No mutagenic activity was detected in the Ames test in bacteria (with or without metabolic activation), in an in vitro test for forward mutations in cultured mammalian cells, or in a nucleus anomaly test. In doses of 50-500 mg/ kg/ day (6-60 times the maximum recommended human dose based on mg/ m 2 comparison and 37-375 times the maximum recommended human dose based on a mg/ kg comparison), Lotensin had no adverse effect on the reproductive performance of male and female rats. Pregnancy Categories C (first trimester) and D (second and third trimesters) See WARNINGS, Fetal/ Neonatal Morbidity and Mortality. Nursing Mothers Minimal amounts of unchanged benazepril and of benazeprilat are excreted into the breast milk of lactating women treated with benazepril. A newborn child ingesting entirely breast milk would receive less than 0.1% of the mg/ kg maternal dose of benazepril and benazeprilat. Geriatric Use Of the total number of patients who received benazepril in U. S. clinical studies of Lotensin, 18% were 65 or older while 2% were 75 or older. No overall differences in effectiveness or safety were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Benazepril and benazeprilat are substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Pediatric Use Safety and effectiveness in pediatric patients have not been established. | ||||
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