If you would like more information, talk with your doctor.Your doctor or pharmacist can give you information about Tacrolimus Ointment that is written for health care professionals. Fifty-five percent (55%) of the patients were women and 27% were black. 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.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%.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. Do not touch the tip of the dropper or ointment tube to the surface of the eye or any other surface. Tacrolimus is transferred across the placenta. 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. This medicine should not be used continuously for a long time. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects. Localized symptoms are most common during the first few days of Tacrolimus Ointment application and typically improve as the lesions of atopic dermatitis resolve. This medicine should come with a Medication Guide. Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed Long-term Safety of Topical Calcineurin Inhibitors Has Not Been EstablishedWhat is the most important information patients should know about Tacrolimus Ointment?What should patients avoid while using Tacrolimus Ointment?Tacrolimus Ointment is not indicated for children less than 2 years of age.Tacrolimus (ta kroe' li mus) Ointment, 0.03% and 0.1% What is the most important information I should know about Tacrolimus Ointment?What should I tell my doctor before starting Tacrolimus Ointment?If you are a caregiver applying Tacrolimus Ointment to a patient, or if you are a patient who is not treating your hands, wash your hands with soap and water after applying Tacrolimus Ointment. For more information, you can also call Accord Healthcare Inc. at 1-866-941-7875.This Medication Guide has been approved by the U.S. Food and Drug Administration.The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. 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).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. 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 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.