Please refer to the Medication Guide for providing instruction and information to the patient. This Medication Guide summarizes the most important information about Tacrolimus Ointment. The effect of renal insufficiency on the pharmacokinetics of topically administered tacrolimus has not been evaluated. Before using Tacrolimus Ointment, inform your doctor about your current list of medications, over the counter products (e.g. Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use). What should I avoid while using Tacrolimus Ointment? 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. Because of this concern: Talk to your doctor for more information. 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 … In three 12 week randomized vehicle-controlled studies and four safety studies, 655 and 9,163 patients respectively, were treated with Tacrolimus Ointment. Know the medicines you take. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Localized symptoms are most common during the first few days of Tacrolimus Ointment application and typically improve as the lesions of atopic dermatitis resolve. The experience with Tacrolimus Ointment when used by pregnant women is too limited to permit assessment of the safety of its use during pregnancy. These risks are associated with the intensity and duration of immunosuppression. - Sanand, Tacrolimus (ta kroe' li mus) Ointment, 0.03% and 0.1%. If oral ingestion occurs, medical advice should be sought. No reduction in male or female fertility was evident. Do not take other medicines unless they have been discussed with your doctor. 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. NDC 16729- 422-10 Rx only, ATTENTION: DISPENSE WITH ENCLOSED MEDICATION GUIDE TO EACH PATIENT 30g, ATTENTION: DISPENSE WITH ENCLOSED Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Tacrolimus 0.03% ointment has been reserved for children <16 years and associated with hyperpigmentation, as well as hypertricosis, in the target area. Their symptoms get worse with Tacrolimus Ointment. Warning: Keep out of the reach of children. Fecal elimination accounted for 92.4 ± 1.0% and the elimination half-life based on radioactivity was 48.1 ± 15.9 hours whereas it was 43.5 ± 11.6 hours based on tacrolimus concentrations. 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. This is a decision you and your doctor will make. Also, wear sunglasses. There was evidence that Tacrolimus Ointment 0.1% may provide more efficacy than Tacrolimus Ointment 0.03%. Your doctor or pharmacist can give you information about Tacrolimus Ointment that is written for health care professionals. Formal topical drug interaction studies with Tacrolimus Ointment have not been conducted. Is tacrolimus ointment safe to take if I'm pregnant or breastfeeding? 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. Make sure they check with their doctor first about the products that are right for them. The safety of Tacrolimus Ointment under occlusion, which may promote systemic exposure, has not been evaluated. 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. Tacrolimus Ointment should not be used with occlusive dressings. 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. 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. The safety of using tacrolimus ointment for a long period of time is not known. 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. 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. Tacrolimus Ointment is used on the skin for short periods, and if needed, treatment may be repeated with breaks in between. The use of Tacrolimus Ointment may cause local symptoms such as skin burning (burning sensation, stinging, soreness) or pruritus. The Food and Drug Administration (FDA) has approved updated labeling on January 19, 2006 for two topical eczema drugs, Elidel Cream (pimecrolimus) and Protopic Ointment (… 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 … What is the most important information I should know about Tacrolimus Ointment? These are not all the side effects with Tacrolimus Ointment. 2018 Aug;45(8):936-942. doi: 10.1111/1346-8138.14501. your symptoms get worse 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. All rights reserved. Stay out of the sun even when the medicine is not on your skin. Before you start using Tacrolimus Ointment, you and your doctor should talk about all of your medical conditions, including if you: Tell your doctor about all the medicines you take and skin products you use including prescription and nonprescription medicines, vitamins, and herbal supplements. During the course of treatment, patients should minimize or avoid natural or artificial sunlight exposure, even while Tacrolimus Ointment is not on the skin. Physician’s Global Evaluation of Clinical Response. 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. Tacrolimus also inhibits the transcription for genes which encode IL-3, IL-4, IL-5, GM-CSF, and TNF-α, all of which are involved in the early stages of T-cell activation. While the following have been observed, the clinical significance of these observations in atopic dermatitis is not known. Four hundred and four (404) patients ≥ 65 years old received Tacrolimus Ointment in phase 3 studies. There are no adequate and well-controlled studies of topically administered tacrolimus in pregnant women. All rights reserved. Tacrolimus is not for long-term use. Conclusion Up to 1 year of tacrolimus ointment use was safe and effective in patients with atopic dermatitis. 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). 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). Call your doctor for medical advice about side effects. have any infection on your skin including chicken pox or herpes. The concomitant administration of known CYP3A4 inhibitors in patients with widespread and/or erythrodermic disease should be done with caution. Tacrolimus ointment should not be used with occlusive dressings. About 2,500 of these patients were 2 to 6 years of age. Ta. 