Letoripe Special Precautions

Laboratory Tests: No dose-related effect of Letrozole on any hematologic or clinical chemistry parameter was evident. Moderate decreases in lymphocyte counts, of uncertain clinical significance, were observed in some patients receiving Letrozole tablet 2.5 mg. This depression was transient in about half of those affected. Increases in SGOT, SGPT and gamma GT ≤5 times the upper limit of normal (ULN) and of bilirubin 1.5 times the ULN were most often associated with metastatic disease in the liver.
Effects on ability to drive and use machine: Letrozole tablet has minor influence on the ability to drive and use machines. Since fatigue and dizziness have been observed with the use of letrozole tablet and somnolence has been reported uncommonly, caution is advised when driving or using machines.
Use in Children: The safety and effectiveness in pediatric patients have not been established.
Use in the Elderly: The mean age of patients in the two randomized trials, that compared Letrozole tablet (0.5 mg and 2.5 mg) to megestrol acetate and to aminoglutethimide, was 64 years. Thirty percent of patients were ≥70 years old. The proportion of patients responding to each dose of Letrozole was similar for women ≥70 years old and <70 years old.