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. A very small number of people who have used tacrolimus ointment have had cancer (for example, skin or lymphoma). Check with your … Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed. 0.03% 100g. Warning: Keep out of the reach of children. 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. "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. Background: Vehicle-controlled studies have demonstrated the efficacy and safety of tacrolimus ointment for patients with atopic dermatitis.Objective: This study was undertaken to compare 0.03% and 0.1% tacrolimus ointment with 0.1% hydrocortisone-17-butyrate ointment… Not for ophthalmic use. It is for topical dermatologic use only. 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. Do not swallow Tacrolimus Ointment. The most common adverse events from these studies associated with Tacrolimus Ointment application in pediatric patients were skin burning and pruritus (see ADVERSE REACTIONS). Along with its needed effects, a medicine may cause some unwanted effects. © 1998-2021 Mayo Foundation for Medical Education and Research (MFMER). Your doctor or pharmacist can give you information about Tacrolimus Ointment that is written for health care professionals. 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. 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. However, a link with Tacrolimus Ointment has not been shown. Make sure your doctor knows if you are receiving any type of UV light treatment or "phototherapy". Do not use Tacrolimus Ointment on a child under 2 years old. The use of systemically administered tacrolimus during pregnancy has been associated with neonatal hyperkalemia and renal dysfunction. Conclusion Up to 1 year of tacrolimus ointment use was safe and effective in patients with atopic dermatitis. Please refer to the Medication Guide for providing instruction and information to the patient. A Skin Rash. When administered PO, the mean recovery of the radiolabel was 94.9 ± 30.7%. No phototoxicity and no photoallergenicity were detected in clinical studies with 12 and 216 normal volunteers, respectively. FOR DERMATOLOGIC USE ONLY. 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. Topical corticosteroids (TCS) and tacrolimus ointment (TAC‐O) are recommended as first‐line … The use of Tacrolimus Ointment should be avoided on pre-malignant and malignant skin conditions. Long-term safety of tacrolimus 0.1% ointment is not known. Mayo Clinic does not endorse any of the third party products and services advertised. Only Tacrolimus Ointment 0.03% is for use on children aged 2 to 15 years. Tacrolimus Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. This medicine should not be used continuously for a long time. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. PEDIATRIC – FOR CHILDREN 2-15 YEARS Tacrolimus ointment 0.03%. There are no adequate and well-controlled studies of systemically administered tacrolimus in pregnant women. If patients need to be outdoors after applying Tacrolimus Ointment, wear loose fitting clothing that protects the treated area from the sun. What are the ingredients in Tacrolimus Ointment? In the absence of a clear etiology for the lymphadenopathy, or in the presence of acute infectious mononucleosis, Tacrolimus Ointment should be discontinued. 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. These are not all the side effects with Tacrolimus Ointment. Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use). This medicine is for use on the skin only. Tacrolimus, at oral doses of 3.2 mg/kg during organogenesis in rats, was associated with maternal toxicity and caused an increase in late resorptions, decreased numbers of live births, and decreased pup weight and viability. If needed, treatment may be repeated with breaks in between. If they use moisturizers, apply them after Tacrolimus Ointment. 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. Using this medicine with any of the following medicines is not recommended. Protopic (tacrolimus ointment) is an immunosuppressant topical drug (applied to the skin) used to treat atopic dermatitis (eczema). The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. The most common side effects of Tacrolimus Ointment at the skin application site are stinging, burning, or itching of the skin treated with Tacrolimus Ointment. Oral application is also not recommended. 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. Fifty-five percent (55%) of the patients were women and 27% were black. Over 80% of patients had atopic dermatitis affecting the face and/or neck region. 0.1% 30g, ATTENTION: DISPENSE WITH ENCLOSED MEDICATION GUIDE TO EACH PATIENT. 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%. If you would like more information, talk with your doctor. Ask your doctor what other types of protection from the sun you should use. It works by stopping the immune system from producing substances that may cause eczema. In general as treatment continued, systemic exposure declined as the skin returned to normal. Localized symptoms are most common during the first few days of Tacrolimus Ointment application and typically improve as the lesions of atopic dermatitis resolve. If you have questions about Tacrolimus Ointment, ask your doctor or pharmacist. Call a doctor or poison control center right away if you accidentally swallow this medicine. The adverse event profile for these patients was consistent with that for other adult patients. Available for Android and iOS devices. If you need to be outdoors after applying Tacrolimus Ointment, wear loose fitting clothing that protects the treated area from the sun. 