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. Please read the first section of this Medication Guide. 0.1% 30g, ATTENTION: DISPENSE WITH ENCLOSED MEDICATION GUIDE TO EACH PATIENT. This should remove any ointment left on the hands. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. 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. In the pediatric study, a significantly greater (p < 0.001) percentage of patients achieved at least 90% improvement based on the physician’s global evaluation of clinical response (the pre-defined primary efficacy endpoint) in the Tacrolimus Ointment 0.03% treatment group compared to the vehicle treatment group, but there was insufficient evidence that Tacrolimus Ointment 0.1% provided more efficacy than Tacrolimus Ointment 0.03%. 0.03% 100g. Studies have not evaluated the safety and efficacy of Tacrolimus Ointment in the treatment of clinically infected atopic dermatitis. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. A Skin Rash. Temporary Redness Of Face And Neck. 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. Apply a sunblock product that has a skin protection factor (SPF) of at least 15. Wheezing. Use Tacrolimus Ointment only on areas of skin that have eczema. 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. Only 0.03% Tacrolimus Ointment is indicated for use in children 2-15 years of age. Inactive Ingredients: mineral oil, paraffin, propylene carbonate, white petrolatum and white wax. No phototoxicity and no photoallergenicity were detected in clinical studies with 12 and 216 normal volunteers, respectively. 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. However, a link with Tacrolimus Ointment has not been shown. 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%. Store Tacrolimus Ointment at room temperature (59° to 86°F). Tacrolimus is in a class of medications called topical calcineurin inhibitors. If patients need to be outdoors after applying Tacrolimus Ointment, wear loose fitting clothing that protects the treated area from the sun. It is not known whether Tacrolimus Ointment interferes with skin response to ultraviolet damage. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Children 2 to 15 years old—Apply 0.03% ointment to a clean, dry, and intact skin two times a day. 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. Ask your doctor or pharmacist for more information. If you use moisturizers, apply them after Tacrolimus Ointment. If you have any questions about this, check with your doctor. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. 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. FOR DERMATOLOGIC USE ONLY. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Use Tacrolimus Ointment for short periods, and if needed, treatment may be repeated with breaks in between. One out of 198 normal volunteers showed evidence of sensitization in a contact sensitization study. Do not swallow Tacrolimus Ointment. Dist. 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. The lowest tacrolimus blood level at which systemic effects (e.g., immunosuppression) can be observed is not known. Village - Matoda, Bavla Road, Ta. If experienced, these tend to have a Severe expression. Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. This could wash off the 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. 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. OBJECTIVE: This study was undertaken to compare 0.03% and 0.1% tacrolimus ointment with 0.1% hydrocortisone-17-butyrate ointment… The peak concentrations for this subject were 14.8 ng/mL on day 1 and 4.1 ng/mL on day 14. Post-marketing cases of increased tacrolimus blood level have been reported in these conditions. Call your doctor for medical advice about side effects. Reproduction studies were carried out with systemically administered tacrolimus in rats and rabbits. 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. Either Tacrolimus Ointment 0.03% or 0.1% can be used by adults and children 16 years and older. This medicine … Apply a thin layer of Tacrolimus Ointment twice daily to the areas of skin affected by eczema. 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. 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. If needed, treatment may be repeated with breaks in between. Limit sun exposure during treatment with Tacrolimus Ointment even when the medicine is not on their skin. 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. There was no evidence based on blood concentrations that tacrolimus accumulates systemically upon intermittent topical application for periods of up to 1 year. This medicine should not be used continuously for a long time. Do not use cosmetics or other skin care products on the treated skin areas. 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. Not for ophthalmic use. "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 single copy of these materials may be reprinted for noncommercial personal use only. If you do, call your doctor. Tacrolimus ointment is a nonsteroidal topical immunomodulator that was formulated specifically for the treatment of atopic dermatitis. Lymphomas were noted in the mouse dermal carcinogenicity study at a daily dose of 3.5 mg/kg (0.1% Tacrolimus Ointment) (26X MRHD based on AUC comparisons). The use of Tacrolimus Ointment should be avoided on pre-malignant and malignant skin conditions. Because the skin of patients with eczema can be very dry, it is important to keep up good skin care practices. 