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Valsartan had no adverse effects on the reproductive performance of male or female rats at oral doses up to 200 mg/kg/day. This dose is 6 times the maximum recommended human dose on a mg/m 2 basis. (Calculations assume an oral dose of 320 mg/day and a 60-kg patient.) Pregnancy Pregnancy Categories C (first trimester) and D (second and third trimesters) Text Continues Below
See WARNINGS, Fetal/Neonatal Morbidity and Mortality.
Nursing Mothers
It is not known whether valsartan is excreted in human milk, but valsartan was excreted in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use In the controlled clinical trials of valsartan, 1,214 (36.2%) of hypertensive patients treated with valsartan were 65 years and 265 (7.9%) were 75 years. No overall difference in the efficacy or safety of valsartan was observed in this patient population, but greater sensitivity of some older individuals cannot be ruled out. Of the 2,511 patients with heart failure randomized to valsartan in the Valsartan Heart Failure Trial, 45% (1,141) were 65 years of age or older. There were no notable differences in efficacy or safety between older and younger patients. Page: << Prev | 1 | 2 | 3 | 4 | 5
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