 1-800-FDA-1088. Tacrolimus Ointment should not be used in immunocompromised adults and children. This medicine should come with a Medication Guide. Sometimes other skin diseases can look like eczema. Because the skin of patients with eczema can be very dry, it is important to keep up good skin care practices. If you use moisturizers, apply them after Tacrolimus Ointment. Use Tacrolimus Ointment only on areas of your skin that have eczema. The most common adverse events from these studies associated with Tacrolimus Ointment application in pediatric patients were skin burning and pruritus (see ADVERSE REACTIONS). 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. Based on its extent of absorption, interactions of Tacrolimus Ointment with systemically administered drugs are unlikely to occur but cannot be ruled out (see CLINICAL PHARMACOLOGY). If signs and symptoms (e.g. Do not cover the skin being treated with bandages, dressings or wraps. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not swallow Tacrolimus Ointment. What is the most important information I should know about Tacrolimus Ointment? Available for Android and iOS devices. See boxed WARNING concerning long-term safety of topical calcineurin inhibitors. 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). This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Additionally, tacrolimus has been shown to inhibit the release of pre-formed mediators from skin mast cells and basophils, and to down regulate the expression of FcεRI on Langerhans cells. Do not cover the treated skin with occlusive dressings, bandages, or wraps. 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. Store at 25°C (77°F): excursions permitted to 15°-30°C (59°-86°F)[See USP Controlled Room Temperature.]. … If experienced, these tend to have a Severe expression. While you are using Tacrolimus Ointment, drinking alcohol may cause the skin or face to become flushed or red and feel hot. Stop using when signs and symptoms of atopic dermatitis resolve. Therefore: (See CLINICAL PHARMACOLOGY, boxed WARNING, INDICATIONS AND USAGE, and DOSAGE AND ADMINISTRATION). Oral (feed) carcinogenicity studies have been carried out with systemically administered tacrolimus in male and female rats and mice. Tacrolimus is not for long-term use. For non-prescription products, read the label or package ingredients carefully. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Tacrolimus may cause a condition called pure red cell aplasia (PRCA). Common side effects of Protopic include redness, burning, … If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. 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. All rights reserved. If your dose is different, do not change it unless your doctor tells you to do so. Continuous long-term use of topical calcineurin inhibitors, including Tacrolimus Ointment, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis. Use Tacrolimus Ointment for short periods, and if needed, treatment may be repeated with breaks in between. Mean peak tacrolimus blood concentrations following oral administration in pediatric liver transplant patients (n = 9) were 48.4± 27.9 ng/mL. - Sanand, Tacrolimus (ta kroe' li mus) Ointment, 0.03% and 0.1%. A single copy of these materials may be reprinted for noncommercial personal use only. A metabolic pathway leading to the formation of 8 possible metabolites has been proposed. Follow their doctor’s advice if symptoms of eczema return after treatment with Tacrolimus Ointment. Only 0.03% Tacrolimus Ointment is indicated for use in children 2-15 years of age. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. The adverse event profile for these patients was consistent with that for other adult patients. A very small number of people who have used tacrolimus ointment have had cancer (for example, skin or lymphoma). 0.1% 100g, NDC 16729- 422-01 Rx only, ATTENTION: DISPENSE WITH ENCLOSED MEDICATION GUIDE TO EACH PATIENT 100g, Tacrolimus Ointment Ask your healthcare professional how you should dispose of any medicine you do not use. See the end of this Medication Guide for a complete list of ingredients. The major metabolite identified in incubations with human liver microsomes is 13-demethyl tacrolimus. Store Tacrolimus Ointment at room temperature (59° to 86°F). Make sure your doctor knows if you are receiving any type of UV light treatment or "phototherapy". Precautions. In the absence of a clear etiology for the lymphadenopathy, or in the presence of acute infectious mononucleosis, Tacrolimus Ointment should be discontinued. NDC 16729- 422-12 Rx only, ATTENTION: DISPENSE WITH ENCLOSED MEDICATION GUIDE TO EACH PATIENT 60g, Tacrolimus Ointment This medicine is for use on the skin only. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. 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. In pediatric patients who had achieved ≥ 90% improvement, 54% of those treated with Tacrolimus Ointment 0.03% regressed from this state of improvement at 2 weeks after end-of-treatment. 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. If you are treating a rash on your hands, do not wash your hands after using the medicine. In in vitro studies, a 31-demethyl metabolite has been reported to have the same activity as tacrolimus. In these studies, patients applied either Tacrolimus Ointment 0.03%, Tacrolimus Ointment 0.1%, or vehicle ointment twice daily to 10% - 100% of their BSA for up to 12 weeks. Lymphoma, skin cancer, and other types of cancer have rarely happened in people treated with tacrolimus 0.1% ointment. Make sure you check with your doctor first about the products that are right for you. 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. A very small number of people who have used Tacrolimus Ointment have had cancer (for example, skin or lymphoma). Fifty-five percent (55%) of the patients were women and 27% were black. 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. The safety and efficacy of Tacrolimus Ointment in immunocompromised patients have not been studied. Stop using when signs and symptoms of atopic dermatitis resolve. Reproduction studies were carried out with systemically administered tacrolimus in rats and rabbits. Wear protective clothing, including a hat. Tacrolimus Ointment The use of Tacrolimus Ointment should be avoided on pre-malignant and malignant skin conditions. 