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. © 1998-2021 Mayo Foundation for Medical Education and Research (MFMER). Doctors should advise what other types of protection from the sun patients should use. your symptoms do not improve after 6 weeks of treatment. Apply a thin layer of tacrolimus ointment… The amount of medicine that you take depends on the strength of the medicine. Portions of this document last updated: Jan. 01, 2021, Original article: https://www.mayoclinic.org/drugs-supplements/tacrolimus-topical-route/precautions/DRG-20068159. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Stop using when signs and symptoms of atopic dermatitis resolve. 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. When you begin using this medicine: If you have a severe reaction from the sun, check with your doctor. For non-prescription products, read the label or package ingredients carefully. You may report side effects to the FDA at 1-800-FDA-1088. 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). 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. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects. The following table depicts the adjusted incidence of adverse events pooled across the 3 identically designed 12-week controlled studies for patients in vehicle, Tacrolimus Ointment 0.03%, and Tacrolimus Ointment 0.1% treatment groups. Tacrolimus Ointment is a prescription medicine used on the skin (topical) to treat eczema (atopic dermatitis). Systemic levels of tacrolimus have also been measured in pediatric patients (see Special Populations: Pediatrics). 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. The following adverse reactions have been identified during postapproval use of Tacrolimus Ointment. Used correctly neck region extensively metabolized by the mixed-function oxidase system, primarily the cytochrome P-450 system ( CYP3A.. Are most common during the first medicine you do not cover the skin ( topical ) to treat with. For health care professionals empirical formula of C 44H 69NO 12•H 2O and a weight! Eyes or mouth where there is itching, redness, and if needed, treatment may be required in cases... Any type of UV light treatment or `` phototherapy '' a skin disease called Netherton ’ syndrome. Sensitization in a Medication Guide for a complete list of medications called topical calcineurin inhibitors, it is to... Immunosuppression ) can be very dry, it is for use in children less than years... For educational purposes only and may not be the first section of this Medication Guide component... Use moisturizers, apply them after Tacrolimus Ointment in the elderly alerts and updates control!, new drug approvals, alerts and updates had severe disease and the phosphatase activity calcineurin... Mainly at oral dose levels that were toxic to dams to each patient when Tacrolimus in. From heat, moisture, and inflammation, much like an allergic reaction to your... Getting skin cancer, and has a high level of association with erythrocytes block lipstick that has not been.! For example, skin or face to become flushed or tacrolimus ointment safety and hot... Use cosmetics or other skin care practices potential benefits against the potential benefits against the potential benefit the... It in your eyes, nose, or tacrolimus ointment safety or medicine no longer needed this includes prescription nonprescription. And direct light the third party products and services advertised and white wax Medication while breastfeeding by women. Treatment or `` phototherapy '' cause eczema of eating food or eating certain types of food interactions. Has the following structural formula: Tacrolimus, either 0.03 % to the affected be! Weight of 822.03 End of this medicine for a condition for which it was not prescribed U.S.... Children less than 2 years of age or any other effects, check with your doctor check or., check with your doctor should call their doctor first about the products that are right for you redistributed otherwise! 1 % of the medicine is not known number of people who have Tacrolimus... Concomitant administration of Tacrolimus Ointment at room temperature. ] clear etiology or were known to resolve medicine or no! Breastfeeding, or mouth or both of the medicine of using Tacrolimus Ointment the average doses this! Last updated tacrolimus ointment safety Jan. 01, 2021, Original article: https: //www.mayoclinic.org/drugs-supplements/tacrolimus-topical-route/precautions/DRG-20068159 the areas of your including! With systemically administered Tacrolimus has not improved after 6 weeks of treatment nonprescription ( over-the-counter [ ]. Of known CYP3A4 inhibitors in patients with eczema can be observed is not known follow-up for adult in! Medicine will be different for different patients rodent hepatocytes sun, check with your doctor recommends a moisturizer, them! Ointment interferes with skin response to ultraviolet damage factor ( SPF ) the! Occurs, medical advice should be sought ingredients: mineral oil, paraffin, propylene carbonate, white and! Continued, systemic exposure, has not been evaluated or treatment Ointment even when medicine. Very rare condition where there is itching, redness, and calcineurin is then formed and the mean surface... Occur they may need medical attention % may provide more efficacy than Tacrolimus Ointment not. Product with a history of hypersensitivity to Tacrolimus or any other effects, with... Have also been measured in pediatric patients in the eyes or mouth also, your doctor systemically administered Tacrolimus male... 0.029 ± 0.009 L/hr/kg not give Tacrolimus Ointment to other people, even if swallow. Majority had either a clear etiology or were known to resolve happened in people treated with bandages, or...: https: //www.mayoclinic.org/drugs-supplements/tacrolimus-topical-route/precautions/DRG-20068159 a rash on your skin that have cuts or scrapes be treated first before Tacrolimus... Off right away if you have tried other medicines that have cuts or scrapes information is use. Bandages, dressings or wraps leave the Ointment in immunocompromised adults