Ask your doctor if you have any questions. This medicine is for use on the skin only. Do not get it in your eyes, nose, or mouth. Do not use on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away. The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine.
If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. 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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Do not leave the ointment in the car in cold or hot weather. Make sure that the tube is tightly closed. There is a problem with information submitted for this request. J Crohns Colitis. Topical tacrolimus for atopic dermatitis. Cochrane Database Syst Rev. Joint AAD-NPF Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures.
J Am Acad Dermatol. Efficacy and systemic absorption of topical tacrolimus used in pyoderma gangrenosum. Br J Dermatol. Systemic ciclosporin and tacrolimus in dermatology. Dermatol Ther. Tacrolimus for the management of psoriasis: clinical utility and place in therapy. Psoriasis Auckl. Resolution of severe atopic dermatitis after tacrolimus withdrawal.
Cell Transplant. Topical calcineurin inhibitors in the treatment of oral lichen planus: a systematic review and meta-analysis. Guidelines for the management of vitiligo: the European Dermatology Forum consensus. Pharmacogenetics of tacrolimus after renal transplantation: analysis of polymorphisms in genes encoding 16 drug metabolizing enzymes [published correction appears in Clin Chem Lab Med. Clin Chem Lab Med. The primary focus of this long-term, open-label, noncomparative, multicenter phase 3 study was to assess the long-term safety of 0.
The study was performed at 30 centers in 11 European countries; the ethics committee of each center reviewed the protocol and granted approval of the study before its implementation. Patients were assigned to either 6 or 12 months of study participation at entry. It was planned to enroll approximately patients, with the first to be assigned 12 months of participation. The sample size and duration of exposure were based on guidelines from the International Conference on Harmonisation that describe the extent of population exposure required to assess clinical safety with long-term use of a drug.
Men and women aged 18 years and older with a diagnosis of atopic dermatitis based on the criteria of Hanifin and Rajka 14 were eligible for study participation. The main exclusion criterion was a serious skin disorder other than atopic dermatitis. All patients gave informed consent. At baseline, investigators assessed areas to be treated, dispensed the first ointment supply box, and explained the dosing procedure to the patient.
Treatment consisted of a thin coat of 0. Patients were instructed to continue application for 1 week after cessation of itch and to change the treatment areas or select new areas based on the presence of itch. The treated area was assessed by the investigator at each study visit. Prohibited therapies were other investigational drugs, UV-A and UV-B light treatments, nonsteroidal immunosuppressive agents, and topical corticosteroids.
Adverse events were monitored on an ongoing basis. An adverse event was defined as any undesirable experience that occurred to a patient during the clinical trial regardless of whether it was considered to be related to use of the study drug.
Except as noted, adverse event data are presented irrespective of the causality assessment. Laboratory assessments hematology, clinical chemistry, and renal and hepatic function were performed at the screening visit; day 1; weeks 1, 2, and 4; and once a month thereafter.
At baseline and after 6 and 12 months, skin testing was carried out using an 8-pronged applicator containing 7 preloaded antigens and 1 vehicle control. For determination of tacrolimus concentrations, whole blood samples were collected at day 1, week 1, week 2, month 1, month 3, and the last visit.
The samples were assayed for tacrolimus concentration using a validated high-performance liquid chromatography method with repeated mass spectrometry. The limit of quantification was 0.
Patients assessed the intensity of itch experienced during the previous 24 hours using a cm visual analog scale, with 0 cm indicating "no itch" and 10 cm indicating "worst itch imaginable. Itch was included in the mEASI because it is considered a primary symptom of atopic dermatitis. The evaluable population comprised patients who received at least 1 application of tacrolimus and had at least 1 assessment after baseline.
Data were summarized by descriptive statistics and frequency counts. The COSTART term "flu syndrome" was used to code investigator terms such as "cold," "common cold," "flu," "influenza," and "upper respiratory tract infection.
Adverse events were summarized by frequency counts. Cox regression analyses were used to assess any effect of cumulative ointment use on the time to first occurrence of selected adverse events. Of patients screened, were eligible for study entry. Two hundred patients were assigned to treatment for 6 months and for 12 months.
In total, patients Patient demographic and baseline characteristics are presented in Table 1. Comparison of the mean age of patients 31 years in the total study population with the mean duration of atopic dermatitis 25 years in the total study population indicates that most patients experienced onset of the disease during childhood.
The long duration of the current episode with a mean of several years reflects a patient population with persistent disease. The affected body surface area was extensive at baseline a median of approximately one third of total body surface area , and most patients had active disease on all body regions, including the head and neck.
The most common adverse events were related to local irritation; these were burning sensation, pruritus, and skin erythema Table 2. In practice, pruritus seemed related to burning; patients reported these events in the context of local discomfort. The incidence and intensity of these adverse events, particularly skin burning, decreased with time. For example, the incidence of skin burning at the application site was During months 10 to 12, only 2. The higher incidence of events that occurred exclusively at a treated site compared with the incidence of those that occurred in a patient at both a treated and nontreated site Table 2 suggests that skin burning, pruritus, skin erythema, folliculitis, herpes simplex, alcohol intolerance, and maculopapular rash were specific for the area of application.
Folliculitis, maculopapular rash, and pustular rash are suspected to be related to the occlusive properties of the ointment. Because lack of drug effect and skin infection were not localized to the treated area Table 2 , these events probably represent a generalized flare-up of the disease.
Flu syndrome was reported most frequently during the winter months. There was otherwise no increase in the prevalence of any infection over time. In total, 6 patients 1. There were 5 serious adverse events for which a causal relation with the study drug was unknown or considered possible; all were associated with hospitalization. These constituted 1 patient who experienced a severe flare-up of atopic dermatitis, 1 who experienced a Staphylococcus superinfection of the skin, 1 with eczema herpeticum the patient had a long history of relapses , 1 with varicella, and 1 with cellulitis.
All but cellulitus were present on the application site. Cox regression analyses were performed to assess the effect of cumulative ointment use on the time to first occurrence of skin infection, nonskin infection, adverse events of the digestive system, adverse events of the nervous system, and severe related adverse events that required medical intervention. No significant increase in the risk of these types of adverse events was found with increased cumulative ointment use.
Laboratory measurements showed mean eosinophil counts and lactate dehydrogenase concentrations greater than the reference range at baseline and all study visits, as expected for this study population. One patient experienced an increase in transaminase levels that resolved before treatment discontinuation.
Median whole blood concentrations of tacrolimus were minimal during the study: 0. All tacrolimus blood concentrations within the limit of quantification 0. Results of the Recall Antigen Test showed a patient population with depressed cell-mediated immunity at baseline, but no notable changes were observed with prolonged treatment. The proportion of patients with no positive reactions was also similar over time: 28 patients The greatest decrease in symptoms, as measured by the mEASI, was seen during the first week of treatment Figure 2.
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