Hytrin Use In Pregnancy & Lactation

Teratogenic Effects: Terazosin hydrochloride was not teratogenic in either rats or rabbits when administered at oral doses up to 1330 and 165 times, respectively, the maximum recommended human dose. Fetal resorptions occurred in rats dosed with 480 mg/kg/day, approximately 1330 times the maximum recommended human dose. Increased fetal resorptions, decreased fetal weight and an increased number of supernumerary ribs were observed in offspring of rabbits dosed with 165 times the maximum recommended human dose. These findings (in both species) were most likely secondary to maternal toxicity. There are no adequate and well-controlled studies in pregnant women and the safety of terazosin hydrochloride in pregnancy has not been established. Terazosin hydrochloride is not recommended during pregnancy unless the potential benefit justifies the potential risk to the mother and fetus.
Nonteratogenic Effects: In a peri- and post-natal development study in rats, significantly more pups died in the group dosed with 120 mg/kg/day (greater than 300 times the maximum recommended human dose) than in the control group during the 3-week postpartum period.
Nursing Mothers: It is not known whether terazosin hydrochloride is excreted in breast milk. Because many drugs are excreted in breast milk, caution should be exercised when terazosin hydrochloride is administered to a nursing woman.