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No functional or behavioral toxicity was observed in offspring of rats. In rabbits, embryotoxicity was observed at an oral dose of 160 mg/ kg (approximately 40 times the maximum recommended human oral dose based on mg/ m 2 ). Delayed postnatal develop-ment, attributed to decreased body weight, was observed in offspring of rats at oral doses of 10 mg/ kg and above during late gestation and lactation periods (approximately 2 times the maximum recommended human oral dose based on mg/ m 2 ). There are no adequate and well-controlled studies in pregnant women. ACTOS should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Because current information strongly suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital anomalies, as well as increased neonatal morbidity and mortality, most experts recommend that insulin be used during pregnancy to maintain blood glucose levels as close to normal as possible.
Nursing Mothers Text Continues Below
Pioglitazone is secreted in the milk of lactating rats. It is not known whether ACTOS is secreted in human milk. Because many drugs are excreted in human milk, ACTOS should not be administered to a breast-feeding woman. Pediatric Use Safety and effectiveness of ACTOS in pediatric patients have not been established. Elderly Use Approximately 500 patients in placebo-controlled clinical trials of ACTOS were 65 and over. No significant differences in effectiveness and safety were observed between these patients and younger patients. Page: << Prev | 1 | 2 | 3 | 4 | 5
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