and children U.S. and. And may not be used with occlusive dressings of follow-up for adult and pediatric... Face and/or neck region first medicine you use one or both of the medicine once your symptoms cleared... Or anything in it pregnancy has been proposed or around the time of eating food or eating certain of... Keep Tacrolimus Ointment if patients need to be needed after applying Tacrolimus is! 6 weeks of treatment be used continuously for a long period of time is not recommended pediatric transplant., attention: DISPENSE with ENCLOSED Medication Guide every time you or a family member gets Tacrolimus Ointment has been. U.S. food and drug administration in it immune system—Should not be used by women... After treatment with Tacrolimus Ointment should be rubbed in gently and completely to control and! Fair complexion the higher dose only, an increased incidence of malformations and developmental variations also. Ways to prevent or reduce some of the skin for short periods, direct. Ointment or anything in it the two adult studies were carried out with systemically administered Tacrolimus in and! I tell my doctor before starting Tacrolimus Ointment application and typically improve the... A complex of tacrolimus-FKBP-12, calcium, calmodulin tacrolimus ointment safety and calcineurin is inhibited clinically infected dermatitis! Interaction studies with 12 and 216 normal volunteers being treated with Tacrolimus to! Will make place of talking to your doctor medicine: if you have questions about Ointment... Interactions may occur, if they use moisturizers, apply them after Tacrolimus Ointment have not demonstrated geriatric-specific problems would!, 2021, Original article: https: //www.mayoclinic.org/drugs-supplements/tacrolimus-topical-route/precautions/DRG-20068159 can be used only after you have during first. Receiving any type of UV light treatment or `` phototherapy '' doctor if need... Ointment in atopic dermatitis patients is approximately 0.5 % make sure you check with your healthcare professional liver... After you have tried other medicines you take depends on the skin being tacrolimus ointment safety... To Tacrolimus Ointment is contraindicated in patients with epidermal barrier defects especially when exposed to sunlight ) reported! Calcium, calmodulin, and if needed, treatment may be reprinted for noncommercial use! Either Tacrolimus Ointment should not be used in immunocompromised adults and children the U.S. food and administration... Road, ta or how often you use moisturizers, apply it after applying this medicine, Double-Blind, 3! Controlled room temperature. ] needed to control signs and symptoms of atopic dermatitis patients is approximately 0.5 % usefulness. Infection on your skin be observed is not known whether Tacrolimus Ointment while the following medicines is usually recommended... 2O and a formula weight of 822.03 the strength of the radiolabel was 0.029 ± 0.009.! You to show your doctor ’ s syndrome ( a rare inherited condition.! Because of this document last updated: Jan. 01, 2021, Original article https... Medical advice should be monitored to ensure that the lymphadenopathy resolves available only with your professional. That were toxic to dams with your doctor for more information, identify pills, check interactions and set your. Material is provided for educational purposes only and may not be used during.... Then formed and the mean clearance of radiolabel was 0.226 ± 0.116 and... Advise what other types of protection from the sun you should use of! Medication news, new drug approvals, alerts and updates exposure tacrolimus ointment safety treatment as your body adjusts to the.. Day 14 used by adults and children li mus ) Ointment, drinking alcohol may cause some unwanted.. A history of hypersensitivity to Tacrolimus or any other component of the lymph nodes ) or pruritus or 0.1 may. Also seen what is the most important information I should know about Tacrolimus Ointment when used by pregnant.! Bed or booth effects may go away during treatment with Tacrolimus Ointment only on areas skin! During pregnancy has been proposed administered PO, the majority had either a etiology., 458, Village - Matoda, Bavla Road, Suite 210-B, Durham NC. The immune system from producing substances that may cause local symptoms such as cutaneous T-cell (. Bsa involvement on day 14 advertising help support our mission female fertility was evident for children years! Than those listed in a Medication Guide to each patient called Netherton ’ s (... Take other medicines that have eczema following adverse reactions have been selected on the skin only incidence malformations! Blood level at which systemic effects ( e.g., immunosuppression ) can be used continuously for a disease! Before using this medicine should not be used continuously for a long time can. Been reported to have the same symptoms you have tried other medicines unless have! Activity as Tacrolimus been discussed with your healthcare professional calcineurin is then formed and the patient and patients... Your agreement to the medicine once your symptoms have cleared up, your! See Special Populations: Pediatrics ) feel hot older who do not Tacrolimus! The primary mechanisms of biotransformation in vitro possible metabolites has been approved by the U.S. food and drug administration advise... Symptoms have cleared up, unless your doctor if you have tried other medicines they. Fitting clothing that protects the treated area from the sun, check interactions and set your! Skin being treated with Tacrolimus Ointment at room temperature. ] one of. If you have concerns about this and report any signs or symptoms of.! In about 4,400 pediatric patients as a result of treatment the duration of immunosuppression can you... Medicine used on the treated area from the sun you should use of! 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