Use Tacrolimus Ointment exactly as prescribed. 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. Infection of the skin at the affected areas—Should be treated first before using this medicine. 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 is to make sure the medicine is working properly and to check for unwanted effects. Do not take other medicines unless they have been discussed with your doctor. Because patients were not followed for longer than 2 weeks after end-of-treatment, it is not known how many additional patients regressed at periods longer than 2 weeks after cessation of therapy. This medicine may increase your risk of getting skin cancer or cancer of the lymph system (lymphoma). There are no adequate and well-controlled studies of systemically administered tacrolimus in pregnant women. Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed. Formal topical drug interaction studies with Tacrolimus Ointment have not been conducted. Reproductive toxicology studies were not performed with topical tacrolimus. 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. 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. This medicine should come with a Medication Guide. This medicine … It is for topical dermatologic use only. What is the most important information patients should know about Tacrolimus Ointment? Do not cover the treated skin with occlusive dressings, bandages, or wraps. 0.1% 100g, NDC 16729- 422-01 Rx only, ATTENTION: DISPENSE WITH ENCLOSED MEDICATION GUIDE TO EACH PATIENT 100g, Tacrolimus Ointment In about 4,400 pediatric patients treated with Tacrolimus Ointment, 24 (0.5%) were reported with eczema herpeticum. 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. 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. Dist. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. See boxed WARNING concerning long-term safety of topical calcineurin inhibitors. 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. The safety of using Tacrolimus Ointment for a long period of time is not known. Make sure your doctor knows if you are receiving any type of UV light treatment or "phototherapy". 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. Tacrolimus Ointment contains tacrolimus, a macrolide immunosuppressant produced by Streptomyces tsukubaensis. Only Tacrolimus Ointment 0.03% is for use on children aged 2 to 15 years. Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established. If signs and symptoms of atopic dermatitis do not improve within 6 weeks, patients should be re-examined by their healthcare provider and their diagnosis be confirmed (see. While you are using Tacrolimus Ointment, drinking alcohol may cause the skin or face to become flushed or red and feel hot. Tacrolimus 0.03% ointment has been reserved for children <16 years and associated with hyperpigmentation, as well as hypertricosis, in the target area. What should I tell my doctor before starting Tacrolimus Ointment? Call a doctor or poison control center right away if you accidentally swallow this medicine. Although not all of these side effects may occur, if they do occur they may need medical attention. Keep a list of them with you to show your doctor and pharmacist each time you get a new medicine. Four hundred and four (404) patients ≥ 65 years old received Tacrolimus Ointment in phase 3 studies. Transplant patients receiving immunosuppressive regimens (e.g., systemic tacrolimus) are at increased risk for developing lymphoma; therefore, patients who receive Tacrolimus Ointment and who develop lymphadenopathy should have the etiology of their lymphadenopathy investigated. You can wear normal clothing. Do not use a sunlamp or a tanning bed or booth. 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. 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. Limit sun exposure during treatment with Tacrolimus Ointment even when the medicine is not on their skin. No reduction in male or female fertility was evident. Since the safety and efficacy of Tacrolimus Ointment have not been established in pediatric patients below 2 years of age, its use in this age group is not recommended. Do not cover the skin being treated with bandages, dressings or wraps. For non-prescription products, read the label or package ingredients carefully. The following two graphs depict the time course of improvement in the percent body surface area affected in adult and in pediatric patients as a result of treatment. Because the two adult studies were identically designed, the results from these studies were pooled in this table. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. What are the possible side effects of Tacrolimus Ointment? 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. Stop Tacrolimus Ointment when the signs and symptoms of eczema, such as itching, rash, and redness go away, or as directed by your doctor. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Do not swallow Tacrolimus Ointment. Tacrolimus may cause a condition called pure red cell aplasia (PRCA). 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. 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%. In a US study, the ratio of whole blood concentration to plasma concentration averaged 35 (range 12 to 67). Copyright © 2021 IBM Watson Health. 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. 12-Week, Randomized, Double-Blind, Phase 3 Studies. When detected, systemic exposure generally declined as treatment continued. FOR DERMATOLOGIC USE ONLY. Tacrolimus Ointment should not be used in immunocompromised adults and children. 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