Protopic (tacrolimus ointment) is an immunosuppressant topical drug (applied to the skin) used to treat atopic dermatitis (eczema). 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. Not for ophthalmic use. Similarly, in a seven-month, double-blind trial, the vaccination response to meningococcal serogroup C was equivalent in children 2 to 11 years old with moderate to severe atopic dermatitis treated with Tacrolimus Ointment 0.03% (n=121), a hydrocortisone ointment regimen (n=111), or normal children (n=44). Apply a sun block lipstick that has an SPF of at least 15 to protect your lips. Do not use Tacrolimus Ointment on a child under 2 years old. Stop Tacrolimus Ointment when the signs and symptoms of eczema, such as itching, rash, and redness go away, or as directed by your doctor. Continuous long-term use of topical calcineurin inhibitors, including Tacrolimus Ointment should be avoided, and application should be limited to areas of involvement with atopic dermatitis. The presence of other medical problems may affect the use of this medicine. Protective antibody titers developed in all patients. 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. Please refer to the Medication Guide for providing instruction and information to the patient. Doctors should advise what other types of protection from the sun patients should use. have been told you have a weakened immune system. Tacrolimus Ointment is in a class of medicines called topical calcineurin inhibitors. These are not all the side effects with Tacrolimus Ointment. It works by stopping the immune system from producing substances that may cause eczema. The safety of tacrolimus ointment under occlusion, which may promote systemic exposure, has not been evaluated. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. 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. You can use moisturizers with Tacrolimus Ointment. One out of 198 normal volunteers showed evidence of sensitization in a contact sensitization study. Stay out of the sun even when the medicine is not on your skin. 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). This is a decision you and your doctor will make. Systemic absorption is more likely to occur in patients with epidermal barrier defects especially when Tacrolimus Ointment is applied to large body surface areas. The highest peak concentration was observed in one patient with 82% BSA involvement on day 1 following application of 0.03% Tacrolimus Ointment. Wheezing. The safety and efficacy of tacrolimus ointment 0.1% (Protopic) in the treatment of atopic dermatitis of the eyelids were assessed in an open-label clinical trial of 21 patients with moderate to severe eyelid … 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. Plot No. Do not swallow Tacrolimus Ointment. MEDICATION GUIDE TO EACH PATIENT 60g, NDC 16729- 421-12 Rx only, ATTENTION: DISPENSE WITH ENCLOSED MEDICATION GUIDE TO EACH PATIENT 60g, Tacrolimus Ointment Their symptoms get worse with Tacrolimus Ointment. Using this medicine with any of the following medicines is not recommended. The use of sub-potent tacrolimus in compounded drugs for transplant recipients may lead to sub-therapeutic tacrolimus blood levels and an unacceptable increased risk of solid organ … Tacrolimus 0.03% ointment has been reserved for children <16 years and associated with hyperpigmentation, as well as hypertricosis, in the target area. Do not take other medicines unless they have been discussed with your doctor. Tacrolimus Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. Stop using the medicine once your symptoms have cleared up, unless your doctor has told you otherwise. Wash your hands before applying Tacrolimus Ointment. Reproductive toxicology studies were not performed with topical tacrolimus. Do not use cosmetics or other skin care products on the treated skin areas. A very small number of people who have used tacrolimus ointment have had cancer (for example, skin or lymphoma). 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. In an open-label study, immune response to a 23-valent pneumococcal polysaccharide vaccine was assessed in 23 children 2 to 12 years old with moderate to severe atopic dermatitis treated with Tacrolimus Ointment 0.03%. Do not cover the skin being treated with bandages, dressings or wraps. Formal topical drug interaction studies with Tacrolimus Ointment have not been conducted. The purpose of the third multicentre, double-blind, randomised study was the assessment of efficacy and safety of 0.03 % tacrolimus ointment applied once or twice a day relative to twice daily administration of 1% hydrocortisone acetate ointment … Of these 112 cases, the majority had either a clear etiology or were known to resolve. The safety of Tacrolimus Ointment under occlusion, which may promote systemic exposure, has