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. Patients should call their doctor if they swallow Tacrolimus Ointment. The safety of using tacrolimus ointment for a long period of time is not known. Keep a list of them with you to show your doctor and pharmacist each time you get a new medicine. - Ahmedabad – 382 210, If you notice any other effects, check with your healthcare professional. While the following have been observed, the clinical significance of these observations in atopic dermatitis is not known. Children younger than 2 years of age—Use is not recommended. Lymphoma, skin cancer, and other types of cancer have rarely happened in people treated with tacrolimus 0.1% ointment. 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 leave the ointment in the car in cold or hot weather. 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. Use Tacrolimus Ointment only on areas of skin that have eczema. 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. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. It is not known whether Tacrolimus Ointment interferes with skin response to ultraviolet damage. 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%. 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%. 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. 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. You may report side effects to the FDA at 1-800-FDA-1088. 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. This is to make sure the medicine is working properly and to check for unwanted effects. Wash your hands before applying Tacrolimus Ointment. 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. Response rates for each treatment group are shown below by age groups. Apply a thin layer of Tacrolimus Ointment to the affected skin twice daily. Drug information provided by: IBM Micromedex. Wear protective clothing, including a hat. The absolute bioavailability of tacrolimus from Tacrolimus Ointment in atopic dermatitis patients is approximately 0.5%. 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. Children 2 to 15 years old—Apply 0.03% ointment to a clean, dry, and intact skin two times a day. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. 0.03% 30g, NDC 16729- 421-10 Rx only, ATTENTION: DISPENSE WITH ENCLOSED MEDICATION GUIDE TO EACH PATIENT 30g, ATTENTION: DISPENSE WITH ENCLOSED 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. 12,10,31 In In adult patients, treatment with tacrolimus 0.03% yielded similar results to tacrolimus ointment … The amount of medicine that you take depends on the strength of the medicine. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. Do not cover the skin being treated with bandages, dressings or wraps. There was evidence that Tacrolimus Ointment 0.1% may provide more efficacy than Tacrolimus Ointment 0.03%. Tacrolimus Ointment is not indicated for use in children less than 2 years of age. itch, rash, and redness) do not improve within 6 weeks, patients should be re-examined by their healthcare provider to confirm the diagnosis of atopic dermatitis. Studies have not evaluated the safety and efficacy of Tacrolimus Ointment in the treatment of clinically infected atopic dermatitis. The minimum amount should be rubbed in gently and completely to control signs and symptoms of atopic dermatitis. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. 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. 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). 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 both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. What should I avoid while using Tacrolimus Ointment? 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 plasma protein binding of tacrolimus is approximately 99% and is independent of concentration over a range of 5-50 ng/mL. have a skin disease called Netherton’s syndrome (a rare inherited condition). This product is available in the following dosage forms: In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. Is tacrolimus ointment safe to take if I'm pregnant or breastfeeding? There was no evidence based on blood concentrations that tacrolimus accumulates systemically upon intermittent topical application for periods of up to 1 year. This is a decision you and your doctor will make. Portions of this document last updated: Jan. 01, 2021, Original article: https://www.mayoclinic.org/drugs-supplements/tacrolimus-topical-route/precautions/DRG-20068159. For more information, you can also call Accord Healthcare Inc. at 1-866-941-7875. Stop using when signs and symptoms of atopic dermatitis resolve. Store at 25°C (77°F): excursions permitted to 15°-30°C (59°-86°F)[See USP Controlled Room Temperature.]. 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. Tacrolimus Ointment is in a class of medicines called topical calcineurin inhibitors. As with other topical calcineurin inhibitors, it is not known whether tacrolimus is distributed into the lymphatic system. : 457, 458, 2018 Aug;45(8):936-942. doi: 10.1111/1346-8138.14501. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. 12-Week, Randomized, Double-Blind, Phase 3 Studies. Mean peak tacrolimus blood concentrations following oral administration in pediatric liver transplant patients (n = 9) were 48.4± 27.9 ng/mL. 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. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. 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. 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. The minimum amount should be rubbed in gently and completely to control signs and symptoms of atopic dermatitis. 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 medicine should come with a Medication Guide. The effect of renal insufficiency on the pharmacokinetics of topically administered tacrolimus has not been evaluated. You may report side effects to FDA at 1-800-FDA-1088. Ingestion occurs, medical advice about side effects may occur ( 8 ):936-942. doi: 10.1111/1346-8138.14501 based blood... Also cause interactions to occur in patients with widespread and/or erythrodermic disease should be avoided pre-malignant... 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