Effect of the cardioprotective agent stobadine on reproduction in rats.

The cardioprotective drug stobadine in the form of dipalmitate salt DP 1031 was evaluated for its effects on perinatal and postnatal development in the rat. Doses of 5, 15 and 50 mg/kg/day representing approximately 1, 3, and 10 times the anticipated maximum daily human therapeutic dose were administered to rats orally in aqueous suspension. Treatment of pregnant rats with stobadine continuously from day 15 of gestation through parturition and lactation had no adverse effects on reproductive parameters of dams or on survival and development of F1 offspring at any dose used. There were only signs of slight maternal toxicity at 50 mg/kg/day, which consisted of sedated behaviour, reduced liver weight and reversible histopathological changes in kidney tissue. (Tab. 3, Fig. 4, Ref. 24).