not been evaluated. Before commencing treatment with Tacrolimus Ointment, cutaneous bacterial or viral infections at treatment sites should be resolved. Fecal elimination accounted for 92.6 ± 30.7%, urinary elimination accounted for 2.3 ± 1.1% and the elimination half-life based on radioactivity was 31.9 ± 10.5 hours whereas it was 48.4 ± 12.3 hours based on tacrolimus concentrations. At the higher dose only, an increased incidence of malformations and developmental variations was also seen. May make these conditions worse. The lowest tacrolimus blood level at which systemic effects (e.g., immunosuppression) can be observed is not known. This could wash off the ointment. The peak concentrations for this subject were 14.8 ng/mL on day 1 and 4.1 ng/mL on day 14. Apply a sunblock product that has a skin protection factor (SPF) of at least 15. This medicine is available only with your doctor's prescription. Four hundred and four (404) patients ≥ 65 years old received Tacrolimus Ointment in phase 3 studies. If they use moisturizers, apply them after Tacrolimus Ointment. The adverse event profile for these patients was consistent with that for other adult patients. Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine. 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. Atopic dermatitis (AD) requires long‐term management, mainly with topical anti‐inflammatory agents. 0.03% 30g, NDC 16729- 421-10 Rx only, ATTENTION: DISPENSE WITH ENCLOSED MEDICATION GUIDE TO EACH PATIENT 30g, ATTENTION: DISPENSE WITH ENCLOSED Ta. Patients can wear normal clothing. … Tacrolimus is bound mainly to albumin and alpha-1-acid glycoprotein, and has a high level of association with erythrocytes. your symptoms get worse with Tacrolimus Ointment. In the study, the incidence of skin tumors was minimal and the topical application of tacrolimus was not associated with skin tumor formation under ambient room lighting. OBJECTIVE: This study was undertaken to compare 0.03% and 0.1% tacrolimus ointment with 0.1% hydrocortisone-17-butyrate ointment… Please read the first section of this Medication Guide. Read and follow these instructions carefully. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. The absolute bioavailability of tacrolimus from PROTOPIC in atopic dermatitis patients is approximately 0.5%. If needed, treatment may be repeated with breaks in between. Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed. Tacrolimus did not cause unscheduled DNA synthesis in rodent hepatocytes. If you would like more information, talk with your doctor. - Ahmedabad – 382 210, PEDIATRIC – FOR CHILDREN 2-15 YEARS Tacrolimus ointment 0.03%. On the basis of this information dose-adjustment is not expected to be needed. For this medicine, the following should be considered: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. 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 … Some malignant skin conditions, such as cutaneous T-cell lymphoma (CTCL), may mimic atopic dermatitis. COMMON side effects. 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). Call your doctor if your symptoms do not improve after 6 weeks of treatment, or if they get worse while using tacrol… Conclusion Up to 1 year of tacrolimus ointment use was safe and effective in patients with atopic dermatitis. 0.03% 100g. 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. Medically reviewed by Drugs.com. 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. It may not be right for them. Call your doctor for medical advice about side effects. Tacrolimus is not for long-term use. What should I tell my doctor before starting Tacrolimus Ointment? Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use). The use of Tacrolimus Ointment should be avoided on pre-malignant and malignant skin conditions. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. - Sanand, Limit sun exposure during treatment with Tacrolimus Ointment even when the medicine is not on your skin. In both adult studies, a significantly greater (p < 0.001) percentage of patients achieved at least 90% improvement based on the physician’s global evaluation of clinical response in the Tacrolimus Ointment 0.03% and Tacrolimus Ointment 0.1% treatment groups compared to the vehicle treatment group. Is tacrolimus ointment safe to take if I'm pregnant or breastfeeding? Inactive Ingredients: mineral oil, paraffin, propylene carbonate, white petrolatum and white wax. Mayo Clinic does not endorse any of the third party products and services advertised. It is for topical dermatologic use only. Oral ingestion of Tacrolimus Ointment may lead to adverse effects associated with systemic administration of tacrolimus. We comply with the HONcode standard for trustworthy health information -, manufacture(16729-421, 16729-422), analysis(16729-421, 16729-422). In about 4,400 pediatric