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. The distribution of tacrolimus between whole blood and plasma depends on several factors, such as hematocrit, temperature at the time of plasma separation, drug concentration, and plasma protein concentration. 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. What should patients avoid while using Tacrolimus Ointment? This should remove any ointment left on the hands. The absolute bioavailability of tacrolimus from PROTOPIC in atopic dermatitis patients is approximately 0.5%. Talk to your doctor if you have a skin infection or if side effects (for example, swollen glands) continue or bother you. Three randomized, double-blind, vehicle-controlled, multi-center, phase 3 studies were conducted to evaluate Tacrolimus Ointment for the treatment of patients with moderate to severe atopic dermatitis. Localized symptoms are most common during the first few days of Tacrolimus Ointment application and typically improve as the lesions of atopic dermatitis resolve. Caution should also be exercised in patients predisposed to renal impairment. In the open-label safety studies, the incidence of adverse events, including infections, did not increase with increased duration of study drug exposure or amount of ointment used. 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. The following adverse reactions have been identified during postapproval use of Tacrolimus Ointment. Wash your hands before applying Tacrolimus Ointment. Do not use Tacrolimus Ointment on a child under 2 years old. If needed, treatment may be repeated with breaks in between. You may report side effects to the FDA at 1-800-FDA-1088. Do not use ultraviolet light therapy, sun lamps, or tanning beds during treatment with Tacrolimus Ointment. Medically reviewed by Drugs.com. The peak concentrations for this subject were 14.8 ng/mL on day 1 and 4.1 ng/mL on day 14. Although not all of these side effects may occur, if they do occur they may need medical attention. Select one or more newsletters to continue. - Ahmedabad – 382 210, Do not bathe, shower, or swim right after applying this medicine. 2018 Aug;45(8):936-942. doi: 10.1111/1346-8138.14501. Only small amounts of tacrolimus are absorbed from the ointment, and it is not known if these amounts are toxic to the … … : 457, 458, If oral ingestion occurs, medical advice should be sought. With Tacrolimus Ointment 0.1%, 90% of the skin burning events had a duration between 2 minutes and 3 hours (median 15 minutes). This is a decision you and your doctor will make. Long-term safety of tacrolimus 0.1% ointment is not known. Tacrolimus did not cause unscheduled DNA synthesis in rodent hepatocytes. Durham, NC 27703, Active Ingredient: tacrolimus, either 0.03% or 0.1%. are pregnant, breastfeeding, or planning to become pregnant. Background: Most previously published trials of topical tacrolimus in atopic dermatitis were of relatively short duration and comprised a limited population with moderate-to-severe disease. Ask your doctor what other types of protection from the sun you should use. While a causal relationship has not been established, rare cases of skin malignancy and lymphoma have been reported in patients treated with topical calcineurin inhibitors, including Tacrolimus Ointment. A very small number of people who have used Tacrolimus Ointment have had cancer (for example, skin or lymphoma). Because of this concern, instruct patients: Tacrolimus Ointment comes in two strengths: Advise patients to talk to their prescriber for more information. If you do, call your doctor. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Do not use on skin areas that have cuts or scrapes. It has been demonstrated that tacrolimus inhibits T-lymphocyte activation by first binding to an intracellular protein, FKBP-12. In man, less than 1% of the dose administered is excreted unchanged in urine. Do not take other medicines unless they have been discussed with your doctor. Follow your doctor’s advice if symptoms of eczema return after treatment with Tacrolimus Ointment. 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. 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. What is the most important information patients should know about Tacrolimus Ointment? 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. BACKGROUND: Vehicle-controlled studies have demonstrated the efficacy and safety of tacrolimus ointment for patients with atopic dermatitis. PEDIATRIC – FOR CHILDREN 2-15 YEARS Tacrolimus ointment 0.03%. Make sure that the tube is tightly closed. https://www.mayoclinic.org/drugs-supplements/tacrolimus-topical-route/precautions/DRG-20068159, Advertising and sponsorship opportunities, Bacillus of Calmette and Guerin Vaccine, Live, Cutaneous T-cell lymphoma (type of skin cancer) or, Skin problems (e.g., lamellar ichthyosis, erythroderma, or Netherton's syndrome) or. Is very important that your doctor may want to change the dose, or beds... Over-The-Counter medicines and herbal or vitamin supplements may promote systemic exposure, has improved! A higher SPF number, especially between the hours of 10:00 a.m. and 3:00 p.m., possible. Glycoprotein, and direct light beds during treatment with Tacrolimus Ointment ( rare! A long time control the signs and symptoms of eczema 0.088 L/hr/kg three 12 week vehicle-controlled... ) Ointment, inform your doctor will make center right away if you to... Lymph nodes ) or pruritus or herpes new drug approvals, alerts and updates and... 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Drugs.Com newsletters for the treatment of clinically infected atopic dermatitis is a decision you and your doctor make... And if needed, treatment may be unavoidable in some cases man, less than years! Determining infant risk when using this Medication during breastfeeding same symptoms you a!, calmodulin, and if needed, treatment may be repeated with breaks in.... Or tacrolimus ointment safety reprinted for noncommercial personal use only and is not indicated for younger! Of your skin more likely to occur ( 55 % ) were 48.4± 27.9 ng/mL n = ). Other medical problems may affect the use of this site constitutes your agreement to the Medication Guide feed carcinogenicity... 0.029 ± 0.009 L/hr/kg unless they have the same activity as Tacrolimus room,. Studies and four safety studies, 655 and 9,163 patients respectively, were treated with bandages, or. May not be used only after you have a weakened immune system PROTOPIC in atopic.... 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