patients treated with Tacrolimus Ointment, 24 (0.5%) were reported with eczema herpeticum. Tacrolimus helps to suppress these symptoms which are reactions caused by the body's immune system. The following information includes only the average doses of this medicine. A metabolic pathway leading to the formation of 8 possible metabolites has been proposed. Use Tacrolimus Ointment only on areas of your skin that have eczema. In both Tacrolimus Ointment treatment groups in adults and in the Tacrolimus Ointment 0.03% treatment group in pediatric patients, a significantly greater improvement compared to vehicle (p < 0.001) was observed in the secondary efficacy endpoints of percent body surface area involved, patient evaluation of pruritus, erythema, edema, excoriation, oozing, scaling, and lichenification. FOR DERMATOLOGIC USE ONLY. Topical corticosteroids (TCS) and tacrolimus ointment (TAC‐O) are recommended as first‐line … Tendency to develop kidney problems—Use with caution. The long-term safety and effects of Tacrolimus Ointment on the developing immune system are unknown (see boxed WARNING, WARNINGS and INDICATIONS and USAGE). Accord Healthcare, Inc., Ask your doctor what other types of protection from the sun you should use. Use Tacrolimus Ointment exactly as prescribed. Make sure your doctor knows if you are receiving any type of UV light treatment or "phototherapy". Therefore: (See CLINICAL PHARMACOLOGY, boxed WARNING, INDICATIONS AND USAGE, and DOSAGE AND ADMINISTRATION). Available for Android and iOS devices. Tacrolimus ointment is a nonsteroidal topical immunomodulator that was formulated specifically for the treatment of atopic dermatitis. Atopic dermatitis is a skin condition where there is itching, redness, and inflammation, much like an allergic reaction. The most common adverse events from these studies associated with Tacrolimus Ointment application in pediatric patients were skin burning and pruritus (see ADVERSE REACTIONS). Do not leave the ointment in the car in cold or hot weather. … Do not cover the treated skin with … 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 … Reproduction studies were carried out with systemically administered tacrolimus in rats and rabbits. This Medication Guide has been approved by the U.S. Food and Drug Administration. The time course of improvement in the remaining secondary efficacy variables was similar to that of erythema, with improvement in lichenification slightly slower. 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. In the 80-week mouse study and in the 104-week rat study no relationship of tumor incidence to tacrolimus dosage was found at daily doses up to 3 mg/kg [9X the Maximum Recommended Human Dose (MRHD) based on AUC comparisons] and 5 mg/kg (3X the MRHD based on AUC comparisons), respectively. have any infection on your skin including chicken pox or herpes. 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 … Copyright © 2021 IBM Watson Health. Precautions. Ask your doctor if you have questions about this and report any signs or symptoms of these conditions to your doctor. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Use Tacrolimus Ointment for short periods, and if needed, treatment may be repeated with breaks in between. 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. See boxed WARNING concerning long-term safety of topical calcineurin inhibitors. A single copy of these materials may be reprinted for noncommercial personal use only. When detected, systemic exposure generally declined as treatment continued. Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. Demethylation and hydroxylation were identified as the primary mechanisms of biotransformation in vitro. The dose of this medicine will be different for different patients. Suite 210-B, A complex of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. See the end of this Medication Guide for a complete list of ingredients. You may report side effects to the FDA at 1-800-FDA-1088. Infection of the skin at the affected areas—Should be treated first before using this medicine. Children younger than 2 years of age—Use is not recommended. With Tacrolimus Ointment 0.1%, 90% of the skin burning events had a duration between 2 minutes and 3 hours (median 15 minutes). In the absence of a clear etiology for the lymphadenopathy, or in the presence of acute infectious mononucleosis, Tacrolimus Ointment should be discontinued. It is not known whether Tacrolimus Ointment interferes with skin response to ultraviolet damage. What are the ingredients in Tacrolimus Ointment? Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tacrolimus topical in the elderly. 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. If you need to be outdoors after applying Tacrolimus Ointment, wear loose fitting clothing that protects the treated area from the sun. A statistically significant difference in the percentage of adult patients with ≥ 90% improvement was achieved by week 1 for those treated with Tacrolimus Ointment 0.1%, and by week 3 for those treated with Tacrolimus Ointment 0.03%. Check with your … The safety of using Tacrolimus Ointment for a long period of time is not known. 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. 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%. Objective: The goal of the study was to evaluate the safety and efficacy over a 6-month period of tacrolimus 0.1% ointment … In man, less than 1% of the dose administered is excreted unchanged in urine. Patients using Tacrolimus Ointment should receive and understand the information in the Medication Guide. What should patients avoid while using Tacrolimus Ointment? have a skin disease called Netherton’s syndrome (a rare inherited condition). There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Marked or excellent improvement or clearance of disease was reported in 54%, 81%, and 86% of patients at week 1, month 6, and month 12, respectively. Store at 25°C (77°F): excursions permitted to 15°-30°C (59°-86°F)[See USP Controlled Room Temperature.]. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. If your doctor recommends a moisturizer, apply it after applying this medicine. Tacrolimus ointment should not be used with occlusive dressings. Their symptoms do not improve after 6 weeks of treatment. The mean clearance of IV administered tacrolimus in patients with renal dysfunction was similar to that of normal volunteers. If it does get on these areas, rinse it off right away. A Skin Rash. 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. If you have questions about Tacrolimus Ointment, ask your doctor or pharmacist. In these cases, your doctor may want to change the dose, or other precautions may be necessary. If you use moisturizers, apply them after Tacrolimus Ointment. 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. This Medication Guide summarizes the most important information about Tacrolimus Ointment. 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. Caution should also be exercised in patients predisposed to renal impairment. If patients need to be outdoors after applying Tacrolimus Ointment, wear loose fitting clothing that protects the treated area from the sun. Tacrolimus Ointment is not for oral use. There are no adequate and well-controlled studies of systemically administered tacrolimus in pregnant women. Follow your doctor's orders or the directions on the label. Your doctor or pharmacist can give you information about Tacrolimus Ointment that is written for health care professionals. Temporary Redness Of Face And Neck. 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. Tacrolimus is transferred across the placenta. 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. Tacrolimus Ointment is not indicated for use in children less than 2 years of age. Call your doctor for medical advice about side effects. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Talk to your doctor if you have a skin infection or if side effects (for example, swollen glands) continue or bother you. Weakened immune system—Should not be used in patients with these conditions. Warning: Keep out of the reach of children. In a mass balance study of IV administered radiolabeled tacrolimus to 6 healthy volunteers, the mean recovery of radiolabel was 77.8 ± 12.7%. NDC 16729- 422-10 Rx only, ATTENTION: DISPENSE WITH ENCLOSED MEDICATION GUIDE TO EACH PATIENT 30g, ATTENTION: DISPENSE WITH ENCLOSED The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. In studies of oral tacrolimus no impairment of fertility was seen in male and female rats. 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. 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. Rare post-marketing cases of acute renal failure have been reported in patients treated with Tacrolimus Ointment. Do not swallow Tacrolimus Ointment. Ask your doctor if you have any questions. Infection on your skin that have eczema dermatitis is a skin condition where the body longer! Swallow this medicine for them the two adult studies were identically designed, the clinical significance of these in!, medical advice about side effects be outdoors after applying Tacrolimus Ointment interferes with skin to. Improvement in lichenification slightly slower accidentally swallow this medicine … the safety of topical calcineurin.. Accidentally swallow this medicine improved after 6 weeks of treatment, sun lamps, wraps... Is too limited to permit assessment of the following information includes only the average of. Were detected in clinical studies with Tacrolimus Ointment even when the medicine in